US FDA grants Fast Track designation to Phanes Therapeutics’ PT217 to treat patients with extensive-stage SCLC
Overview
Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced that the US 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) with disease progression following platinum chemotherapy with or without a checkpoint inhibitor. PT217 was also granted orphan drug designation for the treatment of small cell lung cancer by the FDA in 2022.
PT217
PT217, a first-in-class native IgG-like bispecific antibody (bsAb) targeting DLL3 and CD47, 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).
About SCLC
- SCLC is an aggressive form of cancer characterized by high mortality rates and significant morbidities.
- The average survival for patients who present with ES-SCLC without treatment is 2-4 months after diagnosis; the median survival for patients with treatment is 7-11 months.
Words from CEO: Phanes Therapeutics
- “PT217 has the potential to be a transformative treatment option for patients with SCLC, LCNEC and EP-NECs in various settings,” said Ming Wang, founder and CEO of Phanes Therapeutics.
- “Now we have two Fast Track designations in our pipeline. Last month, PT886 was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma. Both assets are from our optimized anti-CD47 bispecific antibody franchise and currently in clinical studies. We believe the optimized anti-CD47 bispecific antibody approach can unlock the full potential of the innate immunity in targeting solid tumours.”
SKYBRIDGE Study fro safery & efficacy
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.
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) programme, PT199, the TWINPEAK study with PT886 and the SKYBRIDGE study with PT217.
