Restructuring, Setbacks

Immune Design buries its PhIII work on cancer, and investors hit the panic button

More than a year after touting some early glimmers of success for a combination of their drug CMB305 and Tecentriq (atezolizumab), Immune Design is throwing in the towel after determining that their ongoing Phase II program is headed to failure.

Investors are not in the least pleased with the changeup for CMB305, their lead drug. The biotech’s shares $IMDZ shed half their value after the decision was announced.

Immune Design is restructuring as a result of the setback, which will help preserve cash into 2021 as the company switches to survival mode.

Carlos Paya

Company CEO Carlos Paya had stoked interest in the drug’s impact on NY-ESO-1/positive soft tissue sarcoma at ESMO in Madrid last year. On Thursday, though, the company issued a statement — sans quotes — saying that they were dropping the planned Phase III SYNOVATE study in relapsed synovial sarcoma patients after they failed to track a survival benefit and would see if collaborators would continue the work in sarcoma.

That may be a long shot.

Their new focus is G100, a TLR4 agonist which they much prefer to discuss now. With their share price crushed and their platform tech on immuno-oncology under a cloud, the biotech laid out plans to hustle the drug into a combination study with Keytruda for fourth line follicular lymphoma patients. And they believe they have a shot at an accelerated approval — if it all works according to plan, which includes tracking a 40% or better ORR in a single-arm study.

In a call with analysts, the CEO said they will roll out more mid-stage data at ASH. And more combos are planned as well.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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