Policy & Regulation
Phanes Therapeutics PT217 receives US FDA orphan drug designation
22 June 2022 -

Phanes Therapeutics, Inc., a US-based company that deals with innovative discovery research and clinical development in oncology, announced on Tuesday that it has received orphan drug designation from the United States Food and Drug Administration (FDA) for its PT217 intended to treat small cell lung cancer (SCLC).

PT217 is a first-in-class bispecific antibody aimed at Delta-like ligand 3 (DLL3) and cluster of differentiation 47 (CD47) being developed for patients with SCLC and other neuroendocrine cancers.

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 US upon regulatory approval.

Dr Ming Wang, Phanes Therapeutics founder and CEO, said, 'PT217 has the potential to be a transformative treatment option for SCLC patients whose initial response to chemotherapy is short-lived and inevitably becomes resistant to chemotherapeutic agents. We have built a strong pipeline in immuno-oncology by leveraging our proprietary technology platforms and expect to file an IND for PT217 by the third quarter of this year. This orphan drug designation follows two recent IND clearances for our PT199, an anti-CD73 monoclonal antibody and PT886, an anti-Claudin 18.2/anti-CD47 bispecific antibody, programs which we are progressing into the clinic.'

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