Phanes Therapeutics Begins First Patient Dosing in BTC Study with Spevatamig and Chemotherapy

Phanes Therapeutics Initiates First Patient Dosing in Crypto Study of Spevatamig

On September 8, 2025, Phanes Therapeutics, Inc. announced a significant milestone in its ongoing commitment to innovative cancer treatment. The clinical stage biotech company officially began administering doses of spevatamig to the first patient involved in its clinical study aimed at tackling biliary tract carcinoma (BTC). This moment marks the initial step in a multi-step process designed to explore the efficacy of spevatamig when used alongside traditional chemotherapy treatments.

Introducing Spevatamig

Spevatamig is a groundbreaking bispecific antibody designed to exhibit properties similar to native IgG antibodies. It specifically targets claudin 18.2 and CD47 within the body. Notably, this unique therapeutic agent has already received orphan drug designation (ODD) from the FDA for treating pancreatic cancer back in 2022, showcasing its potential as a pivotal player in targeting hard-to-treat cancers. In 2024, it garnered Fast Track designation for addressing metastatic claudin 18.2-positive pancreatic adenocarcinoma, further highlighting the urgency and need for new treatment options in oncology.

The collaboration between Phanes and Merck further strengthens the study's outlook, as they partnered to investigate spevatamig in conjunction with Merck's anti-PD-1 therapy, pembrolizumab. This collaboration aims to enhance patient outcomes in advanced cancer settings where existing therapies have limited success.

The TWINPEAK Clinical Trial

The TWINPEAK study, designated as a multi-center Phase I/II clinical trial (NCT05482893), is focused on evaluating the safety, tolerability, and pharmacokinetics of spevatamig. Currently, it assesses the drug's preliminary efficacy in patients diagnosed with advanced adenocarcinomas originating from the stomach, gastroesophageal junction, pancreas, or biliary tract—all aggressive forms of cancer.

Phanes has also initiated clinical trials in China, specifically the Phase I (CTR20241655) and Phase II (CTR20252758) studies, which are actively recruiting patients. This global approach underscores the urgency of finding new effective treatments for BTC.

Phanes Therapeutics: A Commitment to Oncology

Founded with the goal of advancing innovative drug discovery, Phanes Therapeutics has developed a robust pipeline of treatment options. The company is currently conducting three distinct Phase I/II clinical trials. The MORNINGSTAR study is evaluating mavrostobart, a high-quality monoclonal antibody, while the TWINPEAK study investigates spevatamig. Additionally, the SKYBRIDGE study focuses on peluntamig, another first-in-class bispecific antibody that has received both orphan drug and Fast Track designations by the FDA.

Phanes Therapeutics has made impressive strides by leveraging its proprietary platforms, including PACbody®, SPECpair®, and ATACCbody®, which collectively guide the development of novel biologics. These efforts target significant unmet medical needs within the cancer care landscape.

For more information on Phanes Therapeutics and its cutting-edge research, interested parties are encouraged to visit www.phanesthera.com. Media inquiries can be directed to their press contact at [email protected] and business inquiries are welcomed at [email protected]