Cancer Immunotherapy Stocks to Watch (NASDAQ: $ONCY)
(TSX: $ONC.TO) (Nasdaq: $CADL) (Nasdaq: $BNTX) (NASDAQ: $IMTX) @Oncolytics @CandelTx @BioNTech_Group
@immatics
Tapping into Immune
Systems for Next Generation Treatments
February 15,
2024 - Investorideas.com, a global investor news source covering
biotech and pharma stocks issues a sector snapshot on cancer immunotherapy featuring
Oncolytics Biotech® Inc. (NASDAQ:
ONCY) (TSX:
ONC), a clinical-stage immunotherapeutics
company focused on oncology.
Read this in full at https://www.investorideas.com/news/2024/biotech/02151Cancer-Immunotherapy-Stocks.asp
According to the American Association for Cancer Research “Cancer immunotherapeutics work by unleashing
the power of a patient’s immune system to fight cancer and, over the last
decade, have emerged as one of the most exciting new approaches to cancer
treatment.”
“The prolific
growth in the cancer immunotherapy sector, fuelled by technological advances
and a high prevalence of cancer-related cases, is set to significantly enhance
the global market landscape. The market, which was valued at US$ 96.40 billion
in 2023, is estimated to achieve a remarkable CAGR of 10.02% between the years
2023 and 2030, with projections placing its value at approximately US$ 188.11
billion by the end of the decade,” reports ResearchandMarkets.
Oncolytics Biotech® Inc. (NASDAQ:
ONCY) (TSX:
ONC) is developing pelareorep, a unique
immunotherapy with the power to awaken the immune system and unlock its
antitumor potential. Pelareorep is delivered intravenously and is systemically
active, setting it apart from other immunotherapies that must be injected into
the tumor.
The Company just announced
the expansion of enrollment for the anal cancer cohort of the GOBLET study
evaluating pelareorep in combination with atezolizumab (Tecentriq®)
in patients with second-line or later unresectable squamous cell carcinoma of
the anal canal (SCCA). The study was expanded based on positive data from Stage
1 of the study, presented at the 2nd International Multidisciplinary
Anal Cancer Conference (IMACC) in November 2023 (link
to the PR, link
to the poster).
“These exciting clinical data, which exceed
the Simon two-stage success criteria, provide strong support to expand the
evaluation of pelareorep in patients with advanced anal cancer. The results
reported at IMACC 2023 showed that the combination of pelareorep and
atezolizumab provided a 37.5% objective response rate, including one patient
with a long-lasting complete response, and good overall tolerability. These
data represent a meaningful contrast to recent clinical trial results which
show that patients with second-line or later anal carcinoma treated with
checkpoint inhibitor therapy experienced response rates of 10-14%1-3,”
said Dr. Matt Coffey, President and Chief Executive
Officer of Oncolytics.
“We begin the Stage 2 expansion with
substantial optimism for patients and the potential of pelareorep, especially
considering the initial efficacy signal observed for pelareorep-based therapy
in pancreatic cancer. There is currently no established standard therapy for
patients with anal carcinoma who have failed first-line treatment. Continued
positive results could potentially expand the opportunity for pelareorep beyond
the lead indications of breast cancer and pancreatic cancer and open the door
to a rapid regulatory pathway in this rare and significantly under-served
patient population,” continued Dr. Coffey.
Dirk Arnold, M.D., Ph.D., Director of
Asklepios Tumorzentrum Hamburg and primary investigator of the GOBLET trial,
commented, “One of the most difficult challenges in my practice is the limited
number of treatment options that are available for patients with advanced anal
cancer who have progressed on first-line therapy. I am enthusiastic about the
expansion of this cohort because it will enable the continued evaluation of the
pelareorep/atezolizumab combination and could provide important confirmatory
data that may lead to better treatment options for patients with this
late-stage disease.”
“We look forward to
building on the oncology community’s enthusiastic reception of the IMACC 2023
data by expanding enrollment in the anal carcinoma cohort and incorporating
additional sites into the study,” commented Thomas Heineman, M.D., Ph.D., Chief
Medical Officer at Oncolytics. “Careful consideration of recently published
clinical trial results indicates that a modest expansion of fewer than 20
patients will be sufficient to solidify the efficacy signal we have observed to
date and lay the groundwork for a potential future registrational study in this
population. We look forward to continuing our excellent collaboration with the
clinical sites and investigators at AIO and hope to report additional results
in 2025.”
The GOBLET (Gastrointestinal
tumOrs exploring the treatment comBinations with the oncolytic
reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2
multiple indication study in advanced or metastatic gastrointestinal tumors.
The study is being conducted at 12 centers in Germany and is being managed by
AIO-Studien-gGmbH. The co-primary endpoints of the study are objective response
rate (ORR) assessed at week 16 and safety. Key secondary and exploratory
endpoints include additional efficacy assessments and evaluation of potential
biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage
design with Stage 1 comprising four treatment groups:
- Pelareorep in
combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line
advanced/metastatic pancreatic cancer patients;
- Pelareorep in
combination with atezolizumab in 1st line MSI
(microsatellite instability)-high metastatic colorectal cancer patients;
- Pelareorep in
combination with atezolizumab and TAS-102 in 3rd line
metastatic colorectal cancer patients; and
- Pelareorep in
combination with atezolizumab in 2nd line advanced and
unresectable anal cancer patients.
Candel Therapeutics, Inc.(Nasdaq:CADL),
a clinical stage biopharmaceutical company focused on developing multimodal
biological immunotherapies to help patients fight cancer had big gains on news
as it announced
that the US Food and Drug Administration (FDA) granted Fast Track Designation
for CAN-3110 -- a first-in-class, replication-competent herpes simplex virus-1
(HSV-1) oncolytic viral immunotherapy candidate – for the treatment of patients
with recurrent high-grade glioma (HGG) to improve overall survival.
“Receiving FDA Fast Track Designation for
CAN-3110 reinforces the critical need to find effective treatment options for
patients with recurrent HGG and further supports the potential of CAN-3110 to
address the challenges that the standard of care and conventional therapies
have failed to meet,” said Paul Peter Tak, MD, PhD, FMedSci, President and CEO
of Candel. “As recently published in Nature, a strong local and systemic
anti-tumoral response and improved survival in patients with recurrent HGG was
observed following a single injection of CAN-3110. We look forward to reporting
additional data, including the potential benefits from multiple injections of
CAN-3110, from the ongoing phase 1b clinical trial in the second half of 2024.”
From
the news continued: In October 2023, Candel
and academic collaborators at the Brigham and Women’s Hospital published
results from the ongoing phase 1b clinical trial in Nature, demonstrating that
CAN-3110 was well tolerated with no dose-limiting toxicity reported. The
investigators observed a nearly doubling of the expected median overall
survival (mOS) after a single CAN-3110 injection, achieving a mOS of ~12
months, compared to historical reports of less than 6 to 9 months in this
therapy-resistant condition. Positive HSV-1 serology was a predictor of
response and was associated with improved survival (mOS in this population
reached 14 months). Increased infiltrating immune cells in the tumor
microenvironment and expansion of the T cell repertoire after administration
were also associated with improved survival, suggesting that CAN-3110 can
elicit both a local and systemic antitumoral response.
“Recurrent HGG is one of the most
aggressive malignancies for which there is no cure, representing a significant
and urgent unmet need,” said Antonio Chiocca, MD, PhD, Head of Department of
Neurosurgery at Brigham and Women’s Hospital, Professor at Harvard Medical
School, and Principal Investigator. “With Fast Track Designation, I look
forward to the potential of accelerating the development of CAN-3110 and the
possibility of bringing this differentiated therapy to patients with recurrent
high-grade glioma as we strive to improve outcomes and provide hope for
patients and their families.”
BioNTech (Nasdaq:BNTX),
an immunotherapy company pioneering novel therapies for cancer and other
serious diseases and Autolus Therapeutics plc, a clinical-stage
biopharmaceutical company developing next-generation programmed T cell
therapies, recently announced
a strategic collaboration aimed at advancing both companies’ autologous CAR-T
programs towards commercialization, pending regulatory authorizations. In
connection with the strategic collaboration, the companies entered into a
license and option agreement and a securities purchase agreement.
“The collaboration with Autolus enables us
to expand our BNT211 program into trials for multiple cancer indications in a
cost-efficient way. Autolus' state-of-the-art manufacturing facilities’ set-up
for clinical and commercial supply will enhance our own capacities in addition
to our existing U.S. supply network and the ongoing expansion of our site in
Gaithersburg, Maryland,” said Prof. Ugur Sahin, M.D., CEO and Co-Founder of
BioNTech. “Furthermore, this collaboration grants us access to Autolus' precise
cell targeting tools to further support BioNTech’s development of in vivo cell
therapy and antibody-drug conjugate candidates."
From
the news continued: “We see a remarkable
opportunity to leverage our core capabilities, accelerate pipeline programs,
realize cost-efficiencies and expand opportunities beyond autologous cell
therapies,” said Dr. Christian Itin, CEO of Autolus. “We look forward to
investing a portion of the capital raised on delivering on obe-cel’s path in
adult acute lymphoblastic leukemia, potentially offering another treatment
option for patients where there is still an unmet medical need. This
collaboration creates a path for accelerating our respective oncology pipeline
programs and broadening the use of Autolus’ technology outside of autologous
cell therapy applications.”
BioNTech has agreed to purchase $200
million of Autolus’ American Depositary Shares in a private placement. BioNTech
will have a right to appoint a director to the Board of Autolus.
Pharmaceutical Technology reports, “Immatics (NASDAQ: IMTX) is one of
the leading patent filers in cancer immunotherapy. The biopharmaceutical
company is focused on the development of T cell immunotherapies to fight
against cancer. Immatics combines the discovery of targets for cancer
immunotherapies with the development of the right T cell receptors with the
goal of enabling a robust and specific T cell response against targets. It is
committed to delivering the power of T cells and to unlocking new avenues for
patients in their fight against cancer. Bristol-Myers Squibb and Fate
Therapeutics are some of the other key patent filers in cancer immunotherapy.”
In mid-January
Immatics announced the pricing of an underwritten public
offering of 15,925,000 ordinary shares at a public offering price of $11.00 per
share. The gross proceeds from the offering, before deducting the underwriting
discount and offering expenses, are expected to be approximately $175 million.
For investors looking for the next trends in biotech, Pharmaceutical Technology also reports, “Cancer
immunotherapy has shown remarkable success in treating various types of cancers
and has revolutionized cancer treatment in recent years.”
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