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A Beacon of Hope Has Emerged For Leukemia Patients From The Labs of IN8bio, Inc. (NASDAQ: INAB)

By John F. Heerdink, Jr.

In the realm of cutting-edge cancer therapeutics, a beacon of hope has emerged from the laboratories of IN8bio, Inc. (NASDAQ: INAB).  This clinical-stage biopharmaceutical company has recently unveiled promising results from its ongoing Phase 1 clinical trial of INB-100, a groundbreaking allogeneic gamma-delta T cell therapy. The trial, focusing on patients with leukemia undergoing haploidentical hematopoietic stem cell transplantation (HSCT), has demonstrated not only safety but also remarkable efficacy. 

INB-100 Trial Results

The INB-100 trial has enrolled 23 patients, with 16 completing the treatment regimen and of the 16 at the one year mark, 94% remained in remission. Comparatively, data from the University of Kansas demonstrated a 41% relapse rate and a 31% mortality rate across all leukemia patients at one year. Importantly, IN8bio’s INB-100 has had no relapses in AML patients after median follow up at 20.1 months. The results have been remarkably encouraging, with all treated patients achieving complete remission and showing no signs of acute Graft versus Host Disease (aGvHD) grade 3 or higher. With a median follow-up of 21 months, seven out of eight treated patients remain in complete remission, showcasing the potential durability of the therapy’s effect. These promising outcomes have set the stage for IN8bio to present updated results at the 2025 Tandem Meetings, Transplantation & Cellular Therapy Meetings of ACST and CIBTR, hosted in Honolulu, HI. Meeting, where the biotech world eagerly awaits further insights into this innovative approach to leukemia treatment. We look forward to further updates later this year.

Gamma-Delta T Cell Mechanism

Gamma-delta T cells, often likened to a “Swiss Army knife” of the immune system, form the cornerstone of INB-100’s innovative approach. These unique lymphocytes possess an innate ability to recognize and eliminate malignant cells while sparing healthy tissue. The therapy’s mechanism of action orchestrates a cellular symphony, with engineered gamma-delta T cells acting as lead violins, precisely targeting cancer cells. This precision is complemented by the supporting sections of the immune system, providing a robust backdrop of defense. Dr. Lawrence Lamb, IN8bio’s scientific co-founder, emphasizes the therapy’s potential to reduce relapse risk and improve overall survival rates for patients undergoing haploidentical stem cell transplants, highlighting its revolutionary composition in the cancer therapy repertoire.

Promising Leukemia Outcomes

The interim results of INB-100 have struck a resonant chord within the medical community, offering a glimmer of hope in the challenging landscape of high-risk leukemias. Remarkably, all treated AML patients in both the original and expansion cohorts through January 17, 2025 remain in complete remission. The original cohort of AML patients has reached a median CR of 23.3 months, with several patients in remission for over three years. The median duration across all treated AML patients (N=9) is 20.1 months.. This longevity is particularly noteworthy given the typically aggressive nature of myleoid leukemias and their propensity for relapse. The absence of severe acute Graft versus Host Disease (aGvHD) further underscores the therapy’s promise, suggesting a favorable safety profile that could significantly improve the quality of life for patients undergoing haploidentical stem cell transplants.

Future Impact on Cancer Care

The potential impact of INB-100 on cancer care extends beyond its immediate application in leukemia treatment. If successful in larger-scale trials, this innovative gamma-delta T cell therapy could pave the way for a new paradigm in cellular immunotherapy, potentially benefiting patients with various hematological malignancies. The therapy’s ability to induce durable remissions without severe side effects may significantly improve long-term outcomes and quality of life for transplant recipients. As the oncology community eagerly awaits further data, INB-100 stands poised to potentially reshape treatment protocols and offer new hope to patients who have exhausted conventional options.  We expect IN8bio to present the 2025 A,merican Society of Hematology Annual Meeting which they have in years past. The company’s innovative approach could potentially rewrite the score for leukemia treatment, offering a new movement in the symphony of cancer care. While the melody of success resonates through these early results, the scientific community remains cautiously optimistic. As with any groundbreaking therapy, the true test lies in larger-scale trials and long-term follow-ups. Nevertheless, INB-100 has undoubtedly struck a hopeful chord in the ongoing battle against leukemia, potentially heralding a new era in cellular immunotherapy. In the grand opera of medical advancement, IN8bio’s gamma-delta T cell therapy may well be the aria that changes the narrative for leukemia patients worldwide. As we await the full recital of results, one thing is clear: the oncology stage is potentially set for a performance that could resonate for generations to come.

What Does Leadership Say About This?

William Ho, Chief Executive Officer and co-founder of IN8bio (NASDAQ: INAB)

“We’re incredibly pleased with our efforts to continue to deliver consistent, long-term remission results with INB-100. It’s rare to see 100% relapse-free survival in high-risk AML patients, especially over a prolonged period. For patients who may not have had a clear path forward in the past, INB-100 is providing hope, extending survival, and demonstrating the potential to change the standard-of-care. What makes this even more exciting is the safety profile we’ve observed. Gamma-delta T cells are showing that they can do the job of fighting residual cancer cells without causing significant side effects like CRS or neurotoxicity—issues that often plague other cell therapies. As we continue to enroll patients and expand the trial network, we are working diligently to lay the groundwork for the future regulatory pathway towards a potential registrational trial. The IN8bio team is working hard to de-risk the future path to approval and to bring this innovative therapy towards broader patient access. We are committed to providing further updates later this year as we build momentum toward this goal.”

More About William Ho, Director, President, CEO, and Co-Founder

William Ho is a company Co-Founder and has served as our President, Chief Executive Officer, and Director of IN8bio since its inception. Mr. Ho has worked in the biotechnology industry for nearly 24 years. Prior to the founding of IN8bio, from 2014 to 2017, Mr. Ho was the Founder and Managing Partner at AlephPoint Capital, a private healthcare investment fund. Prior to that, Mr. Ho was at New Leaf Venture Partners, a leading healthcare venture capital firm, where he launched and managed the public investments and cross-over portfolio and served as its Public Investment Director from 2010 to 2014. Previously, Mr. Ho served as a Senior Equity Research Analyst at Bank of America from 2006 to 2009 and an Equity Research Analyst at Piper Jaffray & Co. from 2003 to 2006, covering the biotechnology and life-science tools sectors. Earlier in his career, Mr. Ho was responsible for FP&A and operational analysis at CuraGen Corporation and worked as an Associate on the Healthcare Investment Banking team at Cowen, Inc. Mr. Ho was an inductee into the McMaster University Alumni Gallery in 2020 and previously served as a member of their Dean’s Advisory Board for the Faculty of Science. Mr. Ho received an MBA from the University of Notre Dame and a B.S. in Biochemistry from McMaster University.



More About The DeltEx™ Platform

According to IN8bio’s website, The DeltEx™ platform has enabled a deep pipeline of preclinical and clinical product candidates designed to effectively target and potentially eradicate cancer cells to improve patient outcomes.

Key elements of our approach to treating cancer include:
  • Advanced expertise in the manufacturing of ex-vivo, expanded, activated gamma-delta T cells
  • First-in-class proprietary gamma-delta T cell engineering for chemotherapy resistance
  • Advanced next-generation, closed-system, scalable, gamma-delta T cell manufacturing
  • Broad applicability of our engineered DeltEx cells across multiple solid and hematological cancer indications

The innate and adaptive immune responses play critical roles in the fight against cancer. While both systems possess important functions, the most effective tumor killing occurs when they work together. Gamma-delta T cells are a unique subset of immune cells that sit at the nexus of the innate and adaptive systems and possess properties of both. Their multifunctional nature and complex receptor repertoire allow them to distinguish between healthy and cancerous cells. They can effectively kill tumor cells directly as well as recruit and activate additional immune effector cells to target and eradicate the tumor. Notably, gamma-delta T cells can eliminate cancer cells without prior antigen priming and have the ability to antigen present and trigger a broader immune cell response. These properties make gamma-delta T cells promising candidates for use in for both solid and hematological cancer therapies.

IN8bio’s DeltEx™ platform is designed to overcome many of the challenges associated with the expansion, genetic engineering and scalable manufacturing of gamma-delta T cells, allowing the team to harness their unique properties for cancer therapies. IN8bio’s core technology is a novel concept in cellular therapy, drug resistant immunotherapy, or DeltEx™ DRI, which uses intracellular engineering to generate gamma-delta T cells that are resistant to different classes of chemotherapy. These cells can be used in early and frontline treatment settings where they can survive combinations with therapeutic doses of chemotherapy. Chemotherapy, a mainstay of solid tumor treatment, can deplete and damage immune cells, including gamma-delta T cells, limiting their ability to seek and kill tumors. Chemotherapy treatment can also result in the selection of residual tumor cells that are chemotherapy resistant, which leads to disease recurrence. They have leveraged their proprietary genetic modifications to protect their DeltEx™ DRI cells from chemotherapy-induced damage, allowing for their concomitant delivery with chemotherapy so they can identify and kill residual tumor cells when the tumor is experiencing maximum chemotherapy-induced stress. This DeltEx™ DRI approach is the basis for several of our programs, including INB-200 and INB-400.

(Read Original Story: N8bio Reports Updated Positive Results from Phase 1 Trial of INB-100 in Leukemia Patients in )


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