USA News Group News Commentary
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER, BC, March 8, 2025 /PRNewswire/ -- As the global cancer crisis intensifies, the demand for breakthrough treatments is reaching new heights.
Statista data projects a 20% rise in annual cases by 2030 and a staggering 75% increase by 2050. According to the
World Health Organization (WHO), breast cancer cases are projected to rise by nearly 40% by 2050. Despite the concerning trends in cancer incidence, 2025 has seen key advancements from biotech companies at the forefront of oncology research, with
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC),
Exelixis, Inc. (NASDAQ: EXEL),
Cardiff Oncology, Inc. (NASDAQ: CRDF),
ALX Oncology Holdings Inc. (NASDAQ: ALXO), and
Verastem, Inc. (NASDAQ: VSTM) continuing to push the boundaries of cancer treatment.
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Pelareorep Facts (PRNewsfoto/USA News Group)
The article continued: Within a new research report on the Global Oncology Market from
Vision Research Reports, cancer therapies are projected to surpass US$903.81 billion by 2034, growing at a 10.9% CAGR along the way. The
World Economic Forum is optimistic, recently touting 12 new breakthroughs in the fight against cancer.
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.
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In other recent industry developments and happenings in the market include:
Exelixis, Inc. (NASDAQ: EXEL), reported promising results earlier this year from a subgroup analysis of its Phase 3 CABINET trial, which evaluated cabozantinib in patients with advanced gastrointestinal (GI) neuroendocrine tumors (NETs). The data presented at
ASCO GI 2025 showed that cabozantinib significantly improved progression-free survival (PFS) compared to placebo, with a median PFS of 8.5 months versus 5.6 months. The findings highlight cabozantinib's potential to become a new standard of care for GI NETs, an area with limited treatment options. The
FDA is currently reviewing
Exelixis' supplemental New Drug Application (sNDA), with a decision expected by April 3, 2025.
"These new data add to the robust results from the CABINET trial that demonstrate the benefits of cabozantinib across a wide range of patients with neuroendocrine tumors and further underscore the potential of cabozantinib to become a much-needed new option for those with GI NET, which accounts for the majority of real-world patients with this tumor type," said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer,
Exelixis. "We look forward to continuing to work with the U.S.
FDA as they review our regulatory application for cabozantinib for the treatment of patients with previously treated advanced neuroendocrine tumors."
Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, recently shared its Q4 2024 and FY 2024 results and business update as it continues to advance its lead program, onvansertib, a promising PLK1 inhibitor targeting RAS-mutated metastatic colorectal cancer (mCRC).
"2024 was a significant year for
Cardiff Oncology as we shared positive data from the first 30 patients in our lead program in first-line RAS-mut mCRC," said Mark Erlander, Ph.D., CEO of
Cardiff Oncology.
In its latest Phase 2 trial (CRDF-004), patients receiving the 30mg dose of onvansertib showed a 64% objective response rate, nearly doubling the 33% response rate in the control group.
Cardiff also secured a new U.S. patent covering the use of onvansertib in combination with bevacizumab (bev) for previously untreated KRAS-mutant mCRC patients, adding long-term value to its intellectual property.
ALX Oncology Holdings Inc. (NASDAQ: ALXO) is pushing forward with key advancements in its clinical pipeline, including the continued development of evorpacept, a CD47-blocking immunotherapy designed to enhance the effects of existing cancer treatments. The company announced plans to expand clinical trials into breast and colorectal cancer, aiming to evaluate evorpacept in combination with trastuzumab for HER2-positive breast cancer and with cetuximab for colorectal cancer.
"Our conviction in evorpacept's potential to deepen responses to important available anti-cancer antibody therapies, particularly in patients with HER2-positive cancers, has been strengthened by recent data," said Jason Lettmann, CEO at
ALX Oncology. "We look forward to our near-term milestones with ASPEN-03 and ASPEN-04 topline results in head and neck cancer and discussion with the
FDA regarding the registrational path in gastric cancer based on the ASPEN-06 data."
In addition to its immunotherapy efforts,
ALX Oncology is preparing to advance ALX2004, a novel EGFR-targeted antibody-drug conjugate (ADC), into the clinic, with an Investigational New Drug (IND) application planned for Q1 2025.
Verastem, Inc. (NASDAQ: VSTM) is making strides in RAS/MAPK pathway-driven cancers, with new Phase 2 trial data on its lead combination therapy, avutometinib plus defactinib, set to be presented at the 2025
Society of Gynecologic Oncology (SGO) Annual Meeting. The investigational treatment has already earned Priority Review from the
FDA, with a PDUFA decision expected by June 30, 2025, for patients with KRAS-mutant low-grade serous ovarian cancer (LGSOC).
"The presentation of the RAMP 201 primary analysis, which served as the basis of the acceptance of our NDA that is under Priority Review with the
FDA, includes additional subgroup analysis by KRAS mutational status," said Dan Paterson, President, and CEO of
Verastem Oncology. "We also recognize the importance of these findings to the broader cancer community as part of our growing pool of data reinforcing the potential to change expectations in managing RAS/MAPK pathway-driven cancers."
As
Verastem moves forward with its RAMP clinical trials, the company continues to expand its pipeline, including a Phase 3 confirmatory trial (RAMP 301) in LGSOC and a collaboration with
Amgen to evaluate its therapy in combination with LUMAKRAS™ for KRAS G12C mutant lung cancer.
Source:
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