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]).

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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]).

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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.

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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.

Quanterix to Present at Goldman Sachs Global Healthcare Conference

On June 6, 2025 Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, reported that President and Chief Executive Officer Masoud Toloue will present at the Goldman Sachs 46th Annual Global Healthcare Conference in Miami, Florida on Monday, June 9th, at 1:20 p.m. ET (Press release, Quanterix, JUN 6, 2025, View Source [SID1234653769]). Quanterix will also host one-on-one meetings with institutional investors during the conference.

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Webcast Information

The live webcast presentation can be accessed from the Investors section of the company’s website at www.quanterix.com. A replay of the webcast will be available for a limited period following the conference.

To learn more about Quanterix, visit www.quanterix.com/company. To learn more about Quanterix’s Simoa technology, visit www.quanterix.com/simoa-technology.

OS Therapies Submits Request for Regenerative Medicine Advanced Therapy (RMAT) Designation to U.S. FDA for OST-HER2 in the Prevention of Metastases in Recurrent, Fully-Resected, Lung Metastatic Pediatric Osteosarcoma

On June 6, 2025 OS Therapies Inc. (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, reported it has submitted a request for Regenerative Medicine Advanced Therapy (RMAT) Designation to U.S. FDA for OST-HER2 in the prevention of metastases in recurrent, fully-resected, lung metastatic pediatric osteosarcoma (Press release, OS Therapies, JUN 6, 2025, View Source [SID1234653768]). RMAT designations are granted to sponsors with regenerative medicine therapies for serious or life-threatening conditions and provide sponsors with various benefits, including eligibility for an accelerated Biologics License Application (BLA) review.

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OST-HER2 has already received Rare Pediatric Disease Designation (RPDD), Orphan Drug Designation (ODD) and Fast Track Designation (FTD) for osteosarcoma from the U.S. FDA. If OST-HER2 receives a conditional BLA via Accelerated Review prior to September 30, 2026, the Company will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell. The most recent publicly disclosed PRV sale, valued at $155 million, occurred in May 2025.

The Company is awaiting feedback by mid-June 2025 from a Type D meeting with FDA regarding the statistical analysis plan to be used in an End of Phase 2 meeting for OST-HER2 in the prevention of metastases in recurrent, fully-resected, lung metastatic pediatric osteosarcoma. Upon receipt of the Type D Meeting feedback, the Company intends to promptly request the End of Phase 2 meeting with FDA in which it will be seek agreement to allow it to begin a rolling BLA submission in the third quarter of 2025. The grant of the RMAT designation in the third quarter of 2025 complements the company’s parallel efforts in other major markets, including Europe and the United Kingdom, where the company plans to seek EMA PRIME Designation and Conditional Market Access (CMA) applications.

In parallel to regulatory engagement and market access planning for OST-HER2, the Company is preparing for the late stage clinical development of other pipeline candidates. As such, the Company is well positioned for sustained growth across multiple therapeutic modalities.