Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in immuno-oncology announced today that it has received clearance from the US Food and Drug Administration to commence Phase I studies with PT199, its next generation monoclonal antibody (mAb) against CD73 in adult patients with advanced solid tumors.
"The clearance of our first IND is an important milestone for Phanes and the opportunity to bring this potential best-in-class mAb to cancer patients who have few treatment options is why we embarked on this journey," said Dr. Ming Wang, Founder and CEO. "We have built a strong pipeline in immuno-oncology by leveraging our proprietary technology platforms and expect to file two additional INDs in 2022, both first-in-class bispecific antibody programs. This will be a transformational year for Phanes as we expand from a research to a clinical development stage organization".
PT199 is an anti-CD73 mAb with a differentiated mechanism of action and is designed to counter the adenosine-mediated immunosuppressive tumor microenvironment. PT199 fully inhibits both soluble and membrane-bound CD73, unlike some other CD73 inhibitors which exhibit incomplete inhibition. Moreover, at higher concentrations, no loss of inhibition or "hook effect" is observed with PT199. Hence, PT199 addresses the limitations of current CD73 inhibitors and is expected to increase antitumor immune activation, and potentially offer a new treatment option for cancer patients.
The multi-center Phase I clinical trial of PT199 is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT199 alone and in combination with a PD-1 inhibitor, in patients with locally advanced or metastatic solid tumors that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate.
At the upcoming American Association for Cancer Research (AACR) 2022 Meeting in New Orleans, Phanes will present pre-clinical data that describe PT199's differentiated mechanism of action, as well as presentations describing PT886, an anti-claudin18.2/anti-CD47 bispecific antibody being developed for gastric and pancreatic cancers, and PT217, an anti-DLL3/anti-CD47 bispecific antibody for the potential treatment of small cell lung cancer.
About Phanes Therapeutics
Phanes Therapeutics, Inc. is a biotech company focused on innovative drug discovery in immuno-oncology. Based in San Diego, California, the company's management team members previously held senior managerial and R&D positions in leading global pharmaceutical and biotech companies with extensive experience in R&D and commercialization. The company's bispecific antibody platform is PACbody™, a proprietary approach for constructing native IgG-like bispecific antibodies without using protein engineering so that the antibody molecules maintain native structures with superb CMC characteristics, ATACCbody™, a proprietary technology for targeting solid tumors using immuno-oncology molecules with minimal risk of cytokine release syndrome, and SPECpair™, which allows mAb-like manufacturability of bispecific antibodies with native IgG-like structures.