Trethera wins grant to develop SLE treatment candidate TRE-515

Therapy is designed to inhibit enzyme dCK, which aids cell division, growth

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by Margarida Maia |

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Trethera will use a $0.6 million Small Business Technology Transfer (STTR) grant to advance TRE-515, its lead candidate for systemic lupus erythematosus (SLE).

The grant comes from the National Institute for Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), from which the company has received funding previously.

In SLE, sometimes simply called lupus, the immune system launches a mistaken attack against the body’s own tissues. This can cause patients to develop joint pain, skin rashes, and fatigue, among other symptoms.

TRE-515 is designed to inhibit deoxycytidine kinase (dCK), an enzyme that helps cancer and overactive immune cells divide and grow rapidly. Inhibiting the enzyme is expected to slow down cell division and growth.

Because dCK isn’t needed in most healthy cells, TRE-515 also is expected to have few or no side effects. This means it may offer a safer option to treat other diseases too.

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“The potential TRE-515 has to treat a broad spectrum of diseases creates a pipeline in a product that reduces overall development risk,” Ken Schultz, MD, Trethera’s principal investigator and CEO, said in a company press release. “We are grateful that the NIH also recognizes this, providing $4.2 [million] in overall grant funding since September for optic neuritis [inflammation of the eye nerve], solid tumors, and now lupus.”

In a Phase 1 clinical study (NCT05055609) involving heavily treated patients with solid tumors, TRE-515 was found safe, worked within a wide range of doses, and showed early signs of clinical benefit when given once daily by mouth.

PET imaging has shown that dCK is present at higher levels in mice with SLE than in healthy mice. The review group that evaluated Trethera’s grant application suggested dCK biomarkers may thus help identify those who are likely to respond to treatment and provide insights into how TRE-515 works over time.

The work funded by the new 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,” said Peter Clark, PhD, a member of Trethera’s scientific advisory board and an associate professor of molecular and medical pharmacology at the University of California Los Angeles (UCLA).

“We look forward to using these grants to continue working with our UCLA research partners on this first-in-class drug,” Schultz said.

The company won orphan drug status from the U.S. Food and Drug Administration (FDA) for TRE-515 for treating acute disseminated encephalomyelitis and optic neuritis, a hallmark of neuromyelitis optica spectrum disorder.