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MAIA Biotechnology to Present at BIO International Convention 2025

On June 10, 2025 MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported its participation in the upcoming BIO (Biotechnology Innovation Organization) International Convention 2025 taking place June 16-19, 2025, in Boston, Massachusetts (Press release, MAIA Biotechnology, JUN 10, 2025, View Source [SID1234653808]).

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MAIA Chairman and CEO Vlad Vitoc, MD, MBA will deliver a presentation featuring the latest findings from the Company’s THIO-101 Phase 2 clinical trial evaluating ateganosine (THIO) sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo) in advanced non-small cell lung cancer (NSCLC). Ateganosine is a small molecule telomere-targeting anticancer agent that acts by producing direct telomeric DNA damage and inducing cancer-specific immune responses. THIO-101 is expected to be the first completed clinical study of a telomere-targeting agent in the field of cancer drug discovery and treatment. MAIA recently announced the design for the expansion of the THIO-101 trial, which will further assess the efficacy of treatment in third-line NSCLC patients.

Presentation Details
Session date and time: June 18 at 11:30 AM EDT
Presenter: Vlad Vitoc, MD, MBA

Registered participants may request a meeting with MAIA management via the BIO Partnering platform on the BIO 2025 website.

Sanyou Biopharmaceuticals and Medicovestor, Inc. Forge Strategic Partnership to Develop First-in-Class Chemoimmunotherapy Antibody-Drug Conjugates

On June 10, 2025 Sanyou Biopharmaceuticals, a leading Shanghai-based high-tech biopharmaceutical company specializing in biologics R&D reported the signing of a strategic cooperation agreement with Medicovestor, Inc., a New York-based biotechnology company pioneering first-in-class chemoimmunotherapy antibody-drug conjugates (ADCs) (Press release, Medicovestor, JUN 10, 2025, View Source [SID1234653807]).

The agreement, officially signed on June 6, brings together Medicovestor’s proprietary ADC platforms—ADoBind, a novel dimeric antibody architecture, and ADoTope, a bi-epitope targeting system—with Sanyou’s globally leading AI-STAL (Artificial Intelligence-enabled Super Trillion Antibody Library) technology and intelligent drug screening and preclinical research capabilities. The collaboration aims to accelerate the development of first-in-class chemoimmunotherapies for oncology and autoimmune diseases so that it is "chemoimmunotherapy" ADCs.

Medicovestor is a U.S.-based biotechnology company dedicated to developing next-generation chemoimmunotherapies antibody-drug conjugates (ADCs) for the treatment of cancer and autoimmune diseases. The company has two proprietary technology platforms that enable higher efficacy at lower doses and support combination therapies. Its lead program has entered the IND-enabling stage, with a pancreatic cancer therapy submitted for FDA Orphan Drug Designation. Medicovestor currently holds 11 granted patents and 3 pending applications, positioning the company with a distinct competitive edge in the ADC field.

Dr. Seah Lim, Founder of Medicovestor, has over 25 years of experience in the biopharmaceutical industry and is recognized as a leading global expert in translational medicine. In academia, Dr. Lim has served as a full professor at several prestigious universities in the United Kingdom and the United States, including Brown University and the University of Pittsburgh School of Medicine, where he held multiple leadership positions such as Division Chief. In industry, he has worked as a Product Development Consultant for companies including Bausch Health, Genzyme, and Burroughs Wellcome & Company. He also served as the Pediatric Lead in the Global Program at Sanofi and has held advisory roles such as Independent Director and Commercial & Scientific Advisor at Genie Therapeutics, Inc. Dr. Seah Lim brings not only deep scientific and industry expertise but also extensive clinical experience to the company.

"This partnership reflects our commitment to redefining ADCs by integrating our differentiated ADC platforms with Sanyou’s world-class expertise in antibody development to incorporate immunotherapy into ADCs," said Seah Lim, MD, PhD, Founder and CEO of Medicovestor. "Together, our complementary strengths create a powerful engine to unlock novel therapeutic possibilities for patients with limited treatment options."

"We are excited to collaborate with Medicovestor to realize the promise of their highly innovative chemoimmunotherapy ADC platforms," said David Lang, PhD, Founder and CEO of Sanyou Biopharmaceuticals. "By combining scientific excellence with execution capability, we aim to deliver transformative therapies that change patients’ lives."

The partnership includes joint research, technology transfer, and co-development of lead candidates. Both companies plan to announce development milestones and candidate selections in the coming quarters.

Adcendo ApS Announces First Patient Dosed in Phase I/II ADCElerate1 Trial of ADCE-D01

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.

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."

Factor Bioscience to Unveil iMacrophages Engineered to Combat Solid Tumors at the ISSCR Annual Meeting

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.

"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.

Abbisko Therapeutics Announces China NMPA Acceptance of New Drug Application for Pimicotinib for the Treatment of TGCT

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.

"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).