IN8bio Observes Durable Morphologic Complete Responses in Ongoing Phase 1 Clinical Trial of INB-100, an Allogeneic Gamma-Delta T Cell Therapy in High-Risk Leukemia Patients

  • All three patients from the first cohort of high-risk relapsed acute-myeloid leukemia (AML) patients dosed to-date with INB-100 remain alive and progression-free after at least one year.
  • Patients remain in morphological complete remission (CR) with two patients over two years and a third over one year post-transplant, respectively.
  • Safety profile continues to be manageable with no dose-limiting toxicities, no treatment-related Grade 3 or greater adverse events, including graft versus host disease (GvHD), and no cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS).
  • William Ho, CEO and co-founder of IN8bio, will be discussing these results at the 3rd Annual Gamma-Delta T Therapies Summit, at 4:00 p.m. EDT on July 27, in Boston, MA.

NEW YORK, NY, USA I July 27, 2022 I IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, provided a clinical update from the ongoing Phase 1 trial of INB-100. This program is an allogeneic, or donor-derived, gamma-delta T cell therapeutic candidate in development for patients with high-risk leukemias undergoing haploidentical hematopoietic stem cell transplant (HSCT). William Ho, Chief Executive Officer of IN8bio, will be discussing these results at the 3rd Annual Gamma-Delta T Therapies Summit, being held July 26-28, in Boston.

“We are excited about the early signals of long-term durable responses from gamma-delta T cell therapy in these high-risk AML patients with complex cytogenetics,” said Trishna Goswami, M.D., Chief Medical Officer of IN8bio. “Despite the up to 51% anticipated one-year relapse rate of the patients enrolled in the trial, all three remain alive and disease free for more than one-year post-transplant. These data are highly encouraging, with the potential to increase the rates of cures in AML patients without significant added toxicities observed to date.”

The Phase 1 clinical trial continues to show positive clinical trends with the first three patients remaining alive and progression-free. Despite multiple cytogenetic abnormalities and a high risk of relapse, these patients remain in remission 26.5, 24.2 and 12.5 months post-transplant, respectively. Immune system reconstitution at six months post-treatment demonstrates continued normal function including observed elevations in T cells, B cells, and gamma-delta T cells. No treatment emergent serious adverse events (SAEs), including graft-vs-host disease (GvHD), cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) have been observed. The clinical trial is ongoing and additional patients have been recruited, with updated data expected in late 2022.

Patient Characteristics*:

Patient   Age/Sex   Cytogenetics   Prior lines of Treatments   Conditioning   Safety Events   Time Post Transplant*  
002   54 / female   High-risk AML trisomy 8+ and del7; (NGS: Pathogenic variants detected: M5a, FLT3 TKD, NxPM1, DNMT3A, PTPN11)       Reduced intensity conditioning (RIC)   Gr.2 skin GvHD- resolved   26.5 months  
003   45 / female   High-risk AML trisomy 8+ and del7 (NGS: Pathogenic variants detected: IDH2, 47,XX,+8[8]/46,sl,-7[9]/48,sl,+8[3])       RIC   Gr.2 GI GvHD and Gr.2 skin GvHD
Remains on Jakafi for skin GvHD
  24.2 months  
006   66 / male   Relapsed AML s/p 7+3,
high risk (NGS: Pathogenic variants detected: NF1, ASXL1, DDX41p.R525H)
  Cytarabine + daunorubicin (7+3)   RIC   Gr.2 GvHD-resolved   12.5 months  

*As of June 30, 2022

About the INB-100 Phase 1 Trial
The Phase 1 clinical trial (NCT03533816) is a dose-escalation trial of allogeneic derived, gamma-delta T cells from matched related donors that have been expanded and activated ex vivo and administered systemically to patients with leukemia following haploidentical HSCT. Three high-risk AML patients with complex cytogenetics have been treated to-date. The single-institution clinical trial is currently being conducted at the University of Kansas Cancer Center (KUCC). The primary endpoints of this trial are safety and tolerability, and secondary endpoints include rates of GvHD, relapse rate and overall survival.

About IN8bio
IN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell product candidates for solid and liquid tumors. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. IN8bio’s DeltEx platform employs allogeneic, autologous and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells.

IN8bio is currently conducting two investigator-initiated Phase 1 clinical trials for its lead gamma-delta T cell product candidates: INB-200 for the treatment of newly diagnosed glioblastoma and INB-100 for the treatment of patients with leukemia undergoing hematopoietic stem cell transplantation. IN8bio also has a broad portfolio of preclinical programs focused on addressing other solid tumor types. For more information about IN8bio and its programs, please visit www.IN8bio.com.

SOURCE: IN8Bio

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