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Senti Bio's SENTI-202: A Promising AML Therapy in Early Stages

AInvestTuesday, Dec 3, 2024 7:24 am ET
3min read


Senti Biosciences, Inc. recently reported positive initial clinical data from a Phase 1 trial of its investigational cell therapy, SENTI-202, for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML). The company's proprietary Gene Circuit platform, which enables the development of next-generation cell and gene therapies, is the backbone of SENTI-202.

SENTI-202 is a potential first-in-class Logic Gated off-the-shelf chimeric antigen receptor natural killer (CAR-NK) cell therapy designed to selectively target and eliminate CD33 and/or FLT3-expressing hematologic malignancies, including AML, while sparing healthy bone marrow cells. The therapy's unique design incorporates an "or gate" for effective killing of leukemic cells, a "not gate" to protect healthy cells, and controlled release of IL-15 for enhanced CAR-NK cell persistence, expansion, and activity.

The Phase 1 trial's preliminary results are encouraging. Two out of three patients with R/R AML achieved complete remission (CR) at the first dose level, with both CRs being measurable residual disease (MRD) negative. This means that the cancer cells were undetectable in bone marrow samples using the most sensitive locally available methods. Additionally, both patients maintained their remission for 4+ months and 3+ months, respectively, with an additional two months of follow-up since the data cutoff date.

In the clinical results summary, three patients were enrolled at the 1.0 billion CAR+ NK cells/dose level, administered three times on days 0, 7, and 14 of a 28-day cycle following lymphodepletion with fludarabine/cytarabine ("Ara-C"). The lowest dose cohort was cleared by the Safety Review Committee, and dose escalation is continuing at the 1.5 billion CAR+ NK cells/dose level. Two patients achieved CR, one after two cycles and the other after one cycle, with absent MRD by the most sensitive methods available. One patient had no response after one cycle of treatment and was refractory to therapy.

SENTI-202 was generally well-tolerated, with no dose-limiting toxicities (DLTs) and an adverse event profile consistent with other investigational NK cell therapies and patients with underlying AML receiving lymphodepleting chemotherapy. The therapy's transgene was detected in the peripheral circulation of all 3 patients and in all cycles, with a pharmacokinetic (PK) profile generally consistent with other investigational CAR-NK therapy levels.

The positive initial clinical data from the Phase 1 trial of SENTI-202 suggests that the therapy has the potential to address the critical limitations of existing therapies and provide hope to people living with AML. As Senti Bio continues dose escalation and collects additional response and durability data, investors and stakeholders will monitor the progress of this promising therapy.

In conclusion, Senti Bio's SENTI-202 has shown encouraging early results in treating R/R AML, with two out of three patients achieving MRD-negative CR and a well-tolerated safety profile. As the company advances through the clinical development process, investors should closely watch the progress of SENTI-202 and its potential to disrupt the AML treatment landscape.

As Senti Bio reports positive initial clinical data from the Phase 1 trial of SENTI-202, the company's stock price has been on an upward trend. The therapy's promising results and well-tolerated safety profile have contributed to investor confidence in the company's prospects. As the trial progresses and more data becomes available, the market's reaction to Senti Bio and its pipeline will be an interesting aspect to monitor.
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