On September 22, 2026 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for the treatment of cancer and inflammatory diseases, reported that it will host an in-person investor event with a live webcast on Tuesday, October 20, 2026, beginning at 8:30 AM ET, in New York City.

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The event will highlight new data from the ARC-20 platform study, which is evaluating casdatifan, a next-generation HIF-2α inhibitor, alone or in combination, as a first-, second- and late-line treatment for clear cell renal cell carcinoma (ccRCC). Featured presenters will include members of the Arcus management team and Dr. Rana McKay, Professor of Medicine and Urology at the University of California San Diego, who is a leading academic expert in the treatment of kidney cancer with deep experience using HIF-2α inhibitors.

New data to be presented will include:

First-line TKI-free combinations:
Casdatifan plus zimberelimab (anti-PD-1 antibody): Data will include safety and early efficacy, including rate of primary progression, overall response rate (ORR), and progression-free survival (PFS) for 30 patients with a median follow-up of approximately 11 months.
Casdatifan plus ipilimumab plus zimberelimab: Data will include safety and rate of primary progression for approximately 20 patients. Safety data from this cohort will support initiation of the first-line registrational trial PEAK-20, evaluating casdatifan plus ipilimumab plus nivolumab, expected to occur in the fourth quarter of 2026.
Second-line TKI-containing combination:
Casdatifan plus cabozantinib: Efficacy data will include ORR, PFS, and early overall survival (OS) for 43 patients with a minimum of 18 months and a median of approximately 21 months of follow-up and a subgroup analysis of efficacy (including PFS and OS) based on prior therapy. Safety and tolerability data will also be provided for this cohort. This is the same combination and patient population being evaluated in the registrational trial PEAK-1, expected to be fully enrolled at the end of 2026.
Late-line monotherapy:
Casdatifan monotherapy: Data will include OS, as well as updated ORR and PFS, for 121 patients in the pooled monotherapy cohorts, with median follow-up of approximately 28 months.
Arcus will also be highlighting new subgroup analyses, including evaluation of casdatifan monotherapy efficacy for both PFS and OS by prior therapy. In addition, Arcus will share the first translational data correlating pharmacodynamic markers of HIF-2α inhibition with overall survival.
The presentation will also include market opportunity and review of Arcus’s development strategy, which is designed to generate evidence to secure casdatifan as a backbone therapy in ccRCC so that every patient has the opportunity to benefit from casdatifan across each line of therapy over the course of their care.

Please contact Arcus Investor Relations regarding in-person attendance. The event will be broadcast live via webcast here: https://event.summitcast.com/view/oP6P82VnbjK87kUbV5QALF/guest_book?session_id=WJm4z43QhGbWA8FEbbv5AM. A replay will be available following the live event in the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com.

About Casdatifan (AB521)

Casdatifan is a small-molecule inhibitor of hypoxia-inducible factor 2-alpha (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.

The casdatifan development strategy is designed to generate evidence needed to establish casdatifan as a backbone therapy so that every ccRCC patient has the opportunity to benefit from casdatifan across each line of therapy. In addition to partner-operationalized studies, including combinations with casdatifan and anti-PD-X/VEGF bispecifics, Arcus is investigating casdatifan across multiple cohorts in the ARC-20 platform study, alone and in combination with other potential new treatment options, including in:

The first-line setting with cohorts evaluating casdatifan plus zimberelimab, an anti-PD-1 (ongoing); casdatifan plus zimberelimab and ipilimumab, an anti-CTLA-4 (ongoing); and casdatifan plus ivonescimab, an anti-PD-1/VEGF bispecific (planned)
The second-line setting with a cohort evaluating casdatifan plus cabozantinib, a TKI, in immunotherapy-experienced patients (ongoing)
The late-line setting with a cohort evaluating casdatifan plus tivozanib, a TKI, in HIF-2a inhibitor-experienced patients (planned)
Arcus is also enrolling PEAK-1, the global Phase 3 study evaluating casdatifan plus cabozantinib versus cabozantinib in immunotherapy-experienced patients with metastatic ccRCC. Arcus expects to complete enrollment in PEAK-1 and to initiate the Phase 3 PEAK-20 study in first-line metastatic ccRCC by year-end 2026.

Casdatifan is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established. Taiho has development and commercial rights in Japan and other countries in Asia, excluding China. Arcus Biosciences holds full rights to casdatifan everywhere else globally.

(Press release, Arcus Biosciences, SEP 22, 2026, View Source [SID1234671010])

On September 22, 2026 Summit Therapeutics Inc. (Nasdaq: SMMT) reported that data from the Phase III HARMONi-GI1 trial, conducted in China and sponsored by Akeso, Inc., featuring the novel, potential first-in-class investigational bispecific antibody ivonescimab, will be featured as part of the Presidential Symposium II at the European Society for Medical Oncology 2026 Congress (ESMO 2026) which takes place October 23–27, 2026, in Madrid, Spain. The presentation will take place on Sunday, October 25 during the Presidential Symposium from 4:30pm – 6:15pm CET (11:30am – 1:15pm EDT).

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The HARMONi-GI1 study is evaluating ivonescimab plus chemotherapy compared with durvalumab plus chemotherapy as a first-line treatment for patients with advanced biliary tract cancer (BTC). HARMONi-GI1 is a single-region, multi-center, Phase III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso.

On August 25, 2026, Akeso announced topline results from HARMONi-GI1. Akeso reported that, at a pre-specified interim analysis, the ivonescimab-based regimen achieved statistically significant and clinically meaningful superiority in the primary endpoint of overall survival (OS) compared to the durvalumab-based regimen. The study also met the key secondary endpoints of progression-free survival (PFS) and objective response rate (ORR).

About the ESMO (Free ESMO Whitepaper) 2026 Presidential Symposium Presentation
Presidential Symposium Presentation
Presentation Title: Ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer: a randomized, controlled, double-blinded, phase 3 trial (HARMONi-GI1)
Presenter: Jian Zhou, MD (Shanghai, China)
ESMO Presentation No.: Presidential Symposium II, LBA8
Session Date & Time: Sunday, October 25, 2026, 4:30pm – 6:15pm CET (11:30am – 1:15pm EDT)

In China, ivonescimab is approved and commercially available for indications in non-small cell lung cancer (NSCLC). Ivonescimab remains investigational and is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This design is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Summit believes ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of ivonescimab’s design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) and increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 5,000 patients have been treated with ivonescimab in clinical studies globally and over 100,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.

There are currently 16 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, five of which are Summit-sponsored global studies, one of which is a multiregional study sponsored by a cooperative group, and 10 of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, Summit began enrolling patients in HARMONi-7. Summit expanded its Phase III clinical development program into colorectal cancer (CRC) in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3. In 2026, Summit announced initiation of HARMONi-GU1, a Phase II/III study in urothelial carcinoma (bladder cancer) with global clinical trial site activations planned to begin by the fourth quarter of 2026.

Akeso is actively conducting additional Phase III clinical studies in settings outside of NSCLC and biliary-tract cancer, including triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024.

(Press release, Summit Therapeutics, SEP 22, 2026, View Source [SID1234671009])

On September 22, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that its Signatera test has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) as a companion diagnostic (CDx) in muscle-invasive bladder cancer (MIBC).

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This approval supports the use of the Signatera test to guide adjuvant atezolizumab (Tecentriq) treatment decisions in patients with MIBC. Natera expects to commercially launch Signatera for MIBC in Japan in the first half of 2027, following the PMDA’s approval of atezolizumab in MIBC.

Regulatory approval was supported by data from IMvigor011, a randomized, double-blind phase III clinical trial that evaluated Signatera-guided adjuvant atezolizumab in patients with MIBC. The trial included more than 20 participating sites in Japan, giving Japanese clinicians firsthand experience with Signatera-guided treatment in this setting.

This marks Signatera’s second PMDA authorization in Japan, after receiving approval in colorectal cancer in June 2026. It follows the U.S. Food and Drug Administration’s (FDA) approval of Signatera as a CDx for adjuvant atezolizumab in MIBC (and the approval by the FDA of atezolizumab), as well as the recently published Category 1 recommendation for MRD-guided adjuvant atezolizumab in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Bladder Cancer.

Bladder cancer affects more than 34,000 people in Japan each year,1 with approximately 20–25% of newly diagnosed cases classified as muscle-invasive.2 MIBC carries a higher risk of recurrence and greater treatment complexity than earlier-stage disease, underscoring the need for precision tools that can help clinicians individualize treatment decisions in the adjuvant setting.

"We look forward to launching this second Signatera MRD indication in Japan, giving patients with muscle-invasive bladder cancer a proven diagnostic tool to guide treatment decisions in the first year after surgery," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology, Natera. "We value our growing partnership with the Japanese oncology community, which has been a leader in adopting MRD into clinical trials and into clinical practice."

(Press release, Natera, SEP 22, 2026, View Source [SID1234671008])

On September 22, 2026 Beactica Therapeutics AB, a Swedish precision medicine company, reported the initiation of IND-enabling studies for BEA-17, the Company’s wholly owned, first-in-class oral degrader of the epigenetic regulators LSD1 and CoREST, being developed as a precision immunotherapy for glioblastoma (GBM). The studies advance BEA-17 from preclinical proof-of-concept into the formal safety, manufacturing and regulatory programme required to support a Clinical Trial Application (CTA) in the EU and/or an Investigational New Drug (IND) application in the US, and the start of first-in-human clinical trials.

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Glioblastoma is the most common and most aggressive primary brain tumour, with a median overall survival of around 15 months and a standard of care that has remained essentially unchanged for more than two decades. Immunotherapies that have transformed other cancers have repeatedly failed in GBM, largely because the tumour maintains a profoundly immunosuppressive, immune-"cold" microenvironment. BEA-17 is designed to overcome this barrier: by degrading LSD1 and its scaffolding partner CoREST, BEA-17 enhances antigen presentation, induces viral mimicry and reprogrammes macrophages towards a pro-inflammatory state. In preclinical models of glioblastoma, BEA-17 in combination with standard of care substantially improved survival and produced durable tumour regression not observed with standard of care alone. BEA-17 has also potentiated anti-PD-1 checkpoint blockade in a preclinical model of colon cancer – effects not seen with catalytic LSD1 inhibitors. BEA-17 is orally bioavailable, brain-penetrant, and has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of glioblastoma.

"Initiating IND-enabling studies is a defining milestone for Beactica and for the BEA-17 programme," said Dr Per Källblad, Chief Executive Officer of Beactica Therapeutics. "With a first-in-class mechanism and compelling preclinical efficacy in combination with standard of care, we are now executing the rigorous safety and manufacturing programme that will carry BEA-17 into first-in-human trials."

The IND-enabling programme comprises GLP-compliant repeat-dose toxicology in rodent and non-rodent species, safety pharmacology, pharmacokinetic studies, and manufacture of a traceable, fully documented batch of BEA-17 drug substance suitable for a Clinical Trial Application and a finalised oral clinical trial formulation.

The work is conducted under GLIOBREAK, a 30-month project supported by a EUR 2.5 million EIC Transition grant under Horizon Europe, announced in February 2026. Beactica expects to complete the IND-enabling programme and submit a Clinical Trial Application in the EU and/or an Investigational New Drug application to the US FDA in 2027.

(Press release, Beactica, SEP 22, 2026, View Source [SID1234671007])

On September 22, 2026 SystImmune Inc. (SystImmune), a clinical-stage biotechnology company advancing next-generation multi-specific antibodies and antibody-drug conjugates (ADCs), reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SI-B037, a bispecific antibody targeting immunosuppression and other synergistic mechanisms.

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The FDA clearance marks SystImmune’s first IND application utilizing New Approach Methodologies (NAMs) as part of its integrated nonclinical safety and translational assessment package. It also underscores the company’s role at the forefront of the global paradigm shift toward modern, human-centric, non-animal testing alternatives encouraged by regulatory authorities worldwide.

"We used human organ-on-chip systems and primary human tissue models, in place of conventional animal toxicology studies," said Dr. Jahan Khalili, Senior Vice President of Research at SystImmune. "Human-relevant models gave us a more direct read on a molecule designed to engage multiple human pathways in the nonclinical package, built around New Approach Methodologies."

"Patients with advanced solid tumors refractory to standard therapies remain in urgent need of novel therapeutic options with coordinated mechanisms of action," said Dr. Anand Achanta, Senior Vice President, Regulatory Affairs and Medical Writing. "We look forward to initiating the Phase 1/1b trial to determine optimal dosing and characterize the clinical activity of SI-B037, while continuing to collaborate closely with regulatory agencies to refine translational endpoints and human-relevant safety models in future studies."

(Press release, SystImmune, SEP 22, 2026, View Source [SID1234671006])