FDA Tightens Survival Standards as Cancer Drug Pipeline Hits $866B Market Milestone

USA News Group News Commentary

Issued on behalf of Oncolytics Biotech Inc.

VANCOUVER, BC, Aug. 28, 2025 /PRNewswire/ -- Federal budget cuts have put pressure on cancer research efforts in the United States, but private investment is helping to fill the gap, with oncology ventures securing hundreds of millions in funding so far in 2025. The Senate's recent restoration of $15 million for the Pancreatic Cancer Research Program (PCARP) was a win, yet its earlier elimination underscored the fragility of public support. Against this backdrop, investors are zeroing in on companies with standout science, solid pipelines, and clear regulatory strategies, including Oncolytics Biotech Inc. (NASDAQ:ONCY), ImmunityBio, Inc. (NASDAQ:IBRX), Agenus Inc. (NASDAQ:AGEN), Sutro Biopharma, Inc. (NASDAQ:STRO), and Castle Biosciences, Inc. (NASDAQ:CSTL).

Major pharmaceutical companies have committed in the range of $20 billion in recent partnerships to advance next-generation immunotherapies, while venture capital investors continue backing innovative oncology startups despite economic headwinds. The timing couldn't be more strategic, as there are several companies demonstrating robust survival data and regulatory alignment now commanding premium valuations as big pharma races to replace expiring patents with breakthrough platforms.

Oncolytics Biotech Inc. (NASDAQ:ONCY) has reached a pivotal inflection point, advancing toward what could become a registration-enabling trial for its breakthrough immunotherapy, pelareorep, in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).

Recently, the company confirmed active discussions with the U.S. Food and Drug Administration (FDA) to finalize pivotal study parameters, positioning Oncolytics for potential initiation of trial activities by Q4 2025. This regulatory engagement represents a critical milestone, transitioning from proof-of-concept research to regulatory-stage development in one of oncology's most challenging therapeutic areas.

The strategic emphasis on mPDAC builds on compelling survival data and addresses a massive unmet medical need. Pelareorep functions as a systemically delivered oncolytic virus that transforms immunologically "cold" tumors into "hot" targets responsive to immune-based treatments. Clinical data reveals pelareorep combinations achieved a remarkable 21.9% two-year overall survival rate in first-line pancreatic cancer patients, substantially outperforming the 9.2% historical benchmark established by standard chemotherapy protocols.

Importantly, pelareorep demonstrated a 62% objective response rate when combined with chemotherapy and checkpoint inhibitors. This outcome carries particular weight given checkpoint inhibitors currently lack approval for pancreatic cancer treatment, suggesting pelareorep may unlock immunotherapy effectiveness in historically resistant tumor types.

"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."

The mechanism behind these outcomes involves pelareorep's dual action profile. The virus selectively replicates within cancer cells and activates broad immune responses against tumor tissue. Translational studies from GOBLET and AWARE-1 trials demonstrate how treatment elevates PD-L1 expression, amplifies interferon signaling, and mobilizes tumor-infiltrating lymphocytes throughout the bloodstream.

"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."

These mechanistic insights, combined with survival data from over 1,100 patients across multiple clinical programs, have shaped management's focus on pancreatic cancer as the lead indication for regulatory advancement.

Leadership changes reflect Oncolytics' execution-oriented approach. CEO Jared Kelly and Chief Business Officer Andrew Aromando both contributed to Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Kelly assumed the CEO role in June 2025, while Aromando joined a few weeks later to oversee business development initiatives. The company has also eliminated its At-the-Market and Equity Line facilities, signaling confidence in current cash resources to reach key development milestones.

Regulatory momentum supports accelerated development timelines. Pelareorep maintains both Fast Track and Orphan Drug designations from the FDA specifically for pancreatic cancer, acknowledging both therapeutic promise and critical patient need. These designations facilitate expedited review processes and can enhance partnership attractiveness with major pharmaceutical companies.

The broader market context highlights the commercial opportunity. Pancreatic cancer maintains among the lowest survival rates of common malignancies, with five-year survival below 14%. While immunotherapies have revolutionized treatment across multiple cancer types, mPDAC has remained largely resistant to immune-based approaches, creating substantial unmet need for effective therapeutic combinations.

During July, Oncolytics conducted a key opinion leader event featuring gastrointestinal oncology specialists who analyzed patient survival outcomes and biomarker validation studies. Expert feedback reinforced that pelareorep's immune activation mechanism addresses fundamental treatment gaps in first-line mPDAC therapy.

Current FDA discussions center on study design parameters that could support regulatory submission for commercial approval. Should the agency accept Oncolytics' proposed framework emphasizing overall survival endpoints, the resulting trial would provide definitive evidence of pelareorep's clinical and commercial viability in pancreatic cancer treatment.

Oncolytics anticipates sharing updated clinical development timelines during Q3 2025, with trial initiation activities potentially commencing by Q4 2025. With robust survival data, established regulatory plans, and experienced leadership driving strategic execution, the company appears well-positioned to advance pelareorep through its most critical development phase.

CONTINUED… Read this and more news for Oncolytics Biotech at:  https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/ 

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

ImmunityBio, Inc. (NASDAQ:IBRX) achieved groundbreaking results in its pilot study for recurrent glioblastoma, reporting 100% disease control in all five patients treated with its investigational immune-boosting regimen combining ANKTIVA, NK cell therapy, and Optune Gio Tumor Treating Fields. Three of the five patients responded to treatment, with two achieving near complete responses while the remaining two maintained stable disease in this chemotherapy-free approach. ANKTIVA treatment increased absolute lymphocyte count in all five patients who had experienced lymphopenia after standard radiation and chemotherapy.

"Although they are early, these results are very encouraging, given the high risk and low survival rates associated with GBM," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "There is compelling evidence that ANKTIVA's mechanism of proliferating NK and T cells plays an important role in treating patients with cancer Independent of tumor type. By activating the immune system the goal of providing durable responses is at hand."

Based on these preliminary findings, ImmunityBio is initiating a randomized Phase 2 trial targeting second-line glioblastoma patients with recurring disease following standard care. The company also announced a new Phase 2 study to assess ANKTIVA in patients with long COVID, expanding its clinical research beyond cancer applications.

Agenus Inc. (NASDAQ:AGEN) reported significant progress in the second quarter of 2025 as it is advancing its botensilimab (BOT) and balstilimab (BAL) immunotherapy combination, which delivered 42% two-year survival in refractory MSS colorectal cancer.

"Our team is committed to advancing BOT/BAL to deliver meaningful benefits to patients with treatment-resistant cancers, and we are working with regulatory agencies to expedite access through a streamlined Phase 3 trial," said Garo Armen, Ph.D., Chairman and CEO of Agenus. "With significant clinical progress, strategic partnerships, and prudent financial management, we are well-positioned to execute our vision of transforming cancer care."

Agenus secured regulatory alignment for its Phase 3 BATTMAN trial initiation in Q4 2025 and expects a $91 million capital infusion from Zydus Lifesciences collaboration upon closing, and anticipates several significant milestones in the second half of 2025, including the global BATTMAN Phase 3 trial launch and new BOT/BAL clinical data presentations at major oncology congresses.

Sutro Biopharma, Inc. (NASDAQ:STRO) delivered exceptional revenue growth in the second quarter of 2025, reporting $63.7 million compared to $25.7 million in Q2 2024, driven primarily by the Astellas collaboration and recognition of previously deferred revenue from Ipsen's decision not to advance the STRO-003 program.

"Over the past several months, we've generated compelling preclinical data across our entire pipeline, further supporting our candidates' best-in-class potential as well as highlighting the unique capabilities of our platform technology," said Jane Chung, CEO of Sutro. "As we look to the second half of the year, we are well capitalized to meet our top priority of pipeline execution which we believe is critical to increasing shareholder value and we continue to look for ways to implement operating efficiencies and further extend our cash runway."

Sutro's pipeline includes STRO-006, an integrin beta-6 ADC expected to enter clinical development in 2026, and a dual-payload ADC platform with an IND filing anticipated in 2027. The oncology company pioneering site-specific antibody drug conjugates maintained a strong cash position of $205.1 million and reduced operating expenses while preparing to initiate clinical trials for STRO-004, its next-generation Tissue Factor-targeting exatecan ADC, in the second half of 2025.

Castle Biosciences, Inc. (NASDAQ:CSTL) announced the publication of new evidence supporting the use of its DecisionDx-SCC test in guiding treatment pathway decisions for NCCN high-risk cutaneous squamous cell carcinoma patients. A new validation study demonstrates that DecisionDx-SCC significantly outperforms current staging systems in predicting risk of local recurrence and metastasis, while a clinician survey confirms test results align with treatment decision-making thresholds for adjuvant radiation therapy and surveillance imaging.

"These new data indicate that DecisionDx-SCC test results provide individualized risk predictions that doctors can use to guide risk-aligned escalation or de-escalation of care in their NCCN high-risk SCC patients," said Dr. Désirée Ratner, Mohs micrographic surgeon and clinical professor of dermatology at the NYU Grossman School of Medicine. "The ability of the test to reliably identify those patients with NCCN high-risk SCC at risk of developing local recurrence or metastasis is not only practice-changing for physicians who treat SCC, but also life-changing for their patients."

The 40-gene expression profile test uses a patient's tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis and stratify patients into Class 1 (low), Class 2A (higher), or Class 2B (highest) risk categories.

Castle Biosciences continues expanding clinical evidence for its genomic tests, with DecisionDx-SCC now validated for predicting local recurrence in addition to metastatic risk and likelihood of benefit from adjuvant radiation therapy.

Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/ 

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