Pfizer and Merck KGaA, Darmstadt, Germany, have joined BioXcel Therapeutics in its clinical collaboration with Nektar Therapeutics, creating an expanded partnership of undisclosed value that will assess a novel triple combination therapy in pancreatic cancer.

The triple combo therapy consists of the Pfizer/Merck KGaA’s marketed cancer immunotherapy Bavencio® (avelumab), Nektar’s Phase III candidate Bempegaldesleukin (NKTR-214), and BioXcel’s lead immuno-oncology candidate BXCL701.

In addition to evaluating the safety and efficacy of the triple combination therapy in pancreatic cancer, BioXcel said, the companies plan to evaluate correlative immune activation markers in blood and tumor tissue.

BioXcel has agreed to initiate and manage the clinical program, with Merck KGaA and Pfizer supplying avelumab and Nektar supplying NKTR-214. BioXcel and Nektar have agreed to equally share all development costs.

“We believe that the expansion of this clinical collaboration provides clear evidence of industry enthusiasm toward BXCL701,” BioXcel CEO Vimal Mehta said in a statement. “We look forward to working closely with Merck KGaA, Darmstadt, Germany and Pfizer as well as Nektar to leverage their clinical and regulatory expertise as we establish the development plan for the triple combination in pancreatic cancer.”

Added Nektar CSO Jonathan Zalevsky: “We believe it is essential to target multiple dimensions of the immune system in parallel to address the multi-faceted etiologies underlying cancer cell growth in difficult-to-treat tumors such as pancreatic cancer.”

Bavencio is a human anti-programmed death ligand (PD-L1) antibody that Merck KGaA and Pfizer are jointly co-developing and co-commercializing through an up-to-$2.85 billion partnership launched in 2014

Bavencio reached the market in 2017, the year it won approval for indications in metastatic urothelial cancer (mUC) and locally advanced or metastatic Merkel cell carcinoma (MCC)—the first treatment approved for the rare, aggressive form of skin cancer.

Bempegaldesleukin preferentially binds to the CD122 receptor on the surface of cancer-fighting immune cells, with the goal of stimulating their proliferation. In clinical and preclinical studies, treatment with bempegaldesleukin resulted in expansion of these cells and mobilization into the tumor micro-environment.

BXCL701 is an orally-available systemic innate-immune activator designed to stimulate both the innate and acquired immune systems. Specifically, BXCL701 is designed to inhibit dipeptidyl peptidase (DPP) 8/9 and blocking immune evasion by targeting Fibroblast Activation Protein (FAP). The DPP 8/9 & FAP Inhibitor is in development as a treatment for pancreatic cancer and neuroendocrine prostate cancer (tNEPC).

According to BioXcel, BXCL701 has shown single agent activity in melanoma, with an established safety profile from 700 healthy subjects and cancer patients. Preclinical combination data evaluating BXCL701, a checkpoint inhibitor and other immuno-oncology agents has demonstrated encouraging anti-tumor activity in multiple tumor types and formation of functional immunological memory.

“This experimental triple combination regimen of BXCL701, NKTR-214 and avelumab is designed to leverage multiple mechanisms of action to better fight pancreatic cancer while potentially generating long-term cancer immunity,” Zalevsky added.

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