22 February 2023, Zwingenberg, Germany

BRAIN Biotech and TransCode Therapeutics join forces to develop a CRISPR-derived technology platform for cancer treatment

BRAIN Biotech AG, industrial biotechnology and enzyme expert, today announced the signing of a joint development agreement (JDA) with TransCode Therapeutics, Inc. (Nasdaq: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics. The objective of the JDA is to co-develop a platform technology that combines a Class 2 CRISPR nuclease, the cell-killing G-dase E, developed by BRAIN Biotech's Akribion Genomics unit with TransCode's TTX nucleic acid delivery platform for the treatment of cancer.

TransCode’s proprietary TTX platform is designed to enable systemic delivery of targeted nucleic acid-based therapeutics to tumors and metastases. Akribion Genomics’ proprietary nuclease is designed to seek out selective genomic characteristics based on the existence of specific RNA biomarkers within target cells. Combining these technologies could unlock the potential of CRISPR-like cell targeting approaches for the treatment of cancer.

In addition, the parties signed a memorandum of understanding to jointly commercialize the combined technologies in the form of joint out-licensing agreements. “Specific depletion of cancer cells based on RNA biomarkers is a novel and powerful approach,” states Dirk Sombroek, PhD, member of the Akribion Genomics team of BRAIN Biotech AG. “The partnership with Transcode and a joint development could unleash the potential of our proprietary nucleases for therapeutic applications.”

Lukas Linnig, lead of Akribion Genomics activities at BRAIN Biotech AG, emphasizes: “Our ultimate goal is to develop the combined technologies into a technology platform that provides a basis for the development of drugs to treat cancer. This partnership with TransCode is therefore an important step on our challenging path to enter the field of cancer therapeutics with a new class of cancer treatment.

Zdravka Medarova, PhD, Co-founder and CTO of TransCode, comments: “Cell targeting technology based on genomic characteristics holds tremendous potential for the treatment of cancer. However, to fulfill the promise of a Class 2 CRISPR toolbox in oncology, it is critical to achieve highly specific and targeted delivery to tumor cells. This capability relies on having a safe and effective delivery vehicle, such as TransCode’s TTX is expected to represent, and a very precise cell-depletion tool, such as BRAIN Biotech’s G-dase E nucleases is believed to be.” She adds: “Combining these technologies could enable the development of further CRISPR-derived RNA biomarker targeting drugs effective against previously undruggable but highly impactful therapeutic targets in cancer.”

“This partnership has the potential to enable a functionally unique tool to fight cancer because unlike our other therapeutic candidates, it does not rely on inhibition or enrichment of cancer-relevant genetic targets but, instead, is designed to specifically kill a cell with a critical pathway dysfunction,” comments Michael Dudley, Co-founder, President and CEO of TransCode Dudley adds, “The timing of this partnership is ideal, given that we are in the process of initiating a first-in-human study aimed at demonstrating TTX’s capability of targeting clinical metastases.”

About BRAIN

BRAIN Biotech AG is a leading European supplier of bio-based products and solutions such as enzymes and proteins, microbial production strains, natural compounds and biotechnological solutions for more sustainable industrial processes. The company focuses on the fields of nutrition, health and environment.

BRAIN Biotech AG is the parent company of the international BRAIN Biotech Group. The Group's business activities are divided into three segments: The BioProducts segment comprises the product business with specialty enzymes and other proteins, for which the Group operates fermentation facilities in the United Kingdom and production facilities in continental Europe and the United States. The BioScience segment offers research-intensive custom solutions based on enzyme technology, strain development, bioprocess development and natural product screening. The BioIncubator segment conducts its own R&D projects or those initiated with partners with high value-added potential. A particularly promising incubator project is the development of the Company's own CRISPR-based gene editing technology platform, which is currently being established and expanded by Akribion Genomics (in foundation planning).

Through its own R&D activities, BRAIN Biotech Group is continuously expanding its product portfolio in the field of specialty enzymes and small molecules. The latter are the starting point for screenings, e.g. for novel drug candidates for pharmaceutical applications.

BRAIN Biotech AG has been listed on the Prime Standard of the Frankfurt Stock Exchange since February 9, 2016 (ticker symbol: BNN; securities identification number: ISIN DE0005203947 / WKN 520394). The company employs approximately 330 people and generated revenues of EUR 55,3 million in the fiscal year 2022/23.

For more information, please visit: https://www.brain-biotech.com, LinkedIn, Threads and YouTube.

About TransCode Therapeutics

TransCode is an RNA oncology company created on the belief that cancer can be effectively treated using RNA therapeutics. The Company has created a platform of drug candidates designed to target a variety of tumor types with the objective of significantly improving patient outcomes. The Company’s lead therapeutic candidate, TTX-MC138, is focused on treating metastatic cancer, which is believed to cause approximately 90% of all cancer deaths totaling over nine million per year worldwide. The Company believes that TTX-MC138 has the potential to produce regression without recurrence in a range of cancers, including breast, pancreatic, ovarian and colon cancer, glioblastomas and others. Two of the Company’s other drug candidates, TTX-siPDL1 and TTX-siLIN28B, focus on treating tumors by targeting PD-L1 and LIN28B, respectively. TransCode also has three cancer-agnostic programs: TTX-RIGA, an RNA–based agonist of the retinoic acid-inducible gene I, or RIG-I, designed to drive an immune response in the tumor microenvironment; TTX-CRISPR, a CRISPR/Cas9–based therapy platform for the repair or elimination of cancer-causing genes inside tumor cells; and TTX-mRNA, an mRNA-based platform for the development of cancer vaccines designed to activate cytotoxic immune responses against tumor cells.

Disclaimer

This press release contains forward-looking statements. These statements reflect the current views, expectations, and assumptions of the management of BRAIN Biotech AG, and are based on information currently available to the management. Forward-looking statements are no guarantees of future performance, and entail both known and unknown risks as well as uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. Numerous factors exist that could influence the future performance of and future developments at BRAIN Biotech AG and the BRAIN Biotech Group. Such factors include, but are not limited to, changes in the general economic and competitive environment, risks associated with capital markets, currency exchange rate fluctuations, changes in international and national laws and regulations, in particular with respect to tax laws and regulations, as well as other factors. BRAIN Biotech AG does not undertake any obligation to update or revise any forward-looking statements.

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