USA News Group
Commentary
Issued on behalf of Oncolytics Biotech
Inc.
VANCOUVER, BC, May 23, 2024
/PRNewswire/ -- USA News Group –
Known as one of the deadliest cancers, researchers are working
diligently to help increase the chance of survival for pancreatic
cancer patients through earlier detection, as according to Johns
Hopkins Medicine up to 80% of patients, are diagnosed at later,
more difficult-to-treat stages. Now, researchers have identified
specific circulating microRNAs (miRNAs) in blood samples that can
identify individuals at high risk of developing pancreatic cancer
within 5 years. The American Cancer Society projects that
approximately 66,440 individuals in the USA, split between 34,530 men and 31,910
women, will be diagnosed with pancreatic cancer in 2024, with,
sadly, about 51,750 expected to die from the disease. In the
background, biotech developers are intensely focused on pioneering
new medical treatments and significantly enhancing the health
outcomes for patients, including recent updates from
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC),
Candel Therapeutics, Inc. (NASDAQ: CADL), AstraZeneca
PLC (NASDAQ: AZN), Merus N.V. (NASDAQ: MRUS), and
Lantern Pharma Inc. (NASDAQ: LTRN).
Pelareorep, an innovative immunotherapeutic agent developed by
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), is making
significant strides in the treatment of various cancers,
particularly breast and pancreatic cancer. After securing Fast
Track Designation from the FDA for its use in pancreatic
cancer in late 2022 due to promising clinical results, the company
has initiated a preliminary collaboration with the Global
Coalition for Adaptive Research (GCAR). This collaboration
focuses on setting the stage for evaluating pelareorep as a
first-line treatment for metastatic pancreatic ductal
adenocarcinoma (PDAC) under GCAR's planned master protocol,
which is expected to produce data essential for the drug's
registration.
"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 CEO 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."
The research into pelareorep utilizing another chemotherapy
backbone, combined with modified FOLFIRINOX (mFOLFIRINOX) +/-
Tecentriq® (from Roche), is advancing under
Oncolytics' GOBLET study for newly diagnosed pancreatic
cancer patients. Following approval from German regulatory and
ethics committees, this new cohort has been cleared to begin
enrolling patients. Additionally, the Pancreatic Cancer Action
Network (PanCAN) supports this segment of the study with a
US$5 million Therapeutic Accelerator
Award, aimed at speeding up the development of new treatments for
pancreatic cancer.
Should the pelareorep/mFOLFIRINOX combination yield favorable
results, it could significantly enhance Oncolytics'
pancreatic cancer treatment strategies. Oncolytics has
already reported promising results from combining pelareorep with
Tecentriq, gemcitabine, and nab-paclitaxel. There is optimism
within the Oncolytics team that improved response rates from
the mFOLFIRINOX combination, compared to historical controls, might
pave the way for a registration-enabling study. This development
could potentially offer two viable pelareorep-based treatment
options for patients with pancreatic cancer. Furthermore, upcoming
translational research will focus on exploring pelareorep's
mechanism of action, especially its impact on the tumor
microenvironment (TME).
Oncolytics will investigate the correlation between tumor
responses and the increase of tumor-infiltrating lymphocytes (TILs)
in the blood during their evaluation, a phenomenon previously
observed in pancreatic cancer studies. The company plans to begin
enrolling patients for the mFOLFIRINOX/pelareorep study cohort in
the second quarter of 2024.
After announcing positive interim data with notable
improvements in estimated median overall survival after
experimental treatment, Candel Therapeutics, Inc. (NASDAQ:
CADL) received FDA orphan drug designation in pancreatic
cancer for its CAN-2409 in combination with valacyclovir and
standard-of-care (SOC) chemoradiation followed by resection.
"Obtaining orphan drug designation marks a significant milestone
for Candel, as we continue to develop CAN-2409 for
pancreatic cancer," said Garrett
Nichols, MD, MS, Chief Medical Officer at Candel. "We
are excited by this FDA designation, which further supports
Candel's efforts in the development of medicines to cure
less prevalent yet challenging to treat cancers. The evidence base
for CAN-2409 is growing, as we read out clinical trials in patients
with difficult-to-treat cancers, such as our recent results in
PDAC, and non-small cell lung cancer later in the current
quarter."
Candel's CAN-2409 is the company's most advanced cancer
treatment candidate. It uses a specially engineered virus to
deliver a specific gene directly into a patient's tumor. This gene
triggers a powerful immune response against the cancer. The
treatment involves taking a drug called valacyclovir, which the
introduced gene converts into a substance that kills cancer cells.
This process not only targets the tumor but also helps the immune
system recognize and attack the cancer across the body.
The FDA was also recently active in giving accelerated
approval for the expanded use of Daiichi Sankyo and
AstraZeneca PLC's (NASDAQ: AZN) drug Enhertu for treatment
across multiple HER2-expressing solid tumors. HER2 is a protein
that stimulates the quick growth of cancer cells, and according to
AstraZeneca is present in solid form in multiple cancers,
including pancreatic cancer.
"As the first antibody drug conjugate to be granted a tumor
agnostic indication, ENHERTU is truly delivering on its potential
across metastatic HER2 targetable tumors," said Dave Fredrickson, Executive Vice President,
Oncology Business Unit, AstraZeneca. "This approval also
elevates the importance of testing for biomarkers, including HER2,
across a broad range of tumors to ensure these patients with
advanced cancer who have few options know whether a targeted
medicine might be right for them."
On a path to being potentially the first targeted therapy for
NRG1+ cancer, Merus N.V. (NASDAQ: MRUS) recently announced
the FDA accepted a Biologics License Application (BLA) for
priority review for the company's bispecific antibody zenocutuzumab
(Zeno) in patients with neuregulin 1 fusion (NRG1+) pancreatic
(PDAC) cancer), as well as NRG1+ non-small cell lung cancer
(NSCLC).
"FDA acceptance of our first BLA represents an important
achievement for Merus and an important potential treatment
opportunity for patients with NRG1+ cancer, a disease with poor
prognosis and high unmet need," said Dr. Andrew Joe, Chief Medical Officer at
Merus. "Zenocutuzumab has the potential to be the first and
only targeted therapy for patients with NRG1+ lung and pancreatic
cancer, and may offer a substantial improvement over currently
available therapies."
The FDA has already awarded Breakthrough Therapy
Designation (BTD) to Zeno for two indications: first, for treating
patients with advanced unresectable or metastatic NRG1+ pancreatic
cancer who have progressed following prior systemic therapy or who
lack satisfactory alternative treatment options, and second, for
the treatment of patients with advanced unresectable or metastatic
NRG1+ non-small cell lung cancer (NSCLC), following progression
with prior systemic therapy.
In an effort to optimize development of the first-in-class drug
candidate XCE853, Lantern Pharma Inc. (NASDAQ: LTRN) has
launched a strategic AI collaboration with Oregon
Therapeutics. Through the collaboration, Lantern will
leverage its proprietary RADR AI platform to uncover biomarkers and
efficacy-associated signatures of XCE853 across solid tumors that
can aid in precision development. Oregon Therapeutics is
developing XCE853 in various cancer indications, including
drug-resistant pancreatic and ovarian cancer, certain hematological
cancers, and several pediatric cancers, including CNS cancers.
"To date, our first-in-class metabolic inhibitor, XCE853, has
exhibited robust preclinical efficacy in both in vitro and in vivo
models across multiple cancer types," said Marc-Henry PITTY, MD,
CEO of Oregon Therapeutics. "Lantern's RADR® AI
platform will leverage the in vitro and in vivo data to potentially
advance XCE853 development in a highly targeted manner and will
help inform disease indications and biomarker signatures that can
aid in the design of future clinical trials and in the pursuit of
combination therapies with other approved cancer drugs."
Oregon Therapeutics has previously performed preclinical
studies indicating that in addition to ovarian and pancreatic
cancer, XCE853 may also be particularly active in renal, prostate,
lung, breast, and head and neck cancers, and leukemia based on
preclinical cell-line studies.
Article Source:
https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
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