Phanes Therapeutics doses first patient in peluntamig and atezolizumab study

Phanes Therapeutics, Inc., a biotech company at the forefront of oncology innovations, has announced a significant milestone: the enrollment and dosing of the first patient in its latest clinical study. This study explores the combination of peluntamig with atezolizumab, known by the brand name TECENTRIQ®, an anti-PD-L1 monoclonal antibody developed by Roche. The trial focuses on patients who are battling extensive-stage small cell lung cancer (ES-SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), or extrapulmonary neuroendocrine carcinomas (EP-NECs).

Peluntamig, a pioneering bispecific antibody developed by Phanes, targets both DLL3 and CD47. This innovative molecule has garnered the attention of the medical community for its potential in treating small cell lung cancer and neuroendocrine carcinomas. Recognizing its promise, the U.S. Food and Drug Administration (FDA) has awarded peluntamig two orphan drug designations specifically for SCLC and NEC. In addition, it has received Fast Track designations for cases of ES-SCLC that show disease progression after platinum-based chemotherapy, whether or not a checkpoint inhibitor is involved, and for metastatic, newly diagnosed, or treatment-emergent neuroendocrine prostate cancer (NEPC).

The current SKYBRIDGE study, a multi-center clinical trial registered under the identifier NCT05652686, is in Phase I/II. It aims to assess the safety, tolerability, pharmacokinetics, and initial efficacy of peluntamig in patients with advanced or treatment-resistant cancers that exhibit DLL3 expression. Beyond the borders of the United States, a Phase I trial of peluntamig is actively ongoing in China, with the trial registration number CTR20242720, and a Phase II clinical trial has recently received approval in the country.

TECENTRIQ® is a product of Genentech, which is part of the Roche Group, and it plays a critical role in this study, working alongside peluntamig to potentially offer a novel therapeutic approach for difficult-to-treat cancers.

Phanes Therapeutics stands out in the biotech field for its focus on cancer treatment innovations. Besides the current study, the company is spearheading three other Phase I clinical trials. Among them is the MORNINGSTAR study, which investigates mavrostobart, a monoclonal antibody program considered best-in-class. There is also the TWINPEAK study, which involves spevatamig, another first-in-class bispecific antibody like peluntamig. Both spevatamig and peluntamig have achieved orphan drug status as well as Fast Track designation from the FDA.

The company's success can be attributed to its advanced proprietary technology platforms—PACbody®, SPECpair®, and ATACCbody®. These platforms enable Phanes to develop groundbreaking biologics that address significant unmet medical needs within oncology, promising hope for patients with challenging cancer diagnoses.

Phanes Therapeutics' endeavors underscore its commitment to transforming cancer treatment through cutting-edge science and collaboration, as evidenced by its partnership with Roche and the use of TECENTRIQ® in its clinical trials. The outcomes of these studies could potentially lead to new, effective treatment options for individuals battling aggressive forms of cancer, thereby making a significant impact on the field of oncology.