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 Oncolytics 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 Oncolytics 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."

Article Source: : https://usanewsgroup.com/2020/02/24/why-biotechnology-companies-are-so-important/

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