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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 (Nasdaq: INAB) announced an upcoming plenary oral presentation at the 29th Annual Meeting of the Society for Neuro-Oncology (SNO) in November 2024. The presentation will provide extended follow-up data from the Phase 1 trial of INB-200, their gamma-delta T cell therapy for newly diagnosed glioblastoma.
Previous data presented at ASCO in June 2024 showed that 92% of evaluable patients exceeded the median progression-free survival of 7 months typically observed with standard-of-care therapy. The presentation will be delivered by Dr. Mina Lobbous from Cleveland Clinic Lerner College of Medicine.
IN8bio (Nasdaq: INAB) has announced an upcoming poster presentation at the 66th American Society of Hematology (ASH) Annual Meeting in San Diego, December 7-10, 2024. The presentation will focus on INB-100, a pilot study of donor-derived gamma-delta T cell therapy following haploidentical hematopoietic stem-cell transplantation. Dr. Joseph McGuirk from The University of Kansas Cancer Center will present Abstract #4823 in the Cellular Immunotherapies session on December 9, 2024, from 6:00 PM to 8:00 PM PDT. The abstract will be available online through ASH's website, with poster reprints accessible on IN8bio's website after the presentation.
IN8bio, Inc. (Nasdaq: INAB) has announced a $12.4 million private placement to fund its current operating plan into 2026. The financing will support the ongoing expansion cohorts in the Phase 1 trial of INB-100 for patients with Acute Myeloid Leukemia (AML). The private placement includes the sale of 25,759,595 shares of common stock, pre-funded warrants for 5,646,853 shares, and warrants to purchase up to 31,406,448 shares.
The proceeds will enable IN8bio to increase enrollment to approximately 25 patients in the expansion cohort at the recommended Phase 2 dose, with completion expected in the first half of 2025. Long-term follow-up results are anticipated in late 2025 and 2026. The company also plans to add a parallel control cohort to assess leukemia patients and compare INB-100 treatment to standard haplotransplantation.
IN8bio (Nasdaq: INAB) has announced a strategic pipeline prioritization and workforce reduction to optimize resource allocation. The company will focus on its INB-100 program for Acute Myeloid Leukemia (AML), which has shown promising results with 100% progression-free survival as of August 30, 2024. IN8bio will suspend enrollment in its Phase 2 clinical trial of INB-400 for glioblastoma (GBM) while continuing to monitor patients in both INB-400 and INB-200 trials.
The company plans to reduce its workforce by 49% and implement cash compensation reductions for executives and board members. These measures are expected to result in clinical cost savings and help preserve cash resources. IN8bio aims to complete additional enrollment for the INB-100 trial in the first half of 2025, with long-term follow-up results anticipated in late 2025 and 2026.
IN8bio, a clinical-stage biopharmaceutical company specializing in gamma-delta T cell therapies, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. William Ho, CEO and co-founder of IN8bio, will be presenting in a fireside chat format on Monday, September 9, 2024, at 2:30 p.m. ET.
The presentation will be accessible via a live webcast, with a replay option available afterwards. Interested parties can find the webcast under the "Events and Presentations" section of the IN8bio website at https://investors.in8bio.com. This event provides an opportunity for investors and analysts to gain insights into IN8bio's innovative approach to cancer treatment using gamma-delta T cell therapies.
IN8bio (Nasdaq: INAB) has solidified its position as a clinical leader in gamma-delta T cell therapy for oncology. The company reported 100% of treated acute myeloid leukemia (AML) patients remain in complete remission. IN8bio received FDA guidance for a registrational trial of INB-100, with IND submission anticipated in Q1 2025. Early clinical data shows prolonged relapse-free survival in both AML and glioblastoma (GBM) programs, surpassing current standard-of-care. Both programs are advancing to Phase 2 clinical development. The company is the first to report improvements in relapse-free survival in both solid and hematological cancers using allogeneic or autologous gamma-delta T cells.
IN8bio (NASDAQ: INAB) reported Q2 2024 financial results and corporate highlights. Key points include:
1. Presented 100% 1-year complete remission in evaluable patients with hematologic malignancies for INB-100 at EHA 2024.
2. Demonstrated 92% of glioblastoma patients treated with INB-200 exceeded median seven-month progression-free survival at ASCO 2024.
3. Showcased robust manufacturing platform for DeltEx gamma-delta T cells at ASGCT 2024.
4. Q2 2024 financials: R&D expenses increased to $5.2 million, net loss was $8.6 million ($0.19 per share), and cash position as of June 30, 2024, was $10.2 million.
IN8bio continues to advance its gamma-delta T cell therapies for solid and hematologic cancers, showing promising results in clinical trials.
IN8bio, a clinical-stage biopharmaceutical company specializing in gamma-delta T cell therapies, announced that its CEO and Co-founder, William Ho, will be participating in the H.C. Wainwright 2nd Annual Immune Cell Engager Virtual Conference.
The event is scheduled for June 25, 2024, at 2:30 p.m. ET. The presentation will include a fireside chat, providing insights into IN8bio's advancements and future plans.
A live webcast and replay of the presentation will be accessible under the 'Events and Presentations' section on the IN8bio website.
IN8bio has released positive data from its Phase 1 trial of INB-100, demonstrating that 100% of evaluable leukemia patients (n=10) achieved durable complete remission at one year. The trial included high-risk and relapsed AML patients who failed multiple therapies, including CAR-T. Long-term in vivo expansion and persistence of gamma-delta T cells were observed, with no dose-limiting toxicities, cytokine release syndrome, or neurotoxicity reported. The trial has been expanded to enroll 10 more patients at the recommended Phase 2 dose. Updated data are expected in late 2024 and 2025, with plans to discuss a potential registrational trial with the FDA. One patient died of idiopathic pulmonary fibrosis, and two patients with TP53 mutations relapsed but remain alive.
IN8bio (Nasdaq: INAB) presented promising preliminary data of INB-200 for glioblastoma at the 2024 ASCO Annual Meeting. The Phase 1 study of INB-200 showed that 92% of patients surpassed the median progression-free survival (PFS) of 7 months achieved with the standard Stupp regimen, with a median follow-up of 11.7 months. Notably, one patient remained progression-free for nearly three years. The study involved 13 patients across three dosing regimens, revealing a favorable safety profile with no serious treatment-related adverse events. All patients completing the full treatment protocol exceeded the median PFS of 7 months, and radiologic evaluations indicated positive treatment effects. IN8bio is now progressing with a Phase 2 study to further evaluate the therapy.
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