VANCOUVER –
USA News Group
– Hope is on the horizon for
revolutionary treatments
meant to target solid tumors, which have historically been some the
toughest cancers to treat
. Beyond extending life expectancy, the incentive to tackle this form of cancer is enormous. The Global Solid Tumor Therapeutics Market is one of the fastest growing sectors in immunology, projected to grow at a high
CAGR of 16%
through to 2029, with expectations to reach
US$424.6 billion by 2027
. Working towards new forms of treatment are a series of biotech developers, including
O
ncolytics Biotech Inc.
(NASDAQ:ONCY) (TSX:ONC),
Gilead Sciences, Inc.
(NASDAQ:GILD),
Novartis AG
(NYSE:NVS),
Bristol-Myers Squibb Company
(NYSE:BMY), and
BioNTech SE
(NASDAQ:BNTX).
Among the breakthrough treatments on the horizon are those involving
CAR T-cell therapy
, where a patient’s T cells are altered in a laboratory to attack cancer cells. Recently,
researchers at Mayo Clinic
reported they’ve devised an immunotherapy technique by loading CAR T cells with
oncolytic viruses
to treat solid tumors.
One platform proving to be synergistic with CAR T therapies involves a non-pathogenic double-stranded RNA virus known as reovirus. Developed under its trade name
pelareorep
, proprietors
O
ncolytics Biotech Inc.
(NASDAQ:ONCY) (TSX:ONC) recently announced the publication of
preclinical data
demonstrating oncolytic virus-mediated synergistic anti-cancer activity when combined with CAR T cell therapy in solid tumors.
The results were published in a paper in
Science Translational Medicine
in collaboration with researchers at several prestigious institutions, including the Mayo Clinic and Duke University.
“Having these results published in such a high-impact journal provides important external validation of their significance,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of
Oncolytics Biotech
. “This is a powerful finding that, if translated to the clinic, could significantly improve the prognosis of patients with a variety of highly prevalent cancers by providing a novel and potentially durable treatment option.”
Preclinical studies published in the paper evaluated the persistence and efficacy of pelareorep-loaded CAR T cells (“CAR/Pela therapy”) in multiple murine solid tumor models, including showing the persistence and anti-cancer activity of CAR T cells improving drastically, and statistically significant survival benefits in murine skin and brain cancer models.
“These exciting results are an excellent example of how we are leveraging collaborations with key opinion leaders and premier research institutions to broaden pelareorep’s potential therapeutic impact,” said Dr. Matt Coffey, President and CEO of
Oncolytics Biotech
and co-author of the paper. “As we pursue this opportunity moving forward, we intend to utilize relationships with academic or industry partners so that we can continue to execute on our clinical and corporate objectives with efficiency.”
In order to meet the growing patient demand for these new types of cancer, the US FDA recently
approved commercial production
at a new state-of-the-art Maryland facility owned and operated by
Kite
, a subsidiary of
Gilead Sciences, Inc.
(NASDAQ:GILD).
“The FDA approval of our Maryland site marks an important milestone within our global CAR T-cell therapy manufacturing network, and will enable us to significantly expand our production capacity and further strengthen our ability to meet the needs of people living with difficult-to-treat blood cancers,” said Christi Shaw, CEO of
Kite
.
The site is set to produce
Kite’s
FDA approved CAR T-cell therapy—in this case used to treat blood cancer. CAR T-cell therapies are individually manufactured for each patient using their own T-cells extracted from their white blood cells.
Kite
therapies are available at over 275 authorized treatment centers (ATCs), or hospitals around the world, including more than
110 leading cancer hospitals
in the U.S.
When
Gilead
identified the potential for
Kite’s
technology, it agreed to acquire the California-based
Kite
for
nearly $12 billion in 2017
.
However, one of the candidates
Kite
was developing involved solid tumors, which was sold to
BioNTech SE
(NASDAQ:BNTX) in July of 2021. Among the
assets sold
to
BioNTech
were
Kite’s
neoantigen TCR cell therapy R&D platform and manufacturing facility in Gaithersburg, Maryland.
Flash forward to 2022, and in a clinical trial sponsored by
BioNTech’s
subsidiary BioNTech Cell & Gene Therapies, their new CAR T-cell therapy has shown an acceptable safety profile and demonstrated
early signs of efficacy
as a monotherapy and in combination with an mRNA vaccine in patients with solid tumors.
“We have five ongoing randomized Phase 2 trials across a range of solid tumor indications,” commented
BioNTech
co-founder and CEO, Ugur Sahin during a
recent earnings call
. “This includes our FixVac, iNeST, Bispecific antibody program… [and] includes the cell therapy facility we acquired from
Kite
as well as the
Medigene
asset acquisition and discovery collaboration that further expanded our TCR pipeline.”
Sahin went on to state that his company believes TCR (T-Cell Receptor therapy) “has the potential to be best-in-class for a range of solid tumors.”
Novartis AG
(NYSE:NVS) recently presented
early clinical data
for its unique KRASG12C inhibitor. The data demonstrated anti-tumor activity, high systemic exposure at its recommended dose, and a favorable safety profile based on initial clinical data in patients with
KRAS G12C
-mutated solid tumors.
The company’s proposed treatment KontRASt-01 (NCT04699188) is a phase Ib/II open-label, multi-center, dose escalation study of JDQ443, in patients with advanced solid tumors harboring the
KRAS G12C
mutation, including NSCLC and colorectal cancer.
“After decades without a breakthrough, we as an industry are entering a transformative era in targeted treatment for
KRAS-mutated
cancers,” said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development at
Novartis
. “Today’s preliminary data are an encouraging signal that we are on the right path as we continue to investigate single-agent and multiple combination strategies designed to enhance efficacy of G12C targeted therapy and improve outcomes of patients with
KRAS G12C
-driven cancers.”
In order to obtain even more
advance research
into options for solid tumor treatment,
Bristol-Myers Squibb Company
(NYSE:BMY) has partnered with
Roche
to leverage the capabilities of artificial intelligence and computation technology in digital pathology. The goal of the projects is to generate information that can be used to advance personalized solid tumor treatment options and aid in more accurate cancer diagnoses.
“We believe digital methods will bring significant improvements in standardization and interpretation of tissue-based assays and will enable broader access to tissue-based assays,” said Sarah Hersey, the vice president for the translational sciences and diagnostics arm of
Bristol Myers Squibb
. “The ability to more deeply interrogate images will present opportunities to better understand disease biology, potentially leading to expanded and improved drug development options and ultimately highly effective patient selection strategies.”
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