Calibr, Synthego, BlueSphere and More Showcase Data at CAR-TCR Summit
22 Sep 2022
Gene TherapyCell Therapy
Courtesy of gorodenkoff/Getty Images
The 7th Annual CAR-TCR Summit is ongoing in Boston, MA, with more than 1,000 experts in CAR and TCR technologies attending. Here’s a look at some of the latest research and data being presented.
Calibr's CAR-T Therapy Generates CRs in 6 of 9 Patients
Calibr, the drug discovery and development division of Scripps Research, presented Phase I data for its next-generation switchable CAR-T cell therapy.
In the small study, six of nine patients receiving the therapy for B-cell cancers demonstrated a complete response.
Calibr's approach involves so-called “on” or “off” switches. In the study, the CAR-T cells are inactive when first dosed, then activated when the patient receives the anti-CD19 SWI019 switch that can turn it off.
Travis Young, VP of biologics at Calibr, called the therapeutic the "first step toward demonstrating the potential of this universal platform to be programmed toward any target."
Synthego’s Industrialized Approach to CRISPR Research
Rebecca Nugent, Ph.D., VP of platform research at Synthego, showed how the company is taking an industrialized approach to CRISPR research in order to accelerate cell and gene therapy development.
The company’s platform involves multiplexing gene editing efficiency and accuracy at the same to in order to “de-risk” biology and develop off-the-shelf gene editing strategies.
In July, the company broke ground on a 20,000-square-foot manufacturing facility that will expand its Halo Platform, allowing it to expand the production of its precision gene editing tools and better assist biopharma customers working on CRISPR-mediated gene therapies. Synthego expects the facility to be operational late this year.
BlueSphere Bio’s TCXpress and iTCXpress TCR Platforms
BlueSphere Bio presented a poster describing its TCXpress and iTCXpress high-through platforms for TCRs.
The TCXpress platform is a high-through T-cell receptor capture, expression and functional screening process that can process thousands of single T-cells directly into functionally expressed TCRs in days. This allows for the creation of libraries without lengthy predictive sequencing.
The company also expects to first Investigational New Drug (IND) application in the first quarter of 2023 for a novel TCR-T-cell therapy in patients with high-risk leukemias, including acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myeloid dysplastic syndrome (MDS) as they relate to allogeneic stem cell transplantation.
CARsGen’s Autologous CAR-T Shows Strong Overall Response Rate
Shanghai, China-based CARsgen Therapeutics presented positive data from the North American Phase II trial of zevorcabtagene autoleucel (zevor-cel). The therapy is an autologous CAR T-cell against BCMA in patients with relapsed and/or refractory multiple myeloma (R/R MM).
Seventeen patients with R/R MM received zevor-cel in the Phase II portion of the Phase Ib/II trial and were followed for a median of 113 days. Patients were heavily pretreated with a median of six previous therapies.
Of the 11 who could be evaluated with at least eight weeks of follow-up, the objective response rate (ORR) was 100%. This improved with longer follow-ups.
The therapy appears to be safe with no patients having Grade 3 or higher cytokine release syndrome, CARsGen reported, although Grade 1 or 2 was observed in 59% of patients. One transient Grade 3 neurotoxicity event was observed, but the patient fully recovered.
Raffaele Baffa, CMO of CARsgen, said the results “indicate a consistent trend of clinical benefit with the data of earlier trials conducted on zevor-cel." These include the investigator-initiated trials and LUMMICAR-1 Phase I trials in China.
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