USA News Group News
Commentary
Issued on behalf of Oncolytics Biotech
Inc.
VANCOUVER, BC, June 27,
2024 /PRNewswire/ -- USA News Group News Commentary
– According to the American Cancer Society, 2024 will be the
first year the USA expects to have
more than 2 million new cancer cases. In order to respond to the
rising rates of cancer, the National Cancer Institute is
making calls for change in how cancer clinical research is
performed "Because our patients can't wait." According to
Spherical Insights, the Global Oncology Drugs Market is
projected to grow by 11.5% CAGR through 2033 to US$564.5 billion, highlighting the need for more
effective therapies and incentives for those who develop them. The
biotech sector is actively addressing this need, with recent
notable developments from several companies, including:
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC),
GSK plc (NYSE: GSK), Guardant Health, Inc. (NASDAQ:
GH), Exelixis, Inc. (NASDAQ: EXEL), and Gilead Sciences,
Inc. (NASDAQ: GILD).
The article continued: According to the World Health
Organization, the global cancer burden is growing amidst a
mounting need for services. As well, an alarming trend is emerging,
where cancer cases in younger people are rising sharply.
Oncolytics Biotech® Announces Productive FDA Type C Meeting
on its Metastatic Breast Cancer Program
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a
leading clinical-stage company specializing in immunotherapy for
oncology, today announced that the Company received productive
feedback from its Type C meeting with the U.S. Food and Drug
Administration (FDA), supporting the planned potential
registration-enabling trial for pelareorep in HR+/HER2- metastatic
breast cancer (mBC). The FDA supports progression-free
survival as the primary endpoint of the study, with overall
survival as a key secondary endpoint. The Company's proposed study
will enroll patients who have failed hormonal therapy and have
received no more than one line of antibody-drug conjugate (ADC)
therapy.
"Aligning with the FDA on key design elements and
objectives of our planned registrational trial for pelareorep marks
a critical step towards bringing this innovative treatment to
patients," said Thomas Heineman,
M.D., Ph.D., Chief Medical Officer at Oncolytics. "Our
de-risked program builds on compelling data and key learnings from
two randomized studies, BRACELET-1 and IND-213, which demonstrated
clinically meaningful benefit in patients receiving pelareorep and
paclitaxel compared to paclitaxel alone. Additionally,
translational data from the AWARE-1 study highlights pelareorep's
immune-mediated mechanism of action in breast cancer patients. We
are now well-positioned to deliver on our mission of making
pelareorep available to breast cancer patients in need of better
treatment options."
Wayne Pisano, Interim CEO and
Chair of the Board of Oncolytics, commented, "We are
appreciative of the thoughtful dialog with the FDA and are
pleased to have reached an important regulatory milestone that
provides a clear path forward for pelareorep's advancement towards
registration in HR+/HER2- mBC. Looking ahead, initiating a
registration-enabling trial has become a major corporate objective,
and in parallel, we remain on track to report survival data from
the BRACELET-1 study in HR+/HER2- mBC in the second half of the
year. We believe these data will further bolster our compelling
data package and underscores the therapeutic potential of
pelareorep. We remain committed to improving the standard of care
and addressing the high unmet medical needs of these patients."
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 industry developments and happenings in the market
this week include:
GSK plc (NYSE: GSK), a global biopharma company, recently
released positive results from an interim analysis of the
DREAMM-8 phase III head-to-head trial evaluating belantamab
mafodotin, in combination with pomalidomide plus dexamethasone
(PomDex), versus a standard of care, bortezomib plus PomDex, as a
second line and later treatment for relapsed or refractory multiple
myeloma. As per the release, the drug combination reduced the risk
of disease progression or death by nearly 50% versus standard
of care.
"With the robust results from the DREAMM-8 phase III
head-to-head trial, we now have consistent data from two phase III
trials supporting the potential for belantamab mafodotin
combinations to redefine the treatment of multiple myeloma at or
after first relapse," said Hesham
Abdullah, Senior Vice President, Global Head Oncology,
R&D, of GSK. "This is exciting news given the high unmet
need for new and efficacious combinations once patients relapse or
stop responding to initial treatments. We continue to share data
and discuss our path forward with regulators."
Guardant Health, Inc. (NASDAQ: GH), a leading precision
oncology company, recently announced the launch of a new
version of its Guardant360 TissueNext test that expanded the number
of genes it identifies in a tumor tissue sample to 498. In addition
to the panel expansion, Guardant has improved the test's
operational workflow for a faster turnaround time.
"The launch of the new Guardant360 TissueNext test is another
step forward in our mission to conquer cancer with data," said
Helmy Eltouky, Chairman and co-CEO of Guardant Health. "In
addition to identifying guideline-recommended biomarkers, the
upgraded test now provides more comprehensive gene coverage, so
oncologists can make better informed decisions about the optimal
treatment strategy for their patients with advanced cancer and help
improve their outcomes."
Exelixis, Inc. (NASDAQ: EXEL), a globally ambitious
oncology company innovating next-generation medicines and regimens
at the forefront of cancer care, recently settled two patent
litigations with Cipla Ltd. and Cipla USA, Inc. (collectively Cipla) in
response to Cipla's Abbreviated New Drug Application (ANDA)
seeking approval to market generic versions of CABOMETYX®
(cabozantinib) tablets prior to the expiration of the applicable
patents.
Prior to the settlement earlier this year, Exelixis also
announced detailed results of its Phase 3 CONTACT-02 pivotal
trial evaluating the above-mentioned cabozantinib in combination
with atezolizumab in metastatic castration-resistant prostate
cancer at this year's ASCO GU 2024 event. As per the results, the
combination reduced the risk of disease progression or death by
35%.
"Given there are limited options after progression on novel
hormonal therapy, we recognize the need for a regimen that can
delay disease progression, that has an acceptable tolerability
profile and that is widely available to patients who may not have
the means or desire to travel to specialized centers for other
therapies," said Amy Peterson, M.D.,
Executive Vice President, Product Development & Medical
Affairs, and Chief Medical Officer, Exelixis. "We look
forward to discussing these important results with the U.S. Food
and Drug Administration, and to learning more in the next
analysis of overall survival, anticipated this year."
Through its recently-acquired Kite subsidiary, Gilead
Sciences, Inc. (NASDAQ: GILD) recently announced
results from three new analyses for
Yescarta (axicabtagene ciloleucel) in relapsed/refractory
(R/R) large B-cell lymphoma (LBCL), including both new clinical
research and real-world evidence highlighting manufacturing and
product characteristics of Yescarta, and outpatient administration
of both Yescarta and Tecartus® (brexucabtagene autoleucel) at the
2024 European Hematology Association (EHA) Annual Congress,
June 13-16, Madrid.
"We are committed to improving survival outcomes for people
living with difficult-to-treat blood cancers," said Ibrahim
Elhoussieny, Vice President, Medical Affairs, of Kite.
"These new data support the potential benefit of utilizing Yescarta
in earlier lines of treatment, both in terms of manufacturing
success and product characteristics. Additional data support the
safety and feasibility of administering CAR T-cell therapy in the
outpatient setting. These data contribute to the body of evidence
for efficient utilization and delivery of Yescarta and Tecartus and
further support our ambition for patients."
Source:
https://equity-insider.com/unlocking-the-trillion-dollar-ai-market-what-investors-need-to-know/
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