Biotech/Oncology Stocks
Targeting the Pancreatic Cancer Market (NASDAQ: $ONCY) (TSX: $ONC.TO) (NASDAQ: $BLRX)
(NASDAQ: $IMRX) (NASDAQ: $CADL) @Oncolytics @BioLineRx_Ltd @Immuneering
@CandelTx
A Race worth Winning
March 6,
2024 - Investorideas.com, a global investor news source covering
biotech and pharma stocks issues a sector snapshot on developments for
pancreatic cancer treatments, featuring Oncolytics
Biotech® Inc. (NASDAQ:
ONCY) (TSX:
ONC), a clinical-stage immunotherapeutics
company focused on oncology.
Read this article,
featuring ONCY in full at: https://www.investorideas.com/news/2024/biotech/03061Pancreatic-Cancer-Market-Stocks.asp
Research
Nester says, “The global pancreatic
cancer market size is slated to expand at ~18% CAGR between 2024 and 2036. The
market is poised to garner a revenue of USD 36 billion by the end of 2036, up
from a revenue of ~USD 6 billion in the year 2023. The incidence of pancreatic
cancer is increasing globally, which is driving the growth of the market.”
The American Cancer
Society’s estimates for pancreatic cancer in the United States
for 2024 are: “About 66,440 people (34,530 men and 31,910 women) will be
diagnosed with pancreatic cancer. About 51,750 people (27,270 men and 24,480
women) will die of pancreatic cancer. Pancreatic cancer accounts for about 3%
of all cancers in the US and about 7% of all cancer deaths.”
Biotech/oncology stocks targeting the
growing global pancreatic cancer market have made headlines with recent
developments and breakthroughs in treatments.
Oncolytics Biotech® Inc. (NASDAQ:
ONCY) (TSX:
ONC), a clinical-stage immunotherapeutics
company focused on oncology just
announced it has submitted an amendment to
GOBLET to initiate a new Phase 1/2 cohort evaluating pelareorep in combination
with modified FOLFIRINOX (mFOLFIRINOX) with and without atezolizumab (Tecentriq®)
in patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma
(PDAC). This amendment will be reviewed by the Paul Ehrlich Institute (PEI;
Germany’s regulatory body) for approval before patient enrollment can begin.
The cohort, the fifth of the GOBLET gastrointestinal cancer study, is being
supported by the 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.
“We are enthusiastic to have the support of
PanCAN to expand the evaluation of pelareorep in pancreatic cancer and explore
mFOLFIRINOX as another combination that could improve outcomes for patients.
Notably, this patient population is newly diagnosed patients who are receiving
first-line treatment. Chemotherapies, including either mFOLFIRINOX or
gemcitabine and nab-paclitaxel, are the backbone treatment regimens of
pancreatic cancer therapy1. Evaluating pelareorep in combination
with these widely used regimens is an important step in our broad clinical
development program,” said Dr. Matt Coffey, President and Chief Executive
Officer of Oncolytics. “Last fall, we reported a 62% objective response rate
for the GOBLET PDAC cohort studying pelareorep in combination with the
checkpoint inhibitor atezolizumab in addition to gemcitabine and nab-paclitaxel
(link
to the PR, link
to the poster). This response is about
three times that of historical controls and forms the basis of the
registrational program, expected to begin this year. Therefore, we are
enthusiastic about this new mFOLFIRINOX pancreatic cancer cohort and look
forward to enrolling the first patient as soon as possible.”
Dirk Arnold, M.D., Ph.D., Director of
Asklepios Tumorzentrum Hamburg, and primary investigator of the GOBLET trial
commented, “One of the reasons for pancreatic cancer’s poor survival rate is
that it effectively evades the immune system and can induce an
immunosuppressive tumor microenvironment (TME)2. Pelareorep is an
attractive combination partner because of its ability to address both issues by
activating the innate and adaptive immune systems while driving the remodeling
of the tumor microenvironment. Positive results from the Phase 2 study
evaluating pelareorep combined with atezolizumab and chemotherapy reported last
fall support the potential use of these agents together. I am hopeful that the
combination of pelareorep and mFOLFIRINOX (with or without atezolizumab) will
yield positive response data and advance the development of new treatment
options for patients with pancreatic cancer.”
“This study is designed to evaluate whether
pelareorep can enhance outcomes in patients receiving mFOLFIRINOX, one of the
most commonly used metastatic pancreatic cancer treatments. Combining
pelareorep with mFOLFIRINOX represents an expansion of our existing pancreatic
cancer program and maximizes the potential of pelareorep-based combination
therapies to benefit pancreatic cancer patients,” commented Thomas Heineman,
M.D., Ph.D., Chief Medical Officer at Oncolytics. “The mFOLFIRINOX cohort
utilizes a screened selection design within a Simon two-stage approach that will also allow evaluation of the
contribution of atezolizumab to the pelareorep/mFOLFIRINOX combination. In
addition, this study is designed to provide valuable translational assessments,
such as the expansion of tumor-infiltrating lymphocytes (TILs) in the blood,
which has been associated with tumor responses. We look forward to building on
PanCAN’s strong relationships with the pancreatic cancer community and
furthering our collaboration with AIO-Studien-gGmbH
(AIO) on the GOBLET study.”
BioLineRx
Ltd. (NASDAQ: BLRX), a commercial stage biopharmaceutical
company pursuing life-changing therapies in oncology and rare diseases recently announced that the first patient has been dosed in the
randomized CheMo4METPANC Phase 2 combination clinical trial evaluating the
company's CXCR4 inhibitor motixafortide, the PD-1 inhibitor cemiplimab, and
standard of care chemotherapies gemcitabine and nab-paclitaxel, versus
gemcitabine and nab-paclitaxel alone, in first-line PDAC. The
investigator-initiated trial is being conducted in collaboration with Columbia
University and is the first large, multi-center, randomized study evaluating
motixafortide with a PD-1 inhibitor and first-line PDAC chemotherapies.
"Pancreatic
ductal adenocarcinoma (PDAC) has had limited responses to traditional
immunotherapy, resulting in a poor prognosis for patients and an urgent need
for new treatment approaches," said Philip Serlin, Chief Executive Officer
of BioLineRx. "We are encouraged by our early pilot data and look forward
to continuing to advance the expanded, randomized Phase 2 CheMo4METPANC trial
for patients living with this cancer."
From the news: Findings from the single-arm pilot phase of
the CheMo4METPANC trial were shared by Dr. Gulam Manji, MD, PhD, of Columbia
University at the 10th Annual Immuno-Oncology (IO) 360° Summit in Brooklyn, New
York on Thursday, February 29, 2024. The findings were previously presented
during an oral presentation at the American Association of Cancer Research
(AACR) Special Conference on Pancreatic Cancer in Boston, Massachusetts,
September 28, 2023. As of July 2023, 7 of the 11 patients (64%) in the pilot
phase experienced a partial response (PR) of which 5 (45%) were confirmed PRs
at the time of the data cut; one patient experienced resolution of the hepatic
(liver) metastatic lesion; and three patients (27%) experienced stable disease,
resulting in a disease control rate of 91%.
From the news: Motixafortide, BioLineRx's lead therapeutic
candidate, was approved by the U.S. Food & Drug Administration (FDA) in
September 2023, in combination with filgrastim (G-CSF), to mobilize
hematopoietic stem cells for collection and subsequent autologous
transplantation in patients with multiple myeloma, under the brand name
APHEXDA®. Motixafortide is also being evaluated in a Phase 1 clinical trial
evaluating motixafortide as a monotherapy and in combination with natalizumab
for CD34+ hematopoietic stem cell (HSC) mobilization for gene therapies in
sickle cell disease (SCD).
Immuneering
Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking
to develop and commercialize universal-RAS/RAF medicines for broad populations
of cancer patients announced in February that the FDA granted Fast Track designation
for its lead clinical-stage program, IMM-1-104, for the treatment of patients
with PDAC who have failed one line of treatment. 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. 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,” said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of
Immuneering.
From the news: Vincent Chung, M.D., FACP, Professor,
Department of Medical Oncology and Therapeutics Research, is the principal
investigator of the Phase 1/2a clinical study with IMM-1-104 at City of Hope,
one of the largest cancer research and treatment organizations in the United
States.
“The FDA’s
decision reinforces the importance of developing effective, novel treatments to
improve the health outcomes of patients with pancreatic ductal adenocarcinoma.
The development of well-tolerated oral medicines would improve the lives of
these patients. City of Hope offers many clinical trials testing innovative
treatments for people with pancreatic cancer," Chung said.
Candel Therapeutics, Inc.(Nasdaq: CADL), a clinical stage biopharmaceutical company
focused on developing multimodal biological immunotherapies to help patients
fight cancer, previously announced that the FDA granted Fast Track Designation
for its lead investigational adenovirus asset CAN-2409 plus prodrug
(valacyclovir) for the treatment of patients with PDAC to improve overall
survival.
“We are pleased with the FDA's decision to grant Fast Track
Designation for CAN-2409 in pancreatic cancer,” said Paul Peter Tak, MD, PhD,
FMedSci, President and CEO of Candel. “This milestone follows our first interim
data report from the randomized phase 2 clinical trial in patients with
borderline resectable PDAC that showed prolonged and sustained survival after
experimental treatment with CAN-2409, especially when compared to real-world
data on patients receiving radiotherapy treatment. Candel remains on track to
release updated overall survival data from the interim analysis of this clinical
trial in the second quarter of 2024. We are grateful to the patients,
caregivers, investigators and clinical sites that have taken part in this
clinical trial.”
With lives at stake and market opportunity in front of
them, the race is on for companies aiming to fast track solutions for
pancreatic cancer. It’s a race worth winning!
References
1.
Botta G, et al. SWI/SNF
complex alterations as a biomarker of immunotherapy efficacy in pancreatic
cancer. JCI Insight. 2021;6(18):e150453. https://doi.org/10.1172/jci.insight.150453.
2.
Yoon JH, et al.
Immunotherapy for pancreatic cancer. World J Clin Cases. 2021 May
6;9(13):2969-2982. doi: 10.12998/wjcc.v9.i13.2969. PMID: 33969083; PMCID:
PMC8080736.
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