Beijing, Shanghai, Songshan Lake in Guangdong, China; San Diego, USA
On December 4, 2024, Phanes Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of innovative drugs in the field of oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its PT217 for the treatment of primary and treatment-induced prostate neuroendocrine carcinoma (NEPC). This marks the second Fast Track designation awarded to PT217 by the FDA. Earlier this year, PT217 received another Fast Track designation from the FDA for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) who experience disease progression after platinum-based chemotherapy, regardless of whether they have received combination therapy with immune checkpoint inhibitors.PT217 is a globally pioneering bispecific antibody (dual antibody) with a natural IgG structure, targeting DLL3 and CD47, for the treatment of small cell lung cancer (SCLC) and other neuroendocrine cancers, including prostate neuroendocrine cancer (NEPC). In addition to receiving Fast Track designation, PT217 has also been granted Orphan Drug designation by the FDA for the treatment of small cell lung cancer (SCLC) and Orphan Drug designation for the treatment of neuroendocrine carcinoma (NEC).The multicenter Phase I/II clinical trial (NCT05652686) of PT217 in the United States, 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. The Phase I clinical trial of PT217 in China (CTR20242720) is also underway. Earlier this year, Phanes Therapeutics reached a clinical supply agreement with Roche to study the combination of PT217 and Roche's PD-L1 inhibitor atezolizumab.
About Phanes Therapeutics
Phanes Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to the research and development of innovative drugs in the field of oncology. The company currently has three projects in clinical stages, including the best-in-class monoclonal antibody (mAb) project PT199, and two first-in-class bispecific antibody (bsAbs) projects, PT886 and PT217. Both PT886 and PT217 have received FDA Orphan Drug and Fast Track designations.Phanes Therapeutics has already passed through its proprietary technology platformPACbody®、SPECpair®AndATACCbody®Built a robust R&D pipeline to develop novel biologics, addressing highly unmet medical needs in the field of oncology.PACbody®, is a proprietary method for constructing bispecific antibodies without the need for protein engineering, thereby maintaining the natural structure of antibody molecules with superior CMC properties.SPECpair®A technology platform that can use traditional monoclonal antibody preparation processes to produce bispecific antibodies with a natural IgG structure.ATACCbody®Technical Platform: A proprietary technology that uses immune-oncology molecules with adjustable activity to target solid tumors, aiming to minimize the risk of cytokine storms.
For more information about Phanes Therapeutics, please visit the company website:www.phanesthera.com。
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