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Phanes Therapeutics' PT217 Receives Fast Track Designation from FDA

Wednesday, April 10, 2024

Phanes Therapeutics, Inc. (Phanes), a biotechnology company specializing in innovative oncology drug discovery and development, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PT217 for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression following platinum chemotherapy with or without a checkpoint inhibitor. PT217 was previously granted orphan drug designation for the treatment of small cell lung cancer by the FDA in 2022.

PT217 is a first-in-class native IgG-like bispecific antibody (bsAb) targeting DLL3 and CD47, and it is being developed for the treatment of patients with small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), and extrapulmonary neuroendocrine carcinomas (EP-NECs).

SCLC is a highly aggressive form of cancer characterized by high mortality rates and significant morbidities. Patients diagnosed with ES-SCLC typically have an average survival duration of 2-4 months without treatment, which extends to 7-11 months with treatment.

Ming Wang, Founder and CEO of Phanes Therapeutics, expressed optimism about PT217's potential, stating, "PT217 has the potential to be a transformative treatment option for patients with SCLC, LCNEC, and EP-NECs in various settings." Wang also highlighted Phanes Therapeutics' recent achievement of securing two Fast Track designations, with PT886 receiving similar recognition last month for the treatment of metastatic claudin 18.2-positive pancreatic adenocarcinoma. Both assets are from Phanes' optimized anti-CD47 bispecific antibody franchise and are currently in clinical studies. Wang emphasized the belief in the potential of the optimized anti-CD47 bispecific antibody approach to unlock the full potential of the innate immunity in targeting solid tumors.

The multi-center Phase I clinical trial of PT217 (NCT05652686), known as the SKYBRIDGE study, is currently evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of PT217 in patients with advanced or refractory cancers expressing DLL3.



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