Policy & Regulation
Biodesix Initiates Clinical Phase Biomarker Development Programme with German Merck and Pfizer
12 February 2020 - - US-based diagnostic solutions company Biodesix, Inc. has initiated the next phase of their biomarker development programme with Germany-based Merck KGaA, Darmstadt, Germany and US-based Pfizer Inc (NYSE: PFE), the company said.

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 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.

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.

The US Food and Drug Administration also granted accelerated approval for avelumab (Bavencio) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma and patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing 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.

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 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.