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Arcus Biosciences, Inc. (the “Company”) announced the discontinuation of the Phase 3 STAR-221 study

On December 12, 2025, Arcus Biosciences, Inc. (the "Company") reported the discontinuation of the Phase 3 STAR-221 study due to futility. STAR-221 evaluated the anti-TIGIT antibody domvanalimab plus anti-PD-1 antibody zimberelimab and chemotherapy versus nivolumab plus chemotherapy as a first-line treatment for advanced gastric and esophageal cancers.

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The decision is based on the recommendation from the Independent Data Monitoring Committee following its review of data from an event-driven, pre-specified interim analysis of overall survival ("OS"). At the interim analysis, the domvanalimab-based combination did not improve OS relative to nivolumab plus chemotherapy. The safety profile for the domvanalimab-based combination was similar to that of nivolumab plus chemotherapy, and there were no new safety findings identified.

The STAR-221 and the Phase 2 EDGE-Gastric studies will be discontinued, and the Company and Gilead Sciences, Inc. are communicating with investigators to determine appropriate next steps for patients in the study, in addition to conducting a detailed analysis to better understand these results.

Based on existing cash, cash equivalents and marketable securities, the Company expects to be able to fund its planned operations until at least the second half of 2028. Moving forward, the Company’s R&D investment and resources will focus on casdatifan, a potential best-in-class HIF-2a inhibitor, and its emerging small molecule inflammation and autoimmune programs, including an MRGPRX2 inhibitor that is expected to enter the clinic in 2026.

(Press release, Arcus Biosciences, DEC 12, 2025, View Source [SID1234661400])

Genmab Announces Completion of Tender Offer for Outstanding Common Shares of Merus N.V. and Commencement of Subsequent Offering Period

On December 12, 2025 Genmab A/S (Nasdaq: GMAB) ("Genmab") reported that the conditions, including the minimum tender condition, to the previously announced tender offer (the "Offer") by Genmab Holding II B.V., a wholly owned subsidiary of Genmab ("Purchaser"), to acquire all the issued and outstanding common shares of Merus N.V. (Nasdaq: MRUS) ("Merus") for $97 per common share in cash have been satisfied. The transaction meaningfully accelerates Genmab’s shift to a wholly owned model, expanding and diversifying the company’s revenue, driving sustained growth into the next decade and contributing to Genmab’s evolution into a biotechnology leader.

"The Merus acquisition marks a pivotal step in the delivery of Genmab’s long-term strategy and strengthens our path to becoming a global biotechnology leader with sustained growth and profitability. We are energized by the potential of petosemtamab to meaningfully impact the lives of people with head and neck cancer. Backed by our track record of successful development and commercial execution, we look forward to unlocking petosemtamab’s full potential and delivering on its promise to patients," said Jan van de Winkel, Ph.D., President and Chief Executive Officer of Genmab.

The addition of petosemtamab, Merus’ lead asset, to Genmab’s promising late-stage pipeline is a compelling strategic fit with Genmab’s portfolio and aligns with Genmab’s expertise in antibody therapy development and commercialization in oncology. Based on this successful track record in late-stage development and excellence in commercial execution, Genmab expects to launch petosemtamab in 2027, subject to clinical results and receipt of regulatory approvals. Genmab also intends to broaden and accelerate petosemtamab’s development with potential expansion into other lines of therapy. Following the initial approval of petosemtamab, Genmab believes that petosemtamab will be accretive to EBITDA with at least one-billion-dollar annual sales potential by 2029, with multi-billion-dollar annual revenue potential thereafter.

At 5:00 p.m. New York City time on December 11, 2025 (the "Expiration Time"), the Offer and withdrawal rights expired as scheduled. The depositary for the Offer has advised Genmab and Purchaser that, as of the Expiration Time, a total of 71,463,077 of Merus’ issued and outstanding common shares, constituting 94.2% of its issued and outstanding common shares, had been validly tendered pursuant to the Offer and not properly withdrawn. Effective at 12:01 a.m. New York City time on December 12, 2025, Purchaser accepted for payment, and expects to promptly pay for, all Merus common shares validly tendered and not properly withdrawn pursuant to the Offer.

Subsequent Offering Period
Genmab also announced that, as previously disclosed, Purchaser is providing a subsequent offering period of ten business days (the "Subsequent Offering Period"), commencing today, December 12, 2025, that will expire at 5:00 p.m., New York City time on December 29, 2025. During the Subsequent Offering Period, Purchaser will offer to purchase additional common shares at the same consideration of $97.00 per share, less any applicable withholding taxes and without interest. All Common shares validly tendered during the Subsequent Offering Period will be immediately accepted and promptly paid for by Purchaser.

Following completion of the Subsequent Offering Period, Genmab and Purchaser intend to complete the acquisition of 100% of Merus through a series of previously disclosed back-end transactions. Merus shareholders who do not tender their common shares of Merus in the Offer will receive payment for their common shares following the completion of these transactions (subject to applicable withholding taxes and without interest).

(Press release, Genmab, DEC 12, 2025, View Source [SID1234661377])

CASI Pharmaceuticals Announces Up to $20 Million Convertible Note Financing

On December 11, 2025 CASI Pharmaceuticals, Inc. (NASDAQ:CASI, the "Company"), a clinical-stage biopharmaceutical company developing CID-103, an anti-CD38 monoclonal antibody, for patients with organ transplant rejection and autoimmune diseases, reported that the Company has entered into a convertible note purchase agreement (the "Purchase Agreement") with ETP Global III Fund LP, a partnership controlled by Dr. Wei-Wu He (the "Purchaser"), pursuant to which the Company will issue and sell convertible notes in an aggregate principal amount of US $20 million to the Purchaser through a private placement. This investment is planned to provide runway to fund the Company through a Phase 1 study in China in renal allograft anti-body-mediated rejection (AMR) as well as development toward a stable, high concentration protein solution for subcutaneous formulation.

The sale of the convertible notes will be in tranches and subject to multiple closings with certain closing conditions, including Purchaser being satisfied with the business results and financials status of the Company and the use of proceeds upon each closing.

Each convertible note issued pursuant to the Purchase Agreement will mature in 36 months, bearing interest of 12% per annum from the issuance date. Upon maturity, each note may, at the Company’s option, be convertible into ordinary shares of the Company, par value US $0.0001 per share (the "Shares"), at a conversion price of the volume weighted average closing price of the Company’s Shares during the five consecutive trading days immediately preceding the maturity date. The Purchaser also has the right to convert each note into Shares at any time from and including the 91st day after the issuance thereof to and including the maturity date at a conversion price of the volume weighted average closing price of the Company’s Shares during the five consecutive trading days immediately preceding the date of conversion notice by the Purchaser. In no event shall the conversion price be higher than US $2 per ordinary Share or lower than US $1 per Share.

(Press release, CASI Pharmaceuticals, DEC 11, 2025, https://feeds.issuerdirect.com/news-release.html?newsid=8482484705256594&symbol=CASI [SID1234669171])

Innovent Biologics announced that its first independently developed next-generation TRK inhibitor in China, Innovent® (zolectretib), has been approved for marketing

On December 11, 2025 Innovent Biologics (SSE: 688428; HKSE: 09969), a high-tech biopharmaceutical company, reported that its independently developed next-generation TRK inhibitor, Enoxin ( zolectretinib, ICP-723), has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult and adolescent patients aged 12 years and older with solid tumors harboring NTRK fusion genes. This marks the approval of China’s first independently developed next-generation TRK inhibitor for market launch.

In a pivotal registrational clinical trial for patients with NTRK fusion-positive solid tumors, zoletrazinib demonstrated excellent efficacy and safety as a broad-spectrum anticancer drug regardless of tumor type. Registry results showed an overall response rate (ORR) of 89.1%, a disease control rate (DCR) of 96.4%, a 24-month progression-free survival (PFS) rate of 77.4%, and a 24-month overall survival (OS) rate of 90.8%.

As a new generation TRK inhibitor independently developed in China, zoletrazinib is more effective than first-generation TRK inhibitors. It not only provides long-term deep remission but also exhibits strong penetrating brain activity and good overall safety. Furthermore, data shows that it can overcome resistance to first-generation TRK inhibitors. The once-daily oral administration of two tablets also offers great convenience to patients.

Professor Zhang Yizhuo of Sun Yat-sen University Cancer Center stated, "NTRK fusion-positive tumors often progress rapidly and have limited treatment options. Zoletratinib has demonstrated remarkable efficacy, especially in adolescent patients where the overall response rate (ORR) reached 100% . Clinically, zolectratinib’s onset of action is significantly faster than traditional chemotherapy, with many patients observing significant tumor shrinkage within one to two cycles, providing a valuable treatment window for critically ill patients. Furthermore, the duration of zolectratinib’s effective response is long; the longest response we have observed clinically has exceeded 36 months, offering hope for longer survival to patients with solid tumors."

Professor Luo Zhiguo of Fudan University Cancer Hospital stated, "Most of the patients enrolled in our center are sarcoma patients. Zoletratinib achieved an overall response rate (ORR) of 89.5% in patients with soft tissue sarcoma , demonstrating excellent efficacy. Furthermore, its high selectivity significantly reduces off-target toxicity and exhibits good safety, allowing patients to use the medication long-term without affecting their quality of life. For patients with solid tumors requiring long-term treatment, the efficacy and safety advantages of zoletratinib can help them live longer and better."

Professor Wang Qiming of Henan Cancer Hospital emphasized, "Zoletratinib also demonstrates excellent efficacy in NTRK fusion-positive lung cancer patients, with an overall response rate (ORR) of 88.9%, bringing more hope to lung cancer patients. Simultaneously, zolectratinib exhibits remarkable brain-penetrating activity, achieving a 100% intracranial objective response rate (IC-ORR) and a 100% 12-month intracranial sustained response rate (IC-DOR), achieving strong control of brain lesions. From a molecular mechanism perspective, zolectratinib’s unique structure enables it to penetrate the blood-brain barrier and maintain effective therapeutic concentrations in cerebrospinal fluid, providing a new treatment option for patients with brain metastases."

Professor Chen Libo of Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University stated, " The overall response rate (ORR) for thyroid cancer patients enrolled with zoletrinib was 100% . Patients enrolled in our center have maintained continuous remission for two years, demonstrating the superior efficacy of zoletrinib compared to first-generation TRK inhibitors. Furthermore, as a new generation TRK inhibitor, zoletrinib offers new hope for resistant patients. With its excellent efficacy and good tolerability, zoletrinib can provide long-term, sustained, deep remission for patients with NTRK fusion-positive solid tumors."

Dr. Cui Jisong, co-founder, chairman, and CEO of InnoCare Pharma, said, "Zoletratinib is InnoCare Pharma’s third approved innovative drug and our first approved innovative drug in the field of solid tumors. As a broad-spectrum anticancer drug that is not limited to any type of tumor, zoletratinib has significant clinical implications for patients with NTRK fusion-positive solid tumors. We would like to express our special thanks to the doctors, patients, partners, and employees who participated in this clinical trial for their support, and also to the regulatory agencies for their professional and efficient approval process, which allows more patients with solid tumors to receive better treatment earlier. We believe that zoletratinib, as the first independently developed and approved TRK inhibitor in China, will bring new hope to patients with solid tumors in China."

Zolectretinib has been included in the "Pilot Program for Encouraging the Development of Pediatric Anti-tumor Drugs (Starlight Program)" by the China National Medical Products Administration. Innovent Biologics expects to submit an NDA application for zolectretinib for the treatment of pediatric patients (aged 2 to 12) soon.

NTRK fusion genes are present in various types of tumors and have been found in more than 26 types of solid tumors [1] . It is estimated that there are 6,500 new cases of tumors carrying NTRK fusion genes in China each year. These patients have short survival, rapid disease progression and high disability rate. However, due to the low popularity of the current gold standard detection method – next-generation sequencing (NGS), diagnosis is delayed, so there is still an unmet clinical need. The emergence of the broad-spectrum anticancer drug zoletrinib has brought new treatment options to patients.

(Press release, InnoCare Pharma, DEC 11, 2025, View Source [SID1234663149]).

ViroMissile Announces First-in-Human Phase I Trial of IDOV-Immune for Advanced Solid Tumors

On December 11, 2025 ViroMissile, Inc., a cancer immunotherapy company pioneering the IDOV (Intravenously Deliverable Oncolytic Virus) platform, reported the initiation of a first-in-human clinical trial evaluating IDOV-Immune, its investigational oncolytic vaccinia virus therapy, in patients with advanced solid tumors (NCT06910657). Additional trial sites across the United States are expected to begin enrolling in 2026, pending clearance of the U.S. IND. The first patient was dosed at The Alfred Hospital in Melbourne, Victoria, Australia.

"Launching this first-in-human trial marks an important milestone for ViroMissile and our mission to reshape cancer immunotherapy with selective viruses that target tumors while sparing healthy tissue," said Nanhai George Chen, PhD, CEO and founder of ViroMissile. "IDOV-Immune was engineered to penetrate the tumor, destroy cancer cells directly, and activate a coordinated immune response against the disease in a convenient systemic dose. We are excited to begin evaluating this therapy in patients who have exhausted standard options and to advance a new class of immunotherapies that may meaningfully improve outcomes."

The Phase I, open-label, multi-center trial is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary anti-tumor activity of a single intravenous (IV) infusion of IDOV-Immune. The study plans to enroll up to 78 adult participants at study sites across the United States and Australia, including leading cancer centers. The primary objective is to determine the safety and tolerability of IDOV-Immune, including characterization of treatment-emergent adverse events (TEAEs) through Day 90 and dose-limiting toxicities (DLTs) during the first 28 days, and to determine the maximum tolerated dose and recommended dose for Phase 2 studies. Secondary objectives include evaluating the PK and PD profile of IDOV-Immune, characterizing immunologic responses and the development of neutralizing antibodies, and assessing preliminary signs of antitumor activity, including objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and duration of response (DOR) over a 12-month follow-up period.

Shah Rahimian, MD, chief medical officer at ViroMissile, added, "As we enroll patients into this first-in-human study, we are particularly encouraged by the opportunity to evaluate IDOV-Immune as a systemically administered oncolytic therapy. Delivering a single intravenous dose that can reach tumors throughout the body, while also activating both innate and adaptive immunity, represents an important evolution in the field. This trial will help us understand the safety profile, viral kinetics, and early biological activity of IDOV-Immune, and we are deeply grateful to the patients who make this work possible."

(Press release, ViroMissile, DEC 11, 2025, View Source [SID1234661462])