91% ORR! First Patient Dosed with CD19/CD20 CAR-T Therapy IMPT-314; Domestic SLE CAR-T Programs Advance

IMPT-314 is a potential First-in-class CAR-T product targeting CD19/CD20., leveraging an effective bispecific CAR combined with a 4-1BB co-stimulatory domain, designed to limit tumor escape and enhance tolerance and safety. Previously, IMPT-314 received Fast Track designation from the U.S. FDA.The technology of this candidate product is based on the University of California, Los Angeles (Research achievements of Dr. Yvonne Chen, associate professor at UCLA, and Dr. Sarah Larson, clinical associate professor.

Results from a clinical trial led by UCLA show:IMPT-314TreatmentOverall Response Rate in R/R Non-Hodgkin Lymphoma Patients（ORR) is91%（10/11), completelyRemission Rate（CR）For73%（8/11），Median Progression-Free Survival is18.2 months; The drug has good safety,NoneGrade 1 or higher cytokine release syndrome, no neurotoxicity.

ImmPACT Bio has developed a logic circuit CAR-T platform, specifically designed to address antigen escape, toxicity to healthy tissues, and the immunosuppressive tumor microenvironment. This logic circuit platform expresses two different CARs on the surface of CAR-T cells:An activating CAR (aCAR) that can target antigens on the surface of tumor cells; and an inhibitory CAR (iCAR) that can target antigens expressed in healthy cells but lost in tumors.When this therapy comes into contact with healthy cells, the inhibitory CAR is activated, thereby preventing the activation of CAR-T therapy; the opposite occurs when it contacts tumor cells.

▲ Technology Platform (Image Source: Official Website)

In addition, ImmPACT Bio also has the TGF-β CAR technology platform, whichCan be modularly equipped with tumor-targeting binding domains to generate bispecific "OR-Gate" CARs, reconnecting T cells' response to TGF-β, thereby converting this potent immunosuppressive cytokine into a T-cell stimulant. The single-chain bispecific CAR can convert TGF-β signals while directly targeting tumor surface antigens, enabling T cells to robustly eliminate tumor cells even within highly immunosuppressive microenvironments.

These technology platforms have also made ImmPACT Bio a favorite among many investment institutions. It secured $18 million in Series A funding in August 2020 and completed a $111 million Series B financing round in January 2022. Following the financing, Dr. Sumant Ramachandra, CEO of ImmPACT Bio, stated that the company will continue to advance its transformative next-generation CAR-T cell therapy pipeline.

In addition to IMPT-314, ImmPACT Bio also has IMPT-514, which shares the same CAR structure as IMPT-314 and also targets CD19/CD20, for the treatment of active refractory systemic lupus erythematosus (SLE).This is also the first bispecific CD19/CD20 CAR-T therapy for the treatment of SLE.. In August this year, the therapy has been approved for clinical use.

Previously released data show that researchers successfully generated active products using cells from patients with immune diseases. IMPT-514 demonstrated potent autologous B-cell killing properties and limited cytokine secretion in vitro, with improved tissue and lymphoid organ penetration, potentially reshaping the immune response to achieve durable remission. Meanwhile, this candidate product exhibited a favorable safety profile.

As the indications for CAR-T expand, many companies have shifted their focus to SLE in autoimmune diseases, and some companies in China are also making progress.

Relma-cel Injection by JW TherapeuticsIt is an autologous CD19 CAR-T therapy that has been approved for marketing, used to treat adult patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) after two or more lines of systemic therapy, as well as adult patients with refractory or relapsed follicular lymphoma (R/R FL) within 24 months after two or more lines of systemic therapy.

In April this year, the IND for Relma-cel Injection for the treatment of moderate to severe refractory systemic lupus erythematosus was approved. Dr. Albert Li, co-founder, chairman, and CEO of JW Therapeutics, stated that autoimmune diseases are one of the key strategic focuses in JW Therapeutics' layout.

Gracell Biotechnologies' GC012FGC012F is a BCMA/CD19 dual-targeting autologous CAR-T cell therapy developed on Gracell Biotechnologies' proprietary FasTCAR technology platform, incorporating multiple technologies including FasTCAR's "next-day production." Gracell Biotechnologies is currently conducting several clinical studies on GC012F.

In May this year, Gracell Biotechnologies announced the launch of an IIT clinical trial for GC012F targeting refractory systemic lupus erythematosus. By targeting two antigens, GC012F will be able to more deeply and broadly eliminate B cells and plasma cells that produce autoantibodies.

Notably, in April this year, Cabaletta Bio, the partner of IASO Biotherapeutics, announced that the IND for CABA-201 had been approved by the FDA for the treatment of active lupus nephritis (LN) or active systemic lupus erythematosus without renal involvement. Reportedly,The CD19 sequence of this fully human CD19 CAR-T therapy is exclusively licensed from IASO Biotherapeutics.。

Through this collaboration, IASO Bio will be eligible to receive upfront payments totaling approximately USD 162 million for up to two products, as well as potential development and commercialization milestone payments and sales royalties. Meanwhile, IASO Bio holds the priority right to develop and commercialize Cabaletta’s products using the licensed sequences in Greater China.

Overall, CAR-T therapy is making progress in multiple areas. Beyond hematologic tumors, indications with broader markets such as solid tumors and autoimmune diseases remain to be further explored, and CAR-T therapy has already achieved preliminary results in these fields. However, there are still many challenges to be addressed, and we look forward to its further advancements.

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