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Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC., Jan. 28, 2026 /PRNewswire/ -- USANewsGroup.com News Commentary – As the global oncology clinical trials market surges toward a projected $25.61 billion valuation by 2035[1], a structural rotation is favoring 'registration-ready' platforms that demonstrate exceptional efficacy and pivotal-trial alignment with 2026's evolving FDA regulatory frameworks[2]. Investors are increasingly prioritizing late-stage and newly commercial companies poised for rapid maturation as sector fundamentals strengthen. This structural shift creates a window for Oncolytics Biotech Inc. (NASDAQ: ONCY), BioNTech (NASDAQ: BNTX), MAIA Biotechnology (NYSE-A: MAIA), Acrivon Therapeutics (NASDAQ: ACRV), and ImmunityBio (NASDAQ: IBRX). With 2026 set to be a banner year for M&A as buyers facing patent cliffs compete for a limited pool of late-stage assets[3], companies demonstrating disciplined pivotal execution and FDA alignment command asymmetric upside in an environment where executive infrastructure determines valuation floors. Oncolytics Biotech Inc. (NASDAQ: ONCY) is strengthening its operational and clinical leadership as it advances pelareorep toward multiple registration-directed programs in gastrointestinal cancers. The company recently announced the appointments of John McAdory as Executive Vice President of Strategy and Operations and Yujun Wu as Vice President, Head of Biostatistics, bringing deep expertise in late-stage oncology trial execution and regulatory strategy. McAdory joins from CG Oncology, where he served as Vice President of Clinical Operations leading late-stage development programs for oncolytic virus therapies. Wu arrives from Morphic Therapeutic, where he headed Biostatistics through the company's acquisition by Eli Lilly, and previously led statistical strategy for multiple Phase 3 oncology programs at Takeda. Both executives bring direct experience navigating complex registration trials and global regulatory interactions. "John's background running complex, late-stage oncology trials makes him exceptionally well-suited to lead Oncolytics' next phase of execution," said Jared Kelly, CEO of Oncolytics Biotech. "As we progress toward pivotal and registration-enabling studies in anal, pancreatic, and colorectal cancers, his experience will be critical to ensuring disciplined execution, speed, and regulatory alignment." These appointments complete a transformative executive team buildout following Kelly's promotion to CEO last year and the addition of Chief Business Officer Andrew Aromando. They were both crucial contributors to Ambrx Biopharma's $2 billion acquisition by Johnson & Johnson. Oncolytics also recently expanded its Scientific Advisory Board with globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, positioning the company for accelerated clinical development across multiple indications. The company recently announced breakthrough efficacy data showing pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite stable metastatic colorectal cancer patients when combined with standard chemotherapy. This triples the historical 6-11% response rate for chemotherapy alone in this difficult-to-treat patient population. The company is also advancing pelareorep toward potential accelerated approval in anal cancer after reporting third-line data that achieved a 29% objective response rate, nearly tripling historical benchmarks in a setting with no FDA-approved treatment options. The median duration of response reached approximately 17 months. Second-line or later results were equally compelling, with pelareorep achieving 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 of 15.5 months compared to 9.5 months for standard care demonstrates pelareorep's ability to deliver durable clinical benefit in patients with limited treatment options. 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. This regulatory milestone clears the path for initiating a pivotal study in one of oncology's most challenging therapeutic areas. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: BioNTech (NASDAQ: BNTX) received FDA Fast Track designation for BNT113, an investigational mRNA cancer immunotherapy, for the treatment of patients with human papillomavirus type 16 positive head and neck squamous cell carcinoma (HNSCC) expressing PD-L1. The designation was granted based on preliminary safety and efficacy data from the ongoing pivotal Phase 2/3 AHEAD-MERIT clinical trial evaluating BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as first-line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1, a cancer type with limited treatment options where patients experience median overall survival of 20.7 months under current standard of care. Head and neck squamous cell carcinoma is the seventh most common cancer type worldwide with increasing global incidence, with about one third of cases being HPV-positive and approximately 90% of oropharyngeal cancers driven by HPV16. BNT113 is designed to induce HPV16-specific anti-tumor immune responses by encoding the E6 and E7 proteins of HPV16 that are frequently found in HPV16+ solid tumors, with the FDA Fast Track designation enabling more frequent engagement with the FDA to support development and expedite regulatory review of this novel HPV-targeted chemotherapy-free treatment option. MAIA Biotechnology (NYSE-A: MAIA) advanced ateganosine into pivotal development with high probability of technical success based on exceptional efficacy data in third-line non-small cell lung cancer. The telomere-targeting agent secured FDA Fast Track designation and represents the first and only direct telomere-targeting anticancer therapy in clinical development, targeting an estimated $50+ billion global immunotherapy market. " MAIA's strong clinical execution in 2025 delivered exceptional efficacy data for ateganosine sequenced with a checkpoint inhibitor, including disease control, response rates, and survival data well above standard of care benchmarks," said Vlad Vitoc, M.D., founder and CEO of MAIA. "The results clearly differentiate our novel telomere-targeting science and support the U.S. FDA's Fast Track designation granted in 2025, positioning ateganosine for potential eligibility under the Accelerated Approval and Priority Review regulatory pathways." The company advanced concurrent Phase 3 and Phase 2 expansion trials targeting potential early commercial approval within 18 to 24 months. MAIA Biotechnology received a $2.3 million NIH grant supporting U.S. patient enrollment and is advancing second-generation molecules into Phase 1 development with enhanced expected efficacy. Acrivon Therapeutics (NASDAQ: ACRV) announced positive data from its ACR-368 Phase 2b registrational-intent trial showing 39% overall response rate in endometrial cancer with 52% confirmed response rate in serous subtype patients with up to two prior lines of therapy. The company submitted EU Clinical Trial Application for Arm 3 enrollment across more than 20 European sites in four major countries, with enrollment completion expected in Q4 2026. "We are pleased with tangible progress accelerating across multiple high-value opportunities," said Peter Blume-Jensen, M.D., Ph.D., CEO of Acrivon. "We are particularly excited by the observation from our ongoing ACR-368 Phase 2 trial that subjects with serous endometrial cancer with up to two prior lines of therapy are showing over 50% confirmed response rate. This provides an attractive opportunity for rapid Arm 3 enrollment without the need for a pretreatment biopsy, both in the US and more than 20 newly selected sites in major EU countries." Acrivon Therapeutics has submitted a Phase 3 confirmatory protocol to the FDA for ACR-368 combined with anti-PD-1 therapy in frontline endometrial cancer based on strong preclinical synergy data. The company also reported initial ACR-2316 Phase 1 data showing tumor shrinkage in endometrial cancer, SCLC and squamous NSCLC, with ACR-6840 nominated as its next CDK11 inhibitor development candidate. ImmunityBio (NASDAQ: IBRX) announced that it recently held a Type B End-of-Phase meeting with the U.S. FDA regarding the Company's supplemental Biologics License Application for ANKTIVA plus Bacillus Calmette-Guérin in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors. The Company presented more than five years of follow-up data demonstrating durable disease-specific survival of approximately 96% at 36 months with median survival not yet reached even with five years of follow-up, high rates of cystectomy avoidance of 92% and 82% at one and three years respectively, and a safety profile consistent with the currently approved indication in CIS disease with or without papillary tumors. "We appreciate the FDA's collaboration throughout this process and remain fully committed to delivering this much-needed therapy to patients who currently have no approved alternatives when standard of care fails," said Richard Adcock, President and CEO of ImmunityBio. "We have completed the assembly and analysis of the requested additional information and will submit it within the next 30 days for the Agency's review." Based on discussions with the FDA, the Agency recommended that the Company provide certain additional information for its consideration to support a potential resubmission of the sBLA initially submitted in 2025 for the papillary indication, with this additional information not contemplating the initiation or design of a new clinical trial. ImmunityBio commercially launched ANKTIVA for NMIBC CIS with or without papillary tumors in the United States and has since expanded approvals to the United Kingdom and Saudi Arabia, with conditional approval in the European Union. 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. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. 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. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES CITED: Logo: 21% more press release views with Request a Demo

1月23日，CDE官网公示，ImmunityBio公司申报的原研药“N-803（nogapendekin alfa inbakicept）”临床试验申请获受理。 N-803（商品名 Anktiva®）是一种First-in-Class IL-15受体激动剂融合蛋白，通过激活CD8+ T细胞和NK细胞，增强机体抗肿瘤免疫应答。与部分细胞因子类药物不同，Anktiva 不会刺激免疫抑制性的 Treg 细胞，在免疫激活与安全性之间形成差异化优势。 日前，ImmunityBio公布了QUILT-3.078临床2期研究的最新数据，该研究正在评估由IL-15超级激动剂Anktiva（nogapendekin alfa inbakicept）与CAR-NK细胞疗法联合的无化疗免疫治疗方案，用于治疗二线复发或进展的胶质母细胞瘤（GBM）患者，同时也涵盖通过单例患者IND（spINDs）接受治疗的1线至3线患者。 截至2026年1月22日，研究已入组23例在接受标准治疗（包括手术、放疗及替莫唑胺化疗）后出现复发或进展的GBM患者，其中19例仍然存活。该研究的主要终点为总生存期（OS），截至数据更新时，中位总生存期尚未达到，显示该组合方案在延长患者生存方面释放出积极信号。 Anktiva 最早于2024 年4 月在美国获批上市，用于与BCG联合治疗对BCG无应答的非肌层浸润性膀胱癌(NMIBC)。作为近30年来获批的第三款肿瘤免疫治疗细胞因子药物，Anktiva代表了细胞因子疗法领域的重要突破。 2025年，ANKTIVA全年净产品收入约为1.13亿美元，同比增长700%，取得亮眼业绩。目前，该药正在开展覆盖膀胱癌、肺癌、胶质母细胞瘤等多项临床。 2026年1月16 日，ImmunityBio 宣布，其原研药 Anktiva® 获得沙特食品药品监督管理局（SFDA）批准上市，共涉及两项适应症： 1）与免疫治疗联合，用于 既往标准治疗失败的转移性非小细胞肺癌（NSCLC）成人患者。值得注意的是，该适应症以“有条件批准”形式通过，后续仍需开展确认性临床试验以进一步验证其长期疗效。值得注意的是，SFDA 是全球首个在 NSCLC 适应症上对 Anktiva 给予有条件批准的监管机构。 2）与卡介苗（BCG）联合，用于治疗高风险、BCG 无应答的非肌层浸润性膀胱癌（NMIBC，伴原位癌 CIS）。 在给药方式上，Anktiva 在NSCLC适应症中采用皮下注射，而在 NMIBC 中则通过膀胱灌注进行局部给药，体现了不同肿瘤类型下的差异化用药策略。 IL-15靶点进展 IL-15被认为是肿瘤免疫治疗的潜力靶点，目前全球监管机构仅批准一款IL-15靶向药Anktiva，还有多款在研IL-15靶向药，如下表。 其中NKTR-255进展较快，其治疗弥漫性大B细胞淋巴瘤的临床试验已进入2/3期阶段。国内药企中，恒瑞医药的SHR-1501、奥赛康的ASKG315、博际生物的BJ-001、智翔金泰的GR2301等同样值得关注。去年7月，智翔金泰的 IL-15 单抗 GR2301 注射液 获得 CDE 临床受理，用于白癜风治疗，填补了国内该靶点单抗在临床阶段的空白。 全球部分在研 IL-15 靶向药物（药研网整理 | 数据来源：新药情报库） End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。 转载/商务/投稿 | 联系微信15618157102（sum_Gmi） 商务合作 稿件征集 点击了解详情 往期回顾 一文读懂抗体：结构、分类与ADCC/ ADCP/ CDC机制 BCG 2025行业回顾：创新药与中国的加速崛起