Phanes Therapeutics and Roche to Evaluate PT217 with anti-PD-L1 Therapy in Clinical Supply Agreement

Phanes Therapeutics, Inc., a clinical-stage biotechnology company specializing in oncology drug discovery and development, has announced a new clinical supply agreement with Roche. The collaboration will investigate PT217, Phanes' innovative bispecific antibody targeting DLL3 and CD47, in combination with Roche's anti-PD-L1 therapy, atezolizumab. This study will focus on treating small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), and extrapulmonary neuroendocrine carcinomas (EP-NECs).

PT217 has already received significant recognition, having been granted orphan drug designation (ODD) by the FDA in 2022 for the treatment of SCLC. More recently, it was awarded Fast Track designation by the FDA for treating patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression following platinum chemotherapy, with or without a checkpoint inhibitor.

Phanes is actively enrolling patients for a multi-center Phase I clinical trial of PT217, known as the SKYBRIDGE study. This trial is assessing the safety, tolerability, pharmacokinetics, and preliminary efficacy of PT217 in patients with advanced or refractory cancers expressing DLL3. The next phase of the study will evaluate PT217's potential as a combination therapy for SCLC, LCNEC, and EP-NECs. The collaboration with Roche aims to combine PT217 with atezolizumab to explore the enhanced therapeutic benefits for these patients.

Dr. Rita Laeufle, Chief Medical Officer of Phanes, expressed enthusiasm about the collaboration with Roche. She emphasized the significance of DLL3 in SCLC, LCNEC, and EP-NECs, highlighting its role as a crucial target for treating these cancers. Dr. Laeufle believes that the complementary mechanisms of PT217 and atezolizumab could lead to improved patient outcomes. She also noted that this partnership represents a significant milestone for Phanes in its mission to develop innovative cancer treatments.

Phanes is conducting three Phase I clinical trials, including the MORNINGSTAR study with their monoclonal antibody (mAb) program PT199, the TWINPEAK study with PT886, and the SKYBRIDGE study with PT217. Both PT886 and PT217 are first-in-class bispecific antibodies that have received orphan drug designation and Fast Track designation from the FDA.

The company has developed a robust pipeline, leveraging its proprietary technology platforms: PACbody®, SPECpair®, and ATACCbody®. These platforms are designed to create novel biologics that address significant unmet medical needs in cancer treatment. Phanes remains committed to innovation and continues to advance its research and development efforts to provide new therapeutic options for cancer patients.

The collaboration with Roche is expected to bring significant advancements in the treatment of SCLC, LCNEC, and EP-NECs, offering hope for improved patient outcomes and contributing to the broader field of oncology.

Phanes Therapeutics continues to push the boundaries of cancer treatment, with a focus on developing first-in-class therapies that target critical pathways and mechanisms in cancer biology. The combination of PT217 and atezolizumab represents a promising approach that could potentially enhance the efficacy of treatment regimens for patients suffering from these challenging forms of cancer.