On June 25, 2025 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company, held its 2025 Annual Shareholders’ Meeting, chaired by Chairman Mr. Benny T. Hu, reported that the company delivered updates on its ongoing drug development programs, outlining four key strategic milestones poised to drive its transformative growth (Press release, Senhwa Biosciences, JUN 25, 2025, View Source [SID1234654122]):

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Launch of a new HIV "Functional Cure" strategic program
Advancement of partnership discussions with leading global immunotherapy companies
Active negotiations of multiple licensing opportunities
Dual-engine therapeutic breakthroughs from CX-4945 and CX-5461
Silmitasertib (CX-4945): Unlocking New Hope for HIV Cure

In March, Senhwa made the strategic decision to discontinue its Community-Acquired Pneumonia clinical trial, prompting investor concern. This shift, based on compelling interim findings, redirected focus to the promising potential of CX-4945 in HIV treatment.

Dr. Jason Huang, Acting CEO and Chief Medical Officer, revealed that in HIV-positive participants within the Community-Acquired Pneumonia study, a significant and rapid increase in a key immune biomarker was observed, potentially reflecting a marked restoration of previously impaired immune function. This finding suggests that CX-4945 may represent a novel therapeutic option and a new opportunity for those affected by HIV.

At the same time, to address gastrointestinal side effects observed in previous studies, Senhwa is in the final stages of developing a new formulation of CX–4945. The updated formulation is designed to significantly reduce GI discomfort while also extending the compound’s intellectual property protection for an additional 20 years, supporting both patient tolerability and long-term commercial value.

The company is currently consulting with the U.S. FDA on its clinical development pathway and is planning a small-scale pilot study in Taiwan. The trial will focus on evaluating the combined effects of CX–4945 on latent HIV reactivation and immune enhancement. Given the lifelong adherence required by current HIV therapies, a successful approach incorporating CX-4945 could present a scalable and transformative path to functional cure for tens of millions of HIV patients worldwide.

CX-4945 for Basal Cell Carcinoma (BCC): Strong Clinical Efficacy in Refractory Patients

Recent trial results from CX-4945 in patients with advanced BCC who had failed standard and immunotherapy treatments showed highly encouraging outcomes. Among 25 evaluable patients: 3 achieved Partial Response (PR) and 10 achieved Stable Disease (SD). Two patients had Progression-Free Survival (PFS) exceeding 21 months. Senhwa is currently in active discussions with several potential collaborators.

Pidnarulex (CX-5461): Broad-Spectrum Oncology Innovation

As another globally first-in-class asset, CX-5461 is advancing through multiple clinical programs, including the NIH 5-Year Anti-Cancer Initiative and a trial in North America targeting solid tumors with specific genetic deficiencies (BRCA1/2, PALB2). In addition to a monotherapy study in late-stage solid tumors (HRD/non-HRD), the NIH NExT Program is preparing three other protocols: CX-5461 with immunotherapy for colorectal cancer, CX-5461 with ADC, now a major focus in oncology innovation, for breast cancer and CX-5461 monotherapy for MYC-driven lymphomas. All three projects are underway, with IND submissions and patient enrollment expected soon.

Among North American patients in the ongoing trial, several have achieved PR or SD despite failing previous treatments. Most notably, a patient with pancreatic cancer, considered one of the most lethal and treatment-resistant malignancies, has survived over 22 months on CX-5461 while maintaining quality of life. This represents an extraordinary outcome in clinical oncology. Senhwa aims to complete enrollment and data analysis for this trial in 2026 and is concurrently evaluating out-licensing or joint development options.

CX-5461 + Immunotherapy: A Dual-Engine Powerhouse

CX-5461 uniquely reprograms the tumor microenvironment (TME) by activating tumor-infiltrating lymphocytes (TILs) and dendritic cells (DCs), converting "cold" tumors into "hot" tumors. This transformation significantly enhances the responses to immune checkpoint inhibitors (e.g., PD-1/PD-L1), which currently benefit only 20–30% of patients.

Senhwa is planning clinical programs combining CX-5461 with immunotherapy across multiple cancers, including pancreatic cancer, head and neck cancer, and melanoma. The company is in strategic discussions with global immuno-oncology companies and aims to launch these studies in 2026, targeting a share of the multibillion-dollar global immunotherapy market.

A Year of Execution and Transformative Progress Ahead

From HIV to pancreatic cancer and beyond, Senhwa’s multi-front strategy signals its commitment to addressing unmet medical needs. The management team expressed sincere gratitude to shareholders for their patience and continued trust, and reaffirmed its commitment to delivering on key milestones in the shortest possible time to realize the value of shareholder support. Senhwa is positioning itself as a global leader in next-generation therapeutics and a comprehensive solutions provider for unmet medical needs.

On June 25, 2025 Vor Bio, Inc. (Nasdaq: VOR) and RemeGen Co., Ltd. (HKEX: 9995, SHA: 688331) reported entry into an exclusive license agreement granting Vor Bio global rights (excluding China, Hong Kong, Macau and Taiwan) to develop and commercialize telitacicept, a novel dual-target fusion protein approved in China for generalized myasthenia gravis (gMG), systemic lupus erythematosus (SLE), and rheumatoid arthritis (RA) (Press release, Vor BioPharma, JUN 25, 2025, View Source [SID1234654139]). Under the terms of the agreement, Vor Bio will pay RemeGen an initial payment of $125 million consisting of an upfront payment of $45 million as well as $80 million of warrants to purchase common stock with an exercise price of $0.0001 per share. The agreement also provides for potential regulatory and commercial milestones exceeding $4 billion, in addition to tiered royalties.

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Telitacicept is a novel, investigational fusion protein that targets key immune pathways involved in autoimmune disease. By selectively inhibiting BlyS (also known as BAFF) and APRIL—cytokines critical to B cell survival—telitacicept reduces autoreactive B cells and autoantibody production. RemeGen is conducting a global Phase 3 clinical trial which is now enrolling in the United States, Europe, and South America, with initial results expected in the first half of 2027.

Vor Bio also announced that its Board of Directors (the "Board") has appointed Jean-Paul Kress, M.D., as Chief Executive Officer and Chairman of the Board, effective today. This follows Dr. Robert Ang’s resignation from the positions of Chief Executive Officer and director earlier today. Dr. Ang will continue with Vor Bio as a strategic advisor to assist in the transition through October 2025. Dr. Kress’s strategic vision and track record of transformative leadership position him to guide the company into its next phase of growth.

"I am absolutely thrilled to be leading Vor Bio as we transform the company to become a major player in autoimmune disease treatment," said Dr. Kress, Chairman and Chief Executive Officer, Vor Bio. "Targeting BAFF/APRIL signaling with telitacicept represents a significant advancement in addressing autoantibody driven diseases, which is highly differentiated from other modalities in this space. With a clinically advanced asset, we are uniquely positioned to develop this innovative therapy, with the goal of making a meaningful impact for patients living with autoimmune diseases around the world."

Dr. Kress brings decades of executive leadership experience in the pharmaceutical and biotech industries. He most recently served as Chief Executive Officer of MorphoSys, where he led the development, approval and commercialization of Monjuvi (tafasitamab), and advanced the company’s pipeline through the landmark acquisition of Constellation Pharmaceuticals in 2021, strengthening MorphoSys’ position in oncology innovation and ultimately leading to its subsequent acquisition by Novartis in 2024. Prior to that, he was CEO of Syntimmune, guiding its lead immunology program through to acquisition by Alexion Pharmaceuticals. He currently serves on the Board of Sanofi S.A. and has held senior roles across leading biopharma companies.

"Today marks a transformative milestone for RemeGen and the global development of telitacicept," said Dr. Jianmin Fang, CEO of RemeGen. "The strategic out-licensing of telitacicept’s ex-China rights accelerates our mission to deliver this innovative therapy to patients worldwide and will help maximize telitacicept’s clinical and commercial potential on the global scale."

About Telitacicept

Telitacicept is a novel, investigational recombinant fusion protein designed to treat autoimmune diseases by selectively inhibiting BLyS (BAFF) and APRIL—two cytokines essential to B cell and plasma cell survival. This dual-target mechanism reduces autoreactive B cells and autoantibody production, key drivers of autoimmune pathology. In a Phase 3 clinical trial in generalized myasthenia gravis in China, telitacicept demonstrated a 4.8-point improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living scale) vs. placebo at 24 weeks, the primary endpoint of the trial.

Telitacicept is approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG). A global Phase 3 clinical trial in gMG is currently underway across the United States, Europe, and South America to support potential approval in the United States and Europe.

On June 25, 2025 Arbutus Biopharma Corporation (Nasdaq: ABUS) ("Arbutus" or the "Company"), a clinical-stage biopharmaceutical company focused on infectious disease, reported that it has reacquired China rights to its lead compound, imdusiran, from Qilu Pharmaceutical, one of the leading pharmaceutical companies in China (Press release, Arbutus Biopharma, JUN 25, 2025, View Source [SID1234654107]). The parties have mutually agreed to conclude the strategic partnership entered into in 2021 for development, manufacturing and commercialization of imdusiran in mainland China, Hong Kong, Macau and Taiwan markets.

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"I would like to express our deepest thanks to the executive leadership and team at Qilu for the collaborative and fruitful partnership we have enjoyed over the last several years," said Lindsay Androski, President and Chief Executive Officer of Arbutus. "In light of Qilu’s pipeline reprioritization efforts and Arbutus’ renewed focus on advancing our pipeline efficiently, the parties have agreed to terminate our strategic partnership for Greater China. We are thrilled to once again hold global rights for imdusiran, which to date has achieved functional cure in eight patients in combination therapy in two Phase 2a trials."

Dr. Weikang Tao, the global R&D head of Qilu Pharmaceutical commented: "We greatly appreciate the collaboration, efforts and support of both Arbutus and Qilu’s project teams for the development of imdusiran in the Greater China area and we wish Arbutus every success in further advancing the development of imdusiran."

Arbutus has also launched a new Scientific Advisory Board (SAB) consisting of globally recognized leaders in the treatment of chronic hepatitis B virus (cHBV) with extensive experience in late-stage clinical trials. SAB members will advise Arbutus on its strategic evaluation of its cHBV pipeline. Members of Arbutus’ Scientific Advisory Board include:

Jordan J. Feld, MD, MPH, Professor of Medicine at the University of Toronto and Director of the Toronto Centre for Liver Disease at the Toronto General Hospital, where he holds the R. Phelan Chair in Translational Liver Research as a clinician-scientist and leads a large clinical and translational research program focused primarily on viral hepatitis and its complications.
Edward J. Gane, MBChB, MD, FRACP, FAASLD, MNZM, Professor of Medicine at the University of Auckland, New Zealand; Hepatologist and Deputy Director of the New Zealand Liver Unit at Auckland City Hospital. Dr. Gane was involved in early phase development of the first oral cure for hepatitis C and is now focused on developing a finite cure for hepatitis B. He has published over 450 papers and has received many research awards including the Health Research Council Beaven and Liley Medals.
Anna Suk-Fong Lok, MD, DSc (Hon), FAASLD, AGAF, Dame Sheila Sherlock Distinguished University Professor of Hepatology and Internal Medicine, Alice Lohrman Andrews Research Professor of Hepatology in the Department of Internal Medicine, at the University of Michigan. Dr. Lok’s research focuses on hepatitis B, and she has published more than 600 scientific articles including guidelines on hepatitis B.
Mark Sulkowski, MD, Professor of Medicine, Senior Associate Dean for Clinical Trials, and Founding Director of the Office of Clinical Trials at the Johns Hopkins University School of Medicine. Professor Sulkowski also serves as the Director of the Division of Infectious Diseases at the Johns Hopkins Bayview Medical Center and the Medical Director of the Viral Hepatitis Center in the Divisions of Infectious Diseases and Gastroenterology/Hepatology in the Department of Medicine. Professor Sulkowski has been the principal investigator for more than 200 clinical trials on managing viral hepatitis B and C.
Man-Fung Yuen, MBBS, MD, PhD, DSc, Chair Professor of The University of Hong Kong; Li Shu Fan Medical Foundation Professor in Medicine and Chief of the Division of Gastroenterology and Hepatology, Queen Mary Hospital, Hong Kong. Professor Yuen is a world-renowned researcher who has been leading most of the international trials examining novel agents for the treatment of chronic hepatitis B.
As previously reported, to date, across all Phase 2a clinical trials (IM-PROVE I and IM-PROVE II) conducted with imdusiran, Arbutus has reported a total of 8 patients who have been functionally cured and were able to discontinue all therapies including nucleos(t)ide analogue (NA) therapy. Two of the patients who achieved functional cure received no interferon (IFN) as part of their treatment, and seven of the eight patients had baseline hepatitis B surface antigen (HBsAg) levels less than 1000 IU/mL.

About Imdusiran (AB-729)

Imdusiran is an RNAi therapeutic specifically designed to reduce all HBV viral proteins and antigens including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to control the virus. Imdusiran targets hepatocytes using Arbutus’ novel covalently conjugated N-Acetylgalactosamine (GalNAc) delivery technology enabling subcutaneous delivery. To date, Arbutus has reported a total of eight patients with cHBV who have achieved functional cure following treatment with imdusiran and NA therapy in combination with either IFN or low dose nivolumab plus an immunotherapeutic. Clinical data generated thus far has shown imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in HBsAg and hepatitis B virus DNA.

About HBV

Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). HBV can cause chronic infection which leads to a higher risk of death from cirrhosis and liver cancer. Chronic HBV infection represents a significant unmet medical need. The World Health Organization estimates that over 250 million people worldwide suffer from chronic HBV infection, while other estimates indicate that approximately 2 million people in the United States suffer from chronic HBV infection. Approximately 1.1 million people die every year from complications related to chronic HBV infection despite the availability of effective vaccines and current treatment options.

On June 25, 2025 UP Oncolytics, a neuro-oncology biotechnology company based in Milwaukee and a spin-out of the Advocate Aurora Research Institute, reported to have received a $75,000 matching grant from the Wisconsin Economic Development Corporation (WEDC) in partnership with the University of Wisconsin (Press release, UP Oncolytics, JUN 25, 2025, View Source [SID1234654123]). The grant supplements the company’s $500,000 SBIR Phase I Fast Track award from the National Institutes of Health (NIH), received last year.

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The funding will support further preclinical development of UP Oncolytics lead therapy — an oncolytic virus targeting gliomas, the most common form of brain cancer. The company is also exploring its application in other cancer types.

In early 2025, UP Oncolytics established and expanded its research laboratories at Rosalind Franklin University’s Helix 51 biomedical incubator. Under the leadership of Dr. Parvez Akhtar, chief scientific officer and co-founder, the company recruited senior scientist Dr. Steven Markwell from AbbVie. Dr. Markwell, a cell and molecular biologist, previously served as a postdoctoral research fellow at Northwestern University, specializing in pre-clinical glioblastoma models and tumor microenvironment research.

UP Oncolytics has also strengthened its leadership team. Dr. Gary Gordon, a former oncologist trained at Johns Hopkins, has joined the board. He brings more than 13 years of experience as vice president of oncology development at AbbVie, and has held senior roles at Abbott, Ovation Pharmaceuticals, Pharmacia, and G.D. Searle.

Michael Rosen, MBA, managing director of RFU’s Innovation and Research Park and Helix 51, has joined the board as an observer. With more than 20 years of industry experience at Pfizer, Bristol-Myers Squibb, and G.D. Searle, and, as CEO, Mr. Rosen has contributed to the development of three cancer biotech companies in Europe and the U.S., including one that successfully went public.

In the fourth quarter of 2024, the FDA granted Orphan Drug designation to UP Oncolytics for its oncolytic virus therapy for gliomas.

"We are pleased with our progress over the past year, including the establishment of our new laboratories at Helix 51," said neurosurgeon and UP Oncolytics President and CEO Dr. Richard Rovin. "There is an urgent, unmet need for new treatments for malignant gliomas. We are working hard to bring our oncolytic virus into clinical trials."

"We share Dr. Rovin’s enthusiasm for these milestones and look forward to the impact this work could have on glioma patients," said RFU Executive Vice President for Research Dr. Joseph DiMario.

On June 25, 2025 Gilead Sciences, Inc. (NASDAQ: GILD) and Kymera Therapeutics, Inc. (NASDAQ: KYMR), reported that they have entered into an exclusive option and license agreement to accelerate the development and commercialization of a novel molecular glue degrader (MGD) program targeting cyclin-dependent kinase 2 (CDK2) with broad oncology treatment potential including in breast cancer and other solid tumors (Press release, Gilead Sciences, JUN 25, 2025, View Source [SID1234654124]).

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CDK2-directed MGDs are a new type of drug designed to remove CDK2 – a key contributor in tumor growth – rather than just inhibiting its function. Traditional inhibitors of CDK2 prevent it from working but often interfere with similar proteins, which can cause undesired side effects. MGDs have the potential to provide more precise, safe and effective treatments for cancers that rely on CDK2 activity by selectively removing this protein from cells.

"MGDs are opening exciting new possibilities in cancer research by offering a way to eliminate disease-driving proteins rather than just blocking them. This mechanism aligns within our oncology scientific framework where we evaluate therapeutic agents that selectively target and kill cancer cells with minimal impact on healthy tissue," said Flavius Martin, MD, Executive Vice President, Research, Gilead Sciences. "We are delighted to partner with Kymera to advance this novel oral program with the potential to drive meaningful improvements in the standard of care for patients living with breast cancer and other cancers that are inadequately served with existing therapies."

"We are excited to announce this strategic collaboration with Gilead Sciences, highlighting our dedication to innovation in the field with our first disclosed molecular glue program. We are committed to developing highly selective, potent, oral degrader medicines that address key disease-causing proteins and pathways that are undrugged or inadequately drugged by existing technologies," said Nello Mainolfi, PhD, Founder, President and CEO, Kymera Therapeutics. "Our highly specific, orally active, CDK2 molecular glue degraders have demonstrated a compelling preclinical profile and have the potential to transform the therapeutic landscape for breast cancer patients and other tumor types with high unmet medical need. We are excited to work with the talented Gilead team to accelerate the development and commercialization of this important program."

Terms of the Agreement

Under the terms of the agreement, Kymera is eligible to receive up to $750 million in total payments, including up to $85 million in upfront and potential option exercise payments. In addition, Kymera may also receive tiered royalties ranging from high single-digit to mid-teens on net product sales under the collaboration. Kymera will lead all research activities for the CDK2 program. If Gilead exercises its option to exclusively license the program, Gilead will have global rights to develop, manufacture and commercialize all products resulting from the collaboration.

Gilead does not exclude acquired IPR&D expenses from its non-GAAP financial measures. This transaction with Kymera is expected to reduce Gilead’s GAAP and non-GAAP 2025 EPS by approximately $0.02 – $0.03.