IN8bio (NASDAQ:INAB) outlined updates across its gamma-delta T-cell programs in autoimmune disease and oncology, including preclinical plans for its T-cell engager platform and clinical data in glioblastoma.
President, CEO and Co-Founder Will Ho said the clinical-stage biotechnology company is developing therapies designed to use gamma-delta T cells, a less abundant subset of immune cells that the company believes can coordinate broader immune responses. IN8bio’s work spans both cancer and autoimmune diseases, which Ho described as differing forms of immune-system dysfunction.
Autoimmune T-Cell Engager Program
According to Ho, conventional CD3-based T-cell engagers can activate multiple immune-cell populations, potentially contributing to cytokine release syndrome, or CRS. He said CRS occurs in 60% to 80% of patients treated with CD3-based engagers, with approximately 10% experiencing Grade 3 events.
IN8bio’s approach pairs CD19 targeting with a gamma-delta T-cell receptor-binding component and an expansion domain intended to increase gamma-delta T-cell numbers. The company believes this design could enable B-cell depletion while reducing production of interleukin-6, or IL-6, a cytokine associated with CRS.
Ho cited in vitro data previously presented at the American College of Rheumatology showing that INB-619 reduced CD19-positive cells in a blood-cell culture containing a CD19-positive leukemia cell line. He also described comparison studies involving Amgen’s blinatumomab and Roche’s mosunetuzumab, saying INB-619 achieved comparable or greater B-cell depletion in those experiments, although it required an additional day or two for gamma-delta T-cell expansion.
The company reported that its engager produced little or no IL-6 in the cited laboratory assays. Ho said IN8bio plans to present its first animal data for the program in the fall.
Glioblastoma Study Results
IN8bio also discussed its glioblastoma cell-therapy program, which uses gamma-delta T cells engineered to resist chemotherapy and administered directly into the brain through a catheter placed following tumor resection.
Ho said the Phase I/II study enrolled newly diagnosed glioblastoma patients at the University of Alabama at Birmingham, Ohio State University, Moffitt Cancer Center and Cleveland Clinic. Patients received standard-of-care treatment, including chemotherapy, along with six 28-day maintenance cycles involving an injection of the company’s gamma-delta T cells.
Data from the study were published in the Journal of Clinical Oncology in July, according to Ho. He said the program demonstrated median progression-free survival of 13 months, compared with 6.6 months referenced for standard care, and median overall survival of 19.5 months, compared with 13.2 months. Ho said the median overall-survival endpoint had not yet been reached as of May 15 and that the company expects to provide an update later in the fall.
He also said the company has not observed major adverse events or cases of cytokine release syndrome in the clinic to date. IN8bio expects to meet with the U.S. Food and Drug Administration this year to seek guidance on a potential registrational pathway for the glioblastoma program.
Capital Position and Partnership Discussions
Ho said IN8bio completed a financing in December that raised more than $20 million, led by Coastlands Capital and including participation from Alyeska, Franklin Templeton, 683 Capital Management, Stonepine Capital Management and Dellora Investments, among others.
He said a potential second closing tied to upcoming animal data could provide an additional $20 million and fund the company through an investigational new drug application. The company said it has cash on hand to pursue its stated milestones.
Regarding partnering, Ho said IN8bio has ongoing discussions with pharmaceutical and biotechnology companies. He said potential conversations around the glioblastoma program may advance after FDA guidance clarifies the registrational path. He also cited potential licensing interest in the company’s leukemia program and said the company expects the first in vivo data from its T-cell engager program to be important for potential partner interest.
Ho acknowledged that cell therapy has faced a difficult market environment, citing recent program cancellations across the sector. He said IN8bio developed its T-cell engager program partly to pursue an off-the-shelf modality that may align more closely with established pharmaceutical development and commercial models.
About IN8bio (NASDAQ:INAB)
IN8bio is a clinical-stage biopharmaceutical company developing γδ T cell therapeutic and γδ T cell engager (TCE) product candidates to address unmet medical needs. γδ T cells are
a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The Company’s lead programs consist of INB-100, an allogeneic γδ T cell candidate for adult patients with high-risk
leukemias undergoing haploidentical stem cell transplantation.
