All patients treated with INB-200 who completed mandated doses to date have exceeded a progression-free survival (PFS) of seven months
Most patients exceeded the expected median PFS based on age and tumor status; two patients from Cohort 2 remain alive beyond two years
Additional enrolled patients await dosing with completion of enrollment in Cohort 3 expected in 2023 and long-term follow up to be presented at medical meetings in 2024
“Every patient in the Phase 1 trial that completed the mandated doses has exceeded the standard-of-care median progression-free survival of four to seven months, with one patient in Cohort 2 remaining alive and progression free past 28.5 months following three doses,” said
The current standard-of-care regimen for newly diagnosed GBM consists of primary resection, six weeks of chemoradiation therapy followed by six cycles of maintenance monthly temozolomide therapy, which achieves a median PFS of 7 months and an overall survival (OS) of approximately 14 to 16 months. The Phase 1 trial assesses the safety and preliminary efficacy of the addition of DeltEx DRI gamma-delta T cells to standard-of-care maintenance therapy. The trial assesses three different dosing regimens from a single dose delivered on cycle 1 day 1 in Cohort 1, to three doses delivered on day 1 of cycles 1-3 in Cohort 2, to finally six doses delivered on day 1 of cycles 1-6 in Cohort 3. All patients receive 1x107 cells per dose, however the number of doses varies depending on the cohort of enrollment.
The poster presentation at SNO included efficacy and safety data as of the data cutoff on
- All patients who completed mandated doses surpassed a PFS of seven months, with most also exceeding the expected PFS based on their age and tumor status.
- One patient (009) with an IDH-mutant glioma remains alive and progression free at 28.5+ months; comparative data published in the
New England Journal of Medicine (NEJM) inAugust 2023 demonstrate that IDH-mutant patients in the control arm of a clinical trial demonstrated a median PFS of 11.1 months. - No treatment-related serious adverse events (SAEs), dose-limiting toxicities (DLTs), cytokine release syndrome (CRS), infusion reactions, or immune effector cell-associated neurotoxicity syndrome (ICANS) have been reported in any cohort.
- The most common treatment-emergent adverse events (TEAEs) were mostly Grade 1-2 toxicities consisting of white blood cell and platelet count decreases related to standard-of-care temozolomide.
- Preserved gamma-delta T cells found in relapsed tumor 148 days after initial DRI infusion, pointing to durability of gamma-delta T cells in treating cancer.
- The poster is available on the Company’s website here.
About INB-200
INB-200 is a genetically modified autologous DRI product candidate for the treatment of solid tumors. This novel platform utilizes genetic engineering to generate chemotherapy-resistant gamma delta T cells which can be administered concurrently with standard-of-care treatment in solid tumors. This is a powerful, synergistic treatment approach enabling gamma-delta T cells to persist in the presence of chemotherapy, and maintain their natural ability to recognize, engage and kill cancer cells.
INB-200 is the first genetically engineered gamma-delta T cell therapy to be administered to patients with solid tumors and our initial indication is in GBM.
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Forward Looking Statements
This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of INB-200 to treat patients with newly diagnosed GBM, including future outcomes of the INB-200 program; the ability of the DeltEx platform to effectively identify and eradicate tumor cells; the development and continued progress and success of our preclinical and clinical trials and programs and product candidates; and IN8bio’s ability to achieve anticipated milestones, including expected data readouts from its trials, enrollment of additional patients in its clinical trials, advancement of clinical development plans and to develop new preclinical programs.
Company Contact:
+ 1 646.600.6GDT (6438)
info@IN8bio.com
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