Azenosertib

Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Jan. 12, 2026 /PRNewswire/ -- USANewsGroup.com News Commentary – The oncology landscape is entering a high-velocity regulatory phase as genomics in cancer care expands toward a projected $69.16 billion by 2032[1]. This massive growth is driven by the systematic integration of genotype-directed treatment pathways into standard medical practice. The precision medicine market is now on a trajectory to expand from $138.67 billion in 2026 to over $537.17 billion by 2035[2]. This strategic pivot toward registration-ready precision assets fuels the 2026 investment case for Oncolytics Biotech Inc. (NASDAQ: ONCY), CG Oncology (NASDAQ: CGON), Zentalis Pharmaceuticals (NASDAQ: ZNTL), ArriVent BioPharma (NASDAQ: AVBP), and PDS Biotechnology (NASDAQ: PDSB). The financial momentum behind expedited development pathways is reaching a fever pitch: the orphan drug market is projected to surge from $216.66 billion in 2025 to $687.47 billion by 2035[3]. Current FDA accelerated approval frameworks have already demonstrated meaningful population health gains across 65% of solid tumor indications studied[4]. This validates a new generation of registration-directed study designs that prioritize objective response rates as critical catalysts for major capital allocation in the fight against rare and resistant cancers. Oncolytics Biotech Inc. (NASDAQ: ONCY) is advancing pelareorep, an investigational immunotherapy, toward potential accelerated approval in anal cancer after reporting third-line data that nearly tripled historical response rates in a setting with no FDA-approved treatment options. The company announced updated clinical data from GOBLET Cohort 4 showing pelareorep combined with atezolizumab achieved a 29% objective response rate in patients with third-line metastatic squamous cell anal carcinoma (SCAC). These responses included two complete responses among 14 evaluable patients. Notably, the median duration of response was approximately 17 months (67 weeks). Historical third-line SCAC studies typically show objective response rates of approximately 10% or less, and when responses do occur, duration of response is generally limited. The third-line results build on equally compelling second-line data, where pelareorep achieved a 30% response rate, more than doubling the 13.8% benchmark for the only FDA-approved immunotherapy in this setting. The median duration of response reached 15.5 months compared to 9.5 months for standard care, with two durable complete responses. This depth and durability of responses in heavily pretreated patients address a critical unmet need. There are currently no FDA-approved therapies for patients with third-line anal cancer, making pelareorep's activity particularly significant for a patient population with virtually no options outside of chemotherapy. Based on these results and after initial encouraging feedback from the FDA, Oncolytics plans to advance pelareorep into a registration-directed clinical study in second-line and later SCAC. Oncolytics is planning a Type C meeting with the FDA in Q1 2026 to discuss and receive guidance on this development plan. If the objective response rate and duration of response observed in GOBLET Cohort 4 are reproduced in the planned registration study, Oncolytics believes the resulting dataset would be sufficient to support accelerated approval in this indication, consistent with regulatory precedent in rare cancers with no available therapies. "As we continue to analyze the Goblet data, we are finding important trends that are helping to shape our clinical development strategy," said Jared Kelly, Chief Executive Officer of Oncolytics. "When you isolate to anal cancer patients with two prior lines of treatment and see a strong signal like this, it points the arrow in a direct line to a registration study in an indication where there are no FDA-approved therapies. We already had good data here, but looking closer, it becomes clearer that we can make an immediate impact on patients' lives who have no options." The company's broader gastrointestinal oncology strategy received validation through expansion of its Scientific Advisory Board with three globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center. Oncolytics has also secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, positioning it to launch the only immunotherapy registration trial currently planned for this disease. Leading the charge is CEO Jared Kelly and Chief Business Officer Andrew Aromando, who were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: CG Oncology (NASDAQ: CGON) announced an expedited timeline for the topline data readout now expected in the first half of 2026 for its Phase 3 PIVOT-006 clinical trial comparing adjuvant intravesical cretostimogene grenadenorepvec versus surveillance in patients with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC). PIVOT-006 is the first Phase 3 randomized trial in this patient population, encompassing the broadest range of patient types per AUA/SUO Guidelines, including HG Ta solitary lesions < 3cm, with enrollment completed early across over 90 sites. "We are thrilled to announce that we now expect PIVOT-006 topline Phase 3 data in the first half of 2026, which is nearly one year ahead of schedule thanks to the unprecedented early completion of enrollment," said Arthur Kuan, Chairman and CEO of CG Oncology. "The IR population is estimated to be greater than fifty thousand patients in the US alone, and we look forward to broadening our potential reach to individuals living with IR NMIBC." The expedited timeline represents nearly one year of advancement from the original schedule. Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy studied in more than 400 patients with NMIBC across multiple clinical trials, including the pivotal BOND-003 trial. Zentalis Pharmaceuticals (NASDAQ: ZNTL) provided a corporate update highlighting key milestones and expected momentum in the azenosertib development program for 2026, including completion of enrollment in DENALI Part 2a with dose confirmation expected in the first half of 2026. DENALI Part 2 trial topline readout is expected by year end 2026 with potential to support accelerated approval, while initiation of the ASPENOVA Phase 3 randomized confirmatory trial is planned in the first half of 2026. "2026 represents a pivotal year for Zentalis as we advance azenosertib toward potential approval in Cyclin E1-positive platinum-resistant ovarian cancer and continue to assess its role in additional indications," said Julie Eastland, Chief Executive Officer of Zentalis. "With our strong financial foundation providing an estimated runway into late 2027, we remain focused on executing our strategy to bring this potentially first-in-class, non-chemo, oral therapy to the approximately 50% of PROC patients who are Cyclin E1-positive—a population with significant unmet needs." Strong data across three trials established a solid foundation for the lead indication in Cyclin E1-positive platinum-resistant ovarian cancer. The Company maintained a strong cash position with $280.7 million in cash, cash equivalents and marketable securities as of September 30, 2025. ArriVent BioPharma (NASDAQ: AVBP) announced the first patient has been dosed in the global pivotal Phase 3 ALPACCA study evaluating firmonertinib monotherapy for first-line treatment of EGFR PACC mutant non-small cell lung cancer (NSCLC), with firmonertinib having the potential to redefine first-line treatment in this underserved population as a once daily, oral, brain-penetrant, chemo-free monotherapy. The ALPACCA pivotal trial is designed to support potential accelerated and full regulatory approvals with global ex-China annual incidence of NSCLC patients with EGFR PACC mutations estimated at approximately 42,000 patients. "Initiation of our pivotal Phase 3 ALPACCA trial marks an important milestone in our strategy to expand the global reach of firmonertinib," said Bing Yao, Ph.D., Chairman and Chief Executive Officer of ArriVent. "Patients with EGFR PACC mutant NSCLC currently have limited treatment options and represent a clear unmet medical need. We believe firmonertinib is strongly positioned to bring meaningful innovation to NSCLC patients with PACC mutations and the potential to become a cornerstone therapy across the EGFR mutant spectrum." The randomized Phase 3 study evaluates firmonertinib 240 mg once daily versus the investigator's choice of osimertinib or afatinib in first-line patients with EGFR PACC mutant NSCLC. Firmonertinib was granted FDA Breakthrough Therapy Designation for previously untreated EGFR exon 20 insertion mutations. PDS Biotechnology (NASDAQ: PDSB) announced FDA alignment on the use of progression-free survival as the primary endpoint and submitted an amended protocol for Phase 3 VERSATILE-003 trial following a constructive Type C meeting held with the FDA in December 2025. The submission follows positive final results from the Company's VERSATILE-002 trial, which showed promising median overall survival and durable PFS, with the proposed amendment changing the PFS endpoint to a primary endpoint that can be evaluated earlier with significant statistical power. The amendment retains median overall survival and safety as requirements for full FDA approval and is supported by dialogue with the agency, providing a pathway to potentially accelerate regulatory submission. PDS Biotech specializes in developing novel immunotherapies to transform cancer care, with PDS0101 being developed in combination with checkpoint inhibitors. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. 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This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. 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Completed enrollment in DENALI Part 2a; dose confirmation expected in 1H 2026 DENALI Part 2 trial topline readout expected by year end 2026; potential to support accelerated approval Initiation of the ASPENOVA Phase 3, randomized, confirmatory trial planned in 1H 2026 SAN DIEGO, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today provided a corporate update and highlighted key milestones and expected momentum in the azenosertib development program for 2026. "2026 represents a pivotal year for Zentalis as we advance azenosertib toward potential approval in Cyclin E1-positive platinum-resistant ovarian cancer (PROC) and continue to assess its role in additional indications," said Julie Eastland, Chief Executive Officer of Zentalis. "The completion of DENALI Part 2a enrollment marks significant progress, positioning us for dose confirmation in the first half of 2026, followed by an expected topline readout by year end that could support accelerated approval, subject to FDA feedback. Equally important, we expect to initiate ASPENOVA, our randomized Phase 3 confirmatory trial in the first half of 2026, evaluating azenosertib vs. standard-of-care chemotherapy in this biomarker-selected population. Beyond the Cyclin E1-positive PROC setting, this year we plan to continue evaluating the potential of azenosertib in earlier lines of ovarian cancer and other indications where WEE1 inhibition may play a meaningful role. "With our strong financial foundation providing an estimated runway into late 2027, we remain focused on executing our strategy to bring this potentially first-in-class, non-chemo, oral therapy to the approximately 50% of PROC patients who are Cyclin E1-positive—a population with significant unmet needs," Ms. Eastland added. 2025 Accomplishments Completed enrollment in DENALI Part 2a, supporting registration-intended development of azenosertib. The Company completed enrollment in Part 2a of the Phase 2 DENALI clinical trial (NCT05128825). Part 2a is designed to confirm the primary dose-of-interest with a target enrollment of up to approximately 30 patients at each of two dose levels: 400mg QD 5:2 and 300mg QD 5:2 (intermittent daily dosing with five days on, two days off dosing schedule). Aligned with the FDA on confirmatory ASPENOVA Phase 3 trial design. The Company aligned with the FDA on the design for ASPENOVA, a Phase 3 randomized, confirmatory trial of azenosertib vs. standard-of-care chemotherapy in patients with Cyclin E1-positive PROC. Strong data across three trials in PROC established a solid foundation for the lead indication in Cyclin E1-positive platinum-resistant ovarian cancer. For example, in Part 1b of DENALI at the 400mg 5:2 dosing schedule, azenosertib demonstrated clinically meaningful results with a manageable safety profile. In addition, Cyclin E1 overexpression, regardless of CCNE1 gene amplification status, was observed as a predictive biomarker to identify patients who could potentially benefit from azenosertib. Zentalis estimates that approximately 50% of PROC patients overexpress Cyclin E1 protein based on its proprietary immunohistochemistry cutoff. Maintained a strong cash position supporting an estimated runway into late 2027 following strategic restructuring to focus pipeline and resources. As of September 30, 2025, the Company had cash, cash equivalents and marketable securities of $280.7 million. The Company believes that its existing cash, cash equivalents and marketable securities is expected to provide runway into late 2027, beyond the anticipated DENALI Part 2 topline readout. Anticipated 2026 Milestones DENALI Part 2a dose confirmation expected in first half of 2026. Confirmatory ASPENOVA Phase 3 trial initiation expected in first half of 2026. The planned Phase 3 trial is expected to be conducted concurrently with DENALI Part 2. DENALI Part 2 topline readout on track and expected by year end 2026. DENALI Part 2, if successful, has the potential to support an accelerated approval, subject to FDA feedback. About Azenosertib Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death. Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment. About DENALI Clinical Trial DENALI is a multi-part Phase 2 registration-intent clinical trial (NCT05128825) studying azenosertib in platinum-resistant ovarian cancer (PROC) patients. Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg QD 5:2 (intermittent daily dosing with five days on, two days off dosing schedule). Interim results from Part 1b were presented at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting. Part 2 is enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis' proprietary immunohistochemistry cutoff. Part 2 includes Part 2a, a dose confirmation portion evaluating two doses, 300mg QD 5:2 and 400mg QD 5:2, and Part 2b, a portion designed to complete enrollment at the selected dose informed by Part 2a results. The trial design was aligned with the U.S. Food and Drug Administration (FDA). Part 2, in total, is designed for accelerated approval, pending study outcome and discussions with the FDA. About Zentalis Pharmaceuticals Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.​ For more information, please visit www.zentalis.com. Follow Zentalis on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the potential for azenosertib to be first-in-class; the significance of the referenced data on the late-stage development of azenosertib; the potential benefits of azenosertib, including the potential for azenosertib to be an important treatment option for patients with ovarian cancer or other indications; the broad franchise potential of azenosertib; the Company’s biomarker-driven strategy for azenosertib; the potential to advance research on additional areas of opportunity for azenosertib outside PROC; our anticipated milestones and the timing thereof, including the anticipated timing of DENALI Part 2a dose confirmation and the topline readout from DENALI Part 2, and the initiation, design, conduct and timing of our confirmatory APSENOVA Phase 3 trial; our anticipated cash runway; and our planned regulatory strategy for azenosertib and the timing thereof, including the potential for DENALI Part 2 to support an accelerated approval. The terms “anticipate,” “advance,” “believe,” “design,” “develop,” “expect,” “intent,” “look forward,” “on track,” “plan,” “position,” “potential,” “runway,” “strategy,” “target,” and “will” and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our substantial dependence on the success of azenosertib; our plans, including the costs thereof, of development of companion diagnostics; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; our product candidates may cause serious adverse side effects; inability to maintain our collaborations, or the failure of these collaborations; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption “Risk Factors” in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release. Contact:Aron FeingoldVP, Investor Relations & Corporate Communicationsir@zentalis.com