Form 8-K - Current report
20 11월 2023 - 11:04PM
Edgar (US Regulatory)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 20, 2023
IN8bio, Inc.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
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001-39692 |
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82-5462585 |
(State or Other Jurisdiction of Incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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350 5th Avenue, Suite 5330 New York, New York |
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10118 |
(Address of Principal Executive Offices) |
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(Zip Code) |
Registrant’s Telephone Number, Including Area Code: 646 600-6438
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock, $0.0001 par value |
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INAB |
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The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
On November 20, 2023, IN8bio, Inc. (the “Company”) issued a press release announcing updated clinical data from the Phase 1 INB-200 trial, which was presented at the Society for Neuro-Oncology 28th Annual Meeting in Vancouver, British Columbia on November 17, 2023. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01 |
Financial Statements and Exhibits. |
d) Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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IN8bio, Inc. |
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Date: November 20, 2023 |
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By: |
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/s/ Patrick McCall |
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Patrick McCall |
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Chief Financial Officer and Secretary |
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(Principal Financial and Accounting Officer) |
Exhibit 99.1
IN8bios INB-200 Demonstrates Extended Progression-Free
Survival in Patients with Newly Diagnosed Glioblastoma
All patients treated with INB-200
who completed mandated doses to date have exceeded a progression-free survival (PFS) of seven months
Most patients exceeded the
expected median PFS based on age and tumor status; two patients from Cohort 2 remain alive beyond two years
Additional enrolled
patients await dosing with completion of enrollment in Cohort 3 expected in 2023 and long-term follow up to be presented at medical meetings in 2024
NEW YORK, November 20, 2023 (GLOBE NEWSWIRE) IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company developing innovative
gamma-delta (gd) T cell therapies, presented data demonstrating that all patients treated with INB-200 who completed
mandated doses have exceeded a progression-free survival (PFS) of seven months to date. This survival data shows the potential of IN8bios DeltEx Drug Resistant Immunotherapy (DRI)genetically modified and chemotherapy-resistant
gamma-delta T cells to treat patients with newly diagnosed glioblastoma (GBM). The poster highlighting the updated clinical data from the Phase 1 INB-200 trial was presented at the Society for Neuro-Oncology
(SNO) 28th Annual Meeting in Vancouver, British Columbia on November 17, 2023.
Every
patient in the Phase 1 trial that completed the mandated doses has exceeded the standard-of-care median progression-free survival of four to seven months, with one
patient in Cohort 2 remaining alive and progression free past 28.5 months following three doses, said Trishna Goswami, MD, Chief Medical Officer at IN8bio. We are excited by the safety and efficacy results across cohorts in this study
and look forward to dosing additional patients with the added hope of improving their treatment outcomes. Following up on our oral presentation at this years ASCO Annual Meeting, these encouraging results demonstrate the early promise of
IN8bios DeltEx DRI gamma-delta T cells for treating GBM patients and potentially other solid tumor cancers.
The current standard-of-care regimen for newly diagnosed GBM consists of primary resection, six weeks of chemoradiation therapy followed by six cycles of maintenance monthly temozolomide
therapy, which achieves a median PFS of 7 months and an overall survival (OS) of approximately 14 to 16 months. The Phase 1 trial assesses the safety and preliminary efficacy of the addition of DeltEx DRI gamma-delta T cells to standard-of-care maintenance therapy. The trial assesses three different dosing regimens from a single dose delivered on cycle 1 day 1 in Cohort 1, to three doses delivered on
day 1 of cycles 1-3 in Cohort 2, to finally six doses delivered on day 1 of cycles 1-6 in Cohort 3. All patients receive 1x107 cells per dose, however the number of doses varies depending on the cohort of enrollment.
The poster presentation at SNO included efficacy and safety data as of the data cutoff on October 20,
2023. Ten patients have been treated with INB-200: three in Cohort 1 (1 dose), four in Cohort 2 (3 doses) and three in Cohort 3 (6 doses). Key findings from the ongoing study include:
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All patients who completed mandated doses surpassed a PFS of seven months, with most also exceeding the expected
PFS based on their age and tumor status. |
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One patient (009) with an IDH-mutant glioma remains alive and
progression free at 28.5+ months; comparative data published in the New England Journal of Medicine (NEJM) in August 2023 demonstrate that IDH-mutant patients in the control arm of a clinical trial
demonstrated a median PFS of 11.1 months. |
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No treatment-related serious adverse events (SAEs), dose-limiting toxicities (DLTs), cytokine release syndrome
(CRS), infusion reactions, or immune effector cell-associated neurotoxicity syndrome (ICANS) have been reported in any cohort. |
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The most common treatment-emergent adverse events (TEAEs) were mostly Grade
1-2 toxicities consisting of white blood cell and platelet count decreases related to standard-of-care temozolomide.
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Preserved gamma-delta T cells found in relapsed tumor 148 days after initial DRI infusion, pointing to durability
of gamma-delta T cells in treating cancer. |
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The poster is available on the Companys website here. |
About INB-200
INB-200 is a genetically modified autologous DRI product candidate for the treatment of solid tumors. This novel platform utilizes genetic engineering to generate chemotherapy-resistant gamma delta T cells which can
be administered concurrently with standard-of-care treatment in solid tumors. This is a powerful, synergistic treatment approach enabling gamma-delta T cells to persist
in the presence of chemotherapy, and maintain their natural ability to recognize, engage and kill cancer cells.
INB-200 is the first genetically engineered gamma-delta T cell therapy to be administered to patients with solid
tumors and our initial indication is in GBM.
About IN8bio
IN8bio is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of gamma-delta T cell product candidates for
solid and liquid tumors. 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. IN8bios DeltEx platform employs allogeneic,
autologous, iPSC and genetically modified approaches to develop cell therapies, designed to effectively identify and eradicate tumor cells.
IN8bio has
initiated a Phase 2 trial of INB-400 in GBM at multiple centers across the United States and has two ongoing Phase 1 trials in solid and hematological tumors, including
INB-200 for GBM and INB-100 for patients with hematologic malignancies undergoing transplantation. IN8bio also has a broad portfolio of preclinical programs focused on
addressing other hematological and solid tumor cancers. For more information about IN8bio and its programs, please 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 the potential of INB-200 to treat patients with newly
diagnosed GBM, including future outcomes of the INB-200 program; the ability of the DeltEX platform to effectively identify and eradicate tumor cells; the development and continued progress and success of our
preclinical and clinical trials and programs and product candidates; and IN8bios ability to achieve anticipated milestones, including expected data readouts from its trials, enrollment of additional patients in its clinical trials, advancement
of clinical development plans and to develop new preclinical programs. 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 IN8bios ability to meet anticipated deadlines and milestones; uncertainties inherent in the initiation and completion of preclinical
studies and clinical trials and clinical development of IN8bios 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 IN8bios product candidates; expectations for regulatory approvals to conduct trials or to market
products; IN8bios 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.
These and other factors 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
November 9, 2023, 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.
Patrick McCall
+ 1 646.600.6GDT (6438)
info@IN8bio.com
Investors & Media:
Argot Partners
IN8bio@argotpartners.com
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