USA News Group
Commentary Issued on behalf of Oncolytics Biotech
Inc.
VANCOUVER, BC, May 9, 2024 /PRNewswire/ -- USA News Group – In the fight against cancer,
a political stumbling block was recently put in place by the US
Congress after it voted against the renewal of funding for
President Biden's "Cancer Moon Shot" designed to advance cancer
research towards a cure. The need for solutions is mounting, as
health authorities, on behalf of the United Nations, are
predicting global cancer cases to rise around 77% by 2050, with
richer countries expected to have the greatest absolute increase in
cancer. As analysts from Custom Market Insights forecast the
global cancer immunotherapy market to soar to US$314.4 billion by 2032, expanding at a 7.2%
CAGR, the biotech sector continues to advance cancer treatment and
diagnostics, with recent updates coming from Oncolytics
Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Candel Therapeutics,
Inc. (NASDAQ: CADL), AstraZeneca PLC (NASDAQ: AZN),
Halozyme Therapeutics, Inc. (NASDAQ: HALO), and Janux
Therapeutics, Inc. (NASDAQ: JANX).
In the case of pelareorep, an intravenously delivered
immunotherapy agent developed by Oncolytics Biotech Inc.
(NASDAQ: ONCY) (TSX: ONC), the case is getting stronger for it to
one day become a treatment for multiple cancers, including most
prominently pancreatic cancer. Near the end of 2022, the FDA
granted pelareorep a Fast Track Designation for the treatment
of pancreatic ductal adenocarcinoma (PDAC) after it demonstrated
some optimistic results. Now Oncolytics is continuing to
move its flagship asset forward, having recently received
regulatory clearance to evaluate pelareorep in combination with
modified FOLFIRONOX +/- Tecentriq® (from Roche) in
pancreatic cancer in a new cohort for its ongoing GOBLET study,
following German regulatory and ethics approvals.
The new cohort is also being supported by a US$5 million Therapeutic Accelerator Award from
the Pancreatic Cancer Action Network (PanCAN)—an innovative
program established to accelerate the development of new treatments
for pancreatic cancer.
"Oncolytics is pleased to announce receipt of regulatory
clearance to initiate the mFOLFIRINOX cohort in patients with newly
diagnosed metastatic PDAC," said Dr. Matt
Coffey, President and CEO of Oncolytics. "We believe
that working with PanCAN will help to further enrich
Oncolytics' clinical relationships with the pancreatic
cancer community. We are also grateful for PanCAN's
Therapeutic Accelerator Award, which is enabling the evaluation of
this combination therapy."
Positive results from a combination with mFOLFIRINOX could
greatly enhance pelareorep's potential in addressing pancreatic
cancer. So far, Oncolytics has already reported
data for pelareorep in combination with gemcitabine and
nab-paclitaxel. According to the Oncolytics team, if the
mFOLFIRINOX combination shows a compelling efficacy signal, this
therapeutic approach could also be advanced to a
registration-enabling study, providing two opportunities for
pelareorep-based treatment to benefit pancreatic cancer patients.
In addition, translational research studies planned for this cohort
will help to further elucidate pelareorep's mechanism of action,
including its ability to shape the tumor microenvironment
(TME).
"Oncolytics has taken a very strategic approach to the
development of pelareorep in pancreatic cancer by focusing its
clinical studies on combinations with the most widely used
treatment regimens," said Dirk
Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum
Hamburg and primary investigator of the GOBLET trial. "My
experience to date with the GOBLET study, including the positive
metastatic PDAC and encouraging anal cancer data reported last
year, makes me enthusiastic to initiate enrollment in the
mFOLFIRINOX cohort."
Notably, Oncolytics plans to evaluate the correlation
between tumor responses and the expansion of tumor-infiltrating
lymphocytes (TILs) in the blood, an effect that was observed in
earlier pancreatic cancer studies. According to the company, they
will be initiating enrollment into the mFOLFIRINOX/pelareorep study
cohort in Q2 2024.
In the case of Candel Therapeutics, Inc. (NASDAQ: CADL),
another potential treatment for pancreatic cancer was given a nod
by the FDA in the form of an Orphan Drug
Designation given to Candel's most advanced multimodal
biological candidate, CAN-2409. The news of the designation came
weeks after Candel reported updated overall survival
data from its ongoing randomized phase 2 clinical trial of
CAN-2409 plus valacyclovir (prodrug), together with standard of
care (SoC) chemoradiation, followed by resection for borderline
resectable 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."
Pharma giant AstraZeneca PLC (NASDAQ: AZN) recently saw
its revenue spike in Q1 2024, bolstered by sales of its cancer
medicines, according to Bloomberg. Over the last few weeks,
AstraZeneca has been making more progress across the
oncology scene, including the release of topline findings from
its Phase III DESTINY-Breast06 study, showing significant
progression-free survival benefits in certain patients with
metastatic breast cancer with its antibody-drug conjugate Enerhertu
with partners Daiichi Sankyo.
As well, AstraZeneca also reported results for its
CALQUENCE combination regimen, which demonstrated a statistically
significant and clinically meaningful improvement in
progression-free survival improvement in 1st-line mantle
cell lymphoma from its ECHO Phase III trial.
"These impactful results in mantle cell lymphoma show that
bringing CALQUENCE to the first-line setting significantly delays
disease progression and, for the first time, shows potential to
extend survival," said Susan
Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca. "The improvement in progression-free survival
together with the differentiated safety profile of CALQUENCE are
both important as we strive to transform outcomes earlier in the
course of disease treatment."
In combination with its Enhanze drug-delivery technology,
Halozyme Therapeutics, Inc. (NASDAQ: HALO) was recently
linked to the acceptance of an approval-seeking FDA
application involving a subcutaneous formulation of
Bristol-Myers Squibb's
blockbuster cancer drug Opdivo. As per the announcement, the
application covers Opdivo co-formulated with Halozyme's
Enhanze drug-delivery technology across all previously approved
adult, solid-tumor Opdivo indications as monotherapy maintenance
following completion of Opdivo plus Yervoy combination therapy or
in combination with chemotherapy or cabozantinib.
Back in January, Halozyme also saw its other
co-collaborator, Roche, receive European Commission
approval of Tecentriq® SC with Enhanze, representing the EU's
first subcutaneous PD-(L)1 cancer immunotherapy for multiple cancer
types.
"As the first subcutaneous PD-(L)1 cancer immunotherapy in
Europe, Tecentriq SC can provide a
new treatment option that can enhance the treatment experience for
patients and caregivers while freeing up resources in constrained
healthcare systems," said Dr. Helen
Torley, President and CEO of Halozyme.
Back in February, Janux Therapeutics, Inc. (NASDAQ: JANX)
announced encouraging safety and efficacy data in ongoing dose
escalation trials for PSMAxCD3-TRACTr JANX007 in metastatic
castration-resistant prostate cancer (mCRPC) and EGFRxCD3-TRACTr
JANX008 in late-stage solid tumors.
"The clinical data provide compelling proof-of-concept for the
TRACTr platform in a setting where many other approaches have
failed due to material safety issues or lack of efficacy," said
David Campbell, Ph.D., President and
CEO, Janux Therapeutics. "Our TRACTr platform provides an
entry point to multiple, large solid tumor indications that are
intractable with conventional TCE approaches. We look forward to
continuing to advance these clinical trials and expanding to
additional TCE targets, as we look to fulfill our mission to
meaningfully address the unmet medical needs for cancer patients,
especially those with late-stage disease."
The market's immediate reaction was quite positive upon
these results, but by mid-April Janux began working with an
adviser after drawing interest in a potential takeover. According
to Bloomberg, Janux is likely to draw interest from
bigger drugmakers who are looking to acquire new medicines to
replenish their portfolios or expand into cancer treatments.
Janux develops tumor-activated immunotherapies to treat
cancer, and has already seen its shares quadruple this year.
Article Source:
https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
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