NEW YORK - IN8bio, Inc. (NASDAQ:INAB), a clinical-stage biotechnology company, has announced that all patients (n=10) treated with its INB-100 gamma-delta T cell therapy in a Phase 1 trial achieved complete remission for one year. The trial included high-risk and relapsed acute myeloid leukemia (AML) patients who were unresponsive to previous therapies, including CAR-T.
The data, presented at the European Hematology Association 2024 Hybrid Congress, showed that INB-100 led to the first-ever durable in vivo expansion and persistence of an allogeneic cellular therapy, with gamma-delta T cells remaining in patients' blood for 365 days post-treatment. This is significant as high relapse rates post hematopoietic stem cell transplantation (HSCT) are a major challenge in treating hematologic malignancies.
Patients in the trial had previously undergone HSCT with reduced intensity conditioning (RIC), which typically has a 50% relapse rate within the first year. Still, the trial's results have demonstrated a favorable safety profile without dose-limiting toxicities, cytokine release syndrome, neurotoxicity, or serious infections. One patient did pass away from idiopathic pulmonary fibrosis, a known transplant toxicity, without disease progression.
Despite two patients with TP53 mutations experiencing relapse, they remain alive, indicating a potential improvement in survival outcomes. The trial has been expanded to include an additional ten patients at a recommended Phase 2 dose, with ongoing enrollment and treatment.
IN8bio plans to discuss a potential registrational trial with the U.S. Food and Drug Administration (FDA) in the coming summer. This could further establish the efficacy and safety profile of INB-100 and its potential to improve relapse-free survival for patients with blood cancers post-allogeneic stem cell transplantation.
The company is hosting a conference call today at 4:15 pm ET to review the clinical data. The press release states that the Phase 1 trial is being conducted at The University of Kansas Cancer Center and includes safety and tolerability as primary endpoints.
IN8bio is also advancing other gamma-delta T cell therapies for solid and liquid tumors through its DeltEx platform. The company has ongoing trials for solid and hematological tumors and a portfolio of preclinical programs targeting various cancers.
This report is based on a press release statement from IN8bio, Inc.
In other recent news, IN8bio Inc. has maintained its Buy rating and a shares target of $7.50 from Laidlaw, following the presentation of clinical study results. The Phase I study of INB-200 in treating glioblastoma (GBM) was discussed at the American Society of Clinical Oncology (ASCO) meeting.
The results showed a consistent treatment effect over an extended period, seen as a positive indicator for the future of the INB-400 study. Further details are expected to be released at the Society for Neuro-Oncology (SNO) meeting later this year.
Simultaneously, preliminary results from IN8bio's Phase 1 study of INB-200, a treatment for newly diagnosed GBM, showed promising outcomes. The study data indicated that 92% of patients treated with INB-200 surpassed the median progression-free survival of seven months. The company is now advancing to a Phase 2 trial with INB-400, a related therapy.
Lastly, Laidlaw initiated coverage of IN8bio with a Buy rating and a 12-month price target of $7.50. The firm's positive outlook is bolstered by IN8bio's unique and competitive treatment approaches in the biotech sector. These recent developments highlight the ongoing progress in IN8bio's research and development efforts.
InvestingPro Insights
As IN8bio, Inc. (NASDAQ:INAB) continues to make strides in the biotechnology sector with its promising clinical trial results for INB-100 gamma-delta T cell therapy, investors and industry watchers are closely monitoring the company's financial health and stock performance. Here are some key insights based on real-time data from InvestingPro that may interest stakeholders:
InvestingPro Data:
- The company's Market Cap stands at $73.91 million, reflecting the market's current valuation of IN8bio.
- IN8bio has experienced a significant 1 Month Price Total Return of 44.12%, which aligns with the positive clinical trial news and may indicate growing investor confidence.
- Despite the challenges faced by the company, such as a negative P/E Ratio (Adjusted) of -2.11 for the last twelve months as of Q1 2024, the short-term price performance has been strong.
InvestingPro Tips:
- IN8bio holds more cash than debt on its balance sheet, which is a positive sign for investors looking for companies with financial resilience.
- Analysts have noted that the company is quickly burning through cash, which is a critical factor to consider when evaluating the company's long-term sustainability.
With these factors in mind, potential investors can gain a more comprehensive view of IN8bio's financial situation and market performance. For those interested in delving deeper into these metrics and uncovering additional insights, InvestingPro offers more tips on IN8bio, which can be found at https://www.investing.com/pro/INAB. To access these valuable resources, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. There are 11 more InvestingPro Tips available that can further guide investment decisions regarding IN8bio.
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