By John Vandermosten, CFA

NASDAQ:INAB

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IN8bio, Inc (NASDAQ:INAB) updates survival data for its INB-100 trial in a February 11^th press release in preparation for presentation of data at the Transplantation & Cellular Therapy (TCT) Meetings in Hawaii last week. Data for patients enrolled in the trial were updated from early August 2024 to January 17^th, 2025. All of the acute myeloid leukemia (AML) patients across both original and expansion cohorts remain in complete remission (CR), with a median follow-up of 20.1 months. All of the AML patients achieved one year of progression free survival (PFS) and overall survival (OS). Since our last update, IN8bio has participated in multiple investor and scientific conferences, including Biotech Showcase, Noble’s Emerging Growth Conference, the American Society of Hematology Annual Meeting and the TCT meetings.

INB-100

IN8bio’s are centered on populating the expansion cohort for the INB-100 trial. The scientific team has met with the FDA in a Type B meeting to help guide the design of the registrational path for INB-100 in acute myeloid leukemia (AML). The trial will expand to enroll 25 patients at the recommended Phase II dose. The expansion portion of the trial is anticipated to be complete by 1H:25 with long term follow up results available by late 2025 and in 2026. IN8bio is looking for new centers to add to its active Westwood, Kansas location. The trial will also evaluate a prospective parallel observational cohort as a control.

As efforts for the expansion cohort are underway, IN8bio provided another interim update for its trial as of January 17^th, 2025. Data were updated on the occasion of a scientific presentation at the 2025 Transplantation & Cellular Therapy (TCT) Meetings being held in Hawaii from February 12^th to 15^th. A poster was published that summarized the data. It is titled Pilot Study of Donor Derived, Ex-Vivo Expanded/Activated Gamma-Delta T Cell Infusion Following Haploidentical Hematopoietic Stem-Cell Transplantation and Post-Transplant Cyclophosphamide. The data is about five months ahead of the prior update in early August and finds that patients treated with INB-100 have continued to produce prolonged and durable remissions. All of the patients continue to be relapse free with the original cohort of AML patients reaching a median complete remission (CR) of 23.3 months and several patients in remission for over three years. The median CR of all patients (N=9) in the study is now 20.1 months.

The results are remarkable as real-world survival rates for AML patients following hematopoietic stem cell transplantation (HSCT) are lower. For example, the Center for International Blood and Marrow Transplant Research (CIBMTR) reports a PFS of 67.8% and OS of 74.7% at one-year and the Kansas University Cancer Center (KUCC) PFS of 57.4% and OS of 66.7% at one-year.^[1] Furthermore, the patient characteristics in the INB-100 trial were more severe than those in the comparator studies with INB-100 patients being older, presenting more complex, high risk disease and failing multiple prior therapies. With regard to safety and side effects, patients did not undergo cytokine release syndrome (CRS) or neurotoxicity. Graft vs. Host Disease (GvHD) was tolerable and treatable with steroids and patients experienced only limited mild infections. Grade 4 treatment emergent adverse events (TEAEs) included a decrease in platelet count, white blood cell count, neutrophils and lymphocytes. Other common less severe TEAEs included increase in creatine, hypomagnesemia, hypokalemia and diarrhea.

INB-100 Phase I Findings:

• Zero Relapses in AML Patients: No relapses observed in any AML patient treated with INB-100, with a median follow-up of over 20 months (N=8);
• Superior 1-Year Survival Rates: PFS at 90.9%, OS at 100% (N=11);
• Favorable Safety Profile: No cytokine release syndrome (CRS), neurotoxicity (ICANS), or Dose Limiting Toxicities (DLT’s). No treatment-related deaths;
• Gamma Delta T Cell Persistence and Expansion: Evidence of in vivo expansion and long-term persistence, reinforcing the therapy’s potential to maintain immune surveillance against residual leukemic cells.

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^{[1] These results were gathered and presented by IN8bio.}