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])

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.

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"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])

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.

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"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])

On December 11, 2025 NiKang Therapeutics Inc. ("NiKang"), a clinical stage biotech company focused on developing innovative small molecule oncology medicines to bring transformative therapies to patients in need, reported the presentation of detailed preclinical data on NKT5097 at the 2025 San Antonio Breast Cancer Symposium (SABCS 2025) being held December 9-12, 2025, in San Antonio, TX. NKT5097 is a first-in-class, orally bioavailable small molecule engineered to selectively degrade CDK2 and CDK4 simultaneously, offering potential therapeutic benefits for patients with HR+ breast cancer and tumors driven by aberrant CDK2/cyclin E pathway activation.

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NiKang has initiated a Phase 1, open-label, dose escalation study of NKT5097 as a single agent. This first-in-human study (NCT07029399) is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of NKT5097 in patients with advanced or metastatic solid tumors, with a focus on breast cancer and tumors with CCNE1 amplification.

"We are excited to share these compelling preclinical data for NKT5097 at this year’s SABCS," said Zhenhai Gao, Ph.D., co-founder, president and CEO of NiKang. "Our research has centered on designing a molecule that selectively degrades CDK2 and CDK4 while sparing CDK1, CDK6, CDK7, and CDK9, with the goal of significantly reducing the gastrointestinal and hematologic toxicities associated with currently approved CDK4/6 inhibitors and addressing emerging resistance mechanism. NKT5097 represents the first compound from our industry-leading CDK2/4 degrader portfolio. Its unique ability to simultaneously degrade both CDK2 and CDK4 offers a promising therapeutic strategy that may deliver deeper and more durable clinical benefits for patients."

Poster Presentation Details:

Title:

Discovery of NKT5097: a first-in-class, highly potent and selective, orally bioavailable CDK2/4 dual degrader for cancer therapy

Presenter:

Ke Liu

Abstract Number:

847

Presentation Number:

PS4-04-30

Date and Time:

Thursday, December 11, 2025, 5:00 PM – 6:30 PM

About NKT5097

NKT5097 is a first-in-class, highly potent and selective, orally bioavailable CDK2/4 dual degrader, designed to achieve sustained inhibition of the CDK2 and CDK4 pathway. By maximizing selective suppression of these pathways, NKT5097 has the potential to harness the full therapeutic benefits of CDK2 and CDK4 inhibition. NKT5097 is currently under evaluation in a Phase 1 clinical study in advanced or metastatic solid tumors as a single agent (NCT07029399).

(Press release, NiKang Therapeutics, DEC 11, 2025, View Source [SID1234661388])

On December 11, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported the publication of one of the largest and most comprehensive patient cohorts to date from the landmark TRACERx study, in the journal Cell. The study, titled "Longitudinal ultrasensitive ctDNA monitoring for high-resolution lung cancer risk prediction," demonstrates the clinical importance of ultrasensitive, tumor-informed molecular residual disease (MRD) testing in stage I to III non-small cell lung cancer (NSCLC).

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The study, led by Professor Charles Swanton at the Francis Crick Institute and University College London (UCL) in collaboration with Personalis, analyzed 431 NSCLC patients tracked for a median of > 5 years using the NeXT Personal test. It demonstrated that the NeXT Personal test allows for highly sensitive detection of small traces of circulating tumor DNA (ctDNA) in blood samples from lung cancer diagnosis through to surveillance, even in hard-to-detect subtypes.

Key Findings:

Comprehensive Cancer Detection From Diagnosis Through Surveillance: NeXT Personal demonstrated exceptional sensitivity and specificity for detecting residual and recurrent cancer throughout the patient course at diagnosis (pre-surgery), post-surgical (landmark), during adjuvant, and during long-term surveillance monitoring, with many of the detections (~36-43%) in the ultrasensitive range.
Cancer Detection Ahead of Imaging: Cancer was detected a median of ~5 to ~9 months and up to ~57 months ahead of standard of care imaging post-surgery and during surveillance.
Ultrasensitive Detection and Risk Stratification: The study demonstrated NeXT Personal detection of ctDNA pre-treatment, post-surgery, and during surveillance was associated with higher risk of relapse and worse overall survival. The study also identified an intermediate risk patient subgroup with ultrasensitive ctDNA detections that can benefit from close clinical follow-up.
Therapy Monitoring: Patients who did not clear their ctDNA during adjuvant chemotherapy were > 5 times more likely to relapse than those who cleared their ctDNA.
The study utilized Personalis’ NeXT Personal technology, which leverages whole-genome sequencing and proprietary noise suppression to detect ctDNA at levels down to ~1 PPM. The Cell publication highlights that a significant portion of relapsing patients presented with ctDNA levels in the ultrasensitive range, detections which can be missed with less sensitive tests.

"This latest TRACERx study underscores the critical role of ultrasensitive ctDNA monitoring in early-stage lung cancer," said Professor Charles Swanton, Director of the Cancer Research UK Lung Cancer Centre of Excellence and Chief Clinician at Cancer Research UK. "The ability to detect residual disease at extremely low levels allows us to detect traces of cancer earlier after surgical resection in the adjuvant setting and more effectively identify patients at risk for relapse. It also allows us to see how patients are responding to adjuvant therapy with more accuracy, paving the way for more personalized, data-driven treatment strategies."

Richard Chen, M.D., Chief Medical Officer and Executive VP of R&D at Personalis, added: "This publication in Cell confirms that NeXT Personal’s high test-sensitivity and specificity are not just technical specifications, they are key to unlocking clinical utility. By pioneering ultrasensitive MRD testing, we are leading the way in enabling the next generation of cancer care and giving physicians the tools they need to better guide treatment decisions throughout the patient journey."

This publication joins a list of other leading publications this year in Nature Medicine and Annals of Oncology for NeXT Personal, showing the importance of ultrasensitive MRD testing in lung cancer and other cancer types.

(Press release, Personalis, DEC 11, 2025, View Source [SID1234661387])