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INB-100 Achieves Remarkable Remission Rates in Acute Myeloid Leukemia Patients
New therapy significantly improves survival compared to past treatments.
Quiver AI Summary
IN8bio, Inc. recently reported that all acute myeloid leukemia (AML) patients treated with INB-100, an allogeneic gamma-delta T cell therapy, achieved complete remission (CR) with a median follow-up of 20.1 months. Administered after hematopoietic stem cell transplantation (HSCT), INB-100 showed notably improved one-year progression-free survival (PFS) and overall survival (OS) rates compared to historical controls. Its effectiveness among older, high-risk patients was highlighted, with manageable side effects and no serious complications. These encouraging results will be discussed at the 2025 Tandem Meetings, leading to speculation about a shift in standard care for challenging leukemia cases. A conference call is scheduled for further insights on these findings.
Positive Highlights
- All AML patients treated with INB-100 remained in complete remission, marking a significant success in both original and expansion cohorts.
- One-year survival rates were impressive, with 90.9% PFS and 100% OS, greatly surpassing figures from historical patient groups.
- INB-100 proved effective for older, high-risk patients who had previously failed multiple treatment regimens, opening new avenues for difficult cases.
- The safety profile of INB-100 is favorable, with few side effects and no incidents of cytokine release syndrome or neurotoxicity.
Challenges Ahead
- The press release emphasizes forward-looking statements, highlighting uncertainties regarding future achievements and risks to the company’s operations.
- Financial stability concerns exist, particularly the possibility of not raising enough capital, which could impede clinical progress or lead to operational cessation.
- Dependence on third parties and the potential failure to gain regulatory approval raises questions about the commercial feasibility of INB-100.
FAQ
What key results emerged from the INB-100 trial for AML patients?
All patients in the trial maintained complete remission, with encouraging one-year survival statistics.
How long was the median follow-up period for participants?
Patients were followed for a median of 20.1 months.
What safety profile did INB-100 exhibit?
INB-100 demonstrated manageable side effects, with no severe cytokine release syndrome or neurotoxicity reported.
What was the age demographic of the patients treated with INB-100?
The study included older patients, with a median age of 68, many of whom faced high-risk leukemia.
How can individuals join the conference call regarding INB-100 updates?
Registration links for the conference call are provided, and it is recommended to register at least five minutes prior to the call.
Disclaimer: This summary is AI-generated from a press release distributed by GlobeNewswire. For the full release, click here.
$INAB Hedge Fund Activity
Recent activity shows 13 institutional investors increasing their stakes in $INAB, while 12 reduced their holdings in the latest quarter.
Here are notable transactions:
- 683 CAPITAL MANAGEMENT, LLC added 759,493 shares (+128.6%) in Q3 2024, worth an estimated $205,063.
- AIGH CAPITAL MANAGEMENT LLC decreased holdings by 453,360 shares (-21.3%) in Q3 2024, totaling around $122,407.
- ENSIGN PEAK ADVISORS, INC cut their shares by 289,090 (-25.9%), equivalent to about $78,054.
- ALYESKA INVESTMENT GROUP, L.P. sold 206,199 shares (-32.2%), approx. valued at $55,673.
- SIGMA PLANNING CORP increased its position by 190,100 shares (+22.3%) in Q4 2024, for about $48,893.
- BRIDGEWAY CAPITAL MANAGEMENT, LLC liquidated 103,302 shares (-100%), valued around $27,891.
- TWO SIGMA SECURITIES, LLC also removed 69,718 shares (-100%), amounting to roughly $18,823.
For tracking hedge fund holdings, visit Quiver Quantitative’s institutional holdings dashboard.
Full Release
- All AML patients across original and expansion cohorts sustained complete remission (CR) after a median follow-up of 20.1 months.
- Patients treated with INB-100 showed significantly better one-year progression-free survival (PFS) and overall survival (OS) compared to historical controls.
- Gamma-delta T cell persistence supports prolonged and durable remissions in treated patients.
- The company will hold a conference call at 8:30 AM EST today. Use this link to join or access the listen-only version of the webcast here.
NEW YORK, Feb. 11, 2025 (GLOBE NEWSWIRE) — IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical firm focusing on gamma-delta T cell therapies, announced positive new data from a Phase 1 trial of INB-100. This treatment aims to assist patients with complex leukemias such as AML and has shown promise in achieving durable remissions and improved survival when administered post-HSCT. Findings will be presented at the 2025 Tandem Meetings in Honolulu, HI.
Highlights
- All AML patients maintain remission
- Every AML patient treated through January 17, 2025, remains in complete remission. The original cohort achieved a median CR of 23.3 months, with some in remission for over three years. The median duration across all patients is 20.1 months.
- Trial surpasses standard treatment survival outcomes
Comparison with real-world historical data highlights INB-100’s superior survival rates:
- INB-100:
- All patients – 90.9% PFS and 100% OS at one year.
- AML patients – 100% PFS and 100% OS at one year.
- Historical AML controls:
- Data from Center for International Blood and Marrow Transplant Research (CIBMTR) shows lower benchmarks: a PFS of 67.8% and OS of…
- INB-100:
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Promising Results from INB-100 Cancer Treatment for High-Risk Patients
Substantial Progress with Innovative Therapy for Leukemia
- Survival Rates Indicate Effective Treatment
- The Kansas University Cancer Center (KUCC) reported a progression-free survival (PFS) of 57.4% and overall survival (OS) of 66.7% at the one-year mark.
- Additionally, there is a 74.7% PFS at one year for various patients involved in this study.
- Positive Outcomes for High-Risk Patients
- Relapse remains the leading cause of death in patients undergoing hematopoietic stem cell transplant (HSCT).
- Despite their higher risk, many patients, averaging 68 years old, participated in the study, experiencing complex diseases or previous treatment failures, yet achieving long-term remission with manageable side effects.
- Quality of Life Maintained with Therapy
- No occurrence of cytokine release syndrome (CRS) or neurotoxicity (ICANS).
- Graft-versus-host disease (GvHD) was tolerable and managed effectively with steroids.
- Only mild infections were reported.
Dr. Joseph P. McGuirk, Schutte-Speas Professor of Hematology-Oncology at the University of Kansas Cancer Center, expressed optimism regarding these findings: “These data suggest that adding allogeneic INB-100 gamma-delta T cells can lead to substantial, long-lasting remission in high-risk leukemia patients. A striking 100% of treated acute myeloid leukemia (AML) patients remained in remission after almost two years. Patients receiving reduced intensity conditioning often confront significant relapse threats in the first year and typically lack treatment options upon relapse. INB-100 not only aids patients in avoiding relapses but also preserves their quality of life. These results are noteworthy, revealing a rare occurrence in high-risk leukemia cases: sustained remission with minimal adverse effects.”
William Ho, CEO and co-founder of IN8bio, added, “We’re thrilled with the consistent, long-term remission outcomes we’re observing with INB-100. Achieving 100% relapse-free survival in high-risk AML patients over an extended timeframe is exceptional. For those who previously faced uncertain futures, INB-100 offers renewed hope and a chance for improved survival rates. We are especially encouraged by its safety profile, as gamma-delta T cells effectively target cancer cells without causing significant side effects like CRS or neurotoxicity, which are common hurdles in other therapies. Our team remains committed to advancing the regulatory pathway toward potential trials and ensuring broader access to this innovative treatment. We will provide updates later this year as we make progress toward this goal.”
Conference Call Information
IN8bio will hold a conference call and webcast on Tuesday, February 11, 2025, at 8:30 am ET. The live call can be accessed through this link, or on the Events & Presentations page of the company’s website. Participants are encouraged to register at least five minutes before the call using this link, whereupon they will receive the dial-in details and a unique PIN.
For more details about the study, including findings and next steps, please refer to the company’s presentation at the American Society of Transplantation and Cellular Therapy conference: https://investors.in8bio.com/news-events/events-presentations.
About IN8bio
IN8bio is a biopharmaceutical company focused on developing gamma-delta T cell-based immunotherapies for cancer patients. This specialized T cell population has the unique ability to differentiate between healthy and diseased tissues. The company’s primary program, INB-100, evaluates haplo-matched allogeneic gamma-delta T cells administered to patients post-hematopoietic stem cell transplant. IN8bio is also researching autologous DeltEx DRI gamma-delta T cells combined with standard care for glioblastoma. For more information about IN8bio, visit www.IN8bio.com.
Forward-Looking Statements
This press release may contain forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. These statements may include words like “aims,” “anticipates,” “believes,” and “could,” and reflect expectations or predictions about the future. While these statements address IN8bio’s goals for INB-100, including expected enhancements in patient care and trial advancements, actual outcomes may differ. Factors that could affect these projections include regulatory challenges, trial timelines, and efforts to secure funding for research and development. Actual results may vary significantly from these forecasts.
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Challenges Ahead for IN8bio: Financial Stability and Clinical Trials at Stake
Key Concerns for Investors:
IN8bio faces significant uncertainties that could impact its future operations. The company may need to scale back its development programs or potentially cease operations altogether. Key risks include:
- The ability of IN8bio to operate as a going concern
- The potential failure to achieve the benefits expected from its DeltEx platform
- Timing and outcomes of preclinical studies and clinical trials
- The possibility that early results may not predict final trial outcomes
- Delays in trials and studies along with unsatisfactory results
- Adverse effects from testing IN8bio’s product candidates
- Regulatory approval uncertainties for trials or product marketing
- Reliance on third parties, including licensors and clinical research organizations
Any of these factors could lead to actual results diverging from optimistic forecasts. A detailed discussion of these risks can be found in the “Risk Factors” section of IN8bio’s Quarterly Report on Form 10-Q, submitted to the Securities and Exchange Commission (SEC) on November 12, 2024, among other future SEC filings.
IN8bio notes that any forward-looking statements in this release are only valid as of the release date. The company does not commit to updating these statements unless required by law.
Contact Information for Investors & Company Queries:
Glenn Schulman, PharmD, MPH
203.494.7411
gdschulman@in8bio.com
IN8bio, Inc.
Patrick McCall
646.933.5603
pfmccall@IN8bio.com
Media Inquiries:
Kimberly Ha
KKH Advisors
917.291.5744
kimberly.ha@kkhadvisors.com
This article was originally published on Quiver News; read the full story for more insights.
The views and opinions expressed herein are those of the author and do not necessarily reflect those of Nasdaq, Inc.
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