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

Figure 1

LOS ANGELES, June 27, 2023 (GLOBE NEWSWIRE) — 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.

Figure 1. PET scan images showing presence of
target enzyme dCK in normal mice (row A), and
lupus diseased mice (row B).

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.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/866602cb-d70c-4f55-8be8-e35d57205bcd