NEW YORK, NY / ACCESSWIRE / April 28, 2021 / Tarus Therapeutics Inc., a clinical-stage biotechnology company developing adenosine receptor antagonists for cancer immunotherapy, today announced that it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) on April 26, 2021 to support the initiation of a clinical study of TT-4, an oral small molecule drug candidate targeting the Adenosine A2B receptor (A2BR).
The application includes extensive preclinical data on TT-4's biological activity and safety profile, as well as details on how the therapy would be manufactured and administered to trial participants.
If the IND application is allowed by the FDA, the Company plans to initiate a Phase 1a/1b study in the third quarter of 2021 to evaluate TT-4 in patients with advanced solid tumors both as a monotherapy and in combination with other anti-cancer agents.
Adenosine signaling is not only immunosuppressive but can also promote tumor growth and metastasis. A2BR expression is induced by hypoxia via HIF1 (hypoxia-inducible factor) leading to the activation of ERK, JNK and p38 MAPK signaling in tumor cells. This cascade in turn has been shown to result in their proliferation, survival, adhesiveness, invasiveness and motility in animal models of several solid tumors.
"This IND submission is another key milestone for Tarus as we continue to advance our portfolio of adenosine receptor antagonists for cancer immunotherapy. This IND filing brings us one step closer to moving into the clinic our potentially first-in-class A2BR antagonist," said Sushant Kumar, Ph.D., Chief Executive Officer, Tarus Therapeutics. "We look forward to guidance from the FDA on the clinical development of TT-4."
About Tarus Therapeutics Inc.
Tarus is developing small molecule inhibitors of A2AR, A2BR, and Dual A2AR/A2BR inhibitors for cancer immunotherapy and select non-oncology indications. The Company has the most comprehensive portfolio of adenosine receptor antagonists in development, with both first-in-class and best-in-class programs. More information can be found at www.tarustx.com.
CONTACT:
Tarus Therapeutics, Inc.
Sushant Kumar, PhD
President & CEO
[email protected]
SOURCE: Tarus Therapeutics