An anti-PD-1 antibody collaboration

Arcus and Strata announce clinical development collaboration for AB122 and predictive biomarkers

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HAYWARD, Calif. & ANN ARBOR, Mich.—Arcus Biosciences Inc. and Strata Oncology Inc. have recently announced a clinical development collaboration utilizing Strata’s precision drug development platform and proprietary biomarkers to evaluate AB122, Arcus’ clinical-stage anti-PD-1 antibody, in a basket trial.
“We look forward to our clinical collaboration with Strata Oncology,” said Dr. Terry Rosen, CEO of Arcus Biosciences. “The use of these proprietary biomarkers and access to the Precision Oncology Network provide a potential opportunity to identify patient populations underserved by existing PD-1 therapies.
“While Arcus’s primary focus is on developing anticancer combination therapies with its potentially best-in-class small-molecule drug candidates, we intend to efficiently pursue targeted opportunities to bring cost-effective anti-PD-1 therapy to cancer patients otherwise not benefiting from this therapeutic class.”
As part of the partnership, Arcus gains access to Strata’s drug development platform, featuring the capability to design and conduct transformative precision therapy studies. AB122 will be evaluated across the Strata Precision Oncology Network of trial-ready health systems that employ the StrataNGS test to pre-screen advanced cancer populations to enable rapid and predictable enrollment of precision therapy trials.
The StrataNGS comprehensive tumor sequencing test is available to all advanced solid tumor patients through the Strata Trial; it is used to identify potential patients for precision therapy trials and to evaluate proprietary biomarkers that may predict response to therapies.
According to Strata and Arcus spokespersons, “The companies decided to collaborate in order to identify patient populations underserved by existing PD-1 therapies, by leveraging data collected from the Strata Trial. Strata identified a novel biomarker-driven treatment hypothesis for anti-PD-1 therapy across a range of tumor types. The two companies had complementary capabilities, which led to a natural collaboration.”
“Through its network of leading cancer centers across the nation, Strata Oncology enrolls advanced cancer patients into the Strata Trial and provides universal testing with its pan-cancer, targeted, 500-gene assay for solid tumors,” the Arcus and Strata spokespersons say. “The StrataNGS test utilizes DNA and RNA from tumor samples to detect all clinically actionable biomarkers.”
Using observational study data, Strata has demonstrated the potential predictive power of its proprietary biomarkers in multiple settings in which anti-PD-1 therapies are known to be effective. Arcus and Strata hope to extend the use of some of these biomarkers to identify patients who may benefit from AB122 treatment, including tumor types that are generally not responsive to anti-PD-1 therapy.
“We predict that biomarker-positive subsets across a range of tumor types may be responsive, including biliary, breast, colon, endometrium, ovary, pancreas, prostate, sarcoma, cancers of unknown primary and other rare cancer types,” note the Strata and Arcus spokespersons.
AB122 is currently being evaluated in an ongoing Phase 1 monotherapy dose-escalation trial in patients with advanced tumors; ongoing Phase 1/1b combination trials evaluating AB122 in combination with AB928, a potentially best-in-class adenosine receptor antagonist; and AB122 in combination with AB154, a novel anti-TIGIT antibody, in patients with advanced solid tumors.
“Various advanced solid tumors are currently being evaluated in the ongoing Phase 1 AB122 monotherapy dose-escalation trial and for the AB122 in combination with AB154 dose-escalation trial,” point out the Arcus and Strata spokespersons. “For the AB154 trial, the dose-escalation portion will be followed by the initiation of dose-expansion cohorts in solid tumors associated with high levels of TIGIT and/or CD155, the primary ligand for TIGIT, once the recommended doses for AB154 as a monotherapy and in combination with AB122 have been identified.”
“For the ongoing Phase 1/1b combination trials evaluating AB122 in combination with AB928, Arcus expects to evaluate patients with renal cell cancer and patients with metastatic castration-resistant prostate cancer for the dose-expansion arms,” the spokespersons continue. “The near-term goals for the partnership are to activate and rapidly enroll the clinical study across the Strata Precision Oncology Network. As the development partnership progresses, we anticipate finding further opportunities for collaboration.”
Under the terms of the agreement, the companies will share development costs for the clinical collaboration. Strata is eligible to receive $2.5 million upon the achievement of a development milestone, as well as regulatory and commercial milestones and royalties on U.S. net sales of AB122 in the biomarker-identified indication. As further consideration, Arcus issued to Strata restricted shares of its common stock, which are subject to vesting based upon the achievement of regulatory milestones within certain timelines.
“Strata is committed to advancing the development of new precision cancer therapies, and we are excited to bring together two talented teams for this collaboration,” commented Dr. Dan Rhodes, co-founder and CEO of Strata Oncology. “This important effort leverages Strata’s unique ability to identify novel biomarker-driven treatment hypotheses using real-world data from the Strata Trial and rapidly translate those insights into prospective clinical trials across our Precision Oncology Network. Coupled with Arcus’ significant expertise in developing cancer immunotherapies, I am confident we will successfully identify and treat patients who may derive benefit from AB122 based upon specific biomarkers.”

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