HiberCell and Biodesix Initiate Broad Collaboration for Companion Diagnostic Discovery, Development and Commercialization

Initial program to focus on development of a companion diagnostic for HiberCell’s novel immunotherapy, Imprime PGG, to aid in patient selection across multiple oncology programs

NEW YORK & BOULDER, Colo.--(BUSINESS WIRE)--Biodesix, Inc. (Nasdaq: BDSX) today announced an agreement with HiberCell, a biotechnology company developing novel therapeutics for cancer relapse and metastasis, to further the development of an enzyme-linked immunosorbent assay (ELISA) as a companion diagnostic in future registrational trials in breast cancer for Imprime PGG programs. Terms of the partnership were not disclosed.

Biodesix leverages multiple technologies with its proprietary artificial intelligence platform to discover, develop and commercialize diagnostic solutions for unmet clinical needs. Through this agreement, Biodesix will continue its leadership in clinical proteomics by developing a companion diagnostic to select patients for enrollment in HiberCell’s future registrational clinical trials. The ELISA test, which will be validated in Biodesix’s NYS 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 Imprime PGG therapy.

“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., co-founder and chief executive officer of HiberCell. “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.”

“Biodesix is excited to collaborate with HiberCell across their promising portfolio,” said Scott Hutton, president and chief executive officer of Biodesix. “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. Working together on a companion diagnostic for the Imprime PGG program is only touching the surface of what we can do together. This approach to identifying patients for this drug is very novel and holds tremendous promise.”

About Biodesix

Biodesix is a leading diagnostic company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix is the first company to offer 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 and virus that impacts the lung and causes COVID-19. 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. The 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. Biodesix also collaborates with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, visit biodesix.com.

About HiberCell

HiberCell is dedicated to developing therapeutic molecules that overcome foundational scientific barriers that prevent patients from living longer, cancer-free lives. The company recognizes cancer as a chronic disease and is working to develop therapies that address the most common cause of cancer mortality: relapse and metastasis. To that end, HiberCell is actively developing therapies with a focus on modulating stress mediated adaptive biology and reprogramming the immunosuppressive tumor microenvironment given their critical role in cancer recurrence and metastatic disease.

HiberCell is headquartered in New York City with a site in Roseville, Minnesota. For more information, please visit https://www.hibercell.com and follow on LinkedIn.

About Imprime PGG

Imprime PGG is a novel innate immune activator that binds and agonizes dectin-1. This functions 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. Phase II clinical studies of Imprime PGG in combination with checkpoint inhibitors provided mechanistic proof-of-concept data including 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 is continuing studies of Imprime PGG in metastatic breast cancer post HR failure while exploring additional cancer indications that include treatment-naïve, resectable, stage III melanoma.

Note Regarding Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. Biodesix has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. Moreover, Biodesix operates in a competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for its management to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. Biodesix undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

Biodesix Media Contact
Jordona Jackson Smith
jordona@jacksonbio.com
(805) 674-7347

HiberCell Media Contact
Danielle Cantey
Glover Park Group
dcantey@gpg.com
(202) 295-0155