USA News Group
Commentary
Issued on behalf of Oncolytics Biotech
Inc.
VANCOUVER, BC, Aug. 12,
2024 /PRNewswire/ -- USA News Group – Pancreatic cancer is
among the deadliest cancers, prompting researchers to focus on
early detection to improve survival rates. Johns Hopkins
Medicine reports that up to 80% of patients are diagnosed
at advanced stages, making treatment much more challenging. A
recent study in the journal Cell Genomics reveals that
key protein biomarkers for early detection have been identified.
According to analysts at Research Nester, the pancreatic
cancer market is slated to expand by ~18% CAGR between
2024-2035, reaching US$36 billion by
2036. Biotech developers are actively working on innovative
treatments to significantly enhance patient health outcomes, with
recent developments coming from Oncolytics Biotech
Inc. (NASDAQ: ONCY) (TSX: ONC), Halozyme Therapeutics,
Inc. (NASDAQ: HALO), Candel Therapeutics, Inc. (NASDAQ:
CADL), Merus N.V. (NASDAQ: MRUS), and Roche Holding
AG (OTCQX: RHHBY).
Recently, at this year's American Society of Clinical
Oncology (ASCO) Annual Meeting, Oncolytics Biotech Inc.
(NASDAQ: ONCY) (TSX: ONC) presented two abstracts related to
their novel immunotherapy, pelareorep.
Among these was a trial-in-progress abstract for cohort 5 of the
GOBLET study, which will explore the effectiveness of combining
pelareorep with modified FOLFIRINOX (mFOLFIRINOX) with and without
atezolizumab, made by Roche Holding AG (OTCQX: RHHBY),
in newly diagnosed patients with metastatic pancreatic ductal
adenocarcinoma (PDAC). The cohort is supported by a US$5 million Therapeutic Accelerator Award grant
from the Pancreatic Cancer Action Network (PanCAN).
Oncolytics Biotech expects enrollment for this cohort to
start this quarter.
"The first abstract outlines the design of a new GOBLET PDAC
cohort that could significantly expand the potential of the
company's pancreatic cancer program," said Dr. Matt Coffey, President and CEO of
Oncolytics. "The chemotherapy regimens of mFOLFIRINOX and
gemcitabine/nab-paclitaxel are the two most common standards of
care in metastatic pancreatic cancer. We previously reported that
the combination of pelareorep, gemcitabine, nab-paclitaxel, and
atezolizumab yielded tumor response rates nearly triple historical
results. Should the combination of pelareorep and mFOLFIRINOX
produce a similarly positive outcome, an even broader range of
metastatic PDAC patients may benefit from pelareorep-based
therapy."
The GOBLET cohort 5 abstract and poster describe a study
evaluating new treatments for patients with newly diagnosed
metastatic PDAC using a Simon two-stage design. In the first stage,
15 patients per treatment arm are randomly assigned to receive
either pelareorep with mFOLFIRINOX, or pelareorep with mFOLFIRINOX
and atezolizumab. The main goals are to measure the response rate
and safety of the treatments. Additional goals include assessing
progression-free survival, overall survival, and biomarkers. If the
first stage meets its success criteria, one or both groups may
advance to Stage 2, with 17 more patients per treatment arm. Blood
and tumor samples will be collected for further analysis throughout
the study.
Earlier in May, Oncolytics (supported by Roche)
secured regulatory clearance to begin enrolling patients in
this new cohort, which is expected to occur this month.
Roche is also continuing to develop its personalized
neoantigen vaccine, autogene cevumeran, with partners
BioNTech. In the first-in-human trial, investigators
administered the personalized messenger RNA-based vaccine plus
Roche's Tecentriq (atezolizumab) and chemotherapy in 16
pancreatic cancer patients after surgical resection.
Working to improve the way cancer drugs are delivered,
Halozyme Therapeutics, Inc. (NASDAQ: HALO) recently
announced that the FDA updated its Prescription Drug
User Fee Act goal date for the subcutaneous formulation of
Bristol Myers Squibb's Opdivo
(nivolumab) co-formulated with Halozyme's proprietary asset
ENHANZE®. The newly updated goal date is December 29, 2024, moved up from the previous
date of February 28, 2025.
Should the FDA approve this new ENHANZE-formulated
version of Opdivo, it would make the drug the first and only
subcutaneously administered PD-1 inhibitor. Opdivo, an
immunotherapy treatment that utilizes the body's own immune system
to combat cancer, generated over $9
billion in revenue last year and is currently
administered intravenously.
This pending decision is for treatment across all previously
approved adult, solid tumor Opdivo indications as monotherapy,
monotherapy maintenance following completion of Opdivo plus Yervoy
(ipilimumab) combination therapy, or in combination with
chemotherapy or cabozantinib.
Earlier this year, a pilot study suggested that for people
with borderline resectable pancreatic cancer, administrating
nivolumab (aka Opdivo) in combination with chemotherapy before
surgery is safe and may improve long-term outcomes.
Further targeting borderline resectable pancreatic cancer,
Candel Therapeutics, Inc. (NASDAQ: CADL) recently reported
"very encouraging results" in updated survival data from its phase
2 clinical trial of CAN-2409. Within the results, patients reached
an estimated median overall survival of 28.8 months after
experimental treatment with CAN-2409 versus only 12.5 months in the
control group in borderline resectable PDAC. At 24 months, the
survival rate was 71.4% in CAN-2409 treated patients compared to
only 16.7% in the control group after chemoradiation.
"Given the frequent recurrence and short survival with SoC
chemotherapy for non-metastatic PDAC, effective new treatment
options are urgently needed," said Garrett
Nichols, MD, MS, Chief Medical Officer of Candel. "We
are very encouraged by the improved survival associated with
CAN-2409, which has been shown to be durable after prolonged
follow-up based on the updated data in this randomized clinical
trial. CAN-2409 was generally well tolerated without significant
additional local or systemic toxicity when added to SoC
chemoradiation."
Back in May, the FDA granted priority review to
Merus N.V.'s (NASDAQ: MRUS) zenocutuzumab (MCLA-128)
('Zeno') for use in the treatment of patients with neuregulin 1
fusion (NRG1)-positive non-small cell lung cancer (NSCLC) and
pancreatic cancer. The FDA already granted Breakthrough
Therapy Designation (BTD) to Zeno for the treatment of patients
with advanced unresectable or metastatic NRG1+ pancreatic cancer
following progression with prior systemic therapy or who have no
satisfactory alternative treatment options, back in June of
2023.
"FDA acceptance of our first [biologics license
application (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."
Article Source:
https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
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SOURCE USA News Group