IN8bio Announces Prioritized Clinical Trial to Focus on INB-100 for Acute Myeloid Leukemia

• Highest priority clinical program: We are working to add significant value with INB-100 in AML; the ongoing study is actively recruiting additional patients to the expansion cohort to further support the observed 100% progression-free survival in patients with AML as of August 30, 2024.

• Enrollment in the Phase 2 clinical trial of INB-400 in patients with newly diagnosed GBM has been suspended; we will continue to monitor patients for long-term remissions and overall survival in both the INB-400 and INB-200 trials at UAB.
• The Company intends to preserve cash resources while anticipating clinical cost savings and a 49% reduction in headcount. These actions are expected to be completed in Q3 2024.

NEW YORK, Sept. 4, 2024 (GLOBE NEWSWIRE) — IN8bio, Inc. (Nasdaq: INAB)leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer, today announced a plan to optimize resource allocation through process prioritization and a workforce reduction of approximately 49%. The Company will focus on generating robust clinical data from INB-100, its ongoing investigator-sponsored Phase 1 clinical trial in acute myeloid leukemia (AML), to further reduce regulatory pathway risks and confirm the 100% one-year progression-free survival observed to date in this patient population.

The Company will suspend its glioblastoma multiforme (GBM) development program while continuing to monitor patients in the Phase 1 INB-200 clinical trial and those enrolled in the Phase 2 INB-400 clinical trial. INB-200 has completed treatment of patients for up to six repeat doses, and further patient recruitment in the INB-400 trial is paused while the Company explores potential partnership opportunities for the solid tumor program.

“Data from both our INB-100 and INB-200 clinical programs remains positive and robust. We are committed to building on the data for INB-100 in AML and are making the difficult decision to promote fewer pipeline programs, reduce our expenses, and focus on key milestones that can help generate near-term interest and value creation,” said William Ho, CEO and co-founder. “These are difficult but necessary steps that will allow us to continue to advance these novel cellular immunotherapies that are showing signs of clinical activity in challenging oncology patients. We are pleased to be able to focus on INB-100 because IN8bio and its investigators believe that patient outcomes in their study to date exceed those of similar leukemia patients, including those with AML undergoing haploidentical transplantation without receiving INB-100. I want to express my gratitude to all of our employees, including those leaving IN8bio today, for their contributions to our Cancer Zero mission.”

Portfolio prioritization

INB-100 for AML

With the additional funding, the INB-100 study will continue to enroll patients in the expansion cohort with a new target total enrollment of approximately 25 patients at the recommended Phase 2 dose. IN8bio expects to complete this additional enrollment in the first half of 2025, with long-term follow-up results expected in late 2025 and in 2026.

IN8bio held a Type B meeting with the FDA earlier this summer, where the company received regulatory guidance to promote INB-100 for the treatment of AML as a maintenance therapy after transplantation, with relapse-free survival as the primary endpoint. To confirm the improvement in relapse-free survival and overall survival observed to date and to further mitigate the risk of a future registrational randomized controlled trial, IN8bio will also seek to add a control cohort to prospectively evaluate patients with leukemia and enable comparison of patients receiving INB-100 with those receiving standard haplotransplantation alone.

As of August 30, 2024, 100% of AML patients remain free of relapse after receiving INB-100 at a median follow-up of 18.7 months. Previously reported patients with other leukemia diagnoses (ALL and MDS/MPN overlap with concurrent TP53 mutations) who relapsed died of progression. No new relapses have been reported since the last update.

INB-200 and INB-400

The Company has suspended patient enrollment in the INB-400 Phase 2 clinical trial for newly diagnosed GBM while it explores partnership opportunities for the program. IN8bio will continue to monitor patients previously treated in the fully registered INB-200 clinical trial, as well as all patients who have been enrolled and are receiving treatment in the INB-400 Phase 2 clinical trial.

Reduction of workforce

In connection with pipeline prioritization, IN8bio is implementing a workforce reduction of approximately 49% of its current workforce across all functional areas and at its New York and Birmingham, Alabama, headquarters, along with cash compensation reductions implemented across the executive management team and the company’s board of directors. IN8bio expects to incur one-time charges of approximately $0.3 million in connection with the workforce reduction, nearly all of which are cash expenses related to severance. Such charges are expected to be incurred in the third quarter of 2024.

About IN8bio

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 have unique properties, including the ability to distinguish between healthy and diseased tissue. The company’s lead program, INB-100, is focused on AML, evaluating haplo-matched allogeneic gamma-delta T cells administered to patients who have received a hematopoietic stem cell transplant. The company is also evaluating autologous DeltEx DRI gamma-delta T cells in combination with standard of care for GBM. For more information about IN8bio, visit www.IN8bio.com.

Forecast 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 can be identified by the use of 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 ability of INB-100 for AML to generate significant value; the ability of IN8bio to preserve its cash resources, achieve clinical cost savings and optimize resource allocation; the timing and impact of IN8bio’s workforce reductions; the ability of IN8bio to identify partnership opportunities for its GBM clinical development program; the ability of IN8bio’s key milestones to help generate near-term interest and create value; the ability of IN8bio to continue to develop new gamma-delta T cell therapies; the ability of IN8bio to obtain additional financing; the timing and success of IN8bio’s interactions with regulatory agencies, including the FDA; and the ability of IN8bio to achieve anticipated milestones, including expected presentations and readouts of data from its studies, recruitment of additional patients to its clinical trials, progress of its clinical development plans. 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 may differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to site commencement, commencement of clinical trials, patient recruitment and follow-up, and IN8bio’s ability to meet anticipated timelines and milestones; uncertainties related to the initiation and completion of preclinical and clinical studies and clinical development of IN8bio’s product candidates; the risk that IN8bio may be unable to raise additional capital and may be forced to delay, further reduce or explore other strategic options for certain of our development programs or even discontinue its operations; the risk that IN8bio may not achieve the intended benefits of the DeltEx platform; the availability and timing of preclinical and clinical trial results; whether preclinical trial results will be predictive of clinical trial results; whether preliminary or interim clinical trial results will be predictive of final trial results or results of future trials; the risk that trials and research may be delayed and may not produce satisfactory results; potential side effects from testing or use of IN8bio’s product candidates; expectations regarding regulatory approvals to conduct trials or commercialize products; IN8bio’s dependence on third parties, including licensors and clinical trial 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 more 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, and in other documents that IN8bio may file 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 as a result of any new information, future events,

Contact for investors and corporations
Glenn Schulman, Ph.D., M.Pharm., M.Pub.
IN8bio, Inc.
203.494.7411
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