INB-100 shows promise in AML patient remission rates

NEW YORK - IN8bio, Inc. (NASDAQ:INAB), a biopharmaceutical company specializing in gamma-delta T cell therapies, reported positive clinical data from a Phase 1 trial of INB-100, an allogeneic gamma-delta T cell therapy for patients with acute myeloid leukemia (AML). The trial indicated that 100% of AML patients treated with INB-100 post-hematopoietic stem cell transplantation (HSCT) remained in complete remission, with a median follow-up of 20.1 months, outperforming historical control groups. Despite these promising results, InvestingPro data shows the company’s market capitalization stands at just $19.58 million, with shares trading at $0.27.

Patients in the trial demonstrated a one-year progression-free survival (PFS) and overall survival (OS) rate of 100%, significantly higher than the PFS of 67.8% and OS of 74.7% reported by the Center for International Blood and Marrow Transplant Research (CIBMTR) and the Kansas University Cancer Center (KUCC) PFS of 57.4% and OS of 66.7%. According to InvestingPro analysis, analyst price targets range from $1.50 to $8.00, suggesting significant upside potential if the therapy continues to show promise. However, InvestingPro Tips indicate the company is quickly burning through cash, which could impact its ability to advance clinical programs.

The study included patients who were older and had high-risk AML or had failed multiple prior therapies, including CAR-T treatments. Despite the challenging patient profile, the therapy was well-tolerated with manageable side effects, no occurrence of cytokine release syndrome (CRS) or neurotoxicity, and graft-versus-host disease (GvHD) in line with historical data.

Dr. Joseph P. McGuirk, from The University of Kansas Cancer Center, highlighted the potential of INB-100 to support durable relapse-free remissions while preserving the quality of life for high-risk leukemia patients. William Ho, CEO and co-founder of IN8bio, expressed optimism about the therapy’s potential to change the standard-of-care for AML patients, emphasizing the safety profile and the absence of significant side effects.

IN8bio aims to continue the trial expansion and lay the groundwork for a future regulatory pathway towards a potential registrational trial. The new clinical data will be presented at the 2025 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR in Honolulu, HI.

The company is also evaluating its DeltEx DRI gamma-delta T cells for glioblastoma treatment. However, it is important to note that these forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. The information is based on a press release statement.

In other recent news, IN8bio, a biotechnology firm, has gained an extension to meet Nasdaq’s minimum bid price rule, according to a recent SEC filing. The Nasdaq Listing Qualifications Department has given IN8bio until August 4, 2025, to maintain a minimum closing bid price of $1.00 per share for at least 10 consecutive business days. The company is considering strategies, such as a potential reverse stock split, to regain compliance.

In clinical developments, IN8bio has reported promising outcomes from its ongoing Phase 1 trial of INB-100, a therapy for patients with acute myeloid leukemia (AML). Notably, all patients in the trial remained alive and in complete remission after a median follow-up of 19.7 months. The trial has now expanded to include more patients at the recommended Phase 2 dose level.

Analyst firms have also weighed in on IN8bio’s prospects. H.C. Wainwright maintained a positive outlook on IN8bio, reiterating a Buy rating, following the presentation of clinical data from its Phase 1 INB-200 study. On the other hand, Mizuho (NYSE:MFG) Securities lowered its price target for IN8bio shares to $2.00 from the previous $8.00, while still maintaining an Outperform rating on the stock.

Furthermore, IN8bio has announced encouraging results from its Phase 1 trial of INB-200, a therapy for glioblastoma, a type of brain cancer. The study found that 50% of patients receiving multiple doses of INB-200 remained alive and in remission beyond the median overall survival typically observed with the standard regimen. The company has decided to prioritize its INB-100 program for AML and to suspend its Glioblastoma programs, which include INB-200 and INB-400. These are some of the recent developments surrounding IN8bio.

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