Trethera Corporation Receives $2.3 Million SBIR Grant to Develop Novel Prostate Cancer Therapy

Strategic Insights -

Trethera Corporation, a clinical stage biopharmaceutical company, has been awarded a $2.3 million Small Business Innovation Research (SBIR) grant from the National Institute of Health (NIH) to develop a novel therapy for metastatic castration-resistant prostate cancer (mCRPC). The grant will fund testing of Trethera's lead drug candidate, TRE-515, in combination with radiation therapy in mCRPC mouse models. TRE-515 inhibits deoxycytidine kinase (dCK), a key enzyme in the nucleoside salvage pathway, which is essential for the growth of abnormal cells in cancer and autoimmune diseases. The therapy has demonstrated a favorable safety profile and clinical benefit in ongoing first-in-human trials.

Key Takeaways:

  • The NIH grant funds testing of TRE-515 with radiation therapy in mCRPC mouse models to inform future clinical trials.
  • Trethera's lead drug candidate, TRE-515, inhibits deoxycytidine kinase (dCK), a key enzyme in the nucleoside salvage pathway that is essential for the growth of abnormal cells in cancer and autoimmune diseases.
  • The therapy has demonstrated a favorable safety profile and clinical benefit in ongoing first-in-human trials.
  • mCRPC is a devastating disease that claims 70% of patients within 5 years of diagnosis, with 1.5 million men diagnosed globally each year and over 40,000 deaths annually.
  • The FDA has designated TRE-515 a Fast Track drug for prostate cancer and an Orphan Drug for two autoimmune neurologic diseases.
  • Combining radiation with TRE-515 synergistically cripples the ability of cancer cells to recover from DNA damage and enhances the therapeutic response.
  • The NIH peer review panel commented that the therapy has strong preliminary data, a specific dCK inhibitor, "will likely lead to proof of concept that combining TRE-515 with radiation will be an effective approach for preventing resistance... opens new opportunities to apply this inhibitor to a broad range of cancers... has very strong commercial potential ... shown to be safe with no toxicity in dose escalation studies."
  • Trethera is a clinical stage biopharmaceutical company dedicated to pioneering the development of novel treatments for autoimmune diseases and cancers, founded by prominent UCLA scientists.

Statistics:

  • The NIH grant award is $2.3 million to develop a novel therapy for mCRPC.
  • 1.5 million men are diagnosed with prostate cancer globally each year.
  • Over 40,000 deaths occur annually due to prostate cancer.
  • The 5-year mortality rate for mCRPC is 70%.
  • 7 in 10 men experience no clinical benefit from current FDA-approved targeted radiation therapies.
  • TRE-515 has demonstrated a favorable safety profile and clinical benefit in ongoing first-in-human trials.

Sources:

  • Sartor, N Engl J Med. 2018
  • Siegel, Cancer J Clin. 2023
  • Bunimovich, PLoS One. 2014
  • Rawla, World J Oncol. 2019
  • Pluvicto(TM) FDA label
  • 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.