Scripps Research is charting new territory with its Calibr division, a drug discovery and drug development group within the research institute that is advancing its own experimental treatments.
This week Calibr announced it had received the agency’s go-ahead to move a CAR-T cell therapy it has been evaluating for the treatment of certain blood cancers, including relapsed/refractory B-cell malignancies such as non-Hodgkin lymphoma and chronic lymphocytic leukemia, into human testing.
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The CAR-T therapy that Calibr plans to test brings a new approach to the engineered T cell therapy arena with a so-called “switchable” version intended to eliminate life-threatening side effects.
The cell therapy candidate, CLBR001 + SWI019, uses a patient’s own immune cells that have been engineered to root out and kill cancer cells along with a molecular “switch” (SWI019) to activate those cells. Some patients who get T-cell therapies get a side effect known as cytokine release syndrome, in which cytokines cause dangerous inflammation. The idea is that having a control mechanism could allow for more precise regulation of the therapy and manage the strength of the immune system response.
Calibr anticipates enrolling patients for the Phase 1 trial in the first half of 2020. Travis Young, Calibr’s vice president of biologics and CAR-T development program lead, says the program, if successful, holds promise for other types of cancer, too, including solid tumor cancers which as of yet have no CAR-T therapies.
Initially supported by the Wellcome Trust, Calibr inked a deal in 2018 to partner on the switchable CAR-T program with AbbVie (NYSE: ABBV).
Under the terms of the deal, Scripps Research handles pre-clinical research and development and, in some cases, Phase 1 clinical trials. Then AbbVie has an exclusive option to further develop and commercialize the treatment. If it does so, Scripps will be eligible for an assortment of payments, including royalties if the drug makes it to market.
In December, North Chicago, IL-based pharma expanded its partnership with the Scripps Research division to indications beyond cancer.
The CAR-T clinical study is the third launched and being run independently by Scripps. The institute is also testing a bispecific antibody for prostate cancer in a Phase 1 trial.