Recent Updates
Recently added Catalysts
INAB Positive Sentiment Score: 90/100

IN8bio Solidifies Position as a Clinical Leader of Gamma-Delta T Cell Therapy in Oncology with 100% of Treated AML Patients in Complete Remission and Receives FDA Guidance for Registrational Trial of INB-100 Received FDA

Key Takeaway: IN8bio announced promising updates from their Phase 1 trials for INB-100 and INB-200, focusing on gamma-delta T cell therapies for oncology. All treated AML patients with INB-100 have achieved complete remission, and the trials indicate better than expected progression-free survival rates. The company has also received FDA guidance for moving forward with a registrational trial for INB-100. Overall, the clinical results support the advancement of these therapies into Phase 2 trials, showcasing the potential of gamma-delta T cells in cancer treatment.

Market Sentiment Analysis

POSITIVE FACTORS

  • 100% of AML patients treated with INB-100 are in complete remission.
  • The clinical data shows significant potential for gamma-delta T cell therapies in difficult-to-treat cancers.
  • Positive FDA guidance received for the registrational trial of INB-100.
  • No significant cell therapy-related toxicities reported in Phase 1 trials.

Full Press Release Details

IN8bio Solidifies Position as a Clinical Leader of Gamma-Delta
T Cell Therapy in Oncology with 100% of Treated AML
Patients in Complete Remission and Receives FDA Guidance for Registrational Trial of INB-100
NEW YORK, August 12, 2024 IN8bio,
Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer, today announced updated positive clinical data from both of the Company s Phase 1
investigator-sponsored trials of INB-100 for hematological malignancies and INB-200 for GBM. The Company has also completed a Type B meeting with the FDA and received
guidance on the registrational path to advance INB-100 for the treatment of AML.
Every AML patient treated with INB-100 remains in complete remission (CR), and patients across both trials have exceeded expected progression-free survival (PFS) to date. These data continue to demonstrate the broad clinical potential of
gamma-delta T cells for difficult-to-treat cancers and provides support for the advancement of these therapies into Phase 2 trials.
As of August 1, 2024, no new relapses have been reported since the clinical updates provided at the American Society of Clinical Oncology (ASCO) and the
European Hematology Association (EHA) annual meetings.
Our gamma-delta T cell therapies, engineered with our industry-leading manufacturing
technology, continue to demonstrate their potential to eliminate residual cancer cells and to revolutionize cancer treatment, said William Ho, CEO and co-founder of IN8bio. The safety profile of
gamma-delta T cells has been manageable and well-tolerated across both indications with no significant cell therapy-related toxicities reported to date in any patients across these Phase 1 trials.
Program Details as of August 1, 2024:
Mr. Ho, also commented, These therapies take advantage of the gamma-delta T
cells natural ability to target the heterogeneity of cancers, prevent immune escape and disease relapse. Multiple patients have now remained in progression-free remissions longer than expected with many now exceeding expected overall survival,
based on historical data. The safety profile and long-term remissions observed with both INB-100 and INB-200, now exceeding three years, across two difficult
indications, suggest a significant potential advancement for cellular therapies for cancer. With these compelling results to date, IN8bio stands at the forefront of innovation in oncology and gamma-delta T cell development.
Conference Call Details
IN8bio will host a conference call and webcast today, Monday, August 12, 2024, at 8:30 am ET. The webcast can be accessed by clicking this link and
can also be accessed on the Events & Presentations page of the Company s website. To participate in the live call, please register using this link. It is recommended that participants register at least 15 minutes in
advance of the call. Once registered, participants will be informed of the dial-in number and will be provided a unique PIN.
IN8bio is a clinical-stage
biopharmaceutical company developing gamma-delta T cell-based immunotherapies for cancer patients. 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. The company s lead program INB-400 is in a Phase 2 trial in GBM. Additional programs include Phase 1 trials in solid and hematologic tumors, including
INB-200 for GBM and INB-100 for patients with hematologic malignancies undergoing transplantation. For more information about IN8bio, visit www.IN8bio.com.
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: IN8bio s ability to continue advancing our gamma-delta T-cell programs; the broad clinical potential of gamma-delta T cell therapies to revolutionize
cancer treatment; the ability of INB-100 and INB-200 to target difficult to treat cancers and to continue to demonstrate an improvement in relapse free survival across
both AML and GBM; the timing and success of IN8bio s interactions with regulatory agencies, including the FDA; and IN8bio s ability to achieve anticipated milestones, including expected presentations and data readouts from its trials,
enrollment of additional patients in its clinical trials, advancement of clinical development plans and submission of INDs. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you
should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors,
including: risks to site
initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bio s ability to meet anticipated deadlines and milestones,
presented by public health crises as well as rising inflation and regulatory developments; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio s product
candidates; the risk that IN8bio may not realize the intended benefits of its DeltEx platform; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of
clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory
outcomes; potential adverse effects arising from the testing or use of IN8bio s product candidates; expectations for regulatory approvals to conduct trials or to market products; IN8bio s reliance on third parties, including licensors and
clinical research organizations; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled Risk
Factors in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 8, 2024, as well as in other filings IN8bio may make with the SEC in the future. Any
forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future
Glenn Schulman, PharmD, MPH

Frequently Asked Questions

What is the status of INB-100 for AML patients?

All treated AML patients with INB-100 are in complete remission.

What are gamma-delta T cell therapies?

Gamma-delta T cell therapies target cancer while differentiating healthy tissue.

What did the FDA say about INB-100's trial path?

The FDA provided guidance for advancing INB-100 towards a registrational trial.

How have patients responded to INB-100 and INB-200?

Patients have shown longer-than-expected progression-free survival rates.

What is IN8bio's lead program?

IN8bio's lead program is INB-400, currently in a Phase 2 trial for GBM.

Last updated: Aug 12, 2024