USA News Group
Commentary
Issued on behalf of Oncolytics Biotech Inc.
VANCOUVER, BC, May 17, 2024 /PRNewswire/ -- USA News Group – A new study is bringing hope
in the fight against one of the deadliest cancers, revealing a
blood test that can detect early-stage pancreatic cancer with 97%
accuracy. This breakthrough is crucial, as Johns Hopkins
Medicine reports that up to 10% of patients diagnosed early can
become disease-free after treatment. The American Cancer
Society estimates that around 66,440 people (34,530 men and
31,910 women) in the USA will be
diagnosed with pancreatic cancer this year, with approximately
51,750 expected to succumb to the disease. Behind the scenes,
biotech drug developers are working diligently to advance new
treatments and improve patient outcomes, including recent updates
from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX:
ONC), Roche Holding AG (OTCQX: RHHBY), Merus N.V.
(NASDAQ: MRUS), MacroGenics, Inc. (NASDAQ: MGNX), and
Immuneering Corporation (NASDAQ: IMRX).
One innovative immunotherapeutic agent, pelareorep, developed by
Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), is
advancing as a potential treatment for multiple cancers,
particularly breast and pancreatic cancer. After receiving Fast
Track Designation from the FDA for pancreatic cancer in
late 2022 due to encouraging clinical results, Oncolytics has
embarked on a preliminary collaboration with the Global
Coalition for Adaptive Research (GCAR). This partnership is set
to begin planning the evaluation of pelareorep for first-line
metastatic pancreatic ductal adenocarcinoma (PDAC) within
GCAR's anticipated master protocol, which is expected to
generate 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 progressing with its lead asset,
having recently secured regulatory clearance to evaluate
pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX)
+/- Tecentriq® from Roche Holding AG (OTCQX: RHHBY) in newly
diagnosed pancreatic cancer patients in a new cohort of its ongoing
GOBLET study. This approval follows clearance from German
regulatory and ethics bodies. The new cohort is supported by a
US$5 million Therapeutic Accelerator
Award from the Pancreatic Cancer Action Network (PanCAN), an
innovative program designed to expedite the development of new
treatments for pancreatic cancer.
Positive outcomes from the pelareorep/mFOLFIRINOX combination
could significantly boost Oncolytics' efforts in combating
pancreatic cancer. Previously, Oncolytics has shared
encouraging data results from the combination of pelareorep
with Tecentriq, gemcitabine and nab-paclitaxel. The team at
Oncolytics is optimistic that if the mFOLFIRINOX combination
shows improved response rates compared to historical control
trials, it could advance to a registration-enabling study. This
would provide two potential pelareorep-based treatment options for
pancreatic cancer patients. Additionally, planned translational
research for this cohort will delve deeper into understanding
pelareorep's mechanism of action, particularly its effects on the
tumor microenvironment (TME).
In this evaluation, Oncolytics will also explore how
tumor responses correlate with the expansion of tumor-infiltrating
lymphocytes (TILs) in the blood, an effect seen in prior pancreatic
cancer studies. The company intends to commence patient enrollment
for the mFOLFIRINOX/pelareorep study cohort in Q2 2024.
Roche recently had an investigator-led trial of Tecentriq
terminated back in March, while another clinical supply
agreement was reached in May to evaluate another Tecentriq
combination. Roche is also moving forward with partners
BioNTech for a jointly-developed pancreatic cancer vaccine
that demonstrated lasting responses in an early trial. In
Phase II trials, the mRNA vaccine is administered along with
Roche's Tecentriq and chemo against pancreatic cancer.
Now Roche is also working through an agreement with
PathAI, a global leader in artificial intelligence
AI-powered technology for pathology. Under the terms of the deal,
PathAI will work exclusively with Roche Tissue
Diagnostics (RTD) to develop AI-enabled digital pathology
algorithms in the companion diagnostics space.
"This collaboration with Roche is a testament to our
shared commitment to advancing the field of digital pathology and
AI-enabled diagnostics for both drug development and clinical
care," said Dr. Andy Beck, CEO and
Co-Founder of PathAI. "High medical value diagnostic
products with seamless integration into the laboratory workflow
will accelerate the transition to digital pathology as the standard
to aid clinicians in diagnosis and biomarker characterisation."
Recently the FDA granted priority review to a biologics
license application (BLA) from Merus N.V. (NASDAQ: MRUS),
seeking the approval of zenocutuzumab (MCLA-128) ("Zeno") for use
in the treatment of patients with pancreatic cancer (and NSCLC).
The FDA has already granted Breakthrough Therapy Designation
(BTD) to Zeno for the treatment of patients with advanced
unresectable or metastatic NRG1 fusion-positive pancreatic cancer
following progression with prior systemic therapy or who have no
satisfactory alternative treatment options.
"FDA acceptance of our first BLA represents an important
achievement for Merus and an important potential treatment
opportunity for patients with NRG1-positive cancer, a disease with
poor prognosis and high unmet need," said Andrew Joe, MD, Chief Medical Officer at
Merus NV. "Zenocutuzumab has the potential to be the first
and only targeted therapy for patients with NRG1-positive lung and
pancreatic cancer, and may offer a substantial improvement over
currently available therapies."
MacroGenics, Inc. (NASDAQ: MGNX) recently delivered an
update on its corporate progress, which included preclinical data
for its MGC028 at the recent AACR Annual Meeting, after the
antibody-drug conjugate (ADC) demonstrated specific antitumor
activity in in vivo models representing pancreatic cancer
(among other cancers).
"In preclinical studies, MGC028 demonstrated specific antitumor
activity in in-vivo models representing gastric, lung, pancreatic,
colorectal, small cell carcinoma, the head and neck, and
cholangiocarcinoma," said Scott
Koenig, President and CEO of MacroGenics during a
recent earnings call. "In addition, in a nonhuman primate study,
MGC028 was well tolerated at high dose levels with mild reversible
side effects and no ocular toxicity, which is offered a concern
with tubulin-inhibitor-based ADCs. These promising preclinical
results support the continued investigation of MGC028 as a
therapeutic option for treating ADAM9 solid tumors."
Back in February, Immuneering Corporation (NASDAQ: IMRX)
was granted Fast Track Status for its IMM-1-104 for pancreatic
cancer. IMM-1-104 is designed to provide universal-RAS activity
through deep cyclic inhibition of the MAPK pathway with once-daily
oral dosing.
"We welcome FDA's decision to grant Fast Track designation for
IMM-1-104," said Ben Zeskind, Ph.D.,
Co-founder and CEO of Immuneering in a statement. "Our Phase
1/2a study is designed to evaluate IMM-1-104 in pancreatic cancer,
as well as a number of other tumor types associated with the RAS
pathway. We look forward to a data-rich 2024 as we plan to provide
multiple readouts from our study this year."
Article Source:
https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
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