USA News Group
Commentary
Issued on behalf of Oncolytics Biotech
Inc.
VANCOUVER, BC, May 3, 2024
/PRNewswire/ -- According to a "highly troubling" new study, the
rising number of cancer cases in young people is being attributed
to "accelerated aging." Further alarm is being spread by the
United Nations, whose health authorities are predicting
global cancer cases to rise around 77% by 2050, with richer
countries expected to have the greatest absolute increase in
cancer, with an additional 4.8 million new cases predicted in 2050.
With the global cancer immunotherapy market projected by analysts
at Custom Market Insights to reach US$314.4 billion by 2032, growing at a 7.2% CAGR,
the biotech sector continues to make significant developments in
cancer treatment and diagnostics, with recent updates coming from
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC),
Celcuity Inc. (NASDAQ: CELC), Olema Pharmaceuticals,
Inc. (NASDAQ: OLMA), Bio-Rad Laboratories, Inc. (NYSE:
BIO), and AstraZeneca PLC (NASDAQ: AZN).
Since receiving Fast Track Designation from the FDA
in late 2022 for its leading cancer treatment, pelareorep, in the
treatment of pancreatic cancer, Oncolytics Biotech Inc.
(NASDAQ: ONCY) (TSX: ONC) has maintained strong progress. The
company recently announced that it has requested a Type C
meeting with the FDA to discuss an upcoming
registration-enabling trial of pelareorep for 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 noted that ongoing collaborations with clinical
collaborators have been key to preparing a comprehensive and
convincing briefing document. Oncolytics Biotech requested
to meet with the FDA in Q2 2024 to finalize the
registrational trial design and objectives for using pelareorep to
treat metastatic breast cancer. This meeting is essential for
moving this promising treatment closer to patient use. With
forthcoming survival data from its BRACELET-1 study and productive
discussions with the FDA, Oncolytics is hopeful that
2024 will mark a significant milestone 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."
Another company that's developing targeted therapies for
multiple cancer indications is Celcuity Inc. (NASDAQ: CELC).
Within its latest Q4/FY 2023 financial results and corporate
update, Celcuity spoke of how it had dosed its first
patient in a Phase 1b/2 trial
evaluating gedatolisib in combination with darolutamide for the
treatment of metastatic castration-resistant prostate cancer.
"We are excited to begin enrolling patients in our 201 trial and
advancing towards our ultimate goal of providing a transformative
therapeutic option for patients with prostate cancer,"
said Igor Gorbatchevsky, M.D., Chief Medical Officer of
Celcuity. "A significant unmet need remains for patients
with metastatic castration-resistant prostate cancer who have
become resistant to a next generation androgen receptor
inhibitor."
Late last year, Celcuity also presented preclinical
data on the therapeutic effects of gedatolisib in breast
cancer models at the 2023 San Antonio Breast Cancer Symposium. As
its flagship asset, Celcuity's gedatolisib is a potent,
reversible dual inhibitor that selectively targets all Class I PI3K
isoforms and mTOR.
In the process of becoming an impressive comeback story,
Olema Pharmaceuticals, Inc. (NASDAQ: OLMA) has moved from
making job cuts in 2023 to moving forward with pivotal drug
studies in 2024. Recently in March, Olema announced the
publication of data highlighting its proprietary treatment
palazestrant's (OP-1250) ability to inhibit wild-type and mutant
ER+ breast cancer both as monotherapy and in combination with
CDK4/6 inhibitors through a paper titled "Palazestrant (OP-1250), a
Complete Estrogen Receptor Antagonist, Inhibits Wild-type and
Mutant ER-positive Breast Cancer Models as Monotherapy and in
Combination."
"The research described in this paper reviews the deliberate
design and processes used in discovering and optimizing
palazestrant as a molecule purpose-built to address a crucial unmet
need in the treatment of women's cancers, and we are delighted that
Molecular Cancer Therapeutics has featured our work," said
David C. Myles, Ph.D.,
Olema's Chief Discovery and Non-Clinical Development
Officer. "What's even more exciting is to see how faithfully the
pre-clinical research predicted the behavior of palazestrant now
that it is in late-stage clinical development. We saw the potential
then, as told in the paper, and we believe that every day brings us
closer to having a real impact transforming the treatment paradigm
for women with cancer."
Helping to potentially detect breast cancer more easily,
Bio-Rad Laboratories, Inc. (NYSE: BIO) recently
launched its first ultrasensitive multiplexed digital PCR
assay for breast cancer mutation detection in clinical research.
The newly launched ddPLEX ESR1 Mutation Detection Kit assay expands
Bio-Rad's Droplet Digital PCR (ddPCR™) offering for the
oncology market, where highly sensitive and multiplexed mutation
detection assays aid translational research, therapy selection, and
disease monitoring.
"With the ddPLEX ESR1 Mutation Detection Kit, our customers can
achieve new levels of sensitivity and multiplexing without
compromising throughput," said Stephen
Kulisch, Vice President of Marketing for Bio-Rad's
Digital Biology Group. "This launch reflects our ongoing menu
expansion in oncology and our commitment to providing oncology
researchers with technologies that enable everything from biomarker
discovery to clinical trials that support improvements in patient
monitoring."
Shortly after the launch, Bio-Rad partnered with
Alleghany Health Network (AHN) to advance clinical evidence
for monitoring solid tumor cancers using the ddPCR technology. The
collaboration will use ddPCR technology for molecular residual
disease (MRD) monitoring of patients across a range of solid tumor
types.
Even more promising breast cancer data has come out
recently from AstraZeneca PLC (NASDAQ: AZN) and partners
Daiichi Sankyo for their jointly developed antibody drug
conjugate Enhertu (trastuzumab deruxtecan), from their phase 3
breast cancer trial. Results from the DESTINY-Breast06
trial demonstrated a statistically significant and clinically
meaningful improvement in progression-free survival (PFS) compared
to standard-of-care chemotherapy in the primary trial population of
patients with HR-positive, HER2-low metastatic breast cancer
following one or more lines of endocrine therapy.
"DESTINY-Breast06 shows that ENHERTU could become a new standard
of care for patients with HER2-low and HER2-ultralow metastatic
breast cancer following one or more lines of endocrine therapy,"
said Susan Galbraith, Executive Vice
President, Oncology R&D, AstraZeneca. "These data
underscore the potential for treatment with ENHERTU across the
spectrum of HR-positive breast cancer, further redefining the
treatment of metastatic breast cancer."
Article Source:
https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
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