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Phanes Therapeutics, Inc. And Merck Announce a Clinical Trial Collaboration and Supply Agreement to Evaluate PT886 in Combination With KEYTRUDA® (Pembrolizumab)

Tuesday, October 17, 2023

Phanes Therapeutics, Inc., a clinical-stage biotechnology company focused on innovative drug discovery and development in oncology, has announced a clinical collaboration agreement with Merck (known as MSD outside the US and Canada). This collaboration aims to study PT886, a unique bispecific antibody developed by Phanes, which targets claudin 18.2 and CD47, in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with claudin 18.2 positive gastric or gastroesophageal junction (GEJ) adenocarcinomas. PT886 received orphan drug designation (ODD) from the FDA for the treatment of pancreatic cancer.

Phanes is currently enrolling patients in a multi-center Phase I clinical trial of PT886 in the US, evaluating its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with locally advanced or metastatic gastric, GEJ, or pancreatic cancer that has progressed after standard therapy or is considered inappropriate or intolerable (NCT05482893). The next phase of Phanes' research involves investigating the potential of PT886 as a combination therapy for gastric, GEJ, and pancreatic cancers. This collaboration with Merck will assess PT886 in combination with KEYTRUDA® (pembrolizumab) in patients with claudin 18.2 positive gastric or GEJ adenocarcinomas, with or without chemotherapy.

Merck on this innovative approach to treating patients with gastric or gastroesophageal cancers. Claudin 18.2 is a clinically validated target and is known to be overexpressed in these types of GI tumors. Phanes believes that the mechanisms of PT886 and pembrolizumab complement each other and have the potential to improve outcomes for patients. This collaboration represents a significant milestone for Phanes in its mission to develop innovative approaches to cancer treatment.

It's important to note that KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., located in Rahway, NJ, USA.

PT886 is a first-in-class bispecific antibody targeting claudin 18.2 and CD47, constructed using Phanes' proprietary bispecific antibody platforms, PACbody™ and SPECpair™. It has received orphan drug designation (ODD) for the treatment of pancreatic cancer. PT886 is expected to directly eliminate tumor cells through the ADCP activity of macrophages and ADCC activity of NK cells. It also broadens the spectrum of tumor killing by targeting claudin 18.2 and CD47 on the surface of tumor cells. Additionally, PT886 is expected to induce the presentation of tumor neoantigens by channeling tumor cells into antigen-presenting cells (APCs) for phagocytosis and stimulating the adaptive immune system by indirectly activating T cell killing of claudin 18.2 expressing tumor cells through the recognition of tumor neoantigens. The anti-CD47 component of PT886 is differentiated by its minimal binding to human red blood cells while maintaining strong binding activity to CD47 on tumor cells, improving the benefit-to-risk profile compared to other CD47 molecules.



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