On October 16, 2023 Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, reported that it has entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study PT886, its first-in-class bispecific antibody targeting 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 (Press release, Phanes Therapeutics, OCT 16, 2023, View Source [SID1234636033]). PT886 was assembled using Phanes’ proprietary bispecific antibody platforms PACbody and SPECpair and was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA last year.
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Phanes is currently enrolling patients in a multi-center Phase I clinical trial of PT886 in the U.S. evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with locally advanced or metastatic gastric, GEJ, or pancreatic cancer that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate (NCT05482893). The next phase of Phanes’ study is investigating the therapeutic potential of PT886 as a combination therapy in gastric, GEJ and pancreatic cancers. The clinical collaboration with Merck will evaluate PT886 in combination with KEYTRUDA (pembrolizumab) in patients with claudin 18.2 positive gastric or GEJ adenocarcinomas with or without chemotherapy.
"Phanes is very excited about partnering with Merck on this novel approach to treat patients with gastric or gastroesophageal cancers," said Dr. Ming Wang, Founder and CEO of Phanes. "Claudin 18.2 is a clinically validated target and is over-expressed in these types of GI tumors. We believe the mechanisms of PT886 and pembrolizumab are complementary and the combination has the potential to improve outcomes for patients. This collaboration marks another milestone for Phanes in fulfilling our vision of developing innovative approaches to treat cancer."
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
ABOUT PT886
PT886 is a first-in-class bispecific antibody targeting claudin 18.2 and CD47. It was constructed using Phanes’ proprietary bispecific antibody platforms PACbody and SPECpair and was granted orphan drug designation (ODD) for the treatment of pancreatic cancer. PT886 is expected to directly kill tumor cells via both the ADCP activity of macrophages and ADCC activity of NK cells, and by targeting both claudin 18.2 and CD47 expressed on the surface of tumor cells, it can broaden the tumor killing spectrum. Additionally, PT886 is expected to induce the presentation of tumor neoantigens by channeling tumor cells into phagocytotic antigen presenting cells (APCs) and stimulate the adaptive immune system by indirectly activating T cell killing of claudin 18.2 expressing tumor cells through recognition of tumor neoantigens. The anti-CD47 arm of PT886 is differentiated and has demonstrated minimum binding to human red blood cells while maintaining strong binding activity to CD47 on tumor cells, thus improving the benefit/risk profile versus other CD47 molecules.