On June 10. 2025 Abbisko Therapeutics Co., Ltd. (02256.HK) reported that the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for pimicotinib, a highly selective, small-molecule CSF-1R inhibitor, as a Class 1 innovative drug for adult patients with Tenosynovial Giant Cell Tumor (TGCT) (Press release, Abbisko Therapeutics, JUN 10, 2025, View Source [SID1234653804]). Pimicotinib is the first internally discovered and self-developed program from Abbisko Therapeutics to enter the NDA approval process, and has the potential to provide patients with a best-in-class therapy to treat TGCT given its exceptional clinical efficacy, safety, and tolerability as demonstrated in multiple clinical trials.

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"TGCT grows in and around the joints, primarily affecting young and middle-aged adults in their working years. The swelling, pain, stiffness and limited mobility caused by the disease can have a significant impact on the ability to perform daily activities, limiting patients’ work and social lives," said Professor Niu Xiaohui, Director of the Bone and Soft Tissue Tumour Diagnosis and Research Centre at Beijing Jishuitan Hospital. "Based on these new data from the MANEUVER study, pimicotinib has the potential to establish a new treatment paradigm for patients with TGCT."

The submission follows the granting of Priority Review to pimicotinib by the Center for Drug Evaluation (CDE) of the NMPA in May for the treatment of patients with TGCT who require systemic therapy, which is expected to expedite the review process. Pimicotinib also has been granted breakthrough therapy designation (BTD) by the NMPA. In December 2023, Abbisko entered into an agreement with Merck pertaining to the commercial rights to pimicotinib, pursuant to which Merck is responsible for the commercialization of pimicotinib globally.

Yao-Chang Xu, Chairman and CEO of Abbisko Therapeutics, said: "The acceptance of the New Drug Application for pimicotinib marks a significant milestone in the development journey of Abbisko Therapeutics. Pimicotinib demonstrates a meaningful clinical efficacy and safety profile that positions it to be an innovative treatment option for TGCT patients and clinicians. It will reinforce our strength and determination in innovative drug development. "

"With the acceptance of our application for pimicotinib and the initiation of the priority review, we aim to offer patients in China the first approved systemic therapy for TGCT, addressing a tremendous unmet need in this country," said Hong Chow, Head of China and International, Healthcare business of Merck. "Pimicotinib has demonstrated the ability to not only shrink tumors that affect their joints but also improve outcomes like mobility, pain and stiffness, highlighting its potential to be a best-in-class treatment for TGCT. In parallel, we are working to file a New Drug Application to the US Food and Drug Administration, with additional filings planned in other markets."

The application is based on results from Part 1 of the global Phase 3 MANEUVER study, in which once-daily pimicotinib demonstrated a statistically significant improvement in the primary endpoint of objective response rate (ORR) assessed by blinded independent review committee (BIRC) compared with placebo at week 25 (54.0% vs. 3.2% for placebo; p<0.0001). The study also demonstrated statistically significant and clinically meaningful improvements in all secondary endpoints related to key patient-reported outcomes in TGCT, including improvements in active range of motion and physical function and reductions in stiffness and pain. The data were presented earlier this month at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting.

Outside of China, pimicotinib has been granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) and PRIME Designation by the European Medicines Agency (EMA).

On June 10, 2025 Citius Pharmaceuticals Inc. (Nasdaq: CTXR) ("Citius Pharma" or the "Company"), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, reported that it has entered into definitive agreements for the purchase of an aggregate of 4,920,000 shares of its common stock (or pre-funded warrant in lieu thereof) and accompanying short-term warrants to purchase up to an aggregate of 9,840,000 shares of its common stock, at a purchase price of $1.22 per share (or pre-funded warrant in lieu thereof) and accompanying short-term warrant in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Citius Pharmaceuticals, JUN 10, 2025, View Source [SID1234653803]). The short-term warrants will have an exercise price of $1.00 per share, will be exercisable immediately upon issuance, and will expire twenty-four months from the initial exercise date. The closing of the offering is expected to occur on or about June 11, 2025, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $6 million, before deducting the placement agent fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the short-term warrants, if fully-exercised on a cash basis, will be approximately $9.8 million. No assurance can be given that any of such short-term warrants will be exercised. The Company currently intends to use the net proceeds from the offering to support the commercial launch of LYMPHIR, including milestone, regulatory and other payments, as well as for general corporate purposes.

The securities described above are being offered pursuant to a "shelf" registration statement (File No. 333-277319) filed with the Securities and Exchange Commission ("SEC") on February 23, 2024 and declared effective on March 1, 2024. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the securities being offered will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 the registration or qualification under the securities laws of any such state or jurisdiction.

On June 10, 2025 OS Therapies Inc. (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, reported to have selected EVERSANA, a leading provider of global commercial services to the life sciences industry, to support the U.S. commercialization of OST-HER2, a novel immunotherapy for recurrent, fully resected, pediatric lung metastatic osteosarcoma (Press release, OS Therapies, JUN 10, 2025, View Source [SID1234653802]).

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OST-HER2, a Listeria monocytogenes-based immunotherapy, is the first potential new treatment in over 40 years for pediatric osteosarcoma, a rare, aggressive bone cancer that often metastasizes to the lungs, primarily affecting children and adolescents. The therapy has received Orphan, Fast Track and Rare Pediatric Disease Designations from the U.S. Food and Drug Administration (FDA), with a Biologics License Application (BLA) rolling submission targeted to begin in the third quarter of 2025, with potential approval coming as early as year end 2025.

"Working with EVERSANA ensures we have the infrastructure, expertise and agility to bring OST-HER2 to patients and families who have long awaited new options without the need to spend significant capital building our own commercial infrastructure," said Paul Romness, CEO of OS Therapies. "By leveraging EVERSANA’s flexible integrated commercialization operations and deep oncology experience, we will be able to rapidly and cost-effectively fulfill our mission of transforming the treatment landscape for pediatric metastatic osteosarcoma while judiciously managing pre-BLA costs."

EVERSANA will activate its dedicated end-to-end EVERSANA ONCOLOGY Commercialization model, including market access, medical affairs, field deployment, patient services and stakeholder engagement. The fully integrated platform accelerates awareness and access to OST-HER2 among healthcare providers treating osteosarcoma, as well as the potential to treat additional HER2-positive cancers.

"We share OS Therapies’ relentless commitment to helping patients facing the devastating diagnosis of cancer," said Jim Lang, CEO at EVERSANA. "We’ve activated the full scale of our commercialization operation and global team of oncology experts to bring this much-needed innovation to market. This product is just the beginning of OS Therapies’ impact for patients around the world."

The announcement follows OS Therapies’ recent issuance of U.S. Patent #12,239,738, securing commercial manufacturing exclusivity for OST-HER2 and its broader Listeria-based immunotherapy platform through 2040.

On June 10, 2025 ImmVira, a global leading clinical-stage biotechnology company focused on the development of next-generation novel oncolytic immunotherapy for treatment of cancer, reported that the first patient diagnosed with NMIBC has been dosed in a multi-regional Phase II clinical trial evaluating its lead product candidate, MVR-T3011 (Press release, Immvira, JUN 10, 2025, View Source [SID1234653801]).

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At the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting, ImmVira reported MVR-T3011’s preliminary efficacy data in high-risk BCG-failed NMIBC patients, demonstrating an encouraging complete response rate (CRR) of over 80% at the 2×109 PFU dose cohort. Updated results from the expanded cohort of 16 evaluable patients with papillary diseases (as of April 30, 2025, the data cutoff date) maintained robust efficacy, with a sustained Kaplan-Meier (K-M) estimated 3-month recurrence-free survival (RFS) of over 80%.

Based on discussions with and approval by the U.S. FDA, the primary objectives of this Phase II study are to further confirm the recommended phase II dose (RP2D) of intra-vesically administered MVR-T3011, and based on which, assess the anti-tumor efficacy of MVR-T3011 in patients with BCG-unresponsive NMIBC. ImmVira plans to enroll eligible patients at 15-20 cancer centers in the United States and China for evaluation of the clinical efficacy parameters including CRR, event-free survival rate and RFS rate. Meanwhile, safety and pharmacokinetic data will be evaluated.

"The initiation of this multi-country Phase II study marks a major milestone for ImmVira," said ImmVira co-founder, CEO and chairwoman, Dr. Grace Guoying Zhou. "We are delighted with the notable progress and results achieved in the Phase I clinical trial of MVR-T3011 for the treatment of NMIBC and are extremely excited about working with key thought leaders in the U.S. and China to further explore the potential of this drug in NMIBC patients."

Lead study investigator and the Director of Clinical and Translational Research in Urologic Oncology at Rutgers Cancer Center, Dr. Vignesh Packiam, added, "MVR-T3011 represents a novel drug design and has the potential to address an unmet need in NMIBC. Integration of PD-1 Ab and IL-12 genes into the genome of this novel oncolytic immunotherapy can augment immune responses in the tumor microenvironment and prolong the early-phase antitumor efficacy."

About MVR-T3011

MVR-T3011 is a novel oncolytic immunotherapy combining a proprietary replication competent oncolytic virus backbone with payload expression of PD-1 Ab and IL-12. Upon delivery, locally produced IL-12 induces IFN-γ production, enhances oncolytic activity of NK cells and cytotoxic T lymphocytes, promotes anti-angiogenesis and inhibits tumor growth. Simultaneously, the PD-1 antibody acts as an immune checkpoint inhibitor to augment T-cell tumor-killing activity. Extensive and peer-reviewed in vitro and in vivo data have been presented internationally and the drug has, to-date, been evaluated in over 200 Phase I/II patients.

On June 10, 2025 Curadev Pharma, Inc., a clinical-stage biotechnology company developing novel immuno-oncology therapeutics, and Memorial Sloan Kettering Cancer Center (MSK), a world-leading cancer research and treatment institution, reported to have expanding their collaboration through the MSK Therapeutics Accelerator program to advance the development of Curadev’s small-molecule allosteric Stimulator of Interferon Genes (STING) agonist, CRD3874-SI, to be delivered systemically to patients with advanced/metastatic cancer (Press release, Curadev, JUN 10, 2025, View Source [SID1234653800]).

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The collaboration builds on the ongoing Phase 1a/b dose escalation and expansion clinical trial (NCT06021626) currently underway at MSK for sarcoma and Merkel cell carcinoma patients, and aims to explore the potential of CRD3874-SI in treating additional types of cancer. Through the MSK Therapeutics Accelerator program, MSK will provide Curadev with expertise and institutional resources, including medical, clinical, and regulatory advice, to further the development of CRD3874-SI. This expanded collaboration marks a significant milestone in translating promising STING pathway research into broader clinical application and will be overseen by William Tap, MD, Chief of the Sarcoma Medical Oncology Service at MSK, and Ciara Kelly, MBBCh BAO, Interim Clinical Director of MSK’s Sarcoma Oncology Service.

Dr. William Tap said, "MSK and its Division of Solid Tumors are excited to co-develop CRD3874-SI, a novel first-in-class allosteric STING agonist, with Curadev. CRD3874-SI has demonstrated an encouraging safety and efficacy profile in a first-in-human study at MSK. CRD3874-SI is moving forward into multiple solid-tumor expansion cohorts, guided by disease specific experts and the support and structure of the MSK Accelerator Program, which is designed to enhance and expedite the development of novel compounds across malignancies. CRD3874-SI has the potential to offer patients a new treatment option with continued innovation and exploration of the benefits of immunotherapy in cancer care."

Dr. Arjun Surya, Co-founder and CEO of Curadev, added, "We are encouraged by the early readouts with CRD3874-SI systemic monotherapy from our ongoing clinical trial in patients with treatment refractory cancers at MSK and are honored by the opportunity to deepen our collaboration through the MSK Therapeutics Accelerator program. The research and development collaboration between oncologists at MSK and the inventors of CRD3874-SI at Curadev could become a role model for advancing bench to bedside medicines.
MSK’s historic leadership position in the development of cancer immunotherapy and the exemplary dedication of the oncologists we work with is inspiring and make it an ideal partner in Curadev’s effort to investigate the therapeutic potential of its systemically administered allosteric STING agonist in patients with advanced/metastatic cancer."