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Arcus Outlines 2026 Plans for Casdatifan, its Potential Best-in-Class HIF-2a Inhibitor, and its Inflammation Programs

On January 7, 2026 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules for patients with cancer and inflammatory and autoimmune diseases, reported its 2026 priorities for casdatifan and its emerging inflammation and immunology (I&I) programs.

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"As we enter 2026, the highest priorities for Arcus will be the rapid enrollment of PEAK-1, our Phase 3 study evaluating casdatifan in immunotherapy (IO)-experienced ccRCC patients, and the initiation of a 1L Phase 3 study evaluating casdatifan informed by data from multiple ongoing and soon-to-be initiated Phase 1 combination studies," said Terry Rosen, Ph.D., chief executive officer of Arcus. "This year, we also expect to advance our first small molecule for inflammatory disease into the clinic."

Casdatifan (HIF-2a inhibitor for ccRCC)

Upcoming Data Presentations:

Arcus expects to have at least three data readouts for casdatifan, its potential best-in-class HIF-2a inhibitor, during 2026:

In February 2026, Arcus plans to present updated data from the four cohorts of the Phase 1/1b ARC-20 study evaluating casdatifan monotherapy in late-line ccRCC at a medical conference. These data will include updated progression-free survival (PFS) data for the 100mg once-daily (QD) cohort of casdatifan and for all four monotherapy cohorts combined (n=121), as well as updated biomarker data correlating erythropoietin suppression with clinical outcomes.
Mid-year, Arcus expects to present updated data for approximately 45 patients treated in ARC-20 with casdatifan plus cabozantinib in IO-experienced ccRCC; this cohort evaluates the same combination in the same setting as PEAK-1, an ongoing Phase 3 study, which represents Arcus’s "fast-to-market" strategy in ccRCC.
In the second half of the year, Arcus expects to present data from multiple ARC-20 cohorts evaluating casdatifan in early-line metastatic settings, including data from the cohort evaluating casdatifan plus the anti-PD-1 antibody, zimberelimab, in 1L ccRCC.
This will be the first presentation of data for a tyrosine kinase inhibitor (TKI)-sparing HIF-2a inhibitor-based regimen in the 1L setting. Data from this cohort are expected to show an acceptable safety profile and early efficacy, including a low rate of primary progression, which is essential in this setting. The cohort is designed to de-risk Arcus’s strategy to displace TKIs as an early-line treatment.
Development Strategy:

Arcus’s development plan is designed to establish casdatifan as a foundational standard of care across multiple settings of ccRCC, which represents a potential global market opportunity of $5 billion or more.

Arcus’s ongoing Phase 3 study for casdatifan in IO-experienced ccRCC, PEAK-1, is evaluating casdatifan plus cabozantinib, the most widely used TKI in this setting. Similar Phase 3 trials in this setting have completed enrollment in 18 months or less, and Arcus’s goal is to achieve a similar timeline.

Arcus’s strategy in 1L ccRCC is focused on TKI-free regimens, which are enabled by the consistently low rate of primary progression observed with casdatifan across all cohorts and settings evaluated to date. This strategy has the potential to bring about a highly desirable paradigm shift with a first-in-class regimen that delays treatment with TKIs and their associated toxicities to later lines of therapy. The following cohorts are designed to efficiently determine the optimal 1L registrational strategy for casdatifan:

Casdatifan plus zimberelimab (Arcus’s anti-PD-1 antibody): This combination is currently being evaluated in ARC-20, and this cohort has completed enrollment. Arcus plans to present data from this cohort in the second half of 2026.
Casdatifan plus anti-PD-1-containing regimens: Arcus is planning to initiate new cohorts to evaluate two other TKI-free casdatifan plus anti-PD-1-containing regimens in the 1L setting.
Casdatifan plus volrustomig (AstraZeneca’s anti-PD-1/CTLA-4 bispecific antibody): This combination is being evaluated in the eVOLVE-RCC02 study (which is being operationalized by AstraZeneca).
Data from these cohorts will inform and enable the initiation of a Phase 3 study for a casdatifan-containing, TKI-free regimen in the 1L setting. Arcus is targeting initiation of this study by year-end 2026.

Small-Molecule Inflammation & Immunology Programs

Arcus’s I&I strategy leverages the company’s demonstrated capabilities in small-molecule drug discovery, focusing on indications currently dominated by blockbuster injectable biologics and on highly validated targets. Arcus’s I&I portfolio currently includes several oral small molecules, including an MRGPRX2 antagonist and inhibitors of TNF, CCR6 and CD40L. The company is also developing an anti-CD89 antibody that has potential in patients with a type of rheumatoid arthritis that is currently difficult to treat.
Arcus expects to advance its lead inflammation program, a potential best-in-class oral MRGPRX2 antagonist for atopic dermatitis and chronic spontaneous urticaria, into clinical development in 2026. The molecule was designed to have exquisite potency, enabling substantially lower-dose target coverage relative to the most advanced MRGPRX2 antagonist in clinical development, thereby avoiding potential exposure-limiting toxicities.
Arcus also expects to advance an oral small-molecule TNF inhibitor, a potential treatment for rheumatoid arthritis, psoriasis and inflammatory bowel disease (such as ulcerative colitis), into the clinic in late 2026 or early 2027.
Quemliclustat (CD73 inhibitor for pancreatic cancer)

Arcus’s oncology portfolio also includes quemliclustat, a small-molecule CD73 inhibitor, which is being evaluated in PRISM-1, a registrational Phase 3 study in 1L pancreatic cancer that completed enrollment in September 2025. Results from this study are expected in the first half of 2027.
Runway Guidance

Arcus has approximately $1 billion of cash and investmentsi and expects to be able to fund its planned operations until at least the second half of 2028. This guidance includes a rapid wind down of the Phase 3 STAR-221 and Phase 2 EDGE-GASTRIC studies. In the first quarter of 2026, Arcus and Gilead expect to conduct an analysis of STAR-121, a Phase 3 study evaluating domvanalimab plus zimberelimab and chemotherapy in 1L non-small cell lung cancer. Depending on the outcome of this analysis, Arcus could realize additional cost savings.

Presentation at 44th Annual J.P. Morgan Healthcare Conference

Arcus will present at the 44th Annual J.P. Morgan Healthcare Conference at 3:00 pm PT on Wednesday, January 14, 2026. A live webcast of the presentation will be available on the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay will be available following the live event.

Domvanalimab, zimberelimab and quemliclustat are investigational molecules, and neither Arcus nor Gilead has received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established. Casdatifan is also an investigational molecule, and Arcus has not received approval from any regulatory authority for any use globally, and its safety and efficacy have not been established.

About RCC

According to the American Cancer Society, kidney cancer is among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S., and an estimated 80,980 Americans will be diagnosed with kidney cancer in 2025. Clear cell RCC is the most common type of kidney cancer in adults. If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 18%. In 2022, approximately 32,200 patients with advanced kidney cancer required systemic therapy in the U.S., with over 20,000 patients receiving first-line treatment.

About Casdatifan (AB521)

Casdatifan is a small-molecule inhibitor of HIF-2a, a master switch that turns on hundreds of genes in response to low oxygen levels. In a majority of people with the most common form of kidney cancer (clear cell renal cell carcinoma), genetic anomalies result in the dysregulation of this master switch and transformation of normal kidney cells into cancerous ones. Casdatifan was designed to provide deep and durable inhibition of the HIF-2a pathway. Early clinical studies have shown high response rates and a low primary progression rate relative to clinical benchmarks, warranting further investigation in late-stage studies. Casdatifan, which is administered in pill form once daily, has a safety profile that allows it to be investigated in combination with other treatments.

About Zimberelimab

Zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody that binds PD-1, with the goal of restoring the antitumor activity of T cells. Zimberelimab has demonstrated high affinity, selectivity and potency in various tumor types. Zimberelimab is being evaluated in the U.S. and globally as a foundational anti-PD-1 treatment option in multiple ongoing clinical studies in combination with other immunotherapies. Guangzhou Gloria Biosciences Co. Ltd., which holds commercialization rights for zimberelimab in greater China, has obtained approval for zimberelimab for the treatment of recurrent or metastatic cervical cancer and for relapsed or refractory classical Hodgkin’s lymphoma. Zimberelimab is not approved for any use in the U.S. or other regions outside of China. Gloria conducts its development and commercialization activities independent of Arcus and Gilead.

(Press release, Arcus Biosciences, JAN 7, 2026, View Source [SID1234661823])

Rakuten Medical Raises $100 Million in Oversubscribed Series F to Accelerate Development Toward U.S. Regulatory Approval

On January 7, 2026 Rakuten Medical, Inc., a global biotechnology company developing and commercializing its proprietary Alluminox platform-based photoimmunotherapy, reported the closing of a $100 million Series F financing round. This includes $70 million in new capital and the conversion of $30 million in convertible promissory notes with accrued interest.

This upsized financing doubles Rakuten Medical’s initial target, underscoring strong investor confidence in its execution capabilities and the potential of the investigational Alluminox platform-based photoimmunotherapy, an innovative cancer treatment modality.

Toward U.S. Approval of ASP-1929
Rakuten Medical will utilize the Series F proceeds to advance its top priority: securing U.S. regulatory approval for ASP-1929, Rakuten Medical’s designation for its first investigational photoimmunotherapy drug. The company is currently enrolling patients into its global Phase 3 trial (ASP-1929-381, NCT06699212), evaluating ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line therapy for recurrent head and neck cancer. The proceeds will allow Rakuten Medical to strengthen its operational capabilities to accelerate enrollment in the U.S., Taiwan, Japan, Ukraine and Poland. Based on trial results, Rakuten Medical aims to submit a Biologics License Application (BLA) to the U.S. FDA in 2028.

Global Expansion and Broader Clinical Development
Rakuten Medical is leveraging the regulatory dossier submitted in Japan for its approved drug Akalux (ASP-1929) and the BioBlade Laser System device, along with post-market real-world data, to supplement its efforts in seeking approvals in additional countries. With support from strategic partners who have deep expertise in regional regulatory environments, the company aims to accelerate these efforts.

Disclaimer: Rakuten Medical’s Alluminox platform-based photoimmunotherapy is investigational outside Japan.

In parallel, Rakuten Medical is expanding development beyond head and neck cancer through internal programs and support for investigator-initiated trials (IITs). These studies will utilize grants and other funding sources to ensure efficient progress. Additionally, the company will continue driving commercial growth of ASP-1929 photoimmunotherapy for head and neck cancer in Japan, both to expand profitability for the Japan entity and to establish a reliable funding engine to fuel global expansion.

Development Program Beyond Head and Neck Cancer

Solid tumors (including malignant skin tumors): Initiate Phase 1 trial of RM-0256 photoimmunotherapy in Japan in Q2 2026, supported by AMED1 grant funding.
Esophageal and gynecologic cancers: Support two ongoing IITs of ASP-1929 photoimmunotherapy in Japan; the gynecologic cancer IIT is supported by AMED funding.
Pancreatic and non-small cell lung cancers: Support two planned IITs of ASP-1929 photoimmunotherapy in the U.S., potentially supported by external grants
International Composition of Investors
The Series F round was led by TaiAx Life Science Fund L.P. (TaiAx), an international life science venture capital fund. TaiAx was jointly established by Taiwania Capital Management, based in Taipei, Taiwan, and Axil Capital Group, based in Tokyo, Japan.

The round included the largest institutional investor group in company history, including major Japanese financial institutions—Daiwa Securities, Mitsui Sumitomo Insurance, Sumitomo Mitsui Banking—and Taiwanese venture firms ABIES Capital and Nexus CVC. Strategic partner OEP Group also joined, along with existing investors, including SBI Group, Rakuten Group, Inc. and Mickey Mikitani, Rakuten Group Chairman and CEO and Rakuten Medical CEO.

This round creates an exceptionally diverse investor base for Rakuten Medical, anchored in key global markets: the U.S., Japan and Taiwan.

Mickey Mikitani, CEO of Rakuten Medical, commented:
"Securing significant investment from leading life science investors underscores the strength of our technology and the excellence of our team. The Alluminox platform underlines a new treatment modality that requires advanced expertise in both drug development and medical device technology. Rakuten Medical is tightly focused and mission driven, having successfully developed, received approval for and commercialized an innovative therapy in 15 years. This financing will enable us to accelerate clinical development, expand our global reach and prepare for the next phase of growth."

Michael Huang, Managing Partner of Taiwania Capital Management, commented:
"This oversubscribed Series F financing reflects our strong conviction in Rakuten Medical’s differentiated technology and its ability to address profound unmet medical needs. We are thrilled to lead this round and to form a strong, like-minded global syndicate united by a shared vision to advance the future of cancer care."

(Press release, Rakuten Medical, JAN 7, 2026, View Source [SID1234661822])

Arbele Receives FDA Orphan Drug Designation for ARB1002, an Anti-CDH17 Antibody-Drug Conjugate for the Treatment of Pancreatic Cancer

On January 7, 2026 Arbele, a biotechnology company focused on developing innovative targeted cancer therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ARB1002, its investigational antibody-drug conjugate (ADC) for the treatment of pancreatic cancer.

ARB1002 is composed of an anti-CDH17 monoclonal antibody chemically linked to a potent cytotoxic agent. The ADC is designed to selectively bind CDH17, a cell-surface adhesion molecule overexpressed in pancreatic cancer, enabling targeted delivery of the cytotoxic payload to tumor cells while limiting off-target exposure.

"Orphan Drug Designation for ARB1002 marks a significant regulatory milestone for Arbele and reflects the critical need for new treatment options for patients with pancreatic cancer," said Dr Linda Wu, Chief Development Officer of Arbele. "This designation reinforces our confidence in the therapeutic potential of ARB1002 and supports its continued advancement through clinical development."

Pancreatic cancer is among the deadliest solid tumors, with limited effective therapies and poor long-term survival outcomes. The FDA’s Orphan Drug Designation program is intended to incentivize the development of therapies for rare diseases affecting fewer than 200,000 patients in the United States, offering benefits that may include tax credits for qualified clinical development expenses, exemption from certain FDA user fees, and seven years of market exclusivity following regulatory approval.

ARB1002 is planned to enter a Phase 1 clinical trial this year, with Arbele completing IND-enabling studies to support its clinical evaluation in pancreatic cancer.

"This designation highlights CDH17 as a promising target in pancreatic cancer and validates Arbele’s ADC development strategy," added Dr Tony Wong, Chief Technology Officer. "We look forward to continued engagement with the FDA as we progress ARB1002."

(Press release, ARBELE, JAN 7, 2026, View Source [SID1234661821])

RFU Helix 51 Incubator Company Receives Illinois Innovation Voucher Grant Award for Cancer-Drug Development

On January 7, 2026 UP Oncolytics, a biotech company in Rosalind Franklin University’s Helix 51 biomedical incubator, reported that it was awarded an Illinois Innovation Voucher grant for $75,000 for its collaboration with Rosalind Franklin University (RFU). UP Oncolytics is developing a novel treatment for Glioblastoma Multiforme (GBM), the most aggressive form of malignant brain cancer.

GBM is the leading cause of cancer-related deaths among men under 40 in the United States. Approximately 13,000 new cases of GBM are diagnosed annually. The median survival time for patients is about 14 months, and the five-year survival rate remains at only 7.1%. No new therapeutic agents have received approval in the U.S. in the past 20 years.

Established by the Illinois Department of Commerce and Economic Opportunity (DCEO) and administered by the Illinois Science & Technology Coalition (ISTC) to support collaborations between Illinois universities and small businesses, the grant will help UP Oncolytics complete Investigational New Drug (IND) experiments at RFU’s research labs for its initial candidate to treat GBM.

"We are grateful to ISTC and Illinois DCEO for this recognition and award, which will provide vital support to the development of a new therapy for this devastating form of brain cancer," said UP Oncolytics CEO Richard Rovin, MD, who is a neurosurgeon. "I am hopeful there will be an effective treatment in the near future for the patients afflicted by this disease."

"ISTC and Illinois DCEO are providing important support to an exciting early-stage cancer biotech company, which promises new therapeutic treatment options," said Joseph DiMario, PhD, RFU’s executive vice president for research. "We are proud to be assisting UP Oncolytics in the development of this novel therapy for this terrible fatal disease."

UP Oncolytics completed an exclusive license agreement for this novel therapy based on an oncolytic virus from Advocate Health in 2025. It was awarded an NIH SBIR Fast Track grant for this technology and FDA Orphan Drug designation for malignant gliomas, a broader group of brain cancers including GBM. The company expanded its oncology expertise with new board members Dr. Gary Gordon, a Johns Hopkins-trained oncologist and former vice president of clinical oncology at AbbVie, and Michael Rosen, a former oncology biotech CEO and executive with Pfizer, Bristol-Myers Squibb and Searle.

(Press release, UP Oncolytics, JAN 7, 2026, View Source [SID1234661820])

SOPHiA GENETICS and MD Anderson Announce Strategic Collaboration to Accelerate AI-Driven Precision Oncology

On January 7, 2026 SOPHiA GENETICS (NASDAQ: SOPH), a global leader in AI-driven precision medicine, and The University of Texas MD Anderson Cancer Center reported a strategic collaboration that unites SOPHiA GENETICS’ AI-powered analytics with MD Anderson’s clinical and scientific expertise to accelerate data-driven cancer care through new tools that can accurately analyze, interpret and translate diagnostic results into clinical practice.

As part of the collaboration, MD Anderson and SOPHiA GENETICS are launching a series of research and development programs and co-developing an advanced next-generation sequencing oncology test. Built on the advanced AI algorithms of the SOPHiA DDM Platform, the new co-developed test aims to translate complex multimodal data into actionable insights with greater speed and scale. MD Anderson researchers will tap SOPHiA GENETICS’ AI technologies to create bioinformatics pipelines that enable clinicians to rapidly interpret complex RNA-sequencing data to guide diagnosis and treatment for patients with cancer.

Donna Hansel, M.D., Ph.D., Division Head of Pathology and Laboratory Medicine at MD Anderson, said: "Cancer research has evolved rapidly, and we have more health data available than ever before. Our collaboration with SOPHiA GENETICS reflects how our lab is evolving and integrating advanced analytics and AI to better interpret complex molecular information. This collaboration will expand our ability to translate high-dimensional data into insights that can meaningfully advance research and precision oncology."

In addition, MD Anderson and SOPHiA GENETICS will jointly launch a series of research and development programs to explore new ways to characterize tumor evolution in real time, to strengthen the reliability and reproducibility of complex genomic testing, and to enhance the ability to identify optimal clinical trials or research avenues for individual patients. This multi-layered program is designed to fuel next-generation scientific discovery, empowering clinicians and researchers with tools to better understand the dynamic nature of cancer. The collaborative work at MD Anderson will be led by Shashikant Kulkarni, Ph.D., deputy division head for Molecular Pathology, and J. Bryan, M.D., assistant professor, both in the Division of Pathology and Laboratory Medicine.

Philippe Menu, M.D., Ph.D., Chief Product Officer and Chief Medical Officer, SOPHiA GENETICS, said: "This collaboration with MD Anderson amplifies our shared ambition to push the boundaries of what is possible in cancer research. With SOPHiA DDM as a unifying analytical layer, we are enabling new discoveries, accelerating breakthroughs in precision oncology and, most importantly, enabling patients around the globe to benefit from these innovations by bringing leading technologies to all geographies quickly and at scale."

(Press release, MD Anderson, JAN 7, 2026, View Source [SID1234661819])