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IN8bio Recognizes Achievement of 4-Years in Remission for Patient Treated with INB-200 in Glioblastoma Trial

On June 9, 2025 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for cancer and autoimmune diseases, reported that Patient 009 in the Phase 1 trial of INB-200 for newly-diagnosed GBM has recently reached a significant clinical milestone (Press release, In8bio, JUN 9, 2025, View Source [SID1234653774]). The patient, with a grade 4, IDH-mutant glioma, has been in remission and surviving for 4 years having been treated with INB-200. The patient is doing well, has returned to work and has a good quality of life post-treatment with INB-200. Patient 009’s clinical progress and 4-year remission far surpasses progression-free outcomes observed in other clinical trials of IDH-mutant glioma patients.

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"Surviving four years without progression in newly diagnosed astrocytoma WHO4 IDH mutated is a significant achievement demonstrating the potential activity of gamma-delta T cells," said Dr. Burt Nabors, Principal Investigator of the INB-200 trial and Vice-Chair of Research of Neurology and Director for the UAB Division of Neuro-oncology. "This outcome further highlights the potential impact of INB-200 in one of the most aggressive, difficult-to-treat and deadly cancers."

IN8bio recently presented updated Phase 1 data from the INB-200 trial at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The results showed that repeated doses of INB-200 demonstrated an extended mPFS of 16.1 months, more than double the expected 6.9 months typically observed with the standard-of-care Stupp protocol in newly diagnosed GBM. INB-200 is the first genetically modified gamma-delta T cell therapy evaluated in GBM and has demonstrated a favorable safety profile and signals of long-term benefit.

"We are thrilled that our study participant has reached this incredible milestone," said William Ho, CEO and co-founder, IN8bio. "This type of long-term survival and life changing clinical impact is exactly what we strive to achieve at IN8bio. The current standard-of-care for newly diagnosed GBM has not advanced beyond an overall survival of 14-16 months in over two decades. This is a powerful testament to what’s possible when we harness the unique biology of gamma-delta T cells."

Elevation Oncology Enters into Agreement to Be Acquired by Concentra Biosciences for $0.36 in Cash per Share Plus a Contingent Value Right

On June 9, 2025 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported that it has entered into a definitive merger agreement (the "Merger Agreement") with Concentra Biosciences, LLC ("Concentra"), whereby Concentra will acquire Elevation Oncology for $0.36 in cash per share of Elevation Oncology common stock ("Common Stock"), plus one non-tradeable contingent value right ("CVR"), which represents the right to receive: (i) 100% of the closing net cash in excess of $26.4 million; and (ii) 80% of any net proceeds received within five years following closing from any disposition of EO-1022 that occurs within one year following closing, each pursuant to the contingent value rights agreement (the "CVR Agreement") (Press release, Elevation Oncology, JUN 9, 2025, View Source;utm_medium=rss&utm_campaign=elevation-oncology-enters-into-agreement-to-be-acquired-by-concentra-biosciences-for-0-36-in-cash-per-share-plus-a-contingent-value-right [SID1234653773]).

The Elevation Oncology Board of Directors has unanimously determined that the acquisition by Concentra is in the best interests of all Elevation Oncology stockholders and has approved the Merger Agreement and related transactions.

Pursuant and subject to the terms of the Merger Agreement, a wholly owned subsidiary of Concentra will commence a tender offer (the "Offer") by June 23, 2025 to acquire all outstanding shares of Common Stock. Closing of the Offer is subject to certain conditions, including the tender of Common Stock representing at least a majority of the total number of outstanding shares (including any shares held by Concentra), the availability of at least $26.4 million of cash (net of transaction costs, contractual payments to warrant holders and other liabilities at closing), and other customary closing conditions. Elevation Oncology officers, directors and their respective affiliates holding approximately 5.1% of Common Stock have signed tender and support agreements under which such parties have agreed to tender their shares in the Offer and support the merger transaction. The merger transaction is expected to close in July 2025.

Advisors

Fenwick & West LLP is acting as legal counsel to Elevation Oncology. Gibson, Dunn & Crutcher LLP is acting as legal counsel to Concentra.

Anixa Biosciences Announces Poster Presentation on Ovarian Cancer CAR-T Clinical Trial at the ESMO Gynaecological Cancers Congress 2025

On June 9, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt Cancer Center, and the principal investigator of the Phase 1 clinical trial of Anixa’s ovarian cancer CAR-T immunotherapy, will present an e-poster at the European Society for Medical Oncology ("ESMO") Gynaecological Cancers Congress 2025, to be held on June 19-21, 2025 in Vienna, Austria (Press release, Anixa Biosciences, JUN 9, 2025, View Source [SID1234653772]).

Presentation Details:

Title: Phase 1 clinical trial of autologous T-cells genetically engineered with a chimeric receptor to target the follicle stimulating hormone receptor (FSHR) in recurrent ovarian cancer (OVCA)
Session Type: E-Poster
Poster No.: 145eTiP

Samsung Bioepis Enters into a Strategic Partnership with NIPRO for Commercialization of Multiple Biosimilars in Japan

On June 8, 2025 Samsung Bioepis Co., Ltd. ("Samsung Bioepis") reported that the company has entered into a license, development and commercialization agreement with NIPRO Corporation ("NIPRO") for multiple biosimilar candidates including SB17, ustekinumab biosimilar candidate, in Japan (Press release, Nipro, JUN 8, 2025, View Source [SID1234653771]).

Under the terms of the agreement, Samsung Bioepis will be responsible for the development, manufacture and supply of the medicines, while NIPRO will be responsible for commercialization of the medicines in Japan.

"This partnership marks an important step towards expanding our footprint in Japan. Biosimilars have a great potential to bring cost savings and widen access to treatments for healthcare systems, providers, and patients in Japan. We look forward to collaborating with NIPRO, a company renowned for its high-quality medical devices and healthcare solutions, to accelerate access to treatments in the Japanese market," said Kyung-Ah Kim, President and Chief Executive Officer of Samsung Bioepis. "We will continue to advance our development platform and innovate access to treatments for healthcare systems, payers, physicians, and patients around the world."

Entry Into a Material Definitive Agreement

On June 6, 2025, Integra LifeSciences Holdings Corporation (the "Company") reported to have entered into an amendment (the "Amendment") to the Seventh Amended and Restated Credit Agreement, dated as of March 24, 2023, among the Company, a syndicate of lending banks, Bank of America, N.A., as Administrative Agent, Swing Line Lender and L/C Issuer, Citibank N.A., JPMorgan Chase Bank, N.A., Morgan Stanley MUFG Loan Partners, LLC, PNC Bank, N.A., Truist Bank and Wells Fargo Bank, N.A., as Co-Syndication Agents, and The Bank of Nova Scotia, BMO Harris Bank N.A., BNP Paribas, Capital One, National Association, Citizens Bank, N.A., DNB Bank ASA, New York Branch, Santander Bank, N.A. and TD Bank, N.A., as Co-Documentation Agents (as amended, restated, modified and supplemented from time to time prior to the date hereof, the "Credit Agreement") (Filing, 8-K, Integra LifeSciences, JUN 6, 2025, View Source [SID1234653775]). The Credit Agreement was filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC on March 24, 2023.

The Amendment amends the financial covenant requiring the Company to maintain a particular consolidated total leverage ratio. In particular, the Amendment increases the maximum permitted consolidated total leverage ratio from the currently applicable 5.00 to 1.00 (which reflects an increase from 4.25 to 1.00 taken by the Company in connection with the closing of a permitted acquisition and which is applicable through the fiscal quarter ending September 30, 2025) to (a) 5.00 to 1.00 for the fiscal quarters ending March 31, 2025 through June 30, 2026, (b) 4.75 to 1.00 for the fiscal quarter ending September 30, 2026, (c) 4.50 to 1.00 for the fiscal quarter ending December 31, 2026, and (d) 4.00 to 1.00 for the fiscal quarter ending March 31, 2027 and the last day of each fiscal quarter thereafter. During the period commencing on the effective date of the Amendment and ending on the date of delivery of the financial statements and related compliance certificate for the fiscal year ending December 31, 2026 (the "Covenant Relief Period"), the Company will not be permitted to temporarily increase the applicable maximum consolidated total leverage ratio in connection with a permitted acquisition.

In addition to the foregoing, the Amendment, among other things, also: (i) temporarily establishes, during the Covenant Relief Period, a revised applicable rate schedule; (ii) temporarily limits, during the Covenant Relief Period, the Company’s ability to make certain investments; (iii) temporarily restricts, during the Covenant Relief Period, the Company’s ability to incur incremental indebtedness under the Credit Agreement, create certain liens, make certain restricted payments and incur or guarantee indebtedness of excluded subsidiaries; and (iv) temporarily prohibits, during the Covenant Relief Period, the Company from selling, transferring or exclusively licensing material intellectual property to a subsidiary of the Company that is not a loan party under the Credit Agreement or designating any subsidiary that owns or exclusively licenses any material intellectual property as an excluded subsidiary under the Credit Agreement.

The Amendment does not increase the Company’s total indebtedness.

A copy of the Amendment is attached as Exhibit 4.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 1.01. The foregoing summary does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment and the Credit Agreement.