CARsgen Presents First-in-human Outcomes of GPRC5D Focusing on CAR-T CT071 at EHA 2024 By Investing.com

SHANGHAI, June 15, 2024 /PRNewswire/ — CARsgen Therapeutics Holdings Restricted (Inventory Code: 2171.HK), an organization targeted on progressive CAR T-cell therapies for the remedy of hematologic malignancies and strong tumors, declares that the preliminary outcomes from the continuing first-in-human research of CT071 have been offered on the twenty ninth Annual Congress of the European Hematology Affiliation (EHA).

The preliminary outcomes of Part I of CT071 (NCT05838131) have been offered as a poster on the twenty ninth EHA Annual Congress on June 14, 18:00 – 19:00 CEST, which was titled “First-in-human study of GPRC5D-targeted CAR T cells (CT071) with an accelerated manufacturing process in patients with relapsed/ refractory multiple myeloma (RRMM)”.^[1]

“Multiple myeloma is a common yet incurable hematologic malignancy with high unmet need. Despite the numerous recent advances, most patients relapse and become refractory to available therapies and therefore, novel therapies are needed. GPRC5D, a protein highly expressed on the surface of malignant plasma cells with limited expression on normal tissues, represents a promising target for treating multiple myeloma. CT071 is a fully human GPRC5D-targeting autologous second-generation CAR T-cell product manufactured using our expedited CARcelerate^™ platform that shortens the manufacturing time to around 30 hours, supporting a shorter vein-to-vein time and younger T cells. The preliminary results of the ongoing study presented at EHA shows that CT071 has the potential to be the best-in-class GPRC5D targeting CAR-T therapy,” mentioned Raffaele Baffa, M.D., Ph.D., Chief Medical Officer of CARsgen Therapeutics. “We are excited about advancing CT071 and look forward to sharing future updates with the medical community.”

As of February 28, 2024, 10 sufferers have been dosed with CT071”7 sufferers at 1.0×10⁵ cells/kg and three sufferers at 3.0×10⁵ cells/kg. Amongst them, 80% had high-risk cytogenetics, 30% had a number of extramedullary plasmacytomas (EMD), and 40% have been at R-ISS stage III. This was a closely pre-treated inhabitants with a median of 5 prior traces of remedy, together with 90% double-class refractory, 70% triple-class refractory, 40% penta-drug refractory, 50% having obtained autologous stem cell transplantation, and 20% had beforehand been handled with BCMA/CD19 dual-targeting CAR T cells. Not one of the sufferers on the research required bridging remedy attributable to fast manufacturing turnaround.

The median follow-up on the time of information cut-off was 4.07 months (vary: 2.8-7.4). There have been no Grade 3 or larger cytokine launch syndrome (CRS) occasions. No immune effector cell-associated neurotoxicity syndrome (ICANS) was noticed. No adversarial occasions of particular curiosity or dose limiting toxicity (DLT) occurred. 4 sufferers skilled treatment-related SAE, together with pneumonia (n=1), decreased urge for food (n=1) and thrombocytopenia (n=2), and all recovered.

The general response charge was 90%, together with 5 sufferers (50%) with stringent full response (sCR), 2 sufferers (20%) with excellent partial response (VGPR), and a pair of sufferers (20%) with partial response (PR). All of the 9 sufferers with evaluable MRD evaluation at Week 4 achieved MRD negativity (10^-6 threshold) ), together with all 5 sufferers with sCR/CR.  The  pharmacokinetic evaluation demonstrated sturdy cell growth and persistence, with median T_max of 14 days (vary: 12-28) and median C_max of 32280.5 copies/μg gDNA (vary: 8372-106060).

About CT071
CT071 is a CAR T-cell remedy candidate developed using CARsgen’s proprietary CARcelerate^™ platform concentrating on GPRC5D for the remedy of R/R MM or relapsed/refractory plasma cell leukemia (“R/R PCL”). An investigator-initiated trial (NCT05838131) is ongoing in China to judge the protection and efficacy of CT071 for the remedy of R/R MM or R/R PCL. One other investigator-initiated trial (NCT06407947) is ongoing in China for the remedy of newly identified a number of myeloma (NDMM).

About CARsgen Therapeutics Holdings Restricted
CARsgen is a biopharmaceutical firm with operations in China and the U.S. and is targeted on progressive CAR T-cell therapies for the remedy of hematologic malignancies and strong tumors. CARsgen has established a complete CAR T-cell analysis and growth platform, encompassing goal discovery, progressive CAR T-cell growth, scientific trials, and commercial-scale manufacturing. CARsgen has internally developed novel applied sciences and a product pipeline with international rights to deal with main challenges of CAR T-cell therapies, comparable to bettering the protection profile, enhancing the efficacy in treating strong tumors, and decreasing remedy prices. CARsgen’s mission is to turn into a worldwide biopharmaceutical chief that brings progressive and differentiated cell therapies to most cancers sufferers worldwide and makes most cancers curable.

Ahead-looking Statements
All statements on this press launch that aren’t historic reality or that don’t relate to current information or present circumstances are forward-looking statements. Such forward-looking statements categorical the Group’s present views, projections, beliefs and expectations with respect to future occasions as of the date of this press launch. Such forward-looking statements are based mostly on a lot of assumptions and components past the Group’s management. In consequence, they’re topic to vital dangers and uncertainties, and precise occasions or outcomes could differ materially from these forward-looking statements and the forward-looking occasions mentioned on this press launch may not happen. Such dangers and uncertainties embody, however are usually not restricted to, these detailed beneath the heading “Principal Risks and Uncertainties” in our most up-to-date annual report and interim report and different bulletins and stories made out there on our company web site, https://www.carsgen.com. No illustration or guarantee is given as to the achievement or reasonableness of, and no reliance ought to be positioned on, any projections, targets, estimates or forecasts contained on this press launch.

Reference
[1] J Du, et al. EHA 2024. 2024 Jun; Poster P941