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Biodesix Pushes Back Immunotherapy Test Development Timeline

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NEW YORK (GenomeWeb) – Biodesix is pushing back the timeline for its immunotherapy test development program as it works to assess what clinical questions are likely to be the biggest challenges for the field.

In April, the company said it planned to launch a proteomic test for guiding immunotherapy in non-small cell lung cancer patients around the middle of this year. This week, Heinrich Röder, Biodesix's chief technology officer, said the firm had decided to take more time to better understand the clinical need and market for such a test.

"Given the speed at which immunotherapies are moving across indications and within indications, we thought it was prudent to really understand what the long-term clinical questions are we would like to answer in a commercial setting," Röder said.

He added that the company has settled on three main goals for the test it hopes to develop. The first is to identify patients prior to treatment who are unlikely to receive durable benefit from immunotherapy. The second is to distinguish between patients who would benefit from combination therapies and those who would do equally well on a monotherapy. The third goal, which Röder characterized as somewhat "more visionary" than the other two, is to develop a test that will be informative about the likely effectiveness of not only existing immunotherapies but also immunotherapies that may be available in the future.

"We want to have the test be sufficiently broad that it can possibly address some of the future products and combinations that will come on the market, by addressing commonalities between mechanisms of resistance and response," he said.

Röder presented some of Biodesix's immunotherapy work last week at the Society for Immunotherapy of Cancer annual meeting in National Harbor, Maryland. In work in melanoma, some of which the company previously presented, Biodesix and its collaborators developed two different classifiers, one for use with patients treated with checkpoint inhibitors, the other for patients undergoing HD-IL2 therapy. Looking at 119 patients treated with anti-PD1 checkpoint inhibition, 48 with anti-CTLA4 checkpoint inhibition, and 114 with HD-IL2 therapy, they found that for each treatment, they could identify groups of patients receiving little long-term benefit.

The test was also able to identify a group of patients resistant to monotherapy but  responding to combination checkpoint inhibitor therapy.

Röder noted that based on the proteomic analysis underpinning the tests, the anti-PD1 and HD-IL2 resistant patients had elevated levels of complement, acute phase reactants, and wound healing.

In non-small cell lung cancer, the company similarly identified, in a development cohort of 98 subjects and a validation cohort of 32 subjects, a group of patients receiving little long-term benefit from treatment with Bristol-Myers Squibb's PD-1 checkpoint inhibitor Opdivo (nivolumab).

Röder described the research presented at SITC as "collaborative efforts with academic groups that will be used in the development of a test in lung cancer for immune resistance."

"This [research] was done primarily to understand the commonalities between the systems across indications and treatments," he said, adding that he expected the "final test we come out with will be much more efficient and tuned to particular problems."

Like Biodesix's first proteomic test, Veristrat, which is intended to guide EGFR-inhibitor therapy in NSCLC patients, the immunotherapy tests were developed and are run using MALDI mass spec. The company has established a new MALDI discovery platform since the launch of Veristrat that uses more advanced instrumentation and informatics.

According to Röder, Biodesix now plans to work with existing retrospective sample sets to further validate the observations presented at SITC. He added that the company also plans to do prospective studies in a frontline setting, looking at whether the assays can identify patients more or less likely to respond to different treatment approaches, including single immunotherapies and combinations of immunotherapies and chemotherapies.