Breakthrough Cancer Therapies Fuel Regulatory Momentum as Global Market Expands

Equity Insider News Commentary

Issued on behalf of Oncolytics Biotech Inc.

VANCOUVER, BC, Sept. 2, 2025 /PRNewswire/ -- Cancer innovation is reaching new heights as the FDA approved breakthrough therapies for aggressive malignancies, including Modeyso for deadly brain tumors, while breakthrough designations accelerate for next-generation therapies targeting previously resistant cancers. This regulatory momentum builds upon a wave of July breakthrough designations and regulatory milestones spanning multiple cancer types. The expanding regulatory support is generating substantial opportunities for companies with cutting-edge oncology platforms to leverage expedited approval pathways, including Oncolytics Biotech Inc. (NASDAQ: ONCY), NeoGenomics, Inc. (NASDAQ: NEO), Guardant Health, Inc. (NASDAQ: GH), Cellectar Biosciences, Inc. (NASDAQ: CLRB), and Zai Lab Limited (NASDAQ: ZLAB).

Market analysts at Precedence Research project the cancer immunotherapy market to reach $338.40 billion by 2034, expanding at a 10.65% CAGR, as Coherent Market Insights forecasts cellular immunotherapy market to surge toward $20.45 billion by 2032 amid escalating cancer prevalence. The favorable regulatory landscape is generating exceptional opportunities as FDA Fast Track and Breakthrough designations expedite promising therapies through accelerated approval pathways, allowing companies with innovative platforms to secure substantial market position before major pharmaceutical competitors penetrate these specialized segments.

Oncolytics Biotech Inc. (NASDAQ: ONCY) has provided updated safety data that could strengthen its regulatory position as the company advances toward potential registration-enabling trials. The company recently announced comprehensive safety information spanning over 1,200 patients, including more than 300 gastrointestinal cancer patients across 8 clinical studies, with management describing pelareorep as among "the most de-risked immunotherapies" not yet approved in gastrointestinal tumors.

The expanded safety database comes as Oncolytics works toward registration-enabling trials for its investigational immunotherapy, pelareorep, in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). According to CEO Jared Kelly, this safety data should serve as "a positive characteristic for regulators and potential partners."

The safety profile appears consistent across multiple treatment combinations and tumor types. The most frequently reported adverse events remain Grade 1 and 2 flu-like symptoms, with data suggesting pelareorep does not appear to modify the safety profile of established chemotherapy regimens.

The company previously confirmed ongoing discussions with the U.S. Food and Drug Administration (FDA) to finalize pivotal study parameters, with Oncolytics targeting potential initiation of trial activities by Q4 2025. This regulatory engagement represents a transition from proof-of-concept research toward potential regulatory-stage development.

The focus on mPDAC builds on survival data in an area of significant unmet medical need. Pelareorep is a systemically delivered oncolytic virus intended to transform immunologically "cold" tumors into "hot" targets that may become more responsive to immune-based treatments. Clinical data show pelareorep combinations achieved a 21.9% two-year overall survival rate in first-line pancreatic cancer patients, compared to the 9.2% historical benchmark reported for standard chemotherapy protocols.

Pelareorep demonstrated a 62% objective response rate when combined with chemotherapy and a checkpoint inhibitor. This may be particularly relevant since checkpoint inhibitors currently lack approval for pancreatic cancer treatment, suggesting pelareorep might help unlock immunotherapy effectiveness in historically resistant tumors.

"We have turned the corner from proof-of-concept studies and will be sprinting toward regulatory clarity for the remainder of the year," said Jared Kelly, CEO of Oncolytics. "As we shore up our intellectual property, get a clear registration path for pelareorep, and allow our GOBLET data to mature, we will establish our position as the only platform immunotherapy in gastrointestinal tumors."

These observations, combined with survival data from over 1,200 patients across multiple clinical programs, have guided management's focus on pancreatic cancer as the lead indication for regulatory advancement. The expanded safety database may provide additional confidence for regulatory discussions across the broader gastrointestinal platform.

Recent leadership changes reflect an execution-focused approach. CEO Jared Kelly and Chief Business Officer Andrew Aromando both contributed to Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. The company has eliminated its At-the-Market and Equity Line facilities, which management suggests reflects confidence in current cash resources to reach key development milestones.

Pelareorep currently holds both Fast Track and Orphan Drug designations from the FDA specifically for pancreatic cancer, which may facilitate expedited review processes and could enhance partnership discussions with major pharmaceutical companies.

Current FDA discussions reportedly focus on study design parameters that could support regulatory submission for potential commercial approval. Oncolytics expects to share updated clinical development timelines during Q3 2025, with trial initiation activities potentially commencing by Q4 2025. With safety data spanning over 1,200 patients, survival data from multiple studies, and experienced leadership, the company appears positioned to advance pelareorep through what management considers its most critical development phase.

CONTINUED… Read this and more news for Oncolytics Biotech at:  https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/

In other recent industry developments and happenings in the market include:

NeoGenomics, Inc. (NASDAQ: NEO) secured a favorable court ruling granting summary judgment that all of Natera's asserted patent claims are invalid for claiming ineligible subject matter. The District Court for the Middle District of North Carolina will dismiss Natera's claims against NeoGenomics with prejudice and enter a declaratory judgment of invalidity of both asserted patents. This decision allows NeoGenomics to freely commercialize its RaDaR® ST molecular residual disease assay, which has been launched to biopharma customers and submitted to CMS's Molecular Diagnostic Services Program for clinical reimbursement coverage.

"We are pleased with the Court's decision to invalidate Natera's asserted patents. NeoGenomics is committed to providing cancer patients the most comprehensive array of diagnostic testing options to enable the highest quality of personalized care, which includes providing options for their MRD testing," said Tony Zook, CEO of NeoGenomics. "We will continue to vigorously protect and defend our intellectual property to fuel the next wave of innovation and serve our patients."

The company operates a network of CAP-accredited and CLIA-certified laboratories throughout the U.S. and maintains a full-service laboratory in Cambridge, United Kingdom. NeoGenomics continues expanding its comprehensive oncology-focused testing menu to serve oncologists, pathologists, hospital systems, academic centers, and pharmaceutical firms with innovative diagnostic solutions.

Guardant Health, Inc. (NASDAQ: GH) has partnered with the American Cancer Society to expand cancer screening access and advance health equity. The collaboration supports nationwide screening efforts, including the I Love You, Get Screened campaign, community-based health system partnerships, and state coalition work aimed at removing barriers to lifesaving screenings. California continues falling behind national averages, with only 64% of women aged 45 and older up to date on screening mammograms compared to 69% nationally, and 60% colorectal cancer screening rates versus 62% nationwide.

"Guardant Health is proud to partner with the American Cancer Society in the fight to expand cancer screening access," said AmirAli Talasaz, Guardant Health co-founder and co-CEO. "We share a commitment to ensuring that everyone, regardless of race, ethnicity, income, or ZIP code, has access to convenient and timely cancer screening, so we can detect cancer earlier and give them the opportunity for a better outcome."

The partnership will support promoting digital tools on cancer.org and community health interventions that contributed to over 555,000 completed screenings and 7,800 cancers detected in 2024.

Cellectar Biosciences, Inc. (NASDAQ: CLRB) will present clinical data in an oral session at the American Association for Cancer Research Special Conference on Pediatric Cancer, highlighting interim data from the CLOVER-2 Phase 1b study of iopofosine I 131 in relapsed/refractory pediatric high-grade glioma patients. The presentation will occur during a plenary session on September 26, 2025, followed by a 55-minute panel discussion with other experts in the field. The CLOVER-2 trial evaluates safety, tolerability, and therapeutic activity of Cellectar's proprietary phospholipid drug conjugate platform in children, adolescents, and young adults with limited treatment options.

"We are honored that the AACR peer review process has led to the selection of our abstract for a plenary session presentation regarding the treatment of pediatric high-grade glioma patients with iopofosine I 131," said Jarrod Longcor, chief operating officer of Cellectar. "We are highly encouraged with these initial findings from the CLOVER-2 trial in pediatric patients and believe this outcome further validates the clinical potential of iopofosine I 131 to treat aggressive cancers for patients with limited treatment options."

The company's lead asset iopofosine I 131 has received six Orphan Drug, four Rare Pediatric Drug, and two Fast Track designations from the FDA for various cancer indications. Cellectar remains eligible to receive a Pediatric Review Voucher from the FDA upon approval of iopofosine I 131 for pediatric high-grade gliomas.

Zai Lab Limited (NASDAQ: ZLAB) received Innovative Medical Device Designation from China's National Medical Products Administration for Tumor Treating Fields therapy in pancreatic cancer patients based on positive Phase 3 PANOVA-3 trial results. The designation allows Zai Lab to utilize an expedited approval procedure with prioritized review resources and the ability to submit applications before approval in the country of origin. Pancreatic cancer affects approximately 134,000 new cases annually in China, with a five-year survival rate below 10%, representing a significant unmet medical need.

"We are excited that TTFields has been granted the Innovative Medical Device Designation, a status that offers expedited registration and priority review by the NMPA. This designation also allows us to submit the application in China before approval in the country of origin," said Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. "Pancreatic cancer remains one of the most challenging cancers to treat globally, with approximately 134,000 new cases diagnosed annually in China alone."

The company plans to submit for regulatory approval in China during the second half of 2025 and expects close collaboration with the NMPA throughout the review process. Zai Lab successfully obtained approval for Optune in China for glioblastoma treatment in May 2020 following a similar expedited pathway under license from NovoCure.

Source: https://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ 

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