On June 24, 2025 OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, reported that it received positive written feedback from the US Food & Drug Administration ("FDA") Type D Meeting that occurred in mid-June 2025 regarding endpoints required to support an Accelerated Approval Program marketing application for its Phase 2b trial of OST-HER2 in the prevention or delay of recurrence in fully resected, pediatric lung metastatic osteosarcoma (Press release, OS Therapies, JUN 24, 2025, View Source [SID1234654098]). The Company reiterates that additional data from its Phase 2b trial will be presented at the major osteosarcoma conference MIB Factor in Salt Lake City on Saturday June 28, 2025 at 3:30pm MDT.

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Concurrent with this announcement, the Company announced that it has submitted End of Phase 2 Meeting and Breakthrough Therapy Designation (BTD) requests to FDA based on the positive Type D Meeting feedback. The End of Phase 2 Meeting is expected to occur in the third quarter of 2025. This is in alignment with the company’s overall regulatory strategy and timelines.

"We are pleased with the feedback we received from the FDA regarding the use of external control comparators in settings where placebo-controlled randomization trials are not feasible – particularly in rare pediatric diseases such as the indication treated by OST-HER2 ," said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. "Moreover, we received additional collaborative input regarding suggested statistical methods as we seek to compare OST-HER2 active treatment with external control arm(s) to support a Biologics Licensing Application (BLA) via the Accelerated Approval Program. Taken together, the feedback gives us insight on the FDA’s current position and allows us to be fully prepared for the End of Phase 2 Meeting."

OST-HER2 has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will become eligible to receive a Priority Review Voucher (PRV) that it intends to immediately sell. The most recent PRV sale occurred in June 2025, valued at $160 million.

The osteosarcoma treatment market was estimated at $1.2 billion in 2022 according to Data Bridge Market Research. Approximately 50% of patients are diagnosed with a lung metastasis at some point following surgical resection and chemotherapy. 3-year survival rates in patients who were not diagnosed with a metastasis are 59%. 3-year survival rates in patients who were diagnosed with pulmonary metastasis were 30%. The Company believes the market opportunity for OST-HER2 in the prevention of lung metastases is over $500 million.

OST-HER2, an immunotherapy for osteosarcoma that uses a HER2-bioengineered form of the bacterium Listeria monocytogenes to trigger a strong immune response against HER2-expressing cancer cells, is featured in the movie Shelter Me: The Cancer Pioneers. The movie offers a look into canine comparative oncology, a field that compares treatment of cancers in dogs to those in people and covers developing treatments for rare forms of cancer. The movie is available via streaming on PBS’ website.

On June 24, 2025 Bio-Techne Corporation (NASDAQ: TECH) reported a distribution agreement with the U.S. Pharmacopeia (USP) that enables the Company to sell USP monoclonal antibody (mAb) and recombinant adeno-associated virus (AAV) reference standards with its analytical solutions, including the Maurice system, to support monoclonal antibody and gene therapy development around the world (Press release, Bio-Techne, JUN 24, 2025, View Source [SID1234654083]).

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More than 160 antibody therapies against nearly 100 targets and range of diseases have been approved worldwide. Maintaining consistent mAb quality is vital for their efficacy. The need for consistency is becoming increasingly more important as mAb patent protections expire, and biosimilar versions of these therapies become available. This leads to a greater need for manufacturers to rigorously test critical quality attributes throughout mAb development and manufacturing processes to demonstrate product safety and effectiveness.

Separately, gene therapy, which relies on recombinant AAV to deliver gene edits into cells, is one of the fastest-growing sectors in the biopharmaceutical industry. The exceptional growth of these groundbreaking treatments offers cures to previously incurable genetic diseases; however, challenges persist in the development and commercialization processes, including low yields, scalability hurdles, high costs, and analytical complexities. USP reference standards help solve these challenges by providing well-characterized benchmarks for analytical testing, ensuring accuracy, reliability, and regulatory compliance in product development and quality control.

Importantly, both USP mAbs and AAV reference standards provide stringent materials that can be used with Bio-Techne’s leading analytical instruments, such as the MauriceFlex system. By combining these standards with the Company’s rapid, easy-to-use, and multi-functional analytics, therapy manufacturers can achieve reliable, efficient, and integrated characterization for purity, charge, size, and identity applications for complex biologics, from development through product release.

"We are excited about our work with USP. This marks a significant milestone in advancing our commitment to providing cutting-edge tools and solutions to the scientific community," said Will Geist, President of Bio-Techne’s Protein Sciences Segment. "This relationship underscores our dedication to supporting advancements in biotherapeutic development and ensuring the highest standards of quality and safety for patient care."

"We are thrilled to engage Bio-Techne as an authorized distributor, which enables USP to expand access of our solutions within the scientific community and beyond, ensuring that safe and quality therapeutic products reach the market for the benefit of patients worldwide," said Fouad Atouf, Ph.D., Senior Vice President, Global Biologics for USP. "Through working with Bio-Techne, USP is reinforcing its commitment to addressing the most prevalent quality issues with innovative solutions, leveraging our robust framework of science-based quality standards for pharmaceutical manufacturers."

Addressing quality challenges is essential to ensure the safety and quality of biotherapeutics. Both USP and Bio-Techne have a long history of developing solutions to support mAbs and are applying their know-how to solving analytical challenges in AAV-based gene therapies. The ability to purchase USP reference standards from Bio-Techne further simplifies the method development process, enabling customers to assess system suitability and other critical criteria for charge and size based analytical assays on the Maurice system.

On June 24, 2025 Corner Therapeutics, an immunotherapy company pioneering novel approaches to cancer and infection, reported that its Distinguished Scientist, Scientific Co-founder and Board Member, Professor Jonathan Kagan, Ph.D., will deliver an invited oral presentation at the 25th Annual Meeting of the Federation of Clinical Immunology Societies (FOCiS 2025), taking place from June 24 to 27 in Boston, MA (Press release, Corner Therapeutics, JUN 24, 2025, View Source [SID1234654099]).

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On June 24, as part of the Member Society Symposia: Innate Immunotherapy in Cancer: Bridging Fundamental Mechanisms and Clinical Trials, Professor Kagan will present new preclinical and human data demonstrating the ability of Corner’s novel mRNA-encoded immunotherapies to drive durable tissue-resident T cell responses through STING pathway agonism. The presentation will focus on applications in cancer vaccines.

Presentation Details
Title: mRNA-encoded Adjuvant Enzymes Unlock Anti-tumor T-cell Immunity
Date/Time: June 24, 4:30-5pm ET
Location: Boston Marriott Copley Place, Arlington meeting room, Boston, MA

Professor Kagan co-founded Corner Therapeutics in 2019 with the goal of developing immunotherapies through the exquisite control of the innate immune system. Based on Professor Kagan’s research, Corner’s mRNA-based and dendritic cell hyperactivating platforms instruct the innate immune system to engineer its own long-lived, disease-fighting T cells.

Last year, Corner launched its $54 million Series A investment round. The company now partners with leading biopharma companies and nonprofits including the Bill & Melinda Gates Foundation to fully realize the protective promise of both therapeutic and preventative vaccines.

On June 24, 2025 Cidara Therapeutics, Inc. ("Cidara") (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, reported the pricing of an underwritten public offering of 7,954,546 shares of its common stock at a price to the public of $44.00 per share. All of the shares are to be sold by Cidara (Press release, Cidara Therapeutics, JUN 24, 2025, View Source [SID1234654084]).

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The gross proceeds to Cidara from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be $350.0 million. In addition, Cidara has granted the underwriters a 30-day option to purchase up to an additional 1,193,181 shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on June 26, 2025, subject to the satisfaction of customary closing conditions.

J.P. Morgan, Morgan Stanley, Guggenheim Securities and Cantor are acting as joint book-running managers for the offering.

The offering is being made pursuant to a shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission (the "SEC") on May 8, 2025, and declared effective by the SEC on May 15, 2025. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering were filed with the SEC and are available for free on the SEC’s website located at View Source A final prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at [email protected]; Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected]; or Cantor Fitzgerald & Co. by mail at Attention: Capital Markets, 110 East 59th Street, New York 10022 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On June 24, 2025 Xcell Biosciences (Xcellbio), a San Francisco-based instrumentation company focused on cell and gene therapy applications, reported a strategic collaboration with Thermo Fisher Scientific Inc., the world leader in serving science, to advance research in regulatory T cells (Tregs) and tumor-infiltrating lymphocytes (TILs) (Press release, Xcell Biosciences, JUN 24, 2025, View Source [SID1234654100]). While significant progress has been made in the cell therapy space leveraging Chimeric Antigen Receptor T (CAR T) cells, this collaboration aims to advance Treg and TIL cell therapies that specialize in combating autoimmune and solid tumor diseases. With solid tumors representing approximately 90 percent of adult cancers and instances of autoimmune diseases on the rise worldwide, this collaboration looks to target a crucial area for improving global health.

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Leveraging the strengths of both companies, the joint research will focus on developing new methodologies to enhance the efficacy of Tregs and TILs in therapeutic applications. The collaboration also seeks to streamline workflows while improving scalability and reproducibility in cell therapy manufacturing to help make these critical treatments more accessible to patients.

"We are thrilled to collaborate with Thermo Fisher Scientific on groundbreaking research opportunities. By leveraging our AVATAR cell therapy manufacturing platform, we aim to push the boundaries of what is possible in cell and gene therapy. This partnership will enable us to develop more effective treatments for patients in need," said Shannon Eaker, chief technology officer at Xcell Biosciences.

Thermo Fisher has supported the majority of the approved cell therapies in the market by providing critical tools and materials as well as helping to automate and accelerate manufacturing.

"Xcellbio’s interest in utilizing our Gibco CTS Detachable Dynabeads platform within Thermo Fisher Scientific’s modular, closed and automated cell therapy manufacturing workflow is a testament to the strength of our technologies," said Andy Campbell, senior director of research and development at Thermo Fisher Scientific. "In combination with our full portfolio, including the Gibco CTS DynaCellect Magnetic Separation System and the Gibco CTS Rotea Counterflow Centrifugation System, we are confident that this collaboration will significantly shorten and enhance the manufacturing workflow for cell therapies in this space, ultimately helping our customers make the world a healthier place."