IN8bio Announces INB-200 Phase 1 Study Data in Newly Diagnosed Glioblastoma to be Presented at the 2024 ASCO Annual Meeting

Rhea-AI Summary

IN8bio announced the upcoming presentation of updated Phase 1 study results for INB-200 at the 2024 ASCO Annual Meeting. INB-200, an autologous Drug Resistant Immunotherapy (DeltEx DRI), is being evaluated as a first-line treatment for newly diagnosed glioblastoma multiforme (GBM). The study involved 23 patients and showed promising progression-free survival (PFS) rates beyond the median expected with standard treatment. There were no dose-limiting toxicities, although some patients experienced adverse events like decreased white blood cell count and fatigue. The presentation will take place on June 1, 2024.

Positive

• Phase 1 study of INB-200 showed promising PFS rates beyond median expected with standard treatment.
• No dose-limiting toxicities, cytokine release syndrome, or neurotoxicity reported.
• INB-200 successfully infused with TMZ-based lymphodepletion.
• Study results to be presented at a high-profile event like the ASCO Annual Meeting.

Negative

• Common adverse events included decreased white blood cell and platelet count, fatigue, and headache.
• Only 23 patients were enrolled, limiting the robustness of the study results.

NEW YORK, May 23, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB) a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, today announced an upcoming presentation of updated results from its fully enrolled Phase 1 study of INB-200 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held May 31st - June 4th in Chicago, Illinois. INB-200 is evaluating autologous Drug Resistant Immunotherapy (DeltEx DRI) or chemotherapy resistant gamma-delta T cells as a potential first-line treatment for patients with newly diagnosed glioblastoma multiforme (GBM).

“The current standard-of-care for newly diagnosed GBM has not advanced progression-free survival (PFS) beyond 4-7 months or overall survival beyond 14-16 months for over two decades,” said William Ho, CEO and co-founder, IN8bio. “We’re excited to update the status of patients who received INB-200 for front-line GBM in addition to standard-of-care at the upcoming ASCO Annual Meeting. We believe these findings will continue to validate the potential of DeltEx DRI as a novel therapy for patients with GBM. We are advancing our gamma-delta T cell therapy to help address this significant unmet need and look forward to presenting additional trial results at ASCO and throughout the year.”

Details of the 2024 ASCO poster presentation are provided below:

Poster title: INB-200: Fully enrolled Phase 1 study of gene-modified autologous gamma-delta (γδ) T cells in patients with newly diagnosed glioblastoma multiforme (GBM) receiving maintenance temozolomide (TMZ)
Authors: Mina Lobbous, Trishna Goswami, Lawrence Lamb, Kate Rochlin, Thriumaine Pillay, Mariska ter Haak, Louis Nabors
Date/Time: Saturday, June 1, 2024 from 10:00 a.m. – 1:00 p.m. EDT
Presenter: Dr. Mina Lobbous, University of Alabama at Birmingham
Session Title: Central Nervous System Tumors
Abstract #: 2042
Poster Board: #341

Abstract: The Phase 1 study enrolled 23 patients with newly diagnosed GBM who exhibited adequate organ function and a Karnofsky Performance Status (KPS) of ≥ 70%. Patients were administered 1, 3, or 6 doses of DeltEx DRI, consisting of 1 x 10⁷ DRI cells, into the resection cavity along with 150 mg/m² of intravenous TMZ on Day 1 and oral TMZ on days 2-5 of each Stupp maintenance cycle.

DeltEx DRI was successfully infused with peripheral TMZ-based lymphodepletion evidenced with near or below normal range T, B, and NK subsets for up to one year. The majority of patients dosed exceeded the expected median PFS of 7 months with Stupp therapy alone, demonstrating a continued encouraging trend in PFS. Long-term follow-up for durability of PFS and OS continue.

The Phase 1 study results reported no dose-limiting toxicities, cytokine release syndrome, or neurotoxicity. The most common adverse events were decreased white blood cell and platelet count, asthenia, fatigue, hydrocephalus, headache, decreased appetite, urinary tract infection, thrombosis, and balance disorder.

Autologous DeltEx DRI is a gene-modified autologous gamma-delta T cell therapy designed for the treatment of newly diagnosed GBM patients receiving maintenance TMZ therapy. Gamma delta T cells can target NKG2D ligands that are upregulated on tumor cells following exposure to alkylating chemotherapy, leveraging the unique capabilities of this investigational therapy to enable concomitant therapy and continued surveillance against tumor cells.

More details of the Phase 1 study can be found at www.clinicaltrials.gov (NCT04165941).

Abstract can be accessed online at https://abstracts.asco.org beginning at 5:00 p.m. EDT on May 23, 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 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 DeltEx DRI’s potential as a novel therapy in patients with newly diagnosed GBM; IN8bio’s ability to advance its gamma delta T cell therapy to help address the unmet medical needs of patients with newly diagnosed GBM; and the timing of IN8bio’s future presentations and data readouts. 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: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio’s product candidates, including patient enrollment and follow-up and IN8bio’s ability to meet anticipated deadlines and milestones; 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; uncertainties related to 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, that 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 May 9, 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 events, changed circumstances, or otherwise, except as otherwise required by law.

Company Contact

IN8bio, Inc.
Glenn Schulman, PharmD, MPH
+1 203.494.7411
gdschulman@IN8bio.com

Investors

Meru Advisors
Lee M. Stern
lstern@meruadvisors.com

Media Contact

Kimberly Ha
KKH Advisors
+1 917.291.5744
kimberly.ha@kkhadvisors.com

FAQ

What is INB-200?

INB-200 is an autologous Drug Resistant Immunotherapy (DeltEx DRI) being evaluated as a first-line treatment for newly diagnosed glioblastoma multiforme (GBM).

When and where will the INB-200 Phase 1 study results be presented?

The INB-200 Phase 1 study results will be presented at the 2024 ASCO Annual Meeting, from May 31 to June 4 in Chicago, Illinois.

What were the key findings of the INB-200 Phase 1 study?

The INB-200 Phase 1 study showed promising progression-free survival rates beyond the median expected with standard treatment and no dose-limiting toxicities.

What adverse events were reported in the INB-200 Phase 1 study?

Common adverse events included decreased white blood cell and platelet count, fatigue, and headache.

How many patients were involved in the INB-200 Phase 1 study?

The Phase 1 study of INB-200 enrolled 23 patients with newly diagnosed glioblastoma multiforme (GBM).