UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01. | Other Events |
IN8bio, Inc. (“IN8bio” or the “Company”), will present updated data, a summary of which is located below, from its Phase 1 investigator-sponsored trial of INB-100 in patients with hematologic malignancies undergoing haploidentical stem cell transplantation (HSCT) in a poster presentation at the 65th American Society of Hematology (ASH) Annual Meeting on December 11, 2023.
Summary of Clinical Update from Phase 1 Trial of INB-100
| • | 100% of evaluable treated patients (n=10) remain alive, progression free, and in durable complete remission (CR) as of November 3, 2023, with six patients relapse free for over one year and all patients past 100 days. |
| • | In vivo expansion and persistence of allogeneic gamma-delta T cells observed 365 days following a single administration of INB-100. |
| • | Dose response data demonstrates a higher level of gamma-delta T cells in patient who received dose level 2 (DL 2), with those patients showing a 48.9x greater level at day 60 than those who underwent HSCT without INB-100 therapy and 7.6x greater than those in dose level 1 (DL 1). Patients in DL 2 also had an average of 2.7x greater levels at day 365 than levels found in DL 1. |
| • | New cytokine data following gamma-delta T cell infusion demonstrate peripheral increases in pro-inflammatory cytokines in the plasma early post-infusion, demonstrating broad immune activation. |
| • | Elevated CD4+ and CD8+ T cells, NK cells and B cells have also been observed, indicating a broad positive immune response and stable reconstitution of the immune system post-transplant |
| • | Low grade (grade 1-2) acute graft versus host disease observed in 60% of patients. |
| • | No dose-limiting toxicities (DLTs) have been observed. |
| • | All evaluable patients across DL 1 and DL 2 remained on study and in CR, with two patients now remaining progression free for over 3 years. |
| • | Treated patients have remained progression free for 42.7, 40.3, 28.6, 14.3, 12.2, 12.0, 9.0, 5.6, 5.3 and 4.9 months, respectively. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| IN8bio, Inc. | ||||||
| Date: December 11, 2023 | By: | /s/ Patrick McCall | ||||
| Patrick McCall | ||||||
| Chief Financial Officer and Secretary | ||||||
| (Principal Financial and Accounting Officer) | ||||||