FDA approves IND application for switchable CAR T-cell therapy

The FDA approved an application for an investigational new drug (IND) for Calibr’s “switchable” CAR T-cell therapy to treat certain cancers, such as non-Hodgkin lymphoma and chronic lymphocytic leukemia, according to a news release.

Calibr, a drug discovery and development division of Scripps Research, announced the approval on February 3. The division will now look to begin clinical trials for CLBR001 + SWI019, the organization’s novel cell therapy candidate.

The therapy, as described by the Scripps Research Institute news release, “leverages a patient's own immune cells to treat cancer.” If successful, the therapy has the potential to eliminate the life-threatening side effects typically seen in cell therapies to date by putting the immune cells under the control of a molecular “switch.”

"CLBR001 + SWI019 is a first-in-class switchable CAR-T cell platform designed to confer the efficacy associated with engineered T cell therapies, while potentially affording greater safety and versatility through the incorporation of a control switch," said Travis Young, PhD, in a news release.

Young, Calibr's vice president of biologics and leader of its CAR T development program, believes this therapy has the potential to be “universally applied to other types of cancer, including solid tumor cancers that have yet to reap the benefits of CAR T therapies.”

The switchable CAR T-cell therapy Calibr invented incorporates the antibody SWI019, which activates the cell and directs it to engage the cancer target. The switch, which proved extremely effective at eliminating tumors and managing cytokine levels in preclinical trials, has the potential to help doctors regulate the potency of therapies and safety of treatment.

"AbbVie continues to be impressed by Calibr's progress on advancing this innovative switchable cell therapy technology," said Mohit Trikha, PhD, in a news release.

Calibr recently partnered with AbbVie in which the biopharmaceutical company holds specific rights to commercialization. Trikha, the vice president and head of oncology early development and Bay Area site head at AbbVie, continued to say, “This milestone is an important step forward for this potential CAR-T therapy and our recently expanded collaboration with Scripps Research, which holds promise to rapidly advance additional treatment options for patients.”

Calibr expects to begin recruitment and enrollment for this phase I clinical trial in the first half of 2020, with Calibr’s chief medical officer Pamela D. Garzone, PhD, leading the clinical development of CLBR001 + SWI019. The trial has the potential to eventually evolve its platform to include solid tumors.

Reference:

FDA clears investigational new drug application for Calibr's 'switchable' CAR-T therapy [news release]. La Jolla, California. Published February 3, 2020. https://www.eurekalert.org/pub_releases/2020-02/sri-fci020320.php. Accessed February 6, 2020.