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IN8bio, Inc. develops gamma-delta (γδ) T cell therapies and γδ T cell engagers for cancer and autoimmune diseases. Company news centers on clinical and preclinical pipeline updates, including DeltEx Drug-Resistant Immunotherapy γδ T cells in newly diagnosed glioblastoma, INB-100 allogeneic γδ T cells for high-risk leukemias after haploidentical stem cell transplantation, and γδ T cell engager work for oncology and autoimmune indications.
Recurring updates also cover financial results, clinical data presentations at medical meetings, R&D communications, financing activity, Nasdaq inducement grants, and leadership or board changes. The company operates as a clinical-stage biopharmaceutical issuer with common stock traded on Nasdaq under INAB.
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IN8bio, Inc. (Nasdaq: INAB) announced a significant milestone with an oral presentation for its Phase 1 study of INB-200 at the 2023 ASCO Annual Meeting on June 2, 2023. This study evaluates the safety and efficacy of INB-200, a treatment targeting glioblastoma multiforme (GBM), a challenging brain cancer. Current treatments provide limited median progression-free survival of 6-7 months and overall survival of 14-16 months. INB-200 utilizes genetically engineered gamma-delta T cells aimed at enhancing cancer cell elimination and potentially prolonging patient survival. The abstract will be publicly accessible on ASCO's website from May 25, 2023. IN8bio also advances its DeltEx platform for developing innovative cancer therapies, currently conducting two Phase 1 trials and planning a Phase 2 trial for newly diagnosed GBM.
IN8bio, Inc. (Nasdaq: INAB) has achieved FDA orphan drug designation for its genetically modified gamma-delta T cell therapies, INB-400 and INB-410. This designation is notable as it is the first of its kind for these therapies, offering potential 7-year market exclusivity and other benefits. INB-400, an autologous therapy, has been cleared for a Phase 2 trial targeting newly diagnosed glioblastoma multiforme (GBM), with patient enrollment set to begin in the latter half of 2023. With GBM remaining a challenging cancer with limited treatment options, IN8bio's approach combines engineered gamma-delta T cells with standard treatments to enhance tumor elimination. The company anticipates further clinical developments and updates at upcoming medical meetings.
IN8bio, Inc. (Nasdaq: INAB) announced groundbreaking results from the Phase 1 trial of INB-100 for treating high-risk leukemia patients. As of April 21, 2023, all 7 evaluable patients achieved 100% complete remission (CR) and remain alive, with one patient surviving beyond 3 years. The treatment demonstrated significant gamma-delta T cell expansion, achieving an average of 82.9 times greater expansion at 60 days compared to standard care. Low-grade graft versus host disease was reported, with no dose-limiting toxicities observed. The company recommends Dose Level 2 as the next phase, expanding the trial to enroll more patients. A conference call is scheduled for April 24, 2023, to discuss these clinical updates and future directions.
IN8bio has announced promising preclinical data for its innovative non-signaling CAR (nsCAR) platform, particularly in the treatment of acute myeloid leukemia (AML) targeting CD33. The recent findings, highlighted at the AACR Annual Meeting 2023, showcase the ability of gamma-delta T cells to distinguish between cancerous and healthy cells, minimizing side effects. The nsCAR platform demonstrated significant efficacy, with a CD19 targeting construct achieving 80% kill rate against leukemia cells while sparing 95% of healthy B cells. The new INB-330 program aims to address challenges in AML treatments due to CD33's presence on both leukemic cells and healthy stem cells. The company is focused on further optimizing CAR constructs for enhanced targeting capabilities, signaling potential advancements in previously difficult-to-treat cancers.
IN8bio, a clinical-stage biopharmaceutical company, has announced new data on its investigational drug INB-100, an allogeneic gamma-delta T cell therapy for leukemia patients undergoing haploidentical stem cell transplantation. The data, set for presentation at the European Society for Blood and Marrow Transplantation meeting, shows no dose-limiting toxicities, with four patients on the initial dose level achieving durable complete remission (CR). One patient has remained progression-free for nearly three years. The study, which has demonstrated robust immune system reconstitution, is ongoing and focuses on safety, tolerability, and secondary outcomes such as relapse rates.
IN8bio, Inc. (Nasdaq: INAB) reported strong progress in its gamma-delta T cell therapies during Q4 2022, showcasing significant clinical results. All Cohort 1 leukemia patients maintained durable complete responses, lasting 18 months to 2.7 years in the INB-100 trial. The INB-200 trial demonstrated favorable responses, with patients showing progression-free survival exceeding 1.5 years. The next-generation gamma-delta T cell therapy program, INB-300, presented promising proof-of-concept data. Financially, R&D expenses rose to $14.1 million, and a net loss of $28.5 million was recorded, with cash reserves at $18.2 million as of December 31, 2022.