FDA Grants Fast Track to Phanes Therapeutics' PT217 for NEPC

Phanes Therapeutics, Inc., a biotech company in the clinical stage of drug discovery and development for oncology, has announced that the U.S. Food and Drug Administration (FDA) has granted a Fast Track designation to PT217 for treating patients with metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC). Notably, this is the second Fast Track designation for PT217 by the FDA, the first being awarded earlier in the year for extensive-stage small cell lung cancer (ES-SCLC) in patients whose disease progressed following platinum chemotherapy, with or without a checkpoint inhibitor.

PT217 is a pioneering bispecific antibody (bsAb) that targets DLL3 and CD47 and is intended for the treatment of small cell lung cancer (SCLC) and neuroendocrine carcinoma, including NEPC. The FDA has also granted orphan drug designations for PT217 for the treatment of small cell lung cancer and neuroendocrine carcinoma.

The ongoing multi-center Phase I/II clinical trial, named the SKYBRIDGE study (NCT05652686), is evaluating PT217 in patients with advanced or refractory cancers expressing DLL3. This study is looking into the safety, tolerability, pharmacokinetics, and initial efficacy of PT217. Additionally, a Phase I clinical trial is underway in China (CTR20242720). Earlier in the year, Phanes Therapeutics entered into a clinical supply agreement with Roche to investigate PT217 in combination with Roche's anti-PD-L1 therapy, atezolizumab.

Phanes Therapeutics is a company focused on innovative cancer treatments and is currently conducting three Phase I clinical trials. These include the MORNINGSTAR study, which involves PT199, a leading monoclonal antibody (mAb) program; the TWINPEAK study, which involves PT886; and the SKYBRIDGE study, involving PT217. Both PT886 and PT217 are first-in-class bispecific antibodies and have received orphan drug and Fast Track designations from the FDA.

The company has developed a strong pipeline leveraging its proprietary technology platforms, such as PACbody®, SPECpair®, and ATACCbody®, to create novel biologics aimed at addressing unmet medical needs in cancer.