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Brooklyn ImmunoTherapeutics LLC (NYSE American: BTX) ("Brooklyn") today announced it has acquired an exclusive license for mRNA gene editing and cell therapies technology of Factor Bioscience Limited and Novellus Therapeutics Limited pursuant to an exercise of a previously announced option.
The license includes use of an extensively patented process to develop gene editing compounds using mRNA, which preclinical data suggest demonstrate a high degree of efficiency, as well as being non-immunogenic and non-mutagenic.
The licensed platform includes mRNA cell reprogramming, which is considered to be the highest efficiency and footprint-free technology that can be applied to both allogeneic and autologous cells, and is combined with mRNA-based gene editing – along with a proprietary gene editing protein – to eliminate off-target effects. It also includes the proprietary ToRNAdo lipid delivery system that provides efficient delivery of mRNA ex vivo and in vivo to skin, brain, eye and lung tissue.
"As a result of the license acquisition, Brooklyn is now poised to become a key player among companies exploring gene editing for cell therapies. This mRNA gene editing technology has the potential to be disruptive given its high efficiency and relatively low manufacturing costs. We look forward to continuing the work begun by Factor Bioscience and Novellus with this platform and to reporting our progress as our products advance towards the clinic," commented Howard J. Federoff, M.D., Ph.D., Chief Executive Officer and President of Brooklyn. "Our licensing of this technology represents a significant advancement in our approach to treating cancers, blood and other disorders, and transforms us from a single therapeutic company with multiple potential indications to a platform company with multiple products in a pipeline of next-generation engineered cellular medicines."
Brooklyn intends to initiate pre-clinical development programs for sickle cell anemia, other inherited monogenic disorders, and solid and liquid tumors, with the intention of being at the Investigational New Drug (IND) stage for at least one of these disorders by 2024.
About Brooklyn ImmunoTherapeutics
Brooklyn is exploring the role that cytokine-based therapy can have in treating patients with cancer, both as a single agent and in combination with other anti-cancer therapies. The company is also exploring opportunities to advance oncology and blood disorder therapies using leading edge gene editing/cell therapy technology through the newly acquired license from Factor Bioscience and Novellus.
Brooklyn’s most advanced program is studying the safety and efficacy of IRX-2 in patients with head and neck cancer. In a Phase 2A clinical trial in head and neck cancer, IRX-2 demonstrated an overall survival benefit. Additional studies are either underway or planned in other solid tumor cancer indications.
For more information about Brooklyn and its clinical programs, please visit www.BrooklynITx.com.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, concerning Brooklyn's expectations, anticipations, intentions, beliefs or strategies regarding the future that are not statements of historical fact, including statements in the fourth and fifth paragraphs related to potential future development and growth. These statements are based upon the current beliefs and expectations of Brooklyn's management and are subject to significant risks, uncertainties, and other factors. Brooklyn’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors, including, but not limited to: (i) Brooklyn’s ability to successfully, cost-effectively and efficiently develop its technology and products; (ii) Brooklyn’s ability to successfully commence clinical trials of any products on a timely basis or at all; (iii) Brooklyn’s ability to successfully fund and manage the growth of its development activities; (iv) Brooklyn’s ability to obtain regulatory approvals of its products for commercialization; and (v) uncertainties related to the impact of the COVID-19 pandemic on the business and financial condition of Brooklyn, including on the timing and cost of the BR-202 clinical trial. Additional factors and risks are described in Brooklyn’s periodic reports filed with the Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Forward-looking statements are made based on information available to Brooklyn on the date of this press release, and Brooklyn assumes no obligation to update the information contained in this press release.
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