Biodesix Announces Initiation of Clinical Phase Biomarker Development Program with Merck KGaA, Darmstadt, Germany and Pfizer Inc.

Program Aims to Improve Overall Survival in Advanced-Stage Cancers

BOULDER, CO., February 11, 2020 - Biodesix, Inc. announced initiation of the next phase of their biomarker development program with Merck KGaA, Darmstadt, Germany and Pfizer Inc. NEW YORK, NY. The companies have completed initial discovery and development of a new proteomic test that identifies likely responders to the anti-PD-L1 checkpoint inhibitor (BAVENCIO®) (avelumab). Development efforts will now focus on transferring the test into Biodesix’s CLIA lab in Boulder, CO for clinical phase test validation. The new test was developed through retrospective analysis of the circulating proteome of cancer patients treated with the investigational drug candidate, utilizing the proprietary Biodesix Diagnostic Cortex™ artificial intelligence (AI) platform. Data from the initial test discovery and development program will be presented at an upcoming scientific meeting in 2020.

The Diagnostic Cortex platform is based on modern AI techniques to design clinically useful tests that are reproducible and robust, and typically use hundreds of different markers. Based on data found in the circulating proteome and genome, Biodesix designs tests that support treatment decisions including patient selection for immunotherapies, novel therapy combinations, and alternative treatment pathways.

“We are pleased to announce this next phase in our collaboration with Merck KGaA, Darmstadt, Germany and Pfizer with the potential to extend treatment options to more patients. This relationship combines Biodesix’s strengths in test discovery and development, artificial intelligence, and their applications to immunotherapy, with the pharmaceutical leadership of Merck KGaA, Darmstadt, Germany and Pfizer,” said Scott Hutton, Biodesix CEO. “The successful progression of this project is another example of how our proprietary Diagnostic Cortex AI-based biomarker platform is uniquely suited to advancing clinical research and investigating new indications for existing therapies.”

“We are pleased to announce this next phase in our collaboration with Merck KGaA, Darmstadt, Germany and Pfizer with the potential to extend treatment options to more patients. This relationship combines Biodesix’s strengths in test discovery and development, artificial intelligence, and their applications to immunotherapy, with the pharmaceutical leadership of Merck KGaA, Darmstadt, Germany and Pfizer,” said Scott Hutton, Biodesix CEO. “The successful progression of this project is another example of how our proprietary Diagnostic Cortex AI-based biomarker platform is uniquely suited to advancing clinical research and investigating new indications for existing therapies.”

Avelumab Approved Indications

Avelumab (BAVENCIO®) in combination with axitinib is indicated in the US, EU, Japan and other countries for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The US Food and Drug Administration (FDA) also granted accelerated approval for avelumab (BAVENCIO®) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinumcontaining chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with mMCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO®) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity, major adverse cardiovascular events (MACE) [which can be severe and have included fatal cases], and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO® monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusionrelated reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO® in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 clinical chemistry and hematology laboratory value abnormalities reported in at least 10% of patients treated with BAVENCIO® monotherapy include hyponatremia, lymphopenia, GGT increased; in patients receiving BAVENCIO® in combination with axitinib, grade 3-4 clinical chemistry and hematology laboratory value abnormalities included blood triglyceride increased and lipase increased.

For full Prescribing Information and Medication Guide for BAVENCIO®, please see www.BAVENCIO.com. 

About Biodesix

Biodesix is a lung cancer diagnostic solutions company covering the continuum of patient care from early risk classification of lung nodules through treatment guidance in late stage cancer. The company develops diagnostic tests addressing important clinical questions by combining simple blood draws and multi-omics through the power of artificial intelligence. Biodesix is the first company to offer four best-in class non-invasive tests for patients with lung cancer or suspicious lung nodules.

The 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 Nodify XL2™ test and the Nodify CDT ^TM test evaluate the risk of malignancy in incidental pulmonary nodules, enabling physicians to triage patients to the most appropriate course of action. The company’s strong product pipeline addresses key clinical questions in all stages of lung cancer, from risk assessment of early stage disease to informing treatment decisions for emerging therapies. Biodesix also partners with the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges. For more information about Biodesix, please visit www.biodesix.com