December 08, 2021

Calibr announces preliminary clinical data from first-in-human clinical trial of switchable CAR-T Cells (CLBR001 SWI019) in lymphoma patients at 63rd Annual ASH Meeting

Two of the first three patients in the lowest dose cohort experienced a complete response to therapy with the longest response being 11 months (ongoing) at the time of data cut-off

The novel switchable CAR-T therapy showed a favorable profile with no toxicities associated with the cell product (CLBR001) alone, validating the universal platform approach to cell therapy

December 08, 2021

LA JOLLA, CA Calibr, a division of Scripps Research focused on the bench to bedside development of transformative medicines, will present preliminary data on the development of a novel switchable CAR-T cell platform for patients with relapsed/refractory lymphoma and leukemia. Preclinical IND-enabling studies supporting the first-in-human clinical study will be presented on December 11 at 5:30 p.m. and the clinical data will be presented on December 12 at 6:00 p.m. at the 63rd Annual ASH meeting.

CLBR001 SWI019 is the first clinical demonstration of Calibr's novel switchable CAR-T cell platform technology, in which the activity of a universal CAR-T cell product (CLBR001) is controlled through dosage of an antibody-based molecule targeting CD19 referred to as a switch (SWI019). The approach represents a paradigm shift from conventional CAR-T cell therapy in that the activity of the CAR-T cells can be switched on or off through dosing of the switch to the patient. This type of switchable control over the cells is expected to improve safety T cell durability of the therapy. Importantly, the CLBR001 switchable CAR-T is universal; by changing the switch, the CAR-T cells can be programmed to attack different antigen targets and thereby treat multiple cancers.

As of the data cutoff, 5 patients (2 with mantle cell lymphoma (MCL), 2 with follicular lymphoma (FL), and 1 with marginal zone lymphoma (MZL)) had been treated across two cohorts. Two of the first three patients who received the lowest doses of CLBR001 and SWI019 in cohort 1 of the dose escalation trial experienced a complete response to treatment as assessed by Lugano criteria. Durability of the response appears promising, with the longest response ongoing at 11 months. Treatment in cohort 2 is ongoing.

In the preliminary safety and tolerability data for CLBR001 SWI019, no adverse events related to the cell product CLBR001 alone were reported, validating the design of the universal cell product to be functionally off in the absence of SWI019. Following administration of the switch molecule SWI019, two subjects experienced transient cytokine release syndrome (CRS) of severity grades 1 and 3. The subject who experienced Grade 1 CRS also experienced Grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS). These cases of CRS/ICANS resolved quickly with typical CRS treatment followed by holding or reducing SWI019 dose, supporting the ability to adjust the CAR-T response in real time.

We are very excited by initial signs of activity even at the lowest doses of CLBR001 and SWI019, says Travis Young, PhD, Calibr's vice president of biologics and lead on the CAR-T development at Calibr. We believe this underscores the potential of this therapy to not only benefit patients with blood cancers, but patients with solid tumors as well.

Liana Nikolaenko, MD, from City of Hope is the lead author on the poster presentation. Switchable CAR-T cell platform, as designed by Calibr, is a remarkable technology enabling a delivery of the targeted therapy for patients with relapsed or refractory B-cell malignancies with a unique approach to mitigate potential toxicities that could be associated with CAR-T cell treatment, which can be severe and life-threatening, says Nikolaenko. The preliminary results of this novel approach are encouraging.

Calibr has partnered the switchable CAR-T cell platform with AbbVie and together they are collaborating on developing the switchable CAR-T cell platform for solid tumor indications. AbbVie holds certain rights to commercialization.

Presentation times

Poster: 2822 First in Human Study of an On/Off Switchable CAR-T Cell Platform Targeting CD19 for B Cell Malignancies (CLBR001 SWI019)

Session Date/Time: Sunday, December 12, 2021, 6:00 p.m.--8:00 p.m.

Presenter: Liana Nikolaenko, MD, City of Hope

Poster: 1695 IND-Enabling Studies of a Switchable Chimeric Antigen Receptor-T Cell (CLBR001 SWI019) to Support First in Human Clinical Study

Session Date/Time: Saturday, December 11, 2021, 5:30 p.m.--7:30 p.m.

Presenter: Eduardo Laborda, PhD, Calibr at Scripps Research

About CLBR001 SWI019:

Calibr at Scripps Research is currently enrolling patients with B cell malignancies including lymphomas and chronic lymphocytic leukemia to an open label Phase I clinical study to test the safety and tolerability of CLBR001 SWI019 (NCT04450069). Up to 30 patients may be enrolled in the multi-center dose escalation trial to determine the optimal dose of CLBR001 and SWI019. Additional information on the study can be found at https://clinicaltrials.gov/ct2/show/NCT04450069.

About Calibr at Scripps Research:

Calibr was founded on the principle that the creation of new medicines can be accelerated by pairing world-class biomedical research with state-of-the-art drug discovery and development capabilities. Leveraging the unique scientific framework of Scripps Research, Calibr has created a portfolio of drug candidates based on Scripps technologies, and is shaping a new paradigm for advancing nonprofit biomedical research to impact patients while re-investing in further innovative research.

Cancer Calibr Calibr

LINK:	https://www.scripps.edu/news-and-events/press-room/2021/20211208-calib...
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