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Overview of IN8Bio, Inc.
IN8Bio, Inc. (Nasdaq: INAB) is a clinical-stage biotechnology company pioneering the development of gamma-delta T cell-based immunotherapies for the treatment of solid and liquid tumors. Leveraging the unique properties of gamma-delta T cells, the company focuses on creating innovative therapies that address significant unmet medical needs in oncology. Gamma-delta T cells are a specialized subset of T cells with the innate ability to differentiate between healthy and diseased tissues, making them a promising tool for targeted cancer treatment.
Core Business and Technology
IN8Bio's proprietary DeltEx platform employs allogeneic, autologous, and genetically modified approaches to develop gamma-delta T cell therapies. These therapies are designed to enhance tumor targeting, improve treatment durability, and reduce the risk of toxicities often associated with other immunotherapies. Unlike traditional CAR-T therapies, gamma-delta T cells naturally secrete lower levels of inflammatory cytokines, potentially offering a safer and more tolerable treatment option.
Key Clinical Programs
- INB-400: A Phase 2 clinical program targeting newly diagnosed glioblastoma (GBM), a highly aggressive brain tumor with limited treatment options. INB-400 combines autologous gamma-delta T cells with the standard-of-care regimen to improve progression-free and overall survival rates.
- INB-100: A Phase 1 program focused on high-risk leukemia patients undergoing hematopoietic stem cell transplantation. This therapy utilizes haplo-matched allogeneic gamma-delta T cells to reduce relapse rates and improve long-term outcomes.
- Preclinical Pipeline: The company is also exploring additional product candidates, such as INB-200 and INB-300, targeting other solid and hematologic tumors.
Market Position and Differentiation
IN8Bio operates within the competitive landscape of cell-based immunotherapies, which includes CAR-T therapies and other T cell-based approaches. However, the company differentiates itself through its focus on gamma-delta T cells, which offer unique advantages such as innate tumor recognition and reduced risk of severe toxicities like cytokine release syndrome (CRS). This positions IN8Bio as a potential leader in the next generation of immunotherapies.
Challenges and Opportunities
As a clinical-stage company, IN8Bio faces challenges such as regulatory hurdles, manufacturing scalability, and the inherent risks of clinical development. However, its innovative approach and focus on addressing unmet medical needs provide significant opportunities for growth and impact within the biopharmaceutical industry.
Conclusion
IN8Bio, Inc. represents a cutting-edge approach to cancer treatment, utilizing the unique properties of gamma-delta T cells to develop therapies with the potential to transform outcomes for patients with difficult-to-treat cancers. Through its robust pipeline and proprietary technology, the company is well-positioned to make a meaningful impact in the field of oncology.
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.
IN8bio, a clinical-stage biopharmaceutical company, announced promising preclinical results for its gamma-delta T cell therapy platform, INB-300, which targets malignant cells while preserving healthy tissue. The data highlights its potential utility in 'undruggable' tumor types. Presented at the AACR Annual Meeting 2023, INB-300 aims to distinguish between leukemic and healthy cells, achieving an 80% kill rate in leukemia cells compared to just 5% for healthy B cells. Future studies will focus on additional targets like CD33 for acute myeloid leukemia. Investors are encouraged by the innovative approach aiming to improve treatment outcomes.
IN8bio, a clinical-stage biopharmaceutical company, announced that CEO William Ho will give a comprehensive overview at the Cowen 43rd Annual Healthcare Conference on March 7, 2023, at 12:50 PM ET. This presentation will be accessible live and via replay on IN8bio’s website. The company specializes in innovative gamma-delta T cell therapies aimed at treating solid and liquid tumors, with ongoing Phase 1 trials for its INB-200 and INB-100 product candidates. Additionally, IN8bio is set to initiate a Phase 2 trial for INB-400 in glioblastoma. For further details about IN8bio's therapies, visit www.IN8bio.com.
IN8bio (Nasdaq: INAB), a clinical-stage biopharmaceutical company, announced the successful results of its non-signaling gamma-delta CAR-T platform (nsCAR), which targets leukemic cells while preserving healthy B cells. Presented at the 6th CAR-TCR Summit Europe, the nsCAR platform exhibited a greater than 15x difference in cytotoxicity between leukemic cells and healthy B cells. This innovative approach promises to enhance CAR technology for previously 'undruggable' tumors, including acute myeloid leukemia (AML). IN8bio aims to expand its applications in solid tumors, with future clinical trials planned for this promising technology.
IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company, announced that CEO William Ho will present a fireside chat at the H.C. Wainwright Cell Therapy Virtual Conference on February 28, 2023, at 1:30 pm ET. This presentation aims to highlight IN8bio's innovative gamma-delta T cell therapies for solid and liquid tumors. The event will be available live and as a replay on the company's website. IN8bio is conducting Phase 1 trials for its lead candidates, INB-200 and INB-100, and is set to launch a Phase 2 trial for INB-400 in glioblastoma, following IND clearance in late 2022. For further information, visit IN8bio's website.
IN8bio, Inc. (Nasdaq: INAB) announced that CEO William Ho will present at the B. Riley Securities’ 3rd Annual Oncology Conference on January 18, 2023, at 12:00pm ET. The conference will showcase IN8bio’s innovative gamma-delta T cell therapies for solid and liquid tumors, emphasizing their unique ability to differentiate healthy from diseased tissues. Currently, IN8bio is conducting two Phase 1 clinical trials for its leading candidates: INB-200 targeting glioblastoma and INB-100 for leukemia patients. A Phase 2 trial, INB-400, is also set to begin post-IND clearance. For further details, visit IN8bio.com.
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