Trethera Announces Presentation at the Rare Neuroimmune Disorders Symposium Annual Meeting

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Los Angeles, October 15, 2024 — Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announces an upcoming presentation at the 7th Annual Meeting of the Rare Neuroimmune Disorders Symposium (RNDS). Trethera’s CEO, Dr. Ken Schultz, will present research highlighting the use of Trethera’s deoxycytidine kinase (dCK) inhibitor, TRE-515, as a treatment for optic neuritis and acute disseminated encephalomyelitis (ADEM).   

The RNDS meeting is a specialized gathering of patients and translational science experts highlighting notable, novel and rigorous scientific discoveries made in rare neuroimmune disorders that advances understanding of the clinical care of patients with these diseases. Dr. Schultz’s presentation focuses on Trethera advancements in the treatment of optic neuritis, a rare neurologic disease which affects the optic nerve causing sudden blindness or visual impairment. The presentation also emphasizes ADEM, a severe autoimmune disease occurring mainly in 6 to 8 year-old children that can lead to loss of consciousness, coma, and death.

Figure 1: scans showing mouse brain before (left) and after (right) disease induction (brain encircled in a dashed white line). The enzyme dCK becomes upregulated during disease.

Trethera’s clinical stage and first-in-class drug, TRE-515, holds FDA Orphan Drug status for both optic neuritis and ADEM.  FDA Orphan Drug designation confers substantial advantages, including a faster path to market approval, FDA assistance in designing clinical trials, exemption from the $4M drug approval application fee, and eligibility for seven years of marketing exclusivity.  Should the FDA approve TRE-515 for commercial use in ADEM, Trethera would be eligible for a pediatric priority review voucher. TRE-515 is currently being evaluated in a Phase 1 dose escalation solid tumors clinical trial. 

Presentation Details:

  • Presentation Title: Advancements in ADEM & optic neuritis treatment with TRE-515: A clinical stage, dual orphan drug designated, first-in-class, deoxycytidine kinase inhibitor
  • Presenter: Kenneth A. Schultz, MD
  • Session: Research on Rare Neuroimmune Disorders, Part I
  • Date: Saturday, October 19, 2024; 9:00AM – 11:15AM
  • Location: Main Ballroom, Hyatt Regency; 2334 N International Pkwy, Dallas, Texas

About Trethera
Trethera is a clinical stage, privately held, biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally administered capsule twice designated by the FDA as an Orphan Drug.  TRE-515 is a first-in-class clinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors.  It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth, and certain autoimmune diseases might also respond to TRE-515 treatment.  Trethera is developing TRE-515 for use as a monotherapy or in combination to precisely target a metabolic vulnerability of cancer or autoimmune diseases that will transform outcomes for patients.

For more information, please visit us at trethera.com or e-mail Investor Relations at ir@trethera.com.

Note on Forward-Looking Statements
All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

Trethera Receives $2M NIH Grant for Preclinical Development in the Pediatric Neurologic Disease Acute Disseminated Encephalomyelitis

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Los Angeles, July 16, 2024 — Trethera Corporation, a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced today that it was awarded a $2 million NIH Small Business Innovation Research (SBIR) grant for preclinical studies treating acute disseminated encephalomyelitis (ADEM), a neurologic disease principally of children.   Trethera’s clinical stage and first-in-class drug, TRE-515, holds the only FDA Orphan Drug designation for ADEM.   

ADEM is an autoimmune disease that can present with fever and difficulty walking as well as loss of consciousness and coma. Viral infections, such as influenza, mumps, or COVID, frequently precede the disease.  ADEM is a rare disease, affecting 12,000 to 15,000 patients a year in the United States, with most cases occurring in 6 to 8 year-old children. The grant will advance preclinical studies to enable clinic entry for a disease where no approved therapies currently exist.

TRE-515 is the only drug to receive an FDA Orphan Drug designation for the treatment of ADEM, a designation that confers substantial advantages, including FDA assistance in designing clinical trials, access to the FDA Orphan Drug Grants Program, exemption from the $4M drug approval application fee, and eligibility for seven years of marketing exclusivity.  Furthermore, should the FDA approve TRE-515 for commercial use in ADEM, Trethera would be eligible for a pediatric priority review voucher. Combining the study data generated through this grant and the Orphan Drug designation, Trethera plans to collaborate with the FDA to define the most expedient clinical trial path to commercialization.

“Achieving both NIH funding and FDA Orphan Drug designation confers multiple external validations of our potential to treat ADEM,” said Dr. Ken Schultz, principal investigator and Trethera CEO. “Our team is highly motivated by the potential to develop the first FDA approved treatment to save children’s lives and improve outcomes in ADEM. Our strategy of combining TRE-515 commercial development for a rare disease with ongoing efforts to treat more common diseases, such as solid tumors and Crohn’s, provides multiple FDA approval opportunities, thereby reducing overall development risk.” 

“The pathology of ADEM involves a severe bout of inflammation in the central nervous system that can include the brain, spinal cord, and sometimes the optic nerves. The inflammation damages myelin, the protective substance that coats nerve fibers throughout the central nervous system. No medications have been specifically approved by the FDA to treat ADEM,” said UCLA’s Dr. Peter Clark, member of the Trethera Scientific Advisory Board and grant co-investigator.

“Approximately half of ADEM patients recover with hospitalized intensive care.  For others, ADEM can be fatal or lead to lifelong disability.  Any drug that could improve these outcomes for patients would be groundbreaking.  TRE-515 could significantly benefit ADEM patients beyond the available therapeutic options,” said Trethera Scientific Advisory Board member Dr. Larry Steinman.  Dr. Steinman is a distinguished immunologist and pediatric neurologist at Stanford University. 

“The pathology of ADEM involves a severe bout of inflammation in the central nervous system that can include the brain, spinal cord, and sometimes the optic nerves. The inflammation damages myelin, the protective substance that coats nerve fibers throughout the central nervous system. No medications have been specifically approved by the FDA to treat ADEM,” said UCLA’s Dr. Peter Clark, member of the Trethera Scientific Advisory Board and grant co-investigator

Figure 1: Representative stained spinal cord sections from a mouse ADEM model. Arrows point to regions of leukocyte infiltration.  

A discussion summary from the independent panel of NIH scientists and physicians that reviewed Trethera’s proposal noted the “strong scientific premise and rigor…. established safety in Phase I clinical trial for solid tumors… and commercialization potential is high.”

Harvard’s Research Director of Neuroimmunology and Trethera Scientific Advisory Board member, Dr. Michael Levy, noted “The clinical treatment for an ADEM patient remains complex on multiple levels.  Treating a disease with a real mortality risk in a vulnerable pediatric population creates a challenging role for the attending physician especially given the lack of FDA approved therapies.  I look forward to the day TRE-515 can be FDA approved to provide confidence to ADEM patients and their parents.”

Sources: J Neurol. 2020 Oct;267(10); Int Care Med. 2008 Mar;34(3); Neuro. 2001 May 22;56(10)

About Trethera

Trethera is a clinical stage, privately held, biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally administered capsule twice designated by the FDA as an Orphan Drug.  TRE-515 is a first-in-class clinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors.  It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth, and certain autoimmune diseases might also respond to TRE-515 treatment.  Trethera is developing TRE-515 for use as a monotherapy or in combination to precisely target a metabolic vulnerability of cancer or autoimmune diseases that will transform outcomes for patients.

For more information, please visit us at trethera.com or e-mail Investor Relations at ir@trethera.com.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

The content of this press release is solely the views of its authors and does not represent the official views of the NIH.

National Institute of Health to Fund Preclinical Development of Trethera Lead Drug, TRE-515, for Treatment of Crohn’s Disease

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Los Angeles, September 25, 2023 — Trethera Corporation, a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced today that it was awarded a Small Business Technology Transfer (STTR) grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) division of the National Institute of Health (NIH). The award provides $400,000 to translate proof-of-principle early research findings of Trethera’s clinical stage first-in-class drug, TRE-515, as an oral therapy for Crohn’s disease.  

Crohn’s disease is a chronic, relapsing, inflammatory gastrointestinal disorder that can present with diarrhea, fatigue, severe abdominal pain, and weight loss.  Almost 1 million Americans suffer from the disease today, with complications including intestinal fistulas, strictures, and colorectal cancer.  Up to a third of patients fail to respond to first line therapy drugs and nearly half lose their drug response within 5 years.  Steroids can induce remissions but are less effective at maintaining durability and have significant side effects. The disease is primarily driven by autoreactive CD4 T cells of the patient’s own immune system that target antigens in the gut. 

“A high unmet medical need exists for safe, oral therapies that can be used with first-in-line treatments to help patients maintain disease remission, thereby reducing the need for aggressive broadly immunosuppressive agents.  TRE-515 potentially offers a benefit-risk profile that will be ideally suited for patients with moderate to severe Crohn’s disease seeking a well-tolerated agent to diminish relapses,” said Dr. Ken Schultz, principal investigator and Trethera CEO.

Figure 1. PET scan images showing presence of target enzyme dCK in a normal mouse (left), and one with Crohn’s disease (right).

“We are very pleased to receive this grant that recognizes the strong therapeutic potential that could be provided for the treatment of Crohn’s disease through a first-in-class drug targeting deoxycytidine kinase (dCK),” said UCLA’s Dr. Peter Clark, member of the Trethera Scientific Advisory Board and grant co-investigator. “The STTR program at NIH plays a vital role in helping companies develop new technologies that serve important U.S. health care needs.

TRE-515 is an orally delivered, once daily, therapeutic engineered to inhibit dCK, the key enzyme in the nucleoside salvage pathway.  A common characteristic of pathological immune cells in autoimmune diseases is the requirement for elevated nucleotide levels to support abnormal and accelerated cell division.

In contrast, dCK activity is not required in most healthy adult human cells.  Mediated by the rate-limiting enzyme, dCK, the nucleoside salvage pathway may play a pivotal role in enabling the aberrant activated lymphocytes found in Crohn’s disease to divide, suggesting dCK as a potential therapeutic target with expected enhanced safety.

Sources: NEnglJMed.2020 Dec 31;383(27); Lancet.2017 Apr 29;389; Gastro.2010 Apr138; AmJGastro.2009 Mar;104

About Trethera

Trethera is a clinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally administered capsule twice designated by the FDA as an Orphan Drug.  TRE-515 is a first-in-class clinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors.  It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth, and certain autoimmune diseases, such as multiple sclerosis, might also respond to TRE-515 treatment.  Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer or autoimmune diseases that will transform outcomes for patients.

For more information, please visit us at trethera.com or e-mail Investor Relations at ir@trethera.com.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

The content of this press release is solely the views of its authors and does not represent the official views of the NIH.

Globally Recognized Expert in Rare Neurologic Diseases, Dr. Michael Levy, Joins Trethera Scientific Advisory Board

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Los Angeles, September 5, 2023 — Trethera Corporation, a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced today the appointment of Michael Levy, MD, PhD, to its Scientific Advisory Board.  Dr. Levy will have a particular focus on evaluating the clinical development of Trethera’s lead asset, TRE-515, in demyelinating autoimmune diseases.  A demyelinating disease is any condition that causes damage to the protective covering (myelin sheath) that surrounds nerve fibers in the brain, spinal cord, and peripheral nervous system.  When the myelin sheath is damaged, nerve impulses slow or even stop, causing neurological problems.

Dr. Levy is currently an Associate Professor of Neurology at Harvard Medical School and Research Director for the Division of Neuroimmunology at Massachusetts General Hospital, where he leads a team focused on rare autoimmune diseases of the central nervous system. His efforts focus on seeking to understand the causes and to develop treatments for rare autoimmune demyelinating diseases, including optic neuritis, a condition in which inflammation of the optic nerve affects vision, and acute disseminated encephalomyelitis (ADEM), a neural inflammation that primarily impacts children. Dr. Levy will advise Trethera regarding the potential of its first-in-class compound, TRE-515, to treat optic neuritis and ADEM as well as other more common neurologic diseases such as multiple sclerosis (MS).

“We are honored to have Dr. Levy join our advisory board,” said Dr. Ken Schultz, Chairman and CEO of Trethera. “He is a leading authority on rare neurologic autoimmune diseases and has expertise in both early and late-stage clinical trials. His knowledge is especially well suited and valuable given that TRE-515 has achieved FDA Orphan Drug Designations for both optic neuritis and ADEM.”

“I am delighted to support Trethera as it advances TRE-515 as a treatment option for patients with optic neuritis and ADEM,” said Dr. Levy. “Supporting these efforts is especially compelling given the high unmet need.  Both conditions are frequently treated with high-dose corticosteroids, which can be associated with significant side effects and incomplete symptom resolution.  With no approved therapies, and a real mortality risk in a vulnerable pediatric patient population, treating ADEM remains complex on multiple levels.”   

Dr. Levy received his Doctor of Medicine and Philosophy (MD, PhD) from Baylor College of Medicine, completing his neurology residency training at Johns Hopkins Hospital.  He also holds a Bachelor of Arts (BA) degree from the University of Pennsylvania.  He is a fellow of the American Academy of Neurology.

About Trethera

Trethera is a clinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally administered capsule twice designated by the FDA as an Orphan Drug.  TRE-515 is a first-in-class clinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors.  It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth, and certain autoimmune diseases, such as multiple sclerosis, might also respond to TRE-515 treatment.  Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer or autoimmune diseases that will transform outcomes for patients.

For more information, please visit us at trethera.com or e-mail Investor Relations at ir@trethera.com.

About TRE-515

TRE-515 is an orally delivered, once daily, therapeutic engineered to inhibit dCK, the key enzyme in the nucleoside salvage pathway.  A common characteristic of tumor cells in solid malignancies and pathological immune cells in autoimmune diseases is the requirement for elevated nucleotide levels to support abnormal and accelerated cell division.  In contrast, dCK activity is not required in most healthy adult human cells.  Mediated by the rate limiting enzyme, dCK, the nucleoside salvage pathway may play a pivotal role in enabling the rapid cell proliferation of cancer cells and aberrant activated lymphocytes, suggesting dCK as a potential therapeutic target with expected enhanced safety.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

Trethera Receives NIH Grant for Preclinical Development in the Pediatric Neurologic Disease Acute Disseminated Encephalomyelitis

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Los Angeles, August 14, 2023 — Trethera Corporation, a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced today that it was awarded a $600,000 Small Business Technology Transfer (STTR) grant from the National Institute of Allergy and Infectious Diseases (NIAID).   Trethera’s first-in-class small molecule, TRE-515, holds the only FDA Orphan Drug designation for Acute Disseminated Encephalomyelitis (ADEM), an acute neurologic disease principally of children. 

ADEM is an autoimmune disease that can present with fever and difficulty walking as well as loss of consciousness and coma. Viral infections, such as influenza, mumps, or COVID, frequently precede the disease.  ADEM is a rare disease, affecting 12,000 to 15,000 patients a year in the United States, with most cases occurring in 6 to 8 year-old children. The grant will advance IND enabling studies for a disease where no approved therapies currently exist.

TRE-515 has also received FDA Orphan Drug designation for the treatment of ADEM, a designation that confers substantial advantages, including FDA assistance in designing clinical trials, access to the FDA Orphan Drug Grants Program, exemption from the drug approval application fee, and eligibility for seven years of marketing exclusivity.  Furthermore, should the FDA approve TRE-515 for commercial use in ADEM, Trethera would be eligible for a pediatric priority review voucher.

“Achieving both NIH funding as well as FDA Orphan Drug designation confers external validation of our potential to treat ADEM,” said Dr. Ken Schultz, principal investigator and Trethera CEO. “Our team is highly motivated by the potential to develop the first FDA approved treatment to save children’s lives and improve outcomes in ADEM. Our strategy of combining TRE-515 commercial development for a rare disease with ongoing efforts to treat more common diseases, such as solid tumors and multiple sclerosis, provides multiple FDA approval opportunities, thereby reducing overall development risk.” 

“Approximately half of ADEM patients recover with hospitalized intensive care.  For others, ADEM can be fatal or lead to lifelong disability.  Any drug that could improve these outcomes for patients would be groundbreaking.  TRE-515 could potentially significantly benefit ADEM patients beyond the available therapeutic options,” said Trethera Scientific Advisory Board member Dr. Larry Steinman.  Dr. Steinman is a distinguished immunologist and pediatric neurologist at Stanford University. 

“The pathology of ADEM involves a severe bout of inflammation in the central nervous system that can include the brain, spinal cord, and sometimes the optic nerves. The inflammation damages myelin, the protective substance that coats nerve fibers throughout the central nervous system. No medications have been specifically approved by the FDA to treat ADEM,” said UCLA’s Dr. Peter Clark, member of the Trethera Scientific Advisory Board and grant co-investigator.

A discussion summary from the independent panel of NIAID experts that reviewed Trethera’s proposal noted the “rationale for the target is credible and preliminary data is strong… great rigor with third party validation… research methods are appropriate to enable commercial development… significance and commercial potential are high as there is a high unmet need… strong potential for broader application to progressive MS and other diseases.”

Sources: J Neurol. 2020 Oct;267(10); Int Care Med. 2008 Mar;34(3); Neuro. 2001 May 22;56(10)

About TRE-515

TRE-515 is an orally delivered, once daily, therapeutic engineered to inhibit dCK, the key enzyme in the nucleoside salvage pathway.  A common characteristic of tumor cells in solid malignancies and pathological immune cells in autoimmune diseases is the requirement for elevated nucleotide levels to support abnormal and accelerated cell division.  In contrast, dCK activity is not required in most healthy adult human cells.  Mediated by the rate limiting enzyme, dCK, the nucleoside salvage pathway may play a pivotal role in enabling the rapid cell proliferation of cancer cells and aberrant activated lymphocytes, suggesting dCK as a potential therapeutic target with expected enhanced safety.

About Trethera

Trethera is a clinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally administered capsule twice designated by the FDA as an Orphan Drug.  TRE-515 is a first-in-class clinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors.  It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth, and certain autoimmune diseases, such as multiple sclerosis, might also respond to TRE-515 treatment.  Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer or autoimmune diseases that will transform outcomes for patients.

For more information, please visit us at trethera.com or e-mail Investor Relations at ir@trethera.com.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

Trethera Announces Invited Speaker Presentations at the Purine and Pyrimidine Society Symposium and General Assembly

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Los Angeles, June 28, 2023 — Trethera Corporation, a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announces two upcoming presentations at the 20th Annual Symposium and General Assembly of the Purine and Pyrimidine Society.  The Society provides a biennial global scientific forum for biomedical scientists and physicians interested in purines and pyrimidines to present their research findings. 

Presentation Details:

  • First Presentation: Targeting the deoxyribonucleoside salvage pathway in clinical trials with a first-in-human deoxycytidine kinase inhibitor
  • Authors: Kenneth A. Schultz, Peter M. Clark, Curtis B. Thompson, Caius G. Radu
  • Second Presentation: Targeting deoxyribonucleoside salvage with a clinical deoxycytidine kinase inhibitor limits disease in mouse models of multiple sclerosis
  • Authors:  Jessica R. Salas, Bao Ying Chen, Alyssa O. Trias, Kaitlin Ryan, Kenneth A. Schultz, Peter M. Clark
  • Date: Wednesday, June 28, 2023; 8:30AM – 10AM
  • Session 6: Purines and Pyrimidines in the Immune System
  • Location: The Sheraton Gateway; Los Angeles, California

Trethera’s lead asset, TRE-515, is an orally delivered therapeutic engineered to inhibit dCK, the key enzyme in the nucleoside salvage pathway.  A common characteristic of tumor cells in solid

Figure 1. Co-crystal 3D structure of the drug bound to the target enzyme, dCK, at the deoxycytidine binding site.

malignancies and pathological immune cells in autoimmune diseases is the requirement for elevated nucleotide levels to support abnormal and accelerated cell division.  In contrast, dCK activity is not required in most healthy adult human cells.  Mediated by the rate limiting enzyme, dCK, the nucleoside salvage pathway may play a pivotal role in enabling the rapid cell proliferation of cancer cells and aberrant activated lymphocytes, suggesting dCK as a potential therapeutic target with expected enhanced safety.  This Purine and Pyrimidine Society presentation builds on the TRE-515 dose escalation Phase 1 solid tumor trial data announced earlier this year as well as research work described in the journal Immunology (Chen et al. 2023).

About Trethera

Trethera is a clinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally administered capsule twice designated by the FDA as an Orphan Drug.  TRE-515 is a first-in-class clinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors.  It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth, and certain autoimmune diseases, such as multiple sclerosis, might also respond to TRE-515 treatment.  Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer or autoimmune diseases that will transform outcomes for patients.

For more information, please visit us at trethera.com or e-mail Investor Relations at ir@trethera.com.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

Trethera Receives Grant from National Institute of Allergy and Infectious Diseases for the Advancement of TRE-515 in Lupus

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Los Angeles, June 27, 2023 — Trethera Corporation, a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced today that it was awarded a $0.6M Small Business Technology Transfer (STTR) grant from the National Institute for Allergy and Infectious Diseases (NIAID).  The grant will fund Investigational New Drug (IND) enabling activities using TRE-515 to treat systemic lupus erythematosus (SLE), a chronic autoimmune disease with significant morbidity and mortality. Trethera’s lead asset, TRE-515, is a first-in-class deoxycytidine kinase (dCK) inhibitor.

“The potential TRE-515 has to treat a broad spectrum of diseases creates a pipeline in a product that reduces overall development risk,” said Dr. Ken Schultz, principal investigator and Trethera CEO. “We are grateful that the NIH also recognizes this, providing $4.2M in overall grant funding since September for optic neuritis, solid tumors, and now lupus.  We look forward to using these grants to continue working with our UCLA research partners on this first-in-class drug.”  

The NIAID grant follows favorable results announced earlier this year from Trethera’s Phase 1 clinical trial in high risk, heavily pretreated patients with solid tumors. In the all comers designed (i.e., unselected) dose escalation trial for TRE-515, the once daily capsule demonstrated a superb safety profile, wide therapeutic window, biomarkers of target engagement, and early evidence of clinical benefit.

Trethera Scientific Advisory board member, UCLA Associate Professor and co-investigator, Dr. Peter Clark commented, “With this funding, we intend to further showcase the broad therapeutic promise of disrupting the nucleoside salvage pathway to treat autoimmune diseases.

This Phase I grant will serve as proof-of-concept that TRE-515 has potential as a new SLE therapy and possibly lead to advanced studies that expand into mechanistic work and additional SLE models.” A discussion summary from the panel of NIAID experts that reviewed Trethera’s proposal stated, “if successful, the proposal has high potential to impact the SLE field from a drug and biomarker perspective… dCK biomarkers could identify patients likely to respond and confirm drug-target engagement over time… commercialization potential is also high, as this treatment could have broad applicability to other autoimmune diseases.”

SLE is a disease driven by autoreactive immune cells.  SLE can affect vital organs including the kidneys, brain, and lungs, where approximately 35–50% of patients develop organ damage within 5 years of diagnosis.  Patients undergo periods of stable disease interspersed with flares that can cause irreversible organ damage. Current treatments can be effective but not curative, with response rates of less than 50% or below 6 months durability, while being associated with strong side effects.

Sources: Ann Rheum Dis.2021 Jan;80(1); Lancet.2019 8;393(10188); NatureMed.2008 14(783)

About TRE-515

TRE-515 is an orally delivered, once daily, therapeutic engineered to inhibit dCK, the key enzyme in the nucleoside salvage pathway.  A common characteristic of tumor cells in solid malignancies and pathological immune cells in autoimmune diseases is the requirement for elevated nucleotide levels to support abnormal and accelerated cell division.  In contrast, dCK activity is not required in most healthy adult human cells.  Mediated by the rate limiting enzyme, dCK, the nucleoside salvage pathway may play a pivotal role in enabling the rapid cell proliferation of cancer cells and aberrant activated lymphocytes, suggesting dCK as a potential therapeutic target with expected enhanced safety.

About Trethera

Trethera is a clinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally administered capsule twice designated by the FDA as an Orphan Drug.  TRE-515 is a first-in-class clinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors.  It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth, and certain autoimmune diseases, such as multiple sclerosis, might also respond to TRE-515 treatment.  Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer or autoimmune diseases that will transform outcomes for patients.

For more information, please visit us at trethera.com or e-mail Investor Relations at ir@trethera.com.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

Trethera Receives $2 Million National Cancer Institute Grant for Advancement of Clinically Relevant Biomarkers in Phase 1 Trial 

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Los Angeles, May 30, 2023 — Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced today that it was awarded a $2 million Small Business Innovative Research (“SBIR”) grant from the National Cancer Institute (“NCI”).  The grant will fund additional patient dosing studies to identify predictive biomarkers of activity and target engagement of TRE-515 in solid tumors. Trethera’s lead asset, TRE-515, is a first-in-class deoxycytidine kinase (“dCK”) inhibitor. 

“We are honored to receive this highly competitive SBIR grant that supports additional clinical advancement and compelling opportunities for TRE-515,” said Dr. Ken Schultz, principal investigator and Trethera CEO.  “This grant allows further biomarker evaluations, helping to inform patient selection and dosing in order to target multiple types of difficult to treat cancers.” 


The NCI grant follows favorable results announced earlier this year from Trethera’s Phase 1a clinical trial in high risk, heavily pretreated patients with solid tumor malignancies. In the all comers designed (i.e., unselected) dose escalation trial, TRE-515 demonstrated a superb safety profile while also showing antitumor activity for 1 in 4 patients.  

Dr. Tim Donahue, Trethera Board member and UCLA Chief of Surgical Oncology, commented, “With this funding, we intend to further showcase the therapeutic promise of disrupting nucleoside salvage pathway activity with TRE-515 as a late line therapy in solid tumors.  We look forward to advancing TRE-515 through Phase 2 with the prospect of helping patients in need.”

“The preliminary biomarker data support the underlying TRE-515 mechanism as an on-target dCK inhibitor that expects to positively impact disease progression in patients with solid tumors,” stated Dr. Jean DeKernion, Trethera Board member and UCLA Professor Emeritus of Urology. “A direct Phase 2 NCI award is incredibly competitive and a significant mark of distinction.” 

A discussion summary from the panel of NCI experts that reviewed Trethera’s proposal stated, “the drug development plan is state of the art…noted efficacy in stabilizing disease progression in more than one patient in the early phase clinical trial… preliminary studies indicate that this assay can be validated…dCK represents an important and novel therapeutic target.” 

TRE-515 is an orally delivered therapeutic engineered to inhibit dCK, the key enzyme in the nucleoside salvage pathway.  A common characteristic of tumor cells in solid malignancies and pathological immune cells in autoimmune diseases is the requirement for elevated nucleotide levels to support abnormal and accelerated cell division.  In contrast, dCK activity is not required in most healthy adult human cells.  Mediated by the rate limiting enzyme, dCK, the nucleoside salvage pathway may play a pivotal role in enabling the rapid cell proliferation of cancer cells and aberrant activated lymphocytes, suggesting dCK as a potential therapeutic target with expected enhanced safety.

About Trethera

Trethera is a clinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally administered capsule twice designated by the FDA as an Orphan Drug.  TRE-515 is a first-in-class clinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors.  It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth, and certain autoimmune diseases, such as multiple sclerosis, might also respond to TRE-515 treatment.  Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer or autoimmune diseases that will transform outcomes for patients. 

For more information, please visit us at trethera.com or e-mail Investor Relations at ir@trethera.com.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

Dose Escalation Portion of Phase 1 Solid Tumors Trial Produces Favorable Results in Heavily Pretreated Solid Tumor Patients

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Los Angeles, March 15, 2023 — Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, received a unanimous recommendation from the independent safety review committee (“SRC”) to continue clinical trial advancement of Trethera’s lead development asset, TRE-515, its first-in-class deoxycytidine kinase (“dCK”) inhibitor. This recommendation follows favorable results from the company’s Phase 1a dose escalation clinical trial in high risk, heavily pretreated, patients with solid tumor malignancies.

The Phase 1a open-label trial enrolled 19 patients with various solid tumors in the planned five dose escalation cohorts.  The study’s primary endpoints were to determine the safety and maximum tolerability of TRE-515 when administered orally once daily as a single agent.  The secondary endpoints were to (i) establish a recommended Phase 2 dose, (ii) characterize the pharmacokinetics/pharmacodynamics, and (iii) evaluate preliminary antitumor activity.  The protocol also included exploratory objectives such as measuring biomarkers of target engagement. 

In the trial, TRE-515 has demonstrated a manageable safety and tolerability profile resulting in an eight-fold increase above the initial starting dose.  While multiple patients remain on therapy today, details of the most recent SRC and clinical data include:

Safety: Patients (N=19) tolerated TRE-515 well, with adverse events being limited, transient and manageable.  No dose-limiting clinical or laboratory toxicities were observed in any treated patient who received daily doses of 40 mg up to 320 mg.  Two patients were dosed continuously for over 200 days while another two for over 100 days with acceptable safety profiles.

Dose: TRE-515 had nearly dose proportional exposure over the 40 mg to 320 mg dose range, displaying favorable pharmacokinetics characterized by rapid absorption (Tmax less than 2 hours) and a plasma half-life of over 6 hours supporting once daily oral administration.  Exposure levels were favorable relative to potency, even at the lowest dose of 40 mg.

Antitumor Activity: A secondary endpoint of the study included signaling for biological effect. Over all dose levels studied, there were five (N=5) cases of stable disease per RECIST v1.1 criteria reported.  The majority of these patients had been heavily pretreated, meaning 5th line therapy or later, with extensive metastases. 

Biomarkers:Plasma nucleoside concentrations, the substrate for the enzyme dCK, provided compelling evidence (p value <0.0001) of target engagement.  Nucleosides potentially represent a readily accessible liquid biomarker for monitoring response during therapy, adjusting dose levels, and detecting a loss of response.

Overall, these data demonstrate that TRE-515 was well tolerated and showed signs of activity in heavily pretreated patients with high tumor burdens. Further, TRE-515 had predictable exposure and proven evidence of on-target activity. Taken together, the data support further evaluation of TRE-515.  Given the promising data, as well as the SRC unanimous recommendation, discussions with the Food and Drug Agency (“FDA”) have initiated to (i) continue dose escalation, (ii) increase the number of patients, and (iii) include new clinical sites, thereby providing the opportunity for additional patients to receive treatment.  After additional dose escalation concludes, the trial will enter dose expansion and dose range finding to further establish the Recommended Phase 2 Dose (RP2D). 

“Based on the first-in-class mechanism of action, we believe TRE-515 has breakthrough potential. We’ve seen strong trial enrollment and remain optimistic for how TRE-515 can impact the future of cancer care,” said Dr. Zev Wainberg, principal investigator of the trial and medical oncologist at the University of California Los Angeles (UCLA).   “We are especially excited that this data set included advanced biomarkers that will enable us to potentially measure drug impact and malignant progression.”

Dr. Tim Donahue, Trethera Board member and UCLA Chief of Surgical Oncology, commented, “These results establish the initial positive data set for safety and tolerability, suggesting that TRE-515 will have a wide therapeutic window, something uncommon for a cancer therapeutic. Moreover, the observations of first antitumor activity, such as those in a high-risk aggressive pancreatic cancer as 6th line therapy, indicate the therapeutic potential of TRE-515 for patients with considerable cancer burden.”

Figure 1. Co-crystal 3D structure of the drug bound to the target enzyme, dCK, at the deoxycytidine binding site.

TRE-515 is an orally delivered therapeutic engineered to inhibit dCK, the key enzyme in the nucleoside salvage pathway.  A common characteristic of tumor cells in solid malignancies and pathological immune cells in autoimmune diseases is the requirement for elevated nucleotide levels to support abnormal and accelerated cell division.  In contrast, dCK activity is not required in most healthy adult human cells.  Mediated by the rate limiting enzyme, dCK, the nucleoside salvage pathway may play a pivotal role in limiting the rapid cell proliferation of cancer cells and aberrant activated lymphocytes, suggesting dCK as a potential therapeutic target with expected enhanced safety.

“We are pleased to successfully complete the dose escalation period, and excited to continue the study in difficult to treat cancers, as it moves us closer to key FDA submissions which are important steps in bringing this novel, first-in-pathway therapy closer to patients,” added Dr. Ken Schultz, Trethera Chairman and CEO.  “Simultaneous with completing the current study, Trethera is optimizing the biomarker assays and manufacturing processes in preparation for Phase 2 proof-of-concept trials.”

Trethera looks forward to presenting the final data package at a future oncology conference.

About Trethera

Trethera is a clinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally administered capsule twice designated by the FDA as an Orphan Drug.  TRE-515 is a first-in-class clinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors.  It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth, and certain autoimmune diseases, such as multiple sclerosis, might also respond to TRE-515 treatment.  Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer or autoimmune diseases that will transform outcomes for patients.

For more information, please visit us at trethera.com or e-mail Investor Relations at ir@trethera.com.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.

Trethera Announces Appointment of Laurent Dubois to Board of Directors

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Los Angeles, February 15, 2023 — Trethera Corporation (“Trethera”), a clinical-stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced today the appointment of Laurent Dubois to the Trethera Board of Directors as an independent director.  A healthcare executive veteran with over two decades of experience at McKinsey & Company and GE Healthcare, Mr. Dubois also will chair the Board’s Compensation Committee. 

“We are fortunate to have someone of Laurent’s experience and expertise join our efforts to serve patients with cancer and autoimmune diseases,” said Dr. Ken Schultz, Chairman and Chief Executive Officer of Trethera. “Laurent’s background in commercial pharmaceuticals, drug branding, and hospital care delivery will be highly valued as we expand our multifaceted drug into more advanced proof-of-concept clinical trials and work to deepen our relationships with leading biopharmaceutical companies.”  

“I am pleased to join Trethera’s board as it considers the possible commercial development paths for TRE-515 at this crucial evolution stage with very promising Phase 1 dose escalation data now in hand,” said Mr. Dubois.  “There are strong indications that TRE-515 has the potential to treat a wide array of solid tumors and autoimmune diseases.  This potential and the newly issued composition of matter patent providing exclusivity in the world’s largest market until late 2041, place Trethera in an outstanding position to work towards near-term catalysts and prepare for anticipated growth.”

Mr. Dubois, 53, is the former CEO of GE Healthcare Partners, GE’s hospital solutions, consulting and advanced analytics franchise. While there, he served on the GE Healthcare Global Executive Committee and launched the GEHC Command Centers for hospital operations.  Prior to GE, Mr. Dubois was a Partner at McKinsey & Company, where he was a leader of the Pharmaceuticals and Medical Products practice, and served several of the world’s largest pharmaceutical companies. Laurent is currently the CEO of ADB Safegate, a Carlyle portfolio company and the global leader in airside guidance technology for airports.  He began his career in the oil and gas industry, with roles of increasing responsibility at Texaco and TotalEnergies.   

Mr. Dubois holds an Economics & Business Economics masters degree from the Free University of Brussels. He also served on the selection committee of the Prince Albert Fund, a program of the King Baudouin Foundation. 

About Trethera

Trethera is a clinical stage privately held biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers. Founded by prominent UCLA scientists, Trethera is led by experienced management and board members. Trethera’s innovative approach to targeting nucleotide metabolism led to the development of TRE-515, an orally administered capsule twice designated by the FDA as an Orphan Drug.  TRE-515 is a first-in-class clinical stage drug that inhibits deoxycytidine kinase (dCK), the rate-limiting enzyme in the nucleoside salvage pathway, one of two biosynthetic pathways that generate DNA precursors.  It is believed that some forms of cancer may be preferentially dependent on the salvage pathway to support tumor growth, and certain autoimmune diseases, such as multiple sclerosis, might also respond to TRE-515 treatment.  Trethera is developing TRE-515 for use as a monotherapy or in combination, to precisely target a metabolic vulnerability of cancer or autoimmune diseases that will transform outcomes for patients.

For more information, please visit us at trethera.com or e-mail Investor Relations at ir@trethera.com.

Note on Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that Trethera believes or anticipates will or may occur in the future are “forward-looking statements,” which may often, but not always, be identified by the use of such words as “may,” “might,” “will,” “will likely result,” “would,” “should,” “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “continue,” “target” or the negative of such terms or other similar expressions. Although Trethera has a reasonable basis for the forward-looking statements contained herein, Trethera cautions that such statements are based on current expectations about future events and are subject to risks, uncertainties and factors relating to medical and scientific research, all of which are difficult to predict and many of which are beyond Trethera’s control, that may cause actual results to differ materially from those expressed or implied by the forward-looking statements in this press release. These potential risks and uncertainties include, without limitation: the extent to which development of any novel cancer therapies or therapies for autoimmune diseases succeeds; whether Trethera would obtain the necessary regulatory approvals to commence human trials or commercialize TRE-515 or any novel therapies resulting from such research; Trethera successfully implementing its growth strategy, including that relating to its disease therapies; the effects of the global Covid-19 pandemic; changes in economic conditions; competition; and risks and uncertainties applicable to the business of Trethera. The statements in this press release speak only as of the date hereof and Trethera does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise. The Company intends that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.