#United States #San Diego #Peluntamig #Atezolizumab #PhanesTherapeutics

Phanes Therapeutics Initiates First Patient Dosing

In an exciting development for oncology, Phanes Therapeutics, Inc. has announced that it has dosed its first patient in a clinical study involving peluntamig, the company's first-in-class bispecific antibody, in combination with Roche's atezolizumab (TECENTRIQ®). This significant milestone, announced on May 5, 2025, represents a promising step in the fight against cancer, specifically targeting extensive-stage small cell lung cancer (ES-SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), and extrapulmonary neuroendocrine carcinomas (EP-NECs).

The study is designed to evaluate the efficacy and safety of peluntamig when combined with atezolizumab, a well-established anti-PD-L1 monoclonal antibody, which has transformed the treatment landscape for various malignancies. As part of the study architecture, the clinical trial forms part of a collaboration under a clinical supply agreement with Roche, emphasizing the joint effort to enhance disease treatment methodologies for challenging forms of cancer.

What Is Peluntamig?

Peluntamig stands out as a novel bispecific antibody designed to target both DLL3 and CD47, which are often associated with tumor proliferation and immune evasion. The U.S. Food and Drug Administration (FDA) has recognized the potential of peluntamig by granting it orphan drug designation for SCLC and neuroendocrine carcinomas, as well as Fast Track designations for advanced cases of these cancers. This recognition underscores the urgency and need for effective therapeutics in these often difficult-to-treat malignancies.

The SKYBRIDGE Study

The multi-center trial, referred to as the SKYBRIDGE study (NCT05652686), seeks to elucidate the pharmacokinetics, safety, and tolerability of peluntamig while assessing its potential efficacy in patients with advanced cancers that express DLL3. This research not only contributes to growing clinical evidence but also aims to explore treatment avenues that could significantly improve patient outcomes.

Beyond this ongoing trial, Phanes is also conducting a similar Phase I clinical trial in China, alongside an approved Phase II clinical trial, highlighting the global scope and anticipation surrounding peluntamig.

The dual approach of leveraging both peluntamig and atezolizumab—two pioneering therapeutics targeting different aspects of cancer biology—is a strategic maneuver that holds the potential for improved therapeutic responses, especially for patients who have historically faced limited treatment options after standard chemotherapy courses.

Phanes Therapeutics and Its Pipeline

Phanes Therapeutics is distinguished in the biopharmaceutical space for its commitment to addressing high unmet medical needs through innovative drug discovery. The company is currently running three Phase I clinical trials, which include the MORNINGSTAR study focusing on its monoclonal antibody, mavrostobart, and the TWINPEAK study with another bispecific antibody, spevatamig. Phanes Therapeutics effectively utilizes its proprietary technology platforms—PACbody®, SPECpair®, and ATACCbody®—to create biologics that cater to specific medical challenges encountered in oncology.

The substantial efforts invested in drug development by Phanes Therapeutics not only promise to shine a light on areas of high need in cancer treatment but may also pave the way for new therapeutic approaches powered by advanced biotechnologies.

For additional updates and information about Phanes Therapeutics and its research endeavors, interested parties can visit their official website at www.phanesthera.com. Those seeking media inquiries can reach out via the designated email contacts.

By initiating the SKYBRIDGE study, Phanes Therapeutics is setting the stage for significant innovations in cancer treatment that could extend beyond existing therapies, providing hope for patients grappling with advanced cancers.