Senti Biosciences, Inc. SNTI announced that the FDA has cleared its investigational new drug (IND) application to begin clinical studies on its chimeric antigen receptor natural killer (CAR-NK) cell therapy candidate, SENTI-202, for the treatment of relapsed/refractory hematologic malignancies, including acute myeloid leukemia (AML). Shares of the company were up 18.7% on Dec 22, following the announcement of the news.

Per management, a potential first-in-class off-the-shelf CAR-NK cell therapy, SENTI-202, is being developed to selectively target and eliminate CD33 and/or FLT3 expressing hematologic malignancies, like AML and myelodysplastic syndrome (MDS), while not affecting the healthy bone marrow cells.

Following the FDA’s clearance of the IND, Senti Bio plans to initiate a phase I study on SENTI-202 at various sites in the United States and Australia. The first patient in the study is expected to be treated in the second quarter of 2024.

Initial efficacy data from the phase I study is expected by 2024-end while durability data is anticipated in 2025.

Shares of Senti Bio have plunged 58.4% in the past year compared with the industry’s decline of 15.1%.

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Enrollment of adult patients with r/r CD33 and/or FLT3 expressing heme malignancies is currently ongoing in the phase I study on SENTI-202.

If successfully developed, SENTI-202 can become a potential first-in-class allogenic treatment for patients with AML/MDS.

This apart, Senti Bio has another cancer candidate in its portfolio, SENTI-301A.

In November 2023, Senti Bio entered into a collaboration agreement with China-based biotechnology company, Celest Therapeutics, for the clinical development of SENTI-301A to treat solid tumors including liver cancer in China.

In the absence of a marketed product currently, the successful development of its pipeline candidates remains the key focus for Senti Bio.

Zacks Rank & Stocks to Consider

Senti Bio currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector are Taro Pharmaceutical Industries Ltd. TARO Entrada Therapeutics, Inc. TRDA and Puma Biotechnology, Inc. PBYI, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Taro Pharmaceutical’s 2024 earnings per share have improved from 96 cents to $1.10. In the past year, shares of TARO have surged 45.9%.

Earnings of Taro Pharmaceutical beat estimates in two of the last four quarters while missing the same on the remaining two occasions. TARO delivered a four-quarter earnings surprise of 10.06%, on average.