NEW YORK - IN8bio, Inc. (NASDAQ:INAB), a biopharmaceutical company specializing in gamma-delta T cell therapies for cancer treatment, has announced promising clinical trial updates and FDA guidance for its investigational therapies, INB-100 and INB-200. The company shared that all acute myeloid leukemia (AML) patients treated with INB-100 in Phase 1 trials remain in complete remission, exceeding typical progression-free survival rates.
The U.S. Food and Drug Administration (FDA) has provided IN8bio with guidance on the registrational path for INB-100 as a post-transplant maintenance therapy for AML, with relapse-free survival as the primary endpoint. The company plans to submit an Investigational New Drug (IND) application in the first quarter of 2025 and, pending approval, aims to begin a registrational trial the same year.
IN8bio's gamma-delta T cell therapies, including INB-100 for AML and INB-200 for GBM, have entered Phase 2 clinical development. The therapies are designed to eliminate residual cancer cells and potentially revolutionize cancer treatment. The safety profile has been reported as manageable and well-tolerated, with no significant cell therapy-related toxicities observed.
Furthermore, the company's INB-400 program, a Phase 2 trial involving autologous gamma-delta T cells for front-line GBM treatment in combination with standard-of-care, is actively enrolling and treating patients at multiple U.S. cancer centers.
IN8bio's CEO William Ho expressed optimism regarding the therapies' ability to target the heterogeneity of cancers and prevent immune escape and disease relapse. The company will host a conference call and webcast today to discuss these developments further.
IN8bio Inc. has been the center of several key developments. Laidlaw & Company maintained its Buy rating on IN8bio, with a price target of $7.50, following the company's announcement of positive Phase I study results for its INB-100 treatment for Acute Myeloid Leukemia. The results were presented at the European Hematology Association meeting and were commended by Laidlaw's analyst for their potential positive impact on ongoing studies.
Jones Trading also raised its price target for IN8bio shares to $6.50, maintaining a Buy rating. This decision was influenced by IN8bio's announcement that all leukemia patients in their study achieved durable complete remission at the one-year mark post stem cell transplant.
Furthermore, IN8bio reported that 92% of patients treated with INB-200 surpassed the median progression-free survival of seven months in their Phase 1 study. The company's approach to glioblastoma treatment, as demonstrated in the Phase 1 study of INB-200, has shown consistent treatment effects over an extended period.
IN8bio is advancing to a Phase 2 trial with INB-400, a related therapy, and continues to monitor long-term outcomes from the Phase 1 study.
InvestingPro Insights
As IN8bio, Inc. (NASDAQ:INAB) continues to progress in its clinical trials and navigates the path toward potential FDA approval, investors are closely monitoring the company's financial health and market performance. According to InvestingPro, IN8bio holds more cash than debt on its balance sheet, which is a positive sign for the company's financial stability. This could be crucial as the company advances its clinical programs, including the promising INB-100 and INB-200 therapies.
However, it's important to note that IN8bio is quickly burning through cash, which is a concern given the high costs associated with clinical trials and drug development. The company's market capitalization stands at a modest $30.84 million, reflecting the market's current valuation of its potential. With an adjusted P/E ratio of -0.97, the market is pricing in the company's lack of profitability over the last twelve months. Furthermore, the InvestingPro data indicates that the company's stock has experienced a significant decline over the last month, with a 20.38% drop in price total return.
InvestingPro Tips also reveal that analysts have revised their earnings expectations downwards for the upcoming period and do not anticipate the company will be profitable this year. Additionally, IN8bio does not pay a dividend to shareholders, which is common for companies in the biopharmaceutical industry that are in the development phase and not yet generating significant revenue.
For investors seeking more insights and analysis, InvestingPro offers additional tips on IN8bio, which can be found at https://www.investing.com/pro/INAB.
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