Biotech Underdogs Line Up for Pivotal Shots at Game-Changing Cancer Treatments
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER, B.C., July 29, 2025 /PRNewswire/ -- Equity Insider News Commentary – The average age of cancer patients is getting younger, as experts are urgently examining the rise of early-onset incidence across several different cancer types. According to the Cancer Discovery study from the National Cancer Institute (NCI), the largest increases were seen in female breast, colorectal, kidney, uterine, and pancreatic cancers. Biotechs in the oncology space are responding with optimistic new treatments with potential milestones in the near future that may shift the tide in the sector, including Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Celcuity Inc. (NASDAQ: CELC), Evaxion A/S (NASDAQ: EVAX), Lyell Immunopharma, Inc. (NASDAQ: LYEL), and Agenus Inc. (NASDAQ: AGEN).
Globally, the cancer‑drug sector is projected to surpass US$900billion in sales by 2034, according to Vision Research Reports. Next‑generation therapeutics (those powered by precision and personalized medicine) are pegged by Precedence Research to hit US$175.2billion during that same time period, growing at a 7.35% CAGR.
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) has officially entered the most critical phase of its journey yet—pursuing a potential registration-enabled trial in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), for its flagship asset, pelareorep. The company announced it has begun formal discussions with the U.S. Food and Drug Administration (FDA) aimed at finalizing a pivotal study design, with trial start-up activities expected to begin before the end of 2025. For investors and potential partners, this marks a clear shift from promising data to regulatory execution in one of the deadliest solid tumors in medicine.
"We expect to move quickly and decisively down a clear regulatory path," said Jared Kelly, CEO of Oncolytics. "This is about execution and focus. Our goal is to win on survival—and this pivotal study is how we do it. We believe this program not only creates significant value for shareholders but also positions Oncolytics as a highly attractive partner for pharma companies seeking to break open the immunotherapy landscape in mPDAC and other GI tumors."
The move comes as Oncolytics sharpens its focus on pelareorep, a systemically delivered oncolytic virus designed to convert so-called "cold" tumors—those that are typically invisible to the immune system—into "hot" tumors that can respond to immunotherapy. Pelareorep has been studied across over 1,100 patients and has demonstrated promising results in difficult cancers like mPDAC and HR+/HER2- breast cancer, particularly when used in combination with chemotherapy and immune checkpoint inhibitors.
In first-line pancreatic cancer, pelareorep-based regimens have shown a notable 21.9% two-year overall survival rate, compared to a 9.2% historical benchmark. In a separate study pairing pelareorep with chemotherapy and a checkpoint inhibitor, researchers recorded a 62% objective response rate—remarkable given that checkpoint inhibitors are not currently approved for use in this indication.
This robust efficacy signal, along with impressive translational data, helped lay the groundwork for this regulatory step.
"This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep."
Earlier this month, Oncolytics hosted a key opinion leader event featuring gastrointestinal cancer experts who reviewed survival outcomes, biomarker validation, and the drug's potential role in combination therapy. That expert panel helped reinforce the view that pelareorep's mechanism—activating innate and adaptive immune responses in patients—is both biologically sound and commercially relevant.
Oncolytics' execution-focused strategy is being led by Jared Kelly and Andrew Aromando, who both played key roles in Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Kelly was appointed CEO earlier this year, while Aromando recently joined as Chief Business Officer. Together, along with Oncolytics' already-established team, they're guiding the company into late-stage development with a sharp focus on capital efficiency and strategic alignment.
Regulatory designations are already in place to accelerate development. Pelareorep holds Fast Track and Orphan Drug designations for pancreatic cancer (and Fast Track for HR+/HER2‑ mBC breast cancer) from the FDA, meaning the agency has already recognized both the drug's potential and the serious unmet need in this patient population. These statuses not only streamline review processes but also increase the attractiveness of the program to potential pharmaceutical partners.
For context, pancreatic cancer is one of the deadliest common cancers, with a five-year survival rate of less than 14%. Most patients are diagnosed at a metastatic stage, and current treatment options provide limited benefit. Unlike other cancers where immunotherapies like checkpoint inhibitors have transformed care, mPDAC remains largely resistant to those approaches—making the promise of pelareorep especially notable.
What distinguishes pelareorep is its dual capability: it acts as both a viral therapy that replicates in cancer cells and a biological agent that activates the body's own immune response. Tumor samples have shown increased PD-L1 expression, heightened interferon signaling, and infiltration of tumor-killing T cells—all hallmark indicators that the immune system is being mobilized against cancer. These features are seen as essential for the next generation of immuno-oncology approaches.
With this latest milestone, Oncolytics is entering a phase where the outcomes of FDA interaction will shape not only clinical plans but also potential commercial partnerships. If the agency accepts the company's proposed trial framework and endpoints—centered around overall survival—the resulting study could become the definitive test for pelareorep's market potential in mPDAC.
More details on the trial design and timing are expected once FDA feedback is received, but the goal is clear: initiate the pivotal trial start-up activities before the end of 2025 and establish pelareorep as a cornerstone immunotherapy in one of the most underserved cancer settings.
In the meantime, the company remains active in its ongoing breast cancer program and is continuing to explore pelareorep's potential in other gastrointestinal cancers, including KRAS-mutated colorectal cancer. However, first-line pancreatic cancer has now emerged as the lead strategic focus.
The transition from early-stage promise to registration-stage planning marks a decisive evolution in the Oncolytics story. With data in hand, regulatory engagement underway, and a seasoned leadership team at the helm, Oncolytics is advancing into its most consequential chapter yet.
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:
Celcuity Inc. (NASDAQ: CELC) recently announced that its Phase 3 VIKTORIA-1 trial met both progression-free survival (PFS) primary endpoints in patients with HR+/HER2- breast cancer without PIK3CA mutations. Gedatolisib-based combinations showed significant PFS improvements compared to standard therapies, including a 7.3-month gain for the triplet arm (9.3 vs. 2.0 months for fulvestrant monotherapy) and a 5.4-month gain for the doublet (7.4 vs. 2.0 months for fulvestrant monotherapy).
"The efficacy improvement relative to the control that each of the gedatolisib regimens demonstrated was historic for this patient population," said Brian Sullivan, Chairman, CEO and co-founder of Celcuity. "We are excited about the potential opportunity to provide a breakthrough therapeutic option for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer."
The company plans to discuss a potential NDA submission with the FDA following a full data presentation later this year.
Lyell Immunopharma, Inc. (NASDAQ: LYEL) announced impressive new data from its LYL314 trial in relapsed/refractory large B-cell lymphoma, showing an 88% overall response rate and 72% complete response rate in the 3L+ setting. Over 70% of complete responders remained disease-free at 6 months.
"Based on these robust data, and our recent End-of-Phase 1 meeting with the FDA, we have initiated PiNACLE, a single-arm pivotal trial of LYL314 in patients with large B-cell lymphoma in the third- or later-line setting and remain on track to initiate a pivotal trial to evaluate LYL314 in the second-line setting by the beginning of 2026," said Lynn Seely, MD, President and CEO of Lyell.
The pivotal PiNACLE trial is now underway to support potential approval of this next-generation dual-targeting CAR T therapy.
Later this year in October, Evaxion A/S (NASDAQ: EVAX) shared it will be presenting two-year data at ESMO 2025 from its Phase 2 trial of EVX-01, an AI-designed personalized cancer vaccine, showing durable responses in advanced melanoma. Results included a 69% overall response rate and a strong correlation between AI predictions and immune activity. The study supports EVX-01's role as a first-line immunotherapy candidate when paired with checkpoint inhibitors like pembrolizumab.
"We are delighted to have the two-year data from the EVX-01 phase 2 trial accepted for presentation at the ESMO Congress 2025," said Birgitte Rønø, CSO and interim CEO of Evaxion. "As one of the most important and prestigious medical oncology conferences in the world, the congress will be a great place for us to present the data to a large audience, including potential partners."
Also at ESMO 2025, Agenus Inc. (NASDAQ: AGEN) will present survival data from its botensilimab/balstilimab program, including an oral session highlighting survival plateaus across five refractory tumor types.
With over 1,200 patients treated, the agents are showing promising results in historically cold tumors like mCRC and non-melanoma skin cancer. These data continue to support botensilimab as a backbone immunotherapy candidate for solid tumors.
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