USA News Group
Commentary
VANCOUVER, BC, April 30,
2024 /PRNewswire/ -- USA News Group – An alarming rise in
early-onset cancers has medical experts very concerned, as cancer
cases in younger people are rising sharply. In particular, a surge
in cases of breast cancer is being witnessed in Canada, the USA, and the EU, with extra concern to
patients thought to be in remission contracting breast cancer a
second time, according to a new study from the University of Cambridge. However, there's still
optimism towards new treatments, and significant growth of 9.3%
CAGR in the metastatic HR+/HER2- breast cancer market through 2032
has treatment developers working harder to make gains for patients.
Among the biotech companies currently making strides are
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC),
IceCure Medical Ltd (NASDAQ: ICCM), Atossa Therapeutics,
Inc. (NASDAQ: ATOS), Arvinas, Inc. (NASDAQ:
ARVN), and Pfizer Inc. (NYSE: PFE) (NEO: PFE).
Following a Fast Track Designation by the FDA in late
2022 for Oncolytics Biotech Inc.'s (NASDAQ: ONCY) (TSX: ONC)
drug candidate, pelareorep, for pancreatic cancer treatment, the
company is now gaining traction towards another pivotal FDA
engagement, this time focusing on breast cancer. Recently,
Oncolytics announced that they had submitted a Type C
meeting request to the FDA to discuss a forthcoming trial for
pelareorep aimed at treating HR+/HER2- metastatic breast cancer
(mBC) patients.
"A key focus for Oncolytics in 2024 is defining the
regulatory path for pelareorep in breast cancer treatment," said
Matt Coffey, President and CEO of
Oncolytics. "We are optimistic that pelareorep, in
combination with paclitaxel, could significantly enhance clinical
outcomes for patients with HR+/HER2- metastatic breast cancer. Our
position is strengthened by encouraging data from two randomized
studies (BRACELET-1 and IND-213) and the AWARE-1 study, paving the
way for the next phase of pelareorep's development and
registration."
Dr. Coffey has shared that Oncolytics' continuous
interactions with clinical collaborators and partners have been
instrumental in crafting a detailed and persuasive briefing
document. The company looks forward to meeting with the FDA in Q2
2024 to finalize the trial design and goals for using pelareorep in
treating metastatic breast cancer. This meeting is crucial for
advancing this promising therapy toward patient use. With expected
survival data from its BRACELET-1 study and constructive dialogues
with the FDA, Oncolytics is optimistic that 2024 will be a
landmark year for the company and its stakeholders.
"The data from the randomized BRACELET-1 trial showcased
compelling results for the pelareorep/paclitaxel combination
therapy in HR+/HER2- metastatic breast cancer patients, with a
nearly tripled confirmed response rate, a 50% improvement in median
progression-free survival, and a hazard ratio of 0.29 compared to
the paclitaxel alone control," said Thomas
Heineman, M.D., Ph.D., Chief Medical Officer at
Oncolytics. "Importantly, these data support the
statistically significant near doubling of median overall survival
in another randomized phase 2 study, IND-213, which also evaluated
pelareorep and paclitaxel in HR+/HER2- metastatic breast cancer
patients."
Also seeking the FDA's attention, Israel-based IceCure Medical Ltd
(NASDAQ: ICCM) recently reported its final ICE3 breast cancer
cryoablation trial results with 100% patient and physician
satisfaction and 96.3% recurrence-free rate for its ProSense®
System, a minimally-invasive cryoablation technology that destroys
tumors by freezing as an alternative to surgical tumor removal.
With this new data in hand, IceCure has submitted final
data to the FDA, requesting marketing authorization for
ProSense® for the indication of treating patients with early-stage
T1 invasive breast cancer with cryoablation and adjuvant hormone
therapy. ProSense® has already received FDA Breakthrough
Designation and is cleared for use in the US for several other
indications, including treating benign tumors of the breast, and
tumors in the kidney and liver.
"We believe ICE3 is a ground-breaking study and are excited to
report that the efficacy data of our minimally invasive ProSense®
cryoablation procedure show similar outcomes in recurrence compared
to more invasive breast surgery, the current standard of care for
early-stage breast cancer," said Eyal
Shamir, CEO of IceCure. "Initial reimbursement codes
are already in place and our U.S. marketing and commercial team is
ready, as we await the FDA's response. Driven by favorable
healthcare economics combined with patient satisfaction and demand,
we expect rapid adoption pending FDA granting the DeNovo
Classification Request for Marketing Approval."
A new clinical trial was announced by Atossa Therapeutics,
Inc. (NASDAQ: ATOS) to evaluate the company's proprietary
(Z)-endoxifen in combination with abemaciclib (VERZENIO®), a
cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli
Lilly and Company, in women with ER+/HER2- breast cancer. Set
to enroll approximately 20 newly diagnosed women, the new study arm
will have participants receiving 40mg (Z)-endoxifen once daily in
combination with 150mg abemaciclib twice daily for a total of 24
weeks prior to surgery.
"Endocrine therapy in combination with CDK 4/6 inhibition is a
widely used treatment for patients with advanced-stage ER+ breast
cancer and as an adjuvant therapy for node positive, hormone
positive early-stage disease, found at the time of surgical
resection," said Dr. Laura Esserman,
director of the University of California
San Francisco Breast Care Center and founder of
Quantum Leap Healthcare Collaborative. "Women with high
clinical stage but less proliferative tumors (molecularly low risk
or those with late recurrence risk) are challenging to treat. Late
recurrence is high regardless of either endocrine or chemotherapy.
Thus, we are looking for new combined treatments, which can be used
in the pre-surgery (neoadjuvant) setting. We look forward to
learning more about the potential of (Z)-endoxifen in combination
with abemaciclib in the neoadjuvant setting in the I-SPY
TRIAL."
Vepdegestrant (ARV-471) is another treatment that recently
received FDA Fast Track Designation, which is a novel oral
PROteolysis Targeting Chimera (PROTAC®) ER degrader that is being
jointly developed by Arvinas, Inc. (NASDAQ: ARVN), and
Pfizer Inc. (NYSE: PFE) (NEO: PFE). The ongoing Phase 3
VERITAC-2 clinical trial is evaluating vepdegestrant or fulvestrant
in patients with locally advanced or metastatic ER+/HER2- breast
cancer who have been previously treated with an endocrine-based
therapy.
"The receipt of Fast Track designation reinforces the potential
of vepdegestrant to provide an important new therapeutic option for
people with ER+/HER2- breast cancer whose disease has progressed,"
said Roger Dansey, M.D., Chief
Development Officer, Oncology, Pfizer. "We are proud to
continue our legacy of developing innovative treatment options for
people impacted by metastatic breast cancer and look forward to
working with the FDA as we advance our development program
for vepdegestrant."
Article Source:
https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
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SOURCE USA News Group