Phanes Therapeutics' PT217 receives Orphan Drug Designation for Neuroendocrine Carcinoma from the FDA

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Aug 16, 2024, 17:45 ET

SAN DIEGO, Aug. 16, 2024 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to PT217 for the treatment of neuroendocrine carcinoma (NEC).

PT217 is a first-in-class bispecific antibody targeting delta-like ligand 3 (DLL3) and cluster of differentiation 47 (CD47) being developed for patients with NEC. NEC is known to be the most aggressive subgroup of neuroendocrine neoplasms and defined as cancers with poorly differentiated morphology and a high proliferation rate. Most of them have their origin in the lung such as SCLC. Others can develop within the gastrointestinal tract, prostate, and pancreas.

PT217 was granted ODD for the treatment of SCLC by the FDA in 2022 and granted Fast Track designation by the agency in 2024 for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor. Earlier this year, Phanes entered into a clinical supply agreement with Roche to study PT217 in combination with Roche's anti-PD-L1 therapy, atezolizumab.

The FDA's Office of Orphan Products Development grants orphan designation status to drugs and biologics that are intended to treat, diagnose, or prevent rare diseases that affect fewer than 200,000 people in the United States. Orphan drug designation provides certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval.

ABOUT PHANES THERAPEUTICS

Phanes Therapeutics, Inc. is a clinical stage biotech company focused on innovative drug discovery and development in oncology. Currently, it is conducting three Phase I clinical trials, including the MORNINGSTAR study with its best-in-class monoclonal antibody (mAb) program, PT199, the TWINPEAK study with PT886 and the SKYBRIDGE study with PT217. Both PT886 and PT217 are first-in-class bispecific antibodies and have been granted orphan drug designation as well as Fast Track designation by the FDA.

The company has built a strong pipeline by leveraging its proprietary technology platforms: PACbody^®, SPECpair^® and ATACCbody^® to develop novel biologics that address high unmet medical needs in cancer.

For more information about Phanes Therapeutics, please visit www.phanesthera.com

For business development or media inquiries, please contact [email protected] or [email protected], respectively.

SOURCE Phanes Therapeutics