A Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors Harboring Microsatellite Instability (MSI) and/or Deficient Mismatch Repair (dMMR)

This is a first-in-human, Phase I, open-label, multicenter, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of VVD-133214 monotherapy, and in combination with bevacizumab or pembrolizumab, in participants with microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) advanced solid tumors. VVD-133214 is an oral drug that acts on a protein called Werner (WRN), which may promote the growth of cancers that are MSI and/or dMMR. By acting on WRN, VVD-133214 may be able to block the growth of these types of cancer.

Start Date25 Jan 2024

Sponsor / Collaborator

Vividion Therapeutics, Inc.

CTIS2023-503170-20-00

/ Not yet recruitingPhase 1

A Phase I Study of RO7589831 in Participants with Advanced Solid Tumors

Start Date12 Nov 2023

Sponsor / Collaborator

F. Hoffmann-La Roche Ltd.

CTR20262812

/ Not yet recruitingPhase 1

一项评价VVD-133214单药治疗和联合治疗在携带微卫星不稳定型（MSI）和/或错配修复缺陷（dMMR）的晚期实体瘤参与者中的安全性、耐受性、药代动力学、药效学和抗肿瘤活性的I期、开放性研究

[Translation] A phase I, open-label study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of VVD-133214 monotherapy and combination therapy in participants with advanced solid tumors carrying microsatellite instability (MSI) and/or mismatch repair deficiency (dMMR).

主要目的：评价VVD-133214单药治疗和与贝伐珠单抗或帕博利珠单抗联合治疗的安全性和耐受性确定VVD-133214单药治疗和与贝伐珠单抗或帕博利珠单抗联合治疗的最大耐受剂量（MTD）和/或扩展期推荐剂量（RDE）或推荐II期剂量（RP2D）次要目的：表征VVD-133214单药治疗和与贝伐珠单抗或帕博利珠单抗联合治疗的药代动力学（PK）特征评价VVD-133214单药治疗和与贝伐珠单抗或帕博利珠单抗联合治疗的抗肿瘤活性

[Translation]

Primary Objectives: To evaluate the safety and tolerability of VVD-133214 monotherapy and combination therapy with bevacizumab or pembrolizumab; to determine the maximum tolerated dose (MTD) and/or recommended dose for extended phase (RDE) or recommended phase II dose (RP2D) for VVD-133214 monotherapy and combination therapy with bevacizumab or pembrolizumab. Secondary Objectives: To characterize the pharmacokinetic (PK) profiles of VVD-133214 monotherapy and combination therapy with bevacizumab or pembrolizumab; to evaluate the antitumor activity of VVD-133214 monotherapy and combination therapy with bevacizumab or pembrolizumab.

Start Date-

Sponsor / Collaborator

Bayer Healthcare Co., Ltd.

100 Clinical Results associated with RO-7589831

100 Translational Medicine associated with RO-7589831

100 Patents (Medical) associated with RO-7589831

Literatures (Medical) associated with RO-7589831

12 Feb 2026·ACS Medicinal Chemistry Letters

Discovery and Preclinical Evaluations of Potent, Selective, and Allosteric Covalent WRN Inhibitors with Improved PK Properties

Article

Author: Lu, Zhuojian ; Long, Hanxiong ; Zhang, Xuejun ; Xiao, Qi ; Yang, Xiulan ; Liu, Yong ; Xu, Zhaobing ; Liu, Lifei ; Sun, Hongna ; Yan, Bocheng ; Jiang, Wen

Werner syndrome helicase (WRN) has received significant interest due to its implication as a synthetic lethal target in microsatellite instability-high (MSI-H) cancers. Here we report the discovery of a novel allosteric covalent WRN inhibitor, compound 22, via structure-based medicinal design and pharmacokinetic optimization from VVD-214. Compound 22 occupied a new cavity and formed an additional hydrogen bond with K894, thereby improving its activities. Compound 22 exhibited high antiproliferation inhibitory activity against HCT116, an MSI-H colorectal cancer cell line. It also demonstrated favorable preclinical pharmacokinetic properties with superior plasma stability and exposure compared with VVD-214. Furthermore, compound 22 showed statistically significant antitumor activity in the HCT116 xenograft mouse model with clear dose dependence.

25 Dec 2025·JOURNAL OF MEDICINAL CHEMISTRY

Identification of VVD-214/RO7589831, a Clinical-Stage, Covalent Allosteric Inhibitor of WRN Helicase for the Treatment of MSI-High Cancers

Article

Author: Horning, Benjamin D. ; Symons, Kent T. ; Bernard, Steffen M. ; Ashby, Paige ; Wu, Chu-Chiao ; Malmstrom, Robert D. ; Snead, Aaron N. ; Burgess, Laurence ; Lam, Betty ; Song, Xiaodan ; Lamb, Kelsey N. ; Owyang, Zachary A. ; Baltgalvis, Kristen A. ; Weinstein, David S. ; Kikuchi, Shota ; Sigler, John J. ; Patricelli, Matthew P. ; Tabatabaei, Ali ; Simon, Gabriel M. ; Green, Jason C. ; Hoffman, Melissa A. ; Glaza, Thomas A. ; Pastuszka, Martha K. ; Rogness, Don C. ; Pollock, Jonathan

Werner syndrome helicase (WRN) has emerged as a compelling therapeutic target for microsatellite instability-high (MSI-H) cancers, owing to its selective dependency on the helicase activity of WRN. Despite the inherent challenges in targeting helicases, our chemoproteomics approach enabled the identification of compounds that covalently engage C727 within an allosteric pocket of WRN, thereby inhibiting its ability to unwind DNA. Through optimization of each molecular component, particularly focusing on the vinyl sulfone warhead and C2 substitution at the pyrimidine core, an optimal balance of intrinsic reactivity, inhibitory potency, and metabolic stability was achieved, culminating in the identification of VVD-214/RO7589831. This process underscored the tunability of the vinyl sulfone warhead and its effectiveness in covalent drug discovery. VVD-214 induced tumor regression in MSI-H colorectal cancer models and is being evaluated as a promising therapeutic candidate for MSI-H cancers.

01 May 2025·DNA REPAIR

Werner helicase as a therapeutic target in mismatch repair deficient colorectal cancer

Review

Author: Liu, Zhaojin ; Lenz, Heinz-Josef ; Yu, Jian ; Zhang, Lin ; Hao, Suisui

Colorectal cancer (CRC) is one of the leading causes of cancer-related deaths in the United States. A key driver of CRC development is microsatellite instability (MSI), which is caused by DNA mismatch repair deficiency and characterized by hypermutability of short-tandem repeat sequences. A significant portion of MSI CRCs do not respond to checkpoint immunotherapy treatments, highlighting an unmet need for improved therapies. Recent studies have revealed that MSI cancer cells require Werner (WRN), a RecQ family DNA helicase, for survival. Inhibiting WRN has emerged as a promising approach for targeting MSI CRCs that are insensitive to standard therapies. Several highly potent small-molecule WRN inhibitors have been developed and exhibited striking in vitro and in vivo activities against MSI cancers. Two of these WRN inhibitors, HRO761 and VVD-133214, have recently entered clinical trials. In this review, we summarize recent studies on WRN as a synthetic lethal target in MSI CRC and the development of WRN inhibitors as a new class of anticancer agents.

News (Medical) associated with RO-7589831

24 Jun 2026

·www.globenewswire.com

Next-Generation DNA Repair Inhibitors Could Capture Billions in Emerging Market

AUSTIN, Texas, June 24, 2026 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: Oncology research is moving through one of its most active stretches in years. DNA Damage Response (“DDR”) inhibitors, a category of drugs that work by blocking cancer cells' capacity to fix their own damaged DNA, are growing well beyond the poly ADP ribose polymerase (“PARP”) inhibitor that first defined the category. DDR-inhibiting therapies generated an estimated $7 billion-plus in worldwide sales in 2025, and the wider oncology, diagnostics and precision medicine markets are expected to approach about $750 billion by 2030. A fresh wave of inhibitor classes is now taking shape as the next major opportunity. Standing at the leading edge of this shift is Onco-Innovations Limited (CBOE CA: ONCO) (OTCQB: ONNVF) (profile), a Canadian clinical-stage oncology company developing ONC010(TM), a nanoparticle-encapsulated PNKP inhibitor designed to target a DNA repair enzyme that participates in several distinct repair pathways. As the industry works toward the next generation of synthetic lethality assets, Onco-Innovations occupies a distinctive niche as it builds out its position within the biopharmaceutical and biotechnology space, alongside other established companies such as Merck & Co. Inc. (NYSE: MRK), Pfizer Inc. (NYSE: PFE), GSK plc (NYSE: GSK) and Gilead Sciences Inc. (NASDAQ: GILD), all of which are focused on developing therapies for serious illnesses, including cancer. PARP inhibitors reshaped oncology when they first reached patients some 10 years ago, but they represent just one entry point into a much larger and more intricate biological network.Onco-Technologies owns exclusive worldwide rights to a foundational set of PNKP inhibitor technologies.The company’s preclinical program has generated concrete, measurable outcomes that support the biological case for PNKP inhibition in solid tumors.Onco-Innovations holds global rights across three separate layers of protection, with each layer reinforcing the others. Click here to view the custom infographic of the Onco-Innovations editorial. DNA Repair Science Expands Past the PARP Era PARP inhibitors reshaped oncology when they first reached patients some 10 years ago. They put into practice a concept known as synthetic lethality, in which cancers carrying particular DNA repair defects could be selectively destroyed by disabling a secondary repair pathway. The effect was striking in BRCA-mutated cancers, and the drug class has since grown into a market worth billions of dollars. Yet PARP inhibitors represent just one entry point into a much larger and more intricate biological network. The DNA Damage Response system involves dozens of proteins and pathways that cancer cells depend on to withstand chemotherapy, radiation and other forms of cellular stress. Researchers have spent years systematically charting this network in search of new drug targets. A field once confined to academic circles is now attracting serious investment and clinical interest. Artios Pharma, for instance, closed a $115 million Series D financing round late last year to advance mid-stage studies of experimental cancer drugs targeting DNA repair mechanisms beyond PARP, one of the strongest signals yet that this segment has matured into an investable category. The clinical pipeline backs up that narrative. Last month, Artios dosed its first patient in a randomized phase 2 trial of ART6043, a DNA polymerase theta inhibitor, in patients with gBRCA-mutated, HER2-negative breast cancer, advancing a non-PARP DDR target into mid-stage, biomarker-guided development. Also last month, MD Anderson released phase 1 proof-of-concept results for RO7589831, a Werner helicase inhibitor, in cancers exhibiting high microsatellite instability. These are not minor announcements; they demonstrate that novel DDR mechanisms can produce real clinical responses in actual patients. Interest from potential partners in DDR assets has remained resilient even amid broader market turbulence. Last year, Repare Therapeutics out-licensed lunresertib to Debiopharm in a deal worth $10 million upfront, plus up to $257 million tied to milestones. Debiopharm went on to secure U.S. Food and Drug Administration (“FDA”) Fast Track designation for a lunresertib combination in April 2026, converting a licensing arrangement into a formal regulatory achievement. The takeaway for investors appears straightforward: Biomarker-defined DDR assets backed by a credible scientific mechanism can still attract partners and earn regulatory recognition, even when funding conditions remain cautious. Polynucleotide Kinase Phosphatase, or PNKP, is a DNA repair enzyme that functions across numerous repair pathways, addressing both single-strand and double-strand break repair. This broader scope gives PNKP inhibitors a potentially wider therapeutic reach than PARP inhibitors, which act primarily on single-strand break repair. Inhibiting PNKP has already shown preclinical activity in colorectal, lung, breast, prostate, ovarian and blood cancers. With worldwide PARP inhibitor revenue forecast to total roughly $12 billion by 2030, PNKP inhibitors are surfacing as a significant drug class positioned to capture share within the expanding DNA Damage Response segment. Onco-Innovations has established itself as the recognized leader for this novel DDR target. Holding First-Mover Ground in Wide-Open Category Most competitive space in oncology drug development becomes crowded quickly. PARP inhibitors, PD-1 checkpoint drugs and CDK4/6 inhibitors each drew dozens of rivals once their commercial promise became evident. PNKP inhibitors stand apart from that pattern. The target has been described in academic literature for years, yet the drug-development community has been slow to act on it. That hesitancy created an opening, and Onco-Innovations has moved directly into it. The company owns exclusive worldwide rights to a foundational set of PNKP inhibitor technologies. This encompasses the core inhibitor compounds, the nanoparticle delivery science needed to carry those compounds effectively to tumors, and the synthetic lethality applications that define how the therapy is meant to function. Holding rights across molecular design, delivery mechanism and therapeutic application simultaneously is uncommon at this stage of oncology development. The competitive value of this position becomes clearer with added information. Once a new DDR target draws widespread industry attention, patent landscapes become congested, valuations climb and the window for first movers closes. Onco-Innovations entered the PNKP space while that window was still open. The company's patents cover the PNKP inhibitor technology as well as the ONC010 program, extending protection across the small molecule inhibitors themselves, the delivery system and the clinical applications, which together form a wide and durable competitive barrier. The broader DDR market supplies the commercial backdrop. Per the company, DDR-inhibiting products surpassed $7 billion in global sales last year. The global oncology market overall is forecast to approach $500 billion by 2032, representing growth of 131% across a 10-year span. Within that landscape, PNKP inhibitors occupy a category with no approved competitor and no entrenched incumbent. Rather than fighting for share in an already mature market, the company is effectively building the market itself. Laboratory Evidence Lays Groundwork for Clinical Trials Among the central risk factors in early-stage oncology investing is the distance separating laboratory findings from clinical reality. Onco-Innovations has worked methodically to close that gap. The company’s preclinical program has generated concrete, measurable outcomes that support the biological case for PNKP inhibition in solid tumors. The standout finding from animal studies relates to survival outcomes in colorectal cancer. Published preclinical data show that the company's novel nanoparticle formulation, ONC010, extended median survival to 60 days in mice with PTEN-deficient colorectal cancer, compared with 23 days in untreated animals, more than double the survival duration. The same body of research showed substantial tumor growth reduction relative to placebo, paired with a favorable toxicity profile. The lack of observed toxicity in animal models carries particular weight. DDR inhibitors have generally run into off-target effects that constrain their clinical usefulness. Onco-Innovations' nanoparticle delivery system was built specifically to deal with this challenge. By pairing the active pharmaceutical ingredient A83B4C63 with a polymer-based micellar carrier, the platform extends circulation time and encourages preferential buildup within tumor tissue while reducing exposure to healthy cells. The company has continued advancing its Chemistry, Manufacturing and Controls program alongside its preclinical research. Onco-Innovations is carrying out manufacturing scale-up and formulation development with Dalton Pharma Services, while running IND-enabling studies, including pharmacokinetic and biodistribution work, with Nucro-Technics. The company recently reported successful API process development and intermediate-scale production for its PNKP inhibitor technology, the kind of key manufacturing announcements that reduce risk on the path toward a first-in-human trial. The company has also set up a subsidiary in Australia to back anticipated phase 1 development through the Therapeutic Goods Administration regulatory pathway. Activation of a first-in-human phase 1 trial is planned later this year. The anticipated clinical approach is underpinned by validated preclinical data, a clear regulatory roadmap and the possibility of pursuing Fast Track designation, considering the substantial unmet need across the target indications. Intellectual Property Designed to Protect Exclusivity Intellectual property forms the foundation of value in early-stage drug development. Without critical IP, clinical achievements fail to result in commercial exclusivity. Onco-Innovations has constructed its IP portfolio with that principle firmly in place. The company owns global rights across three separate layers of protection, with each layer reinforcing the others. The first layer covers the core PNKP inhibitor molecules, the foundational drug candidates from which ONC010 and future programs are derived. The second layer covers the nanoparticle delivery science, specifically the polymer-based micellar carrier system that enables effective tumor-targeted delivery of the inhibitors. This delivery technology is not a peripheral feature; it is central to the program's ability to achieve efficacy without unacceptable toxicity. The third layer protects synthetic lethality applications, which outlines how the therapy is matched to specific tumor biology to maximize selective destruction of cancer cells. Collectively, these patents provide comprehensive protection for the PNKP technology and the ONC010 program. The portfolio is designed to included not just the current lead compound but the main platform itself, supporting the company's specified objective of increasing its PNKP inhibitor technology across additional cancer types. For example, the company has wrapped up a collaborative project with Kuano, applying a quantum-based computational chemistry platform to generate insights aimed at optimizing PNKP inhibitor technology, further reinforcing the molecular foundation underlying the program. Causal AI Speeds Up Precision-Focused Trial Design Drug development remains costly and slow. The typical oncology drug requires more than a decade and over $1 billion to reach the market, and most candidates that enter clinical trials ultimately fail. Artificial intelligence is being applied with growing frequency to improve those odds, not by substituting for biology but by making it easier to identify the right patients, design more effective trials and interpret results more rapidly. With this in mind, last year Onco-Innovations acquired Inka Health Corp. Inka Health's SynoGraph(TM) platform prototype is a proprietary causal AI engine built specifically for oncology applications. Unlike standard machine learning, which identifies statistical correlations, causal AI is designed to reason about cause-and-effect relationships, a difference that carries significant weight in clinical research, where the gap between association and true causation can be the reason a drug appears effective or ineffective. The SynoGraph offering is designed to support patient stratification, clinical trial design, translational decision-making and evidence generation. The exclusive prototype will combine real-world data, clinical evidence and molecular insights to help predict trial outcomes, treatment efficacy and safety, as well as adverse events. For a company preparing to launch a first-in-human trial, the ability to pinpoint the right patient population before the trial even begins represents a meaningful reduction in clinical risk rather than a mere convenience. Inka Health is also working with both AstraZeneca and GlaxoSmithKline in collaborations centered on predictive modeling, real-world evidence and AI-enabled cancer study. These companies are far from minor partners. And last month, Inka Health started a research partnership within PROmAI, additionally broadening the range of applications for the SynoGraph platform. Folding SynoGraph into the ONC010 development program means Onco-Innovations can use AI-driven patient stratification across its planned clinical studies. This provides the potential to shorten enrollment timelines, enhance the signal within early efficacy data and increase the overall potential for success. Precision-focused trial design is increasingly becoming a significant differentiator within oncology, and Onco-Innovations is working to build that capability internally. Biotech Innovation Continues Advancing Patient Care Recent developments across the biotechnology industry highlight continued progress in the development of innovative therapies and preventive treatments for a wide range of serious diseases. Companies are achieving important regulatory milestones, reporting encouraging clinical trial results and advancing next-generation treatment approaches designed to improve patient outcomes. Merck & Co. Inc. (NYSE: MRK) announced that the FDA has approved an expanded indication for CAPVAXIVE(R) (Pneumococcal 21-valent Conjugate Vaccine). The indication will include children and adolescents aged 2 through 17 years who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk for pneumococcal disease. With this approval, CAPVAXIVE is the only PCV specifically indicated and studied in the United States for use in this patient population. Pfizer Inc. (NYSE: PFE) announced that the FDA has approved an expanded indication for HYMPAVZI(R) (marstacimab-hncq). The expanded indication includes the treatment of patients, diagnosed with hemophilia A or B, who are 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors. HYMPAVZI is now indicated in the United States for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors. GSK plc (NYSE: GSK) is reporting interim phase 2 data from the global phase 2/3 ROSETTA Lung-02 clinical trial. The trial evaluated the investigational PD-L1xVEGF-A bispecific immunomodulator pumitamig, also known as BNT327 or BMS-986545, plus chemotherapy in patients with previously untreated advanced non-small cell lung cancer (“NSCLC”). The data showed encouraging anti-tumor activity, with high response rates observed in both nonsquamous and squamous NSCLC and at each PD-L1 expression level. The data was presented at the 2026 American Society of Clinical Oncology Annual Meeting. Gilead Sciences Inc. (NASDAQ: GILD) announced that the primary efficacy endpoint at Week 48 was met in both the phase 3 ISLEND-1 and ISLEND-2 trials with the investigational oral once-weekly single-tablet HIV treatment regimen of islatravir/lenacapavir. The ISLEND trials are evaluating the efficacy and safety of islatravir 2 mg/lenacapavir 300 mg (ISL/LEN) in people with HIV who are virologically suppressed and switched from BIKTARVY(R) (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) (ISLEND-1) or standard of care antiretroviral regimens (ISLEND-2). The safety profile of ISL/LEN was generally comparable to the comparator regimens studied in the ISLEND trials, and no new safety concerns were identified. As scientific innovation continues to accelerate, the biotechnology sector remains at the forefront of transforming healthcare through novel medicines, advanced biologics and precision treatment strategies. These achievements reflect a growing pipeline of therapies that have the potential to reshape treatment standards and deliver meaningful benefits to patients across diverse disease areas. For more information, visit Onco-Innovations. About BioMedWire BioMedWire (“BMW”) is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, BMW brings its clients unparalleled recognition and brand awareness.BMW is where breaking news, insightful content and actionable information converge.To receive SMS alerts from BioMedWire, “Biotech” to 888-902-4192 (U.S. Mobile Phones Only)For more information, please visit https://www.BioMedWire.comDISCLAIMER: BioMedWire (BMW) is the source of the Article and content set forth above. References to any issuer other than the profiled issuer are intended solely to identify industry participants and do not constitute an endorsement of any issuer and do not constitute a comparison to the profiled issuer. The commentary, views and opinions expressed in this release by BMW are solely those of BMW. Readers of this Article and content agree that they cannot and will not seek to hold liable BMW for any investment decisions by their readers or subscribers. 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Clinical ResultPhase 1Phase 2Phase 3

23 Jun 2026

·www.biospace.com

Vividion Therapeutics Doses First Patient in Phase Ib Combination Study of WRN Inhibitor VVD-214 in Patients with Advanced Colorectal Cancer

VVD-214 targets Werner helicase (WRN), a synthetic lethal vulnerability in cancers with high microsatellite instability (MSI-high) or deficient mismatch repair (dMMR) Global Phase Ib clinical study will evaluate VVD-214 in patients with previously treated MSI-high or dMMR colorectal cancer Progress of VVD-214 demonstrates continued advancement of Vividion’s clinical development capabilities and the potential of its covalent-first chemoproteomics approach to unlock challenging drug targets SAN DIEGO & BERLIN--(BUSINESS WIRE)-- Vividion Therapeutics , Inc. (Vividion), a clinical-stage biopharmaceutical company, and a wholly owned and independently operated subsidiary of Bayer AG, today announced that the first patient has been dosed in a Phase Ib combination clinical trial evaluating VVD-214, an investigational oral inhibitor of Werner helicase (WRN). The study is evaluating VVD-214 in combination with bevacizumab in patients with microsatellite instability-high (MSI-high) or deficient mismatch repair (dMMR) colorectal cancer whose disease has progressed following prior lines of therapy. “Colorectal cancer remains one of the most common and challenging cancers to treat worldwide, and a substantial proportion of cases are driven by underlying defects in DNA repair,” said Aleksandra Rizo, M.D., Ph.D., President and Chief Executive Officer of Vividion. “VVD-214 reflects Vividion’s continued focus on uncovering and advancing therapies against critical cancer dependencies that have historically been difficult to target, including WRN, with the potential to deliver new precision medicines that address this urgent need.” VVD-214 is an investigational oral small-molecule inhibitor of WRN, a DNA repair enzyme that has emerged as a highly sought-after synthetic lethal target for cancers with microsatellite instability. Tumors that are MSI-high or dMMR rely on WRN to maintain DNA replication and repair despite their underlying genomic instability. By inhibiting WRN, VVD-214 is intended to cause lethal DNA damage in cancer cells while minimizing harm to normal cells, offering a potential precision medicine approach for patients with cancers such as colorectal, endometrial, ovarian and gastric tumors. “Advancing precision oncology therapies for cancers driven by specific molecular vulnerabilities is a key focus of Bayer’s oncology strategy,” said Christian Rommel, Ph.D., Global Head of Research and Development at Bayer’s Pharmaceuticals Division. “Targeting WRN represents a promising new therapeutic approach for genetically distinct subsets of some of the most common cancers worldwide, and we are encouraged to see VVD-214 continue to advance through clinical development.” The global Phase Ib clinical trial ( NCT06004245 ) is planned to enroll patients at clinical sites across the U.S., Australia, Belgium, Canada, China, Denmark, France, Malaysia, South Korea, Spain, and the U.K. Preliminary data from the Phase Ia study presented at the American Association for Cancer Research (AACR) 2025 Annual Meeting showed that VVD-214 was well tolerated with early signals of activity. About Vividion Vividion Therapeutics, Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a clinical-stage biopharmaceutical company utilizing novel discovery technologies to unlock difficult-to-drug targets with strong disease-links, and to develop small molecule precision therapeutics for devastating cancers and immune disorders. The company’s platform has enabled it to identify hundreds of previously unknown functional pockets on well-validated protein targets implicated in a wide range of diseases, while simultaneously identifying compounds from its proprietary covalent chemistry library that interact in a highly selective manner with those pockets. The company is leveraging its proprietary chemoproteomic platform to advance a diversified pipeline of highly selective small molecule therapeutics targeting high-value, traditionally undruggable targets in oncology and immunology. For more information, please visit . About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to . Find more information at Follow us on Facebook: aka (2026-0058) Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires. Contacts Vividion Media Contact : Laurie Sherman, phone +1 858 630 8246 Email: media@vividion.com Bayer Global Media Contact : Anna Kanmaz, phone +49 174 14 63 541 Email: anna.kanmaz@bayer.com Bayer U.S. Media Contact: Elaine Colon, phone +1 732 236 1587 Email: elaine.colon@bayer.com

Phase 1AACR

22 Jun 2026

·www.globenewswire.com

Next-Generation DNA Repair Therapies Open New Frontiers in Oncology

AUSTIN, Texas, June 22, 2026 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: Cancer research is entering one of its most dynamic periods in decades. The class of drugs known as DNA Damage Response inhibitors, which work by blocking cancer cells’ ability to repair their own damaged DNA, is expanding rapidly beyond its original anchor, the PARP inhibitor. DDRi therapies collectively represented an estimated $7-plus billion in global sales in 2025, and the broader oncology, diagnostics and precision medicine markets are projected to climb to roughly $750 billion by 2030. New inhibitor classes are emerging as the next major wave. Sitting at the forefront of this shift is Onco-Innovations Limited (CBOE CA: ONCO) (OTCQB: ONNVF), (profile) a Canadian clinical-stage oncology company developing ONC010(TM), a nanoparticle-encapsulated PNKP inhibitor that targets a DNA repair enzyme involved in multiple DNA repair pathways. As the field races to find the next generation of synthetic lethality assets, Onco-Innovations occupies a unique space as it strengthens its position in the biopharmaceutical and biotechnology sector, along with other leading companies, such as AstraZeneca plc (NYSE: AZN), Aprea Therapeutics Inc. (NASDAQ: APRE), Boundless Bio Inc. (NASDAQ: BOLD) and Foghorn Therapeutics Inc. (NASDAQ: FHTX), that are focused on developing therapies for serious diseases, particularly cancer. PARP inhibitors transformed oncology when they arrived in the clinic more than a decade ago, but they are only one entry point into a complex biological system.Onco-Innovations holds exclusive global rights to a foundational portfolio of PNKP inhibitor technology.The company’s preclinical program has produced specific, measurable results that support the biological rationale for PNKP inhibition in solid tumors.ONCO holds exclusive global rights across three distinct layers of protection, each reinforcing the others. Click here to view the custom infographic of the Onco-Innovations editorial. DNA Damage Response Moves Beyond PARP PARP inhibitors transformed oncology when they arrived in the clinic more than a decade ago. They exploited a concept called synthetic lethality: Cancers with certain DNA repair defects could be killed selectively by blocking a secondary repair pathway. The results were dramatic in BRCA-mutated cancers, and the class has grown into a multibillion-dollar market. But PARP inhibitors are only one entry point into a complex biological system. The DNA Damage Response network encompasses dozens of proteins and pathways that cancer cells rely on to survive chemotherapy, radiation and other stresses. Scientists have been systematically mapping this network for new drug targets. What was once a niche academic field is now drawing serious capital and clinical attention. For example, Artios Pharma raised a $115 million Series D round in November 2025 to fund mid-stage studies for experimental cancer drugs targeting DNA repair beyond PARP, one of the clearest signals yet that this sector has reached investable maturity. The clinical pipeline reinforces that message. In May 2026, Artios dosed the first patient in a randomized phase 2 study of ART6043, a DNA polymerase theta inhibitor, in gBRCA-mutated HER2-negative breast cancer. This moved a non-PARP DDR target into mid-stage, biomarker-defined development. That same month, MD Anderson reported phase 1 proof-of-concept data for RO7589831, a Werner helicase inhibitor, in microsatellite-instability-high cancers. These aren’t incremental updates; they are proof that novel DDR mechanisms can generate clinical signals in real patients. Partner appetite for DDR assets is holding up even through market volatility. Last year, Repare Therapeutics licensed lunresertib to Debiopharm for $10 million upfront and up to $257 million in milestones. Debiopharm subsequently secured FDA Fast Track designation for a lunresertib combination in April 2026, turning a licensing deal into a regulatory milestone. The lesson for investors seems clear: Biomarker-defined DDR assets with a credible mechanism have the potential to attract partners and achieve regulatory recognition, even in a cautious funding environment. Polynucleotide Kinase Phosphatase (“PNKP”) is a DNA repair enzyme that operates across multiple repair pathways, including both single-strand and double-strand break repair. This breadth gives PNKP inhibitors a potentially wider therapeutic reach than PARP inhibitors, which primarily target single-strand break repair. PNKP inhibition has demonstrated preclinical activity in colorectal, lung, breast, prostate, ovarian and hematologic cancers. As global PARP inhibitor revenue is projected to reach approximately $12 billion by 2030, PNKP inhibitors are emerging as one of the next major classes to capture market share within the growing DNA Damage Response segment. Onco-Innovations is the established leader for this novel DDR target. First-Mover Position in an Uncrowded Class Most races in oncology drug development are crowded. PARP inhibitors, PD-1 checkpoints and CDK4/6 inhibitors all attracted dozens of competitors as their commercial potential became clear. PNKP inhibitors are different. The target has been understood in the academic literature for years, but the drug-development community has been slow to follow. That delay created an opening that Onco-Innovations has moved right through. The company holds exclusive global rights to a foundational portfolio of PNKP inhibitor technology. This includes the core inhibitor molecules, the nanoparticle delivery science required to bring those molecules to tumors effectively and the synthetic lethality applications that define how the therapy is intended to work. That combination of molecular, delivery and application rights is rare in early oncology development. The competitive significance of this position grows with context. By the time a new DDR target gains broad industry recognition, patent landscapes tighten, valuations rise and the first-mover window closes. Onco-Innovations entered the PNKP space while it was still open. The company’s patents protect the PNKP inhibitor technology and the ONC010 program specifically. That protection spans the small molecule inhibitors, the delivery mechanism and the clinical applications, giving the company a broad and durable competitive moat. The broader DDR market provides the commercial frame. According to the company, DDRi products exceeded $7 billion in global sales in 2025. The global oncology market is projected to approach $500 billion by 2032, representing growth of 131% over a 10-year period. Within that, PNKP inhibitors occupy a class that has no approved competitor and no dominant incumbent. The company is not trying to win share in a mature market; rather, it is building the market. Preclinical Proof Points Toward the Clinic One of the most important risk factors in early oncology investment is the gap between laboratory results and clinical reality. Onco-Innovations has been systematically narrowing that gap. Its preclinical program has produced specific, measurable results that support the biological rationale for PNKP inhibition in solid tumors. The headline finding from animal studies concerns survival in colorectal cancer. According to published preclinical data, the company’s novel nanoparticle formulation, ONC010, extended median survival to 60 days in mice with PTEN-deficient colorectal cancer, compared to 23 days in untreated animals. That is more than a doubling of survival time. The same studies showed meaningful tumor growth reduction compared to placebo, with a favorable toxicity profile. The absence of observed toxicity in animal models is particularly significant. Many DDR inhibitors have struggled with off-target effects that limit their clinical utility. Onco-Innovations’ nanoparticle delivery system is specifically designed to address this problem. By combining the active pharmaceutical ingredient A83B4C63 with a polymer-based micellar carrier, the platform extends circulation time and promotes preferential accumulation in tumor tissue while limiting exposure to healthy cells. The company has been steadily advancing its Chemistry, Manufacturing and Controls program in parallel with its preclinical work. Onco-Innovations is conducting manufacturing scale-up and formulation development with Dalton Pharma Services, and executing IND-enabling studies, including pharmacokinetic and biodistribution, with Nucro-Technics. Earlier this month, the company announced successful API process development and intermediate scale-up for its PNKP inhibitor technology. These are the kinds of manufacturing milestones that de-risk the path to a first-in-human trial. The company has also established a subsidiary in Australia to support planned phase 1 development activities through the Therapeutic Goods Administration pathway. Activation activities for a first-in-human phase 1 trial are anticipated for late 2026. The clinical strategy is supported by validated preclinical data, a regulatory roadmap, and the potential to pursue Fast Track designation given the high unmet need in the target indications. An IP Foundation Built for Exclusivity Intellectual property is the bedrock of value in early-stage drug development. Without it, clinical success doesn’t translate to commercial exclusivity. Onco-Innovations has built its IP portfolio with this reality in mind. The company holds exclusive global rights across three distinct layers of protection, each reinforcing the others. The first layer covers the core PNKP inhibitor molecules. These are the foundational drug candidates from which ONC010 and future programs are derived. The second layer covers the nanoparticle delivery science, or the polymer-based micellar carrier system that makes effective tumor-targeted delivery of the inhibitors possible. This delivery technology is not incidental; it is central to the program’s ability to achieve efficacy without toxicity. The third layer covers synthetic lethality applications, which define how the therapy is paired with specific tumor biology to maximize selective cancer cell killing. Together, these patents protect the PNKP technology and ONC010 program comprehensively. The portfolio is structured to cover not only the current lead compound but the underlying platform, which supports the company’s stated goal of expanding its PNKP inhibitor technology across multiple cancer types. The company recently completed a project with Kuano, using a quantum-based computational chemistry platform to deliver insights for PNKP inhibitor technology optimization, further strengthening the molecular foundation of the program. Causal AI Accelerates Precision Trial Design Drug development is expensive and slow. The average oncology drug takes more than a decade and more than $1 billion to bring to market, and the majority of candidates that enter clinical trials fail. Artificial intelligence is increasingly being applied to reduce those odds, not by replacing biology but by making it easier to identify the right patients, design the right trials and interpret results more quickly. Onco-Innovations acquired Inka Health Corp. in February 2025. Inka Health’s SynoGraph(TM) platform protype is a proprietary causal AI engine designed specifically for oncology applications. Unlike conventional machine learning, which identifies statistical correlations, causal AI is designed to reason about cause and effect, a distinction that matters enormously in clinical research, where the difference between association and causation can determine whether a drug appears to work or not. The SynoGraph platform is being developed to support patient stratification, clinical trial design, translational decision-making and evidence generation. The proprietary platform prototype will integrate real-world data, clinical evidence and molecular insights to support prediction of trial outcomes, treatment efficacy, safety and adverse events. For a company advancing a first-in-human trial, the ability to identify the right patient population before a trial begins is not a luxury but rather a significant reduction in clinical risk. Inka Health has announced collaborations involving AstraZeneca and GlaxoSmithKline focused on predictive modeling, real-world evidence and AI-enabled oncology research. These are not small counterparties. In May 2026, the company announced initiation of a research collaboration within PROmAI, further expanding the SynoGraph application base. The integration of SynoGraph into the ONC010 development program means the company can apply AI-driven patient stratification to its planned clinical studies. That approach has potential to reduce enrollment timelines, sharpen the signal in early efficacy data and improve the likelihood of success. Precision trial design is becoming a competitive differentiator in oncology. Onco-Innovations is working to build that capability in-house. Progress Builds Across Immunology, Oncology Recent developments across the biotechnology sector highlight continued momentum in the pursuit of innovative therapies for immune-mediated diseases, rare disorders and cancer. Companies are advancing programs through regulatory milestones, clinical trial progress and new scientific discoveries that seek to address significant unmet medical needs. AstraZeneca plc (NYSE: AZN) announced that Alexion, its rare disease’s supplemental Biologics License Application (“sBLA”) for Ultomiris (ravulizumab) has been accepted and granted Priority Review by the U.S. Food and Drug Administration (“FDA”) for the treatment of adults with immunoglobulin A nephropathy (“IgAN”). According to the company, the approval was grated based on I CAN phase 3 trial results from prespecified interim analysis in which Ultomiris demonstrated 43.4% reduction in proteinuria vs. placebo at 34 weeks. If approved, Ultomiris would be the first C5 complement inhibitor available for this rare kidney disease. Aprea Therapeutics Inc. (NASDAQ: APRE) presented a poster at last month’s American Society of Clinical Oncology (ASCO) 2026 annual meeting. The poster, titled “Early results from the first-in-human phase 1 study of WEE1 inhibitor APR-1051 in patients with advanced solid tumors (‘ACESOT-1051’).” The presentation highlighted early clinical activity from ACESOT-1051, including partial responses and stable disease in patients across multiple tumor types. According to the announcement, manageable tolerability was confirmed across cohorts. The company noted that patient expansion into uterine serous carcinoma and platinum-resistant ovarian cancer is underway with dose escalation and backfill expansion expected in 2027. Boundless Bio Inc. (NASDAQ: BOLD) presented preclinical data supporting its lead ecDNA-directed therapy (“ecDTx”), BBI-940, at the American Association for Cancer Research (“AACR”) Annual Meeting. According to the announcement, Boundless has identified a novel kinesin target (“Kinesin”) essential to ecDNA segregation and inheritance in cancer cells but nonessential in healthy cells. BBI-940, a potentially first-in-class, oral, and selective Kinesin degrader, is currently being evaluated in the phase 1 KOMODO-1 trial in patients with advanced or metastatic ER+/HER2- breast cancer and TNBC-LAR. Foghorn Therapeutics Inc. (NASDAQ: FHTX) presented new preclinical data for Selective SMARCA2 inhibitor FHD-909 at the AACR annual meeting. The data showed complete and durable tumor regression together with anti-tumor immune memory following combination treatment with an anti-PD-1 antibody in preclinical syngeneic mouse models. The company also reported new preclinical data for its Selective CBP and Selective EP300 degrader programs, demonstrating favorable efficacy and safety profiles across a range of difficult-to-treat cancers, in addition to progress with its Selective ARID1B degrader program. As scientific understanding of disease mechanisms continues to deepen, the industry remains focused on translating laboratory discoveries into meaningful clinical outcomes. Advances in targeted therapies, novel drug-development platforms and biomarker-driven treatment strategies are helping reshape the future of healthcare. Collectively, these efforts reflect a broader commitment to improving patient outcomes through more precise, effective and personalized approaches to treating cancer, autoimmune disorders and other complex diseases. For more information, visit Onco-Innovations. 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Clinical ResultPhase 1

100 Deals associated with RO-7589831

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Indication	Highest Phase	Country/Location	Organization	Date
Colonic Cancer	Phase 2	United States	Bayer Healthcare Co., Ltd.	31 Jul 2026
Colonic Cancer	Phase 2	China	Bayer Healthcare Co., Ltd.	31 Jul 2026
Colonic Cancer	Phase 2	Argentina	Bayer Healthcare Co., Ltd.	31 Jul 2026
Colonic Cancer	Phase 2	Belgium	Bayer Healthcare Co., Ltd.	31 Jul 2026
Colonic Cancer	Phase 2	Brazil	Bayer Healthcare Co., Ltd.	31 Jul 2026
Colonic Cancer	Phase 2	France	Bayer Healthcare Co., Ltd.	31 Jul 2026
Colonic Cancer	Phase 2	Germany	Bayer Healthcare Co., Ltd.	31 Jul 2026
Colonic Cancer	Phase 2	Greece	Bayer Healthcare Co., Ltd.	31 Jul 2026
Colonic Cancer	Phase 2	Hong Kong	Bayer Healthcare Co., Ltd.	31 Jul 2026
Colonic Cancer	Phase 2	Italy	Bayer Healthcare Co., Ltd.	31 Jul 2026

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06004245 (AACR2025) Manual	Phase 1	MSI-H/dMMR Solid Tumors microsatellite instable \| mismatch repair deficient	44	RO7589831	jxvrkpewzk(hmrusovkrt) = yfvjmsxeot fnulmxtmoe (nkqjxorovj, 1.3) View more	Positive	27 Apr 2025

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