▎WuXiEdited by Kant Content Team

"Intelligent" Off-the-Shelf CAR-NK Therapy Shows Positive Early Clinical Results

Senti Biosciences Announces Positive Preliminary Data from Phase 1 Clinical Trial of Investigational Therapy Senti-202SENTI-202 is a potential "first-in-class" logic-gated off-the-shelf chimeric antigen receptor natural killer cell (CAR-NK) therapy., for the treatment of relapsed/refractory hematologic malignancies, including acute myeloid leukemia (AML). SENTI-202 is designed toSelective targeting and elimination of blood malignancies expressing CD33 and/or FLT3, while avoiding harm to healthy bone marrow cells.

As of the data cutoff date of September 19, 2024,Two of the three AML patients treated at the lowest dose level (1 billion CAR-NK cells per infusion) achieved complete remission (CR)., and confirmed by bone marrow biopsy. In addition,These two patients were assessed as minimal residual disease (MRD) negative after treatment. To date, both patients remain in remission (for more than 4 months and 3 months, respectively).

In all three patients, SENTI-202 was well-tolerated, with an adverse event profile consistent with what is observed in AML patients receiving lymphodepleting chemotherapy.

SENTI-202 is a logic-gated, off-the-shelf CAR-NK cell therapy candidate product designed to selectively target and eliminate hematologic malignancies expressing CD33 and/or FLT3, such as AML and myelodysplastic syndrome (MDS), while avoiding the killing of healthy bone marrow cells. SENTI-202 comprises three main components: first,SENTI-202 contains an "OR gate", this is an activation-type CAR that can recognize CD33 or FLT3.By targeting one or both antigens, SENTI-202 aims to effectively kill leukemia progenitor cells and stem cells; secondly, SENTI-202Includes a "NOT gate," which is an inhibitory CAR designed to recognize healthy cells and protect them from killing, potentially expanding the therapeutic window.; Third, SENTI-202Including controlled-release IL-15, aiming to significantly enhance the persistence, expansion, and activity of CAR-NK cells and host immune cells.The NK cells used to construct SENTI-202 are derived from screened healthy adult donors to ensure product quality and are cryopreserved before use.

Senti Biosciences Plans to Recruit More Patients to Test the Therapeutic Effects of Higher Doses of SENTI-202.

Johnson & Johnson Submits Regulatory Application for IL-23 Inhibitor to Treat Pediatric Patients

Johnson & Johnson announced today that it has submitted two supplemental Biologics License Applications (sBLA) to the U.S. FDA.Seeking approval for Tremfya (guselkumab) to treat children aged 6 years and older with moderate to severe plaque psoriasis (PsO) and children aged 5 years and older with active juvenile psoriatic arthritis (jPsA).

The application for PsO is based on Phase 3 clinical data from pediatric patients with moderate to severe plaque psoriasis in the PROTOSTAR study, as well as Phase 3 pharmacokinetic (PK) bridging data from the VOYAGE 1 and 2 studies in adult patients with moderate to severe plaque psoriasis. The application for jPsA is based on PK extrapolation analysis from adult PsA studies (DISCOVER 1 and 2), as well as efficacy and safety data of Tremfya from the PROTOSTAR study.

Tremfya is an anti-IL-23 monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor.IL-23 is a key driver of immune-mediated diseases such as PsO and psoriatic arthritis.

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