Biodesix has agreed to develop a companion diagnostic (CDx) for select patients in HiberCell’s future registrational clinical trials assessing its Imprime PGG immunotherapy in breast cancer, the companies said—the initial program in a broad CDx discovery, development, and commercialization collaboration.

Through a partnership whose value was not disclosed, Biodesix agreed to develop an enzyme-linked immunosorbent assay (ELISA) as a CDx to Imprime PGG using its proprietary artificial intelligence platform.

The ELISA test, to be validated in Biodesix’s New York State CLEP-approved and CLIA-accredited lab, will be designed to test for Anti-β Glucan IgG Antibody (IgG ABA) expression in breast and melanoma serum samples to assess cancer patients’ eligibility for treatment with Imprime PGG.

“Our leadership in clinical proteomics along with our comprehensive approach to diagnostic discovery, development and commercialization will help streamline and accelerate HiberCell’s ability to bring critical therapies to patients,” Biodesix President and CEO Scott Hutton said in a statement.

Based in Boulder, CO, Biodesix offers six non-invasive tests for patients with diseases of the lung. Biodesix launched the SARS-CoV-2 ddPCR™ test and the Platelia SARS-CoV-2 Total Ab in response to the global pandemic. The blood-based Biodesix Lung Reflex® strategy for lung cancer patients integrates the GeneStrat® and VeriStrat® tests to support treatment decisions with results in 72 hours, expediting time to treatment.

Biodesix’s blood-based Nodify Lung™ nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT™ tests, evaluates the risk of malignancy in incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action

“We are pleased to partner with Biodesix to further enable our patient stratification capabilities for our lead clinical asset, Imprime PGG,” said Alan C. Rigby, Ph.D., HiberCell’s co-founder and CEO. “We look forward to a robust collaborative effort with the Biodesix team that is initially focused on rapidly identifying patients for our Imprime PGG clinical trials, while supportive of our efforts to bring a potentially transformative portfolio of therapies to patients living with hard-to-treat recurrent metastatic disease.”

Imprime PGG is a novel innate immune activator designed to binds and agonizes dectin-1. That binding and agonizing is intended to activate innate and adaptive immunity, reprogramming the immunosuppressive tumor microenvironment to enhance antigen presentation, T cell activation and ultimately enhance the immune response against tumors.

HiberCell has cited Phase II trials of Imprime PGG in combination with checkpoint inhibitors, which have generated mechanistic proof-of-concept data that included the activation of innate and adaptive immunity resulting in improved overall survival, overall response and disease control rates in metastatic triple negative breast cancer (mTNBC).

HiberCell said it continues to study Imprime PGG in metastatic breast cancer post hormone receptor (HR) failure while exploring additional cancer indications that include treatment-naïve, resectable, stage III melanoma.

Headquartered in New York City with a site in Roseville, MN, HiberCell specializes in therapeutics for cancer relapse and metastasis.

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