Agenus Begins Clinical Trial Testing New Therapy for Cervical Cancer, Solid Tumors

Agenus Begins Clinical Trial Testing New Therapy for Cervical Cancer, Solid Tumors

The first patient has been dosed in the Phase 1/2 trial testing AGEN2034, Agenus‘ new PD-1 inhibitor, in patients with advanced solid tumors and cervical cancer. The trial is currently enrolling participants.

“The entry of our PD-1 antagonist into the clinic is key to our strategy to pursue combination therapies,” Garo H. Armen, PhD, chairman and CEO of Agenus, said in a press release. “PD-1 is a clinically validated target, and to combine it with our CTLA-4 directed antibody is the backbone of Agenus’ combination strategy.

“We also intend to pursue combinations of PD-1 and CTLA-4 antibodies with our novel portfolio of other checkpoint antibodies as well as our neoantigen cancer vaccines,” he said.

AGEN2034 is an antibody targeting the PD-1 molecule, a receptor expressed at the surface of activated T-cells. When the receptor interacts with the PD-L1 or PD-L2 molecules, the activity of T-cells is neutralized. Cancer cells often hijack this system to prevent T-cells from recognizing and killing them, making PD-1 antibodies a revolutionizing cancer treatment.

The ongoing Phase 1/2 trial (NCT03104699), is an open-label, dose escalation trial that will be conducted in two parts. In part 1, researchers will assess the safety, tolerability, and clinical activity of ascending doses of AGEN2034 in patients with metastatic or locally advanced solid tumors. Each dose cohort will include three patients.

The Phase 2 part of the trial the study will expand to include patients with recurrent, unresectable, or metastatic cervical cancer patients, whose disease progressed after a platinum-containing doublet, such as Taxol (paclitaxel)/Platinol (cisplatin), or Taxol/Platinol/Avastin (bevacizumab).

The study’s primary goal is to assess the dose-limiting toxicity of AGEN2034 and its maximum tolerated dose, as well as the best overall response. Secondary objectives are progression-free survival, duration of response, overall survival, and the dynamics of the drug in the patient’s blood. Preliminary safety and effectiveness data are expected within the next nine to 12 months.

“Immune checkpoint antibodies targeting PD-1/PD-L1 and CTLA-4 have become the mainstay of I-O combinations,” said Jean-Marie Cuillerot, MD, chief medical officer of Agenus. “Co-targeting the PD-1/PD-L1 axis in combination with CTLA-4 has shown a near doubling of clinical efficacy in certain indications.

“We believe our strategy in pursuing virally-induced cancers presents a rapid path to BLA for our PD-1 and CTLA-4 antagonists,” Cuillerot added. “In addition, combination approaches involving our vaccines offer a unique opportunity for differentiation in patients who are unresponsive to checkpoint directed monotherapies.”

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