On June 25, 2025 Novartis reported that it has successfully completed its acquisition of Regulus Therapeutics Inc. ("Regulus") (Press release, Novartis, JUN 25, 2025, View Source [SID1234654109]). With the completion of the acquisition, shares of common stock, par value $0.001 per share (the "Shares"), of Regulus, have ceased trading on the Nasdaq Stock Market LLC and Regulus is now an indirect wholly owned subsidiary of Novartis.

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"We are pleased to complete this transaction and take the next step in advancing clinical development for a potential first-in-class medicine that can help treat patients suffering from ADPKD (autosomal dominant polycystic kidney disease), the most common genetic cause of renal failure worldwide1," said Shreeram Aradhye, President, Development and Chief Medical Officer, Novartis. "We are excited to welcome the talented team at Regulus to Novartis as we continue to build on our pipeline in renal disease with high unmet medical need."

Farabursen is an investigational next-generation oligonucleotide targeting miR-17 with preferential kidney exposure, aiming to reduce the growth of cysts and kidney size, as well as delay progression of disease severity in ADPKD. In March 2025, Regulus announced the successful completion of its Phase 1b multiple-ascending dose clinical trial for farabursen. The Phase 1b trial data showed promising clinical efficacy and safety, including consistent impact on urinary polycystin (PC), a biomarker of mechanistic response, and height-adjusted total kidney volume (htTKV), an established meaningful clinical measure of disease progression.

Novartis’ previously announced tender offer to acquire all of the outstanding Shares in exchange for (i) $7.00 in cash per Share, subject to any applicable withholding and without interest thereon, plus (ii) one contingent value right (each, a "CVR") per Share, representing the right to receive one contingent payment of $7.00 in cash, subject to any applicable withholding and without interest thereon, upon the achievement of a regulatory milestone, expired at one minute past 11:59 p.m., New York City Time, on June 24, 2025. Approximately 56,374,397 Shares were validly tendered, and not validly withdrawn from the tender offer, representing approximately 74.49% of the issued and outstanding Shares. In accordance with the terms of the tender offer, all Shares that were validly tendered and not validly withdrawn have been accepted for payment and paid for.

Following completion of the tender offer, Novartis completed the acquisition of Regulus through the merger of its indirect wholly owned subsidiary, Redwood Merger Sub Inc., with and into Regulus, without a vote of Regulus’ stockholders pursuant to Section 251(h) of the General Corporation Law of the State of Delaware. As a result of the merger, each Share issued and outstanding and not tendered in the tender offer was canceled and extinguished and automatically converted into the right to receive the same consideration (including the CVR) per Share payable in the tender offer.

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 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported new preclinical data and a clinical update on APR-1051, the Company’s next-generation oral WEE1 inhibitor, in human papillomavirus–positive (HPV+) head and neck squamous cell carcinoma (HNSCC) (Press release, Aprea, JUN 25, 2025, View Source [SID1234654106]).

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These findings result from an ongoing translational research collaboration with renowned oncology leader MD Anderson Cancer Center and support the potential of APR-1051 both as a single agent and in rational immunotherapy combinations for biomarker-driven treatment of HPV+ HNSCC. "We are excited by the preclinical data generated by independent researchers, and the early clinical signal of APR-1051 in an HPV-positive cancer patient," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea Therapeutics. "We believe that APR-1051 could offer significant differentiation in the competitive oncology landscape, as a single agent, as well as in combination with checkpoint inhibitors."

Preclinical Highlights from MD Anderson Collaboration:

Potent single-agent activity: APR-1051 demonstrated robust antiproliferative effects across a broad panel of human and murine head and neck cancer cell lines, including HPV+ subtypes, with IC₅₀ values ranging from 8.9 to 230 nM.
Enhanced combination synergy: Significant anti-tumor synergy was observed with APR-1051 and anti–PD-1 therapies in HPV+ HNSCC models, positioning APR-1051 as a candidate for combination-based clinical trials.
Mechanistic rationale: APR-1051 was shown to activate cGAS/STING-mediated immunogenic cell death and to exploit the HPV E6-driven G2 checkpoint dependency in HPV+ tumors. Given WEE1’s central role in regulating the G2/M checkpoint, HPV+ tumor cells appear highly reliant on WEE1 signaling for survival. This provides a biomarker driven strategy for targeted patient selection and optimized clinical outcomes.

Clinical Update from Phase 1 ACESOT‑1051 Trial:

In a 62-year-old male with advanced HPV-positive oropharyngeal squamous cell carcinoma who had progressed after three prior lines of platinum-based therapy, once-daily administration of a subtherapeutic 70 mg oral dose of APR-1051 resulted in stable disease with a 5% tumor reduction at the first radiographic assessment.
The patient tolerated therapy well, with no dose-limiting toxicities reported.
Next Steps and Future Development:

Enrollment in the ACESOT-1051 trial is ongoing and progressing, with dose escalation into higher levels and the continued inclusion of HPV+ patients.
Pending additional data, future trial arms may evaluate APR-1051 in combination with checkpoint inhibitors to address unmet medical needs across distinct patient populations.
Drs. Abdullah Osman and Jeffrey Myers from The University of Texas MD Anderson Cancer Center commented, "We are very encouraged by these early findings and see APR-1051 as a potentially promising addition to the therapeutic portfolio for treating HPV-associated head and neck cancers. The mechanistic rationale and robust preclinical data strongly support the potential for enhanced patient outcomes when APR-1051 is administrated as a single agent or in combination with existing immunotherapies."

Aprea remains committed to advancing APR-1051 as a next-generation precision oncology agent in molecularly defined tumors, leveraging biomarker insights to optimize patient outcomes.

About APR-1051

APR-1051 is an oral, highly selective WEE1 inhibitor designed to minimize off-target activity and optimize pharmacologic selectivity. APR-1051 is currently being evaluated in the ACESOT-1051 Phase 1 clinical trial (NCT06260514) in patients with advanced solid tumors harboring DNA damage response (DDR) alterations.

On June 24, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that the independent Data Safety Monitoring Board (DSMB) has completed its third scheduled safety data review of BriaCell’s pivotal Phase 3 study of Bria-IMT plus immune checkpoint inhibitor (CPI) in metastatic breast cancer ( NCT06072612) (Press release, BriaCell Therapeutics, JUN 24, 2025, View Source [SID1234654343]).

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Following its review, the DSMB raised no safety concerns and recommended that the study continue without modifications. DSMB meetings occur quarterly as per the study protocol, and this marks the third consecutive positive recommendation from the DSMB affirming the favorable safety profile observed to date. Bria Cell’s pivotal Phase 3 study is being conducted under Fast Track designation granted by the US Food and Drug Administration (FDA), reflecting the significant unmet medical need in this patient population.

"The third consecutive DSMB review is a meaningful milestone in our Phase 3 trial, which continues to highlight the excellent safety and tolerability profile of BriaCell’s regimen," commented Dr. William V. Williams, BriaCell’s President & CEO. "This latest positive review further strengthens our confidence in Bria-IMT’s potential as a transformative immunotherapy for patients with metastatic breast cancer."

On June 24, 2025 Vector BioMed, a purpose-driven contract vector development and manufacturing organization (CVDMO) focused on advancing access to cell and gene therapies, reported a strategic partnership with Muni Seva Ashram’s Kailash Cancer Hospital and Research Center (KCHRC) in Gujarat, India (Press release, Kailash Cancer Hospital and Research Center, JUN 24, 2025, View Source [SID1234654101]). This collaboration positions Vector BioMed as the preferred and exclusive CVDMO partner for KCHRC’s cell therapy program, helping expand affordable CAR-T cancer treatment to underserved populations.

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The partnership began in June 2024 after more than a year of due diligence, site visits, and technical evaluations led by KCHRC’s leadership, including Dr. Vikram Patel. The hospital is expected to begin treating its first patients with autologous CAR-T cell therapy in Q1 2026, making it the first site in Gujarat and one of the first in India to deliver advanced treatments outside of a major metropolitan area. Vector BioMed supplies rapid CAR-T formats of prebuilt CARs and validated processes, including a cell manufacturing process ready anti-CD19 CAR-T solution and other IND-ready product options for the production of autologous CAR-T therapies. Constructed to streamline development for hospitals and researchers, this introduces speed, consistency, and a dramatic improvement to the global standard of care for cancer treatment.

Located in rural Gujarat, KCHRC serves over 70,000 outpatients annually, offering reduced (donor supported)- or no-cost care to more than 60% of its patients. The hospital is part of Muni Seva Ashram, a nonprofit institution founded to provide equitable healthcare to India’s most vulnerable communities. With 400 beds, 10 operating rooms, three linear accelerators, and growing GMP capabilities, KCHRC is quickly becoming a regional hub for cutting-edge therapeutics.

"We are pleased to collaborate with Muni Seva Ashram and be a part of bringing financially feasible treatments to patients who never imagined having access," said Dr. Boro Dropulić, CEO of Vector BioMed. "Through this partnership, we’re delivering one of the world’s most advanced cancer therapies to communities that have long been excluded from cutting-edge care. It’s a powerful step toward making world-class care truly universal."

Vector BioMed is supporting the rollout with its LENTIVERSE system, a true platform solution designed for flexibility, affordability, and scalability—especially for low- and middle-income countries (LMICs). The platform technology allows for the treatment of one patient per day, isn’t locked into expensive process technologies, and significantly reduces costs compared to other proprietary systems, making it ideal for nonprofit and resource-limited hospitals like KCHRC.

"This collaboration brings us closer to our goal of providing world-class cancer treatment to every patient who walks through our doors, regardless of their ability to pay," said Dr. Vikram Patel, Chair of Muni Seva Ashram. "Vector BioMed’s knowledge and excellence in vector manufacturing and clinical support has strongly impacted our cell therapy efforts – and will soon greatly impact the lives of our patients."

The partnership is being highlighted in an upcoming live global webinar hosted by the Cell & Gene community (Life Science Connect) titled "Fulfilling the Promise of Advanced Therapies and a Noble Cause," on July 24, 2025 at 11:00am ET / 8:00am PT / 8:30pm IST. The session will explore how advanced therapies can be made accessible in low-resource settings through mission-driven models.