USA News Group News
Commentary
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER, BC, March 8,
2025 /CNW/ -- 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.
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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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:
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:
https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
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