Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER – USA News Group News Commentary – As cancer rates continue to climb worldwide, the push for innovative treatments has never been more urgent. Statista forecasts a 20% increase in new cancer cases by 2030 and an alarming 75% surge by 2050, highlighting the growing need for more effective therapies. Meanwhile, the World Health Organization (WHO) projects that breast cancer cases alone will rise nearly 40% by mid-century. In response to this escalating crisis, biotech companies at the forefront of oncology research are driving critical advancements in treatment. Among them, Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Protara Therapeutics, Inc. (NASDAQ: TARA), Fate Therapeutics, Inc. (NASDAQ: FATE), Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB), and Allogene Therapeutics, Inc. (NASDAQ: ALLO) continuing to push the boundaries of cancer treatment.
The article continued: A new research report from Vision Research Reports projects that the global oncology market will exceed $903.81 billion by 2034, fueled by an annual growth rate of 10.9% CAGR. The World Economic Forum has also expressed optimism, recently highlighting 12 major breakthroughs that could change the landscape of cancer treatment in the years ahead.
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage company focused on immunotherapy for cancer, has just released its Q4 and full-year 2024 financial results, providing investors with a clearer picture of its progress as it moves toward potential future FDA approvals for its lead drug, pelareorep, a promising immunotherapy designed to help the immune system recognize and destroy cancer cells more effectively.
“With multiple clinical trials surpassing expectations in 2024, 2025 is shaping up to be a defining year for Oncolytics,” said Wayne Pisano, Chair of Oncolytics’ Board of Directors and Interim CEO. “Our top priority is HR+/HER2- metastatic breast cancer, in which two randomized trials involving over 100 patients have shown substantial clinical benefit for patients receiving pelareorep and paclitaxel compared to paclitaxel monotherapy. We believe that if we can approximate the benefit we saw in BRACELET-1 in our planned registrational study, the progression-free survival benefit alone would support an accelerated approval submission.”
The data mentioned by Pisano from BRACELET-1 showed that patients receiving pelareorep and paclitaxel lived longer and responded better to treatment compared to those receiving paclitaxel alone. Given the consistency of these results, Oncolytics believes that its upcoming registration-enabling trial could pave the way for an accelerated approval submission with the FDA. This is an important development, as HR+/HER2- breast cancer is one of the most commonly diagnosed and treated breast cancers worldwide, representing a massive market opportunity for the company.
Beyond breast cancer, Oncolytics is making significant progress in two other hard-to-treat cancers: pancreatic cancer and anal carcinoma.
“When adding pancreatic and anal carcinoma to the list of addressable indications where we have generated compelling efficacy signals, pelareorep could have a meaningful impact for a multitude of patients,” added Pisano.
Oncolytics recently presented new data at the 2025 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, showcasing pelareorep’s potential to improve patient outcomes in these aggressive diseases. In anal cancer, results from the ongoing GOBLET study showed that 33% of patients responded to treatment when pelareorep was combined with atezolizumab, a checkpoint inhibitor. Notably, one patient experienced a complete response, with their cancer disappearing and staying undetectable for over 15 months. This level of response in such a difficult-to-treat cancer is highly encouraging, leading Oncolytics to expand the trial to enroll additional patients.
Meanwhile, in pancreatic cancer, the company successfully cleared a critical safety review for its combination study using pelareorep with modified FOLFIRINOX with and without atezolizumab, allowing the trial to progress to the next phase. Pancreatic cancer has one of the lowest survival rates of any major cancer, and with few effective treatments available, pelareorep’s continued success in this area could position Oncolytics as a key player in gastrointestinal oncology.
From a financial standpoint, Oncolytics reported a cash position of $15.9 million at the end of 2024, giving it enough runway to continue executing on its clinical development strategy through the third quarter of 2025. While the company operates at a loss,—as is typical for clinical-stage biotechs—it has been strategically managing its spending to ensure that key trials remain funded. Research and development expenses remained stable compared to the previous year, reflecting a disciplined financial approach that prioritizes high-impact studies.
With several potentially transformative catalysts on the horizon, including the initiation of a registration-enabling study in breast cancer and new pancreatic cancer data expected later in the year, investors will be watching closely to see how Oncolytics navigates its next steps.
The coming months will be crucial for Oncolytics as it pushes forward in its mission to bring pelareorep to market. With strong clinical results, growing regulatory support, and a well-managed cash position, the company is well-positioned to capitalize on its momentum. If its upcoming breast cancer study confirms the benefits seen in BRACELET-1, Oncolytics could find itself on a fast track to regulatory approval, potentially opening the door to a major commercial opportunity.
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:
Protara Therapeutics, Inc. (NASDAQ: TARA) is making significant strides in oncology, with its lead candidate, TARA-002, showing positive six-month data in its Phase 2 ADVANCED-2 trial for non-muscle invasive bladder cancer (NMIBC).
“Following a year of significant progress and execution across our pipeline, we remain well positioned to deliver on our mission to bring transformative therapies to patients with cancer and rare diseases,” said Jesse Shefferman, CEO of Protara Therapeutics. “Notably, supported by positive six-month data from our Phase 2 ADVANCED-2 trial in non-muscle invasive bladder cancer (NMIBC), we continue to believe TARA-002 could represent a differentiated, meaningful addition to the treatment paradigm, both as a monotherapy and in potential combination with other agents. We continue to expect to report initial data from 12-month evaluable patients in our ADVANCED-2 trial by mid-year.”
The company remains on track to report initial 12-month data by mid-2025, which could further validate TARA-002’s potential as a new treatment option in this space. Additionally, Protara expects to provide an interim update from its Phase 2 STARBORN-1 trial evaluating TARA-002 in pediatric lymphatic malformations (LMs) by the end of the first half of 2025.
Fate Therapeutics, Inc. (NASDAQ: FATE) is advancing its off-the-shelf CAR T-cell therapies for oncology, with FT825, its iPSC-derived HER2-targeted CAR T-cell candidate, now moving into higher-dose cohorts in a Phase 1 trial for advanced solid tumors. The study, conducted in collaboration with Ono Pharmaceutical, is evaluating FT825 both as a monotherapy and in combination with monoclonal antibody therapy, with early data showing a favorable safety profile and strong CAR T-cell expansion.
“We begin 2025 with resolve and focus to advance our lead clinical programs in autoimmunity and oncology,” said Bob Valamehr, Ph.D. MBA, President and CEO of Fate Therapeutics. “The team continues to make great progress in our pursuit of achieving therapeutic differentiation for patients with B cell-mediated autoimmune diseases, and we look forward to providing clinical and regulatory updates as we advance our FT819 off-the-shelf CAR T-cell product candidate in SLE. We remain focused on driving patient enrollment and engaging with the FDA to further discuss novel development pathways for CAR T-cell therapy in autoimmune disease, including the use of fludarabine-free conditioning as well as add-on to maintenance therapy without conditioning. We also plan to explore FT819 clinical trial expansion in additional autoimmune diseases.”
As the company pushes forward with its next-generation cell therapies, investors are watching for key updates throughout 2025 as Fate refines its approach to treating hard-to-target solid tumors.
Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB) is advancing its oncology pipeline with a focus on radioimmunotherapy and antibody-based treatments. The company recently realigned its business structure to accelerate the development of its SADA PRIT radiopharmaceutical platform while optimizing the commercial potential of DANYELZA, its FDA-approved therapy for high-risk neuroblastoma. Y-mAbs presented new translational pharmacokinetics data on its GD2-SADA Phase 1 trial in solid tumors, with a full readout expected in Q2 2025, while also securing an exclusive licensing agreement for DANYELZA in Japan, reinforcing its international expansion efforts.
“We delivered on the strategic priorities we set out to achieve in 2024 across our business,” said Michael Rossi, President and CEO of Y-mAbs. “In our DANYELZA business, we saw solid ex-U.S. growth in 2024 from our partners. In the U.S., while DANYELZA revenues stabilized in the face of increased competition from new market entrants and clinical trial activity, we remain committed to further penetrating high-volume centers and reaching more patients with high-risk relapsed/refractory neuroblastoma. In our Radiopharmaceutical business, we demonstrated the tolerability and validity of our SADA PRIT platform pre-targeting approach with the preliminary readout from Part A of our GD2-SADA Phase 1 trial, Trial 1001, in solid tumors, and we look forward to providing a complete data readout in the second quarter of this year.”
Allogene Therapeutics, Inc. (NASDAQ: ALLO) is making strides in allogeneic CAR T-cell therapy, with its lead candidate cemacabtagene ansegedleucel (cema-cel) demonstrating comparable efficacy to approved autologous CAR T therapies in relapsed/refractory large B-cell lymphoma (LBCL). Data from the ALPHA and ALPHA2 trials showed an overall response rate of 67% and a complete response rate of 58%, with some patients maintaining remission for over four years.
“With multiple patients in ongoing complete remissions beyond four years, the lingering question of whether an allogeneic CAR T could deliver durable responses has now been answered,” said Zachary Roberts, M.D., Ph.D., Executive Vice President, Research and Development and Chief Medical Officer of Allogene. “Furthermore, these results provide potent evidence supporting the use of CAR T in patients with low disease burden and the unique opportunity for the ALPHA3 trial to achieve something novel in this disease – predict and intervene before relapse. Opportunities to redefine the standard of care in oncology are rare, but if successful, ALPHA3 has the potential to achieve precisely that.”
With its ongoing ALPHA3 pivotal trial, Allogene is now exploring cema-cel as a first-line consolidation therapy for patients at high risk of relapse, a move that could redefine the standard of care in LBCL treatment.
Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
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