USA News Group
Commentary Issued on behalf of Oncolytics Biotech
Inc.
VANCOUVER, BC, May 15, 2024
/PRNewswire/ -- USA News
Group – Hope is rising in the fight against one of the deadliest
cancers in the world, as a new study recently claimed that a blood
test can accurately detect early-stage pancreatic cancer with 97%
accuracy. According to Johns Hopkins Medicine, up to 10% of
patients who receive an early diagnosis become disease-free after
treatment, meaning the earlier it's detected, the better the
patient's chances to survive. The American Cancer Society
estimates that about 66,440 people (34,530 men and 31,910 women)
will be diagnosed with pancreatic cancer in the USA this year, projecting about 51,750 people
will succumb to the disease. Working diligently behind the scenes,
several biotech drug developers are making progress in new
treatments, including recent updates from Oncolytics
Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Candel Therapeutics,
Inc. (NASDAQ: CADL), ABVC BioPharma, Inc. (NASDAQ:
ABVC), CytomX Therapeutics, Inc. (NASDAQ: CTMX), and
Amgen Inc. (NASDAQ: AMGN).
Pelareorep, an intravenously delivered immunotherapeutic agent
being developed by Oncolytics Biotech Inc. (NASDAQ: ONCY)
(TSX: ONC), is gaining momentum as a potential treatment for
multiple cancers, especially breast cancer and pancreatic cancer.
In late 2022, the FDA granted pelareorep Fast Track
Designation for treating pancreatic cancer, following
promising clinical results. Now Oncolytics has recently
announced a preliminary collaboration with the Global Coalition
for Adaptive Research (GCAR), with the purpose of commencing
planning activities for the evaluation of pelareorep in the
treatment of first-line metastatic pancreatic ductal adenocarcinoma
(PDAC), as part of GCAR's anticipated master protocol for
metastatic pancreatic cancer.
GCAR's activities are already underway to finalize
the seamless Phase 2/3 master protocol design that will evaluate
multiple investigational therapies for pancreatic cancer treatment.
Thus, the intent of the pelareorep study will be to produce
registration-enabling data.
"We are thrilled to collaborate with GCAR and are honored
that pelareorep has been selected as the first therapeutic for
evaluation in GCAR's planned adaptive trial in pancreatic
cancer patients," said Dr. Matt
Coffey, President and Chief Executive Officer of
Oncolytics. "We believe this opportunity presents a
strategic and efficient pathway forward for the development of
pelareorep to address an urgent need for pancreatic cancer
patients. GCAR's anticipated trial design seeks to cut
registrational study time and reduce trial costs, speeding up the
journey to potentially deliver effective cancer treatment
sooner."
Oncolytics is also now advancing its lead asset
further, having recently received regulatory clearance to
evaluate pelareorep in combination with modified FOLFIRINOX +/-
Tecentriq (from Roche) in pancreatic cancer in a new cohort
from its ongoing GOBLET study, following German regulatory and
ethics approvals. The new cohort is bolstered by a US$5 million Therapeutic Accelerator Award from
the Pancreatic Cancer Action Network (PanCAN), an inventive
initiative aimed at rapidly advancing the development of new
treatments for pancreatic cancer.
Achieving these positive results from the pelareorep/mFOLFIRINOX
combination could greatly elevate Oncolytics' prospects in
tackling pancreatic cancer. Oncolytics has previously
reported encouraging data from pelareorep paired with
gemcitabine and nab-paclitaxel. The Oncolytics team believes
that if the mFOLFIRINOX combination demonstrates improvements in
response rate over historical control trials, this treatment
approach could move forward to a registration-enabling study,
offering two potential pelareorep-based therapies for pancreatic
cancer patients. Additionally, planned translational research
studies for this cohort will further explore the understanding of
pelareorep's mechanism of action, including its impact on the tumor
microenvironment (TME).
As a part of this evaluation, Oncolytics will examine the
relationship between tumor responses and the expansion of
tumor-infiltrating lymphocytes (TILs) in the blood, an effect noted
in previous pancreatic cancer studies. The company plans to start
enrolling patients into the mFOLFIRINOX/pelareorep study cohort in
Q2 2024.
For Candel Therapeutics, Inc. (NASDAQ: CADL), the FDA
granted Orphan Drug Designation to their leading multimodal
biological candidate, CAN-2409, for pancreatic cancer treatment.
This recognition came shortly after Candel shared updated
overall survival data from its ongoing randomized phase 2
clinical trial of CAN-2409 combined with valacyclovir (prodrug) and
standard-of-care chemoradiation, followed by surgery for borderline
resectable pancreatic ductal adenocarcinoma (PDAC).
"We recently reported data from the phase 2 randomized clinical
trial of CAN-2409 in borderline resectable pancreatic cancer,
showing that CAN-2409, when added to standard of care, more than
doubled the median overall survival obtained with standard of care
alone," said Paul Peter Tak, MD,
PhD, FMedSci, President and CEO of Candel. "We are pleased
that the FDA has now granted Candel with both Orphan
Drug and Fast Track Designation to this program, as we seek to
reshape the treatment paradigm in pancreatic cancer."
Clinical-stage biopharmaceutical company ABVC BioPharma,
Inc. (NASDAQ: ABVC) recently announced it has entered into a
definitive agreement with private company OncoX BioPharma,
Inc. in its fight against pancreatic cancer. Through its
affiliate Rgene Corporation, ABVC and OncoX
are set to collaborate on combination therapy the duo believes will
help treat pancreatic cancer and improve patient outcomes
significantly, with ABVC and Rgene set to receive an
aggregate license fee of $12.5
million in cash or shares from OncoX within the next
30 days.
"We are excited to announce this collaboration with
OncoX, which represents a significant step forward in our
commitment to developing transformative treatments for pancreatic
cancer," said Dr. Uttam Patil, CEO
of ABVC. "By combining our strengths, we can make meaningful
progress in addressing this devastating disease. The collaboration
will draw on ABVC's portfolio of combination therapies
pipeline, which has shown promise in preclinical and early clinical
studies."
Among ABVC's portfolio is its ABV-1703 (IND 136309) for
pancreatic cancer therapy. As part of an Investigational New Drug
(IND) application for ABV-1703 is the proposal for the clinical
investigation of BLEX 404 as a combination therapy drug with
chemotherapy. BLEX 404 is made with the active ingredient glucan,
which is extracted from Grifola frondose (maitake mushrooms), an
edible fungus with high medical and commercial value in
Asia.
"This partnership exemplifies our dedication to advancing the
field of oncology and bringing hope to patients facing pancreatic
cancer," said Wen-Pin Yen, CEO of
OncoX. "Together with ABVC, we are committed to pushing the
boundaries of innovation to improve outcomes for patients in need.
The two companies aim to deliver a novel treatment option for
pancreatic cancer patients by combining their resources, expertise,
and innovative approaches."
Leading drug developer in the field of masked, conditionally
activated biologic therapeutics, CytomX Therapeutics, Inc.
(NASDAQ: CTMX), recently announced positive initial data from
its ongoing CX-904 Phase 1a dose escalation clinical study with its
global development partner, Amgen Inc. (NASDAQ: AMGN).
CytomX and Amgen are collaborating on CX-904, a
bispecific PROBODY candidate designed to engage T-cells by
targeting the epidermal growth factor receptor (EGFR) on cancer
cells and the CD3 receptor on T cells.
Within the clinical study results, CX-904 not only demonstrated
a favorable safety profile with no cytokine release syndrome, but
also presented encouraging initial signs of efficacy observed for
CX-904 in advanced pancreatic cancer, including 2 of 6 patients
(33%) with a confirmed partial response, and all 6 patients (100%)
with disease control.
"We are delighted to share these initial results today for
CX-904, a highly innovative masked T-cell engager that embodies our
vision at CytomX of transforming lives with safer, more
effective therapies," said Sean
McCarthy, D.Phil., CEO and Chairman of CytomX. "These
data build on more than a decade of innovation at CytomX,
and, we believe, open broad new possibilities for T-cell engagers
across many targets and cancer types. We look forward to continuing
to explore the potential of this exciting agent in multiple EGFR
positive cancers and to determining longer term strategy with our
global development partner, Amgen."
Article Source:
https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
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