NEW YORK - IN8bio, Inc. (NASDAQ: INAB), a biopharmaceutical company focusing on gamma-delta T cell therapies for cancer, has announced encouraging results from its Phase 1 trial of INB-200. The trial investigated the therapy for glioblastoma (GBM), a notoriously aggressive brain cancer.
The study found that 50% of patients receiving multiple doses of INB-200 remained alive and in remission beyond the median overall survival typically observed with the standard Stupp regimen. In contrast, none of the patients who received a single dose showed this outcome.
Biopsies from two patients showed the presence of gamma-delta T cells, along with CD3+ and CD8+ T cells, within the brain tumor environment after treatment. This suggests that INB-200 may improve immune system responses in GBM patients. Additionally, patients treated with multiple doses exhibited improved peripheral T cell recovery, indicating broader immune system benefits.
The majority of the patients in the trial surpassed the expected progression-free survival (PFS) for their age and tumor status. Notably, one patient has remained progression-free for over 40.5 months following treatment. This compares favorably to the median PFS of 6.9 months reported for the Stupp regimen and 8.3 months for those treated with a single dose of INB-200.
The Phase 1 trial also assessed the safety of combining DeltEx drug-resistant immunotherapy (DRI) gamma-delta T cells with maintenance therapy using TMZ, a chemotherapy drug. The trial, which included 13 patients across three dosing cohorts, reported no treatment-related serious adverse events, dose-limiting toxicities, or immune effector cell-associated neurotoxicity syndrome.
Furthermore, radiographic evaluations before and after treatment showed changes in some patients that were attributed to the positive effects of the therapy, including a significant decrease in lesion size for one subject.
IN8bio's approach leverages the unique properties of gamma-delta T cells, which can differentiate between healthy and diseased tissue. The company aims to position its genetically modified, chemotherapy-resistant gamma-delta T cells as a potential first-in-class therapy for solid tumor cancers.
The information presented here is based on a press release statement from IN8bio, Inc. and reflects the results shared at the 29th Annual Meeting of the Society for Neuro-Oncology in Houston, TX.
In other recent news, IN8bio Inc. has seen several significant developments. The biotechnology company reported its third-quarter results for 2024, which included no revenue and a net loss, in line with market expectations. In response to these results, Mizuho (NYSE:MFG) Securities and H.C. Wainwright adjusted their price targets for IN8bio. Mizuho lowered its target to $2 from $8, while H.C. Wainwright reduced its target from $12.50 to $8, with both firms maintaining positive ratings on the company's stock.
IN8bio also announced a strategic shift in its development focus, prioritizing its INB-100 program for Acute Myeloid Leukemia (AML) and suspending its Glioblastoma (GBM) programs. This decision follows a successful private placement in October, which raised $12.4 million, extending the company's cash runway into 2026. Additionally, IN8bio reported the departure of its Chief Medical (TASE:PMCN) Officer, Trishna Goswami, and a reduction in its workforce by approximately 49%.
The company also amended the employment agreements of five key executives and reported encouraging results from its INB-100 program, with a 100% progression-free survival rate among patients. Analyst firms Laidlaw & Company and Jones Trading have maintained their Buy ratings on IN8bio, following these positive results. These are the recent developments for IN8bio.
InvestingPro Insights
While IN8bio's Phase 1 trial results for INB-200 in glioblastoma patients are promising, it's crucial to consider the company's financial position. According to InvestingPro data, IN8bio has a market capitalization of just $23.02 million, reflecting its early-stage status in the biotech sector.
InvestingPro Tips highlight that IN8bio is quickly burning through cash and is not profitable over the last twelve months. This is not unusual for biotech companies in the research and development phase, but it underscores the importance of successful clinical trials for the company's future.
The stock price has fallen significantly over the last three months, with a -40.64% total return, and even more dramatically over the past six months, with a -68.55% return. This volatility is typical in the biotech sector, especially for companies with key trial results pending.
Despite these challenges, two analysts have revised their earnings upwards for the upcoming period, suggesting some optimism about IN8bio's prospects. However, it's worth noting that analysts do not anticipate the company will be profitable this year.
For investors interested in a deeper analysis, InvestingPro offers 8 additional tips that could provide valuable insights into IN8bio's financial health and market position.
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