On October 14, 2026 Phanes Therapeutics, Inc. (Phanes), a clinical-stage biotech company focused on innovative drug discovery and development in immuno-oncology (IO), reported that the first patient has been dosed in the clinical study of spevatamig for the treatment of colorectal cancer (CRC).
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Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted by the FDA orphan drug designation for the treatment of pancreatic cancer in 2022, Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024, and recently, Fast Track designation for the treatment of advanced and metastatic biliary tract carcinoma. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with pembrolizumab. Spevatamig is an innate immunity enhancer (I2E), an emerging class of IO agents. It has the potential to become the first I2E for a solid tumor indication and is combinable with various anti-cancer therapies.
The multi-center Phase I/II clinical trial of spevatamig (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of spevatamig in patients with advanced gastrointestinal cancers, including gastric, gastroesophageal Junction, pancreatic ductal, CRC or biliary tract adenocarcinomas. The Phase I (CTR20241655) and Phase II (CTR20252758) clinical trials of spevatamig in China are currently recruiting patients with gastrointestinal cancers.
(Press release, Phanes Therapeutics, OCT 14, 2026, View Source [SID1234673460])