#United States #San Diego #Phanes Therapeutics #PT217 #FDA Fast Track

Phanes Therapeutics’ PT217 Granted FDA Fast Track Designation for NEPC

Phanes Therapeutics, Inc., a cutting-edge biotech firm based in San Diego, has achieved a significant milestone in its drug development journey. The U.S. Food and Drug Administration (FDA) has awarded Fast Track designation to PT217, a treatment targeting metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC). This designation is a vital step towards expediting the development and review process for drugs that treat serious conditions and fill an unmet medical need.

This particular recognition by the FDA marks the second Fast Track designation for PT217. Earlier in 2024, the same designation was granted for the treatment of extensive-stage small cell lung cancer (ES-SCLC) in patients experiencing disease progression after platinum-based chemotherapy and possibly after a checkpoint inhibitor.

Understanding PT217

PT217 is a pioneering bispecific antibody that uniquely targets both DLL3 and CD47, two proteins implicated in cancer progression. Its dual-action mechanism is designed to enhance the efficacy of treatments for cancers like small cell lung cancer and neuroendocrine cancers, including NEPC.

Currently, PT217 is undergoing evaluation in a multi-center Phase I/II clinical trial, referred to as the SKYBRIDGE study (NCT05652686). This trial is crucial as it investigates the safety, tolerability, pharmacokinetics, and preliminary efficacy of PT217 on patients whose advanced cancers express DLL3. Additionally, there is a Phase I trial in progress in China under registration number CTR20242720, suggesting a growing interest and potential for PT217 in global markets.

Collaboration with Roche

In a strategic move to further advance PT217’s clinical potential, Phanes Therapeutics entered into a clinical supply agreement with Roche. This partnership will study PT217 in conjunction with Roche's prominent anti-PD-L1 therapy, atezolizumab. Such collaborations not only bolster the research efforts but also position PT217 within the context of existing treatment modalities known for their impact on cancer therapy.

About Phanes Therapeutics

Founded with a vision to innovate in oncology, Phanes Therapeutics operates with a robust research pipeline. Apart from PT217, the company is advancing other promising candidates such as PT199 and PT886, both of which have also received Fast Track and orphan drug designations. Phanes is dedicated to addressing significant medical challenges in cancer treatment, leveraging unique technologies like PACbody®, SPECpair®, and ATACCbody® to develop innovative biologics.

As it continues its journey through stringent clinical trials and seeks regulatory approvals, Phanes Therapeutics stands at the forefront of next-generation cancer therapies. Their ongoing commitment to research and collaboration with leading entities in the healthcare sector reflects a strong potential to make significant contributions to oncology.

For more insights into the developments at Phanes Therapeutics, visit their official website at www.phanesthera.com. Additionally, for media inquiries or business development discussions, they invite contacts via their dedicated email channels.