On June 21, 2022 Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in oncology, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to PT217 for the treatment of small cell lung cancer (SCLC) (Press release, Phanes Therapeutics, JUN 21, 2022, View Source [SID1234616146]).

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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 SCLC and other neuroendocrine cancers. SCLC is an aggressive pulmonary carcinoma hallmarked by high early mortality rates and significant morbidities throughout the disease’s progression. The 1-year survival of patients with SCLC is only 32.9%, with only 10.7% of patients surviving 3 years.

"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" said Dr. Ming Wang, Founder and CEO of Phanes Therapeutics. "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."

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.