BlueRock Therapeutics and bit.bio announce collaboration and option agreement for the discovery and manufacture of regulatory T cell (Treg) based therapies

• Research collaboration leverages bit.bio’s machine learning-powered discovery platform to identify transcription factor (TF) combinations for reprogramming induced pluripotent stem cells (iPSCs) into Tregs.
• Agreement includes option for BlueRock to license TF combinations emerging from the collaboration as well as an option to license bit.bio’s opti-ox™ precision cell programming technology for the manufacture and subsequent development of iPSC-derived Treg cell therapies.
• bit.bio receives an upfront payment from BlueRock and is eligible to receive milestone payments and royalties on worldwide sales of all therapies resulting from the collaboration.

CAMBRIDGE, Mass. and CAMBRIDGE, United Kingdom, Aug. 3, 2023 /PRNewswire/ --BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned, independently operated subsidiary of Bayer AG, and bit.bio, the company coding human cells for novel cures, today announced a collaboration and option agreement for the discovery and manufacture of iPSC-derived regulatory T cells (Tregs) for use in creating therapeutics.

“Tregs play a crucial role in maintaining balance in the body’s immune system and controlling excessive immune reactions,” said Stefan Irion, MD, Chief Scientific Officer of BlueRock Therapeutics. “iPSC-derived Treg based therapies have the potential to treat a broad range of autoimmune and inflammatory disorders, and we look forward to collaborating with the bit.bio team to explore how their opti-ox cell programming technology can accelerate our efforts to discover and manufacture Tregs from iPSCs.”

“We are delighted to partner with the team at BlueRock, who are world-leaders in iPSC-derived cell therapies, and together address the significant unmet needs of these patients.” said Mark Kotter, MD PhD, CEO of bit.bio. “Today’s announcement marks an important milestone for bit.bio. As well as providing significant financial contributions, our collaboration is a testament to the unique capabilities of bit.bio’s team.”

Under the terms of the agreement, bit.bio will use its machine learning powered discovery platform to identify transcription factor (TF) combinations for reprogramming iPSCs into Tregs. The agreement also includes options for BlueRock to license bit.bio’s opti-ox precision cell programming technology to control the expression of TF combinations within Treg cell therapies. opti-ox uses a dual genomic safe harbour approach to cell programming, and bit.bio uses opti-ox to drive the rapid TF-mediated conversion of iPSCs into highly defined cell types in a single step. This can be achieved within days and at industrial scale, while maintaining exceptional purity and unparalleled consistency.

BlueRock will be responsible for the global development and commercialization of therapeutic candidates emerging from the collaboration. bit.bio receives an upfront payment and is eligible to receive milestone payments and royalties on worldwide sales of all therapies resulting from the collaboration.

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate” and “intend,” among others. These forward-looking statements are based on BlueRock’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the outcomes our collaboration with bit.bio and ongoing FDA and other regulatory requirements. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Except as expressly required by law, BlueRock does not undertake an obligation to update or revise any forward-looking statement. All of BlueRock’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

About BlueRock Therapeutics LP
BlueRock Therapeutics LP is a clinical stage cell therapy company focused on creating cellular medicines to reverse devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for patients suffering from neurological, cardiovascular, immunological, and ophthalmic diseases. Our lead clinical program, bemdaneprocel, (BRT-DA01) is in Phase I clinical trials for Parkinson’s disease. We were founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, BlueRock became a wholly owned, independently operated subsidiary of Bayer AG as a cornerstone of its newly formed Cell & Gene Therapy Platform. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. For more information, visit bluerocktx.com

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About bit.bio
bit.bio is a synthetic biology company focused on human cells that is advancing medicine (UN SDG9) and enabling curative treatments (UN SDG3). The company does this by industrializing the manufacture of human cells and making them more accessible. The company was spun out of the University of Cambridge in 2016 and has since raised approximately $200m from investors such as Arch Ventures, Foresite Capital, Milky Way, Charles River Laboratories, National Resilience, Tencent, Verition Fund and Puhua Capital.

bit.bio’s opti-ox™ precision cell programming and manufacturing technology enables conversion of induced pluripotent stem cells (iPSCs) into any desired human cell type in a single step. This can be achieved within days and at industrial scale, while maintaining exceptional purity and unparalleled consistency.

Our discovery platform extends this approach to any desired cell type by identifying the transcription factor combinations that define cell states (including identity, cell subtype identity, maturity) using high throughput screens and advanced data analysis. We believe that opti-ox can revolutionize regenerative medicine similarly to how CRISPR is unlocking gene therapy.

bit.bio’s cell therapy pipeline is focused on serious diseases that currently lack effective treatments. Our preclinical research areas include liver, immunology and metabolic disease. In addition, our extensive ioCells™ research cell product portfolio, which includes wild type and disease model cells, is opening up new possibilities for studying human biology and developing new medicines in both research and high throughput and high content drug discovery.

For more information, please visit www.bit.bio

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.

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