On June 10, 2025 Adcendo, a clinical-stage biotech company pioneering the development of first and best-in-class ADCs for cancers with a high unmet medical need, reported that the first patient has been dosed in the Phase I/II ADCElerate1 clinical trial evaluating ADCE-D01 in patients with metastatic and/or unresectable soft tissue sarcoma (STS) (Press release, ADCendo, JUN 10, 2025, View Source [SID1234653806]). The patient was dosed at The Memorial Sloan Kettering Cancer Center in New York.

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ADCElerate1 (NCT06797999) is a first-in-human Phase I/II multicenter, open-label, dose escalation and expansion study evaluating ADCE-D01 as a monotherapy in patients with metastatic and/or unresectable STS. The primary objective of the study is to evaluate the safety and tolerability of ADCE-D01. The secondary objectives are to characterize the pharmacokinetics and to evaluate the preliminary efficacy of ADCE-D01. The study will recruit in the US and Europe with the European clinical trial application recently approved (EUCT number: 2024-516900-41-00).

Dr. Lone Ottesen, Chief Medical Officer of Adcendo, said: "The dosing of the first patient in the ADCElerate1 study is a major milestone for both Adcendo and for the uPARAP program and we are excited to evaluate ADCE-D01’s potential benefit for patients with advanced STS. uPARAP is a highly attractive target for the development of an ADC in mesenchymal cancers, as it is highly overexpressed in multiple STS subtypes, has unique internalization properties, and shows only very low expression in healthy tissues."

Professor Robert Maki, MD, PhD, Sarcoma Oncologist and Early Drug Development Specialist at the Department Musculoskeletal Cancers and Condition, in the Memorial Sloan Kettering Cancer Center, New York, NY, commented: "We are very pleased to be working with Adcendo to develop ADCE-D01 for the many advanced STS patients who currently have very limited treatment options. ADCs have already made a significant impact across the therapeutic landscape, and we are pleased to be able to bring this exciting treatment modality to our sarcoma patients."

On June 10, 2025 Factor Bioscience Inc., a Cambridge-based biotechnology company focused on using its pioneering gene editing platform to develop life-saving cell and gene therapies, reported its participation in the International Society for Stem Cell Research (ISSCR) 2025 Annual Meeting to be held in Hong Kong from June 11-14, 2025 (Press release, Factor Bioscience, JUN 10, 2025, View Source [SID1234653805]). Factor will deliver three presentations covering the latest preclinical data from FACT-112, Factor’s engineered iMacrophage program, as well as recent advances in Factor’s gene editing and cell differentiation platforms.

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"We are excited to present the latest data from our engineered iMacrophage program, as well as recent advances in our gene editing and cell differentiation platforms at ISSCR 2025," said Dr. Matt Angel, Co-Founder, Chairman and CEO of Factor. "The data we will be showcasing this week include the first demonstration of targeted delivery of IL-12, a potent immunomodulatory cytokine with established anti-tumor activity, to the solid tumor microenvironment using engineered macrophages. These results represent a major milestone in our work to develop new therapies to treat cancer."

Dr. Kyle Garland, Factor’s Director of Translational Science, added, "After spending more than a decade laying the groundwork by developing cutting-edge RNA-based cell-engineering technologies, Factor is now leveraging these innovative platforms to develop next-generation therapies for patients in need. We are excited to share these remarkable advances in Hong Kong over the next few days."

Details of the presentations are below:

"Hypoimmune iPSC-derived Macrophages Engineered to Express IL-12 Activate Lymphocytes Against Platinum-Resistant Ovarian Cancer." -to be presented by Ian Hay on June 13 from 4:00-5:00 pm HKST, Organ Generation and Regeneration (OGR) and Clinical Applications (CA) Session 3: (Poster Presentation #F1249), Exhibit & Poster Hall (3BCDE, Level 3).

"UltraSlice mRNA Incorporating 5-Methoxyuridine Efficiently Inserts Transgene Sequences in iPSCs with High Viability and Mitigates dsRNA Production." -to be presented by Cassandra Ng on June 12 from 5:00-6:00 pm HKST, Disease Modeling and Drug Discovery (DMDD) Continued, Pluripotency and Development (PD) Session 2: (Poster Presentation #T1348), Exhibit & Poster Hall (3BCDE, Level 3).

"Directed Differentiation of mRNA-Reprogrammed iPSCs via Bioreactors Generates Clinically Relevant Yields of Neural Stem and Progenitor Cells that can be Engineered to Secrete Therapeutic Proteins." -to be presented by Claire Aibel on June 13 from 5:00-6:00 pm HKST, Organ Generation and Regeneration (OGR) and Clinical Applications (CA) Session 3: (Poster Presentation #F1228), Exhibit & Poster Hall (3BCDE, Level 3).
For more information about the International Society for Stem Cell Research (ISSCR) 2025 Annual Meeting, visit View Source

About FACT-112
FACT-112 is an mRNA-reprogrammed macrophage engineered using Factor’s patented UltraSlice gene editing platform to deliver IL-12 to solid tumors. Factor is developing FACT-112 for the treatment of platinum-resistant ovarian cancer and other malignant neoplasms.

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.