Boehringer Ingelheim and Enara Bio Enter Strategic Collaboration and Licensing Agreement to Discover Novel Shared Antigens for Cancer Immunotherapies

• Collaboration focuses on up to three types of lung and gastrointestinal (GI) cancers

• Latest in a series of strategic acquisitions and partnerships that strengthens Boehringer Ingelheim’s position in the cancer vaccine and T-cell engager spaces

• Agreement and partnership with Boehringer Ingelheim provides additional validation of Enara Bio’s EDAPT™ platform and Dark Antigen™ discovery work and supports ongoing cell therapy based therapeutic approach

Ingelheim, Germany and Oxford and London, UK, January 12th, 2021 – Boehringer Ingelheim and Enara Bio, today announced that they have entered into a strategic collaboration and licensing agreement to research and develop novel targeted cancer immunotherapies, leveraging Enara Bio’s Dark Antigen™ discovery platform. This new collaboration combines Boehringer Ingelheim’s approach to tackle cancer through pairing leading science with innovative immune-oncology platforms, such as oncolytic viruses and cancer vaccines, with Enara Bio’s expertise in cancer antigen identification. The aim is to provide potential new therapies for patients with difficult to treat lung and gastrointestinal cancers.

“We are excited to partner with Enara Bio as part of our mission to bring transformative new treatments to cancer patients,” said Jonathon Sedgwick, Ph.D., Senior Vice President and Global Head, Cancer Immunology & Immune Modulation Research, Boehringer Ingelheim. “We are advancing a unique pipeline of cancer cell-directed agents, immuno-oncology therapies and intelligent combination approaches to help combat cancer. Enara Bio’s unique discovery platform offers a novel and highly differentiated approach that will allow us to look beyond the known proteome to identify and characterize Dark Antigens to support the development of T-Cell Receptor (TCR)-directed immunotherapies and therapeutic vaccines. We believe this is a highly innovative and promising approach to the development of the next wave of cancer immunotherapies.”

Enara Bio’s proprietary Dark Antigen Platform Technology (EDAPT™) will be used to discover and validate novel Dark Antigens in up to three tumor types in the lung and gastrointestinal cancer space. The discovery of shared antigens could lead to the development of vaccines that can be readily utilized to help a broader group of cancer patients.

Dark Antigens represent a new class of cancer-associated antigens that derive from the genomic dark matter, or the portion of the human genome that is normally not expressed as protein. Dark Antigen-encoding sequences are usually silenced in healthy cells but are activated and presented on tumor cells. They are associated with specific cancer types and, importantly, are shared across patients.

Since typically not visible to the immune system, they represent a large potential repertoire of novel antigens that can be developed as targets for new immunotherapies.

“We are extremely pleased to enter this strategic licensing agreement, our first major deal leveraging our pioneering Dark Antigen discovery and validation capabilities,” said Kevin Pojasek, President and CEO of Enara Bio. “Boehringer Ingelheim is an innovation-led company dedicated to producing breakthrough treatments with a significant focus on cancer. We are excited to build this relationship and are encouraged that Boehringer Ingelheim shares our view of the potential of Dark Antigens to be a source of important and unconventional targets for novel cancer immunotherapies. This agreement provides strong validation for our science and our approach to exploiting the cancer-associated antigenic repertoire derived from genomic dark matter and we look forward to a productive collaboration.”

This collaboration with Enara Bio is the latest of several strategic partnerships and acquisitions for Boehringer Ingelheim to build its cancer vaccine platform and provides important validation for Enara Bio’s Dark Antigen platform. The past acquisitions of ViraTherapeutics and AMAL Therapeutics’ vaccine modalities coupled with Enara Bio’s capabilities position Boehringer Ingelheim to develop sophisticated virus and vaccine modalities for its prime/boost vaccine platform.

Under the agreement, Boehringer Ingelheim has the option to license Dark Antigens discovered and validated by Enara Bio. Boehringer Ingelheim will also be responsible for all non-clinical and clinical development, as well as commercialization of associated cancer immunotherapies, including therapeutic vaccines and T-cell redirecting biologics. Enara Bio retains rights to use any discovered antigens for use in cell therapy-based products.

Enara Bio is eligible to receive an upfront payment, together with research/preclinical milestones and licensing fees for each tumor type that is explored. Enara Bio is also eligible to receive more than EUR 876 million in clinical, regulatory and commercial milestones, in addition to royalties on future product sales.

About Boehringer Ingelheim

Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of 19 billion euros. Our significant investment of almost 3.5 billion euros in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

More information about Boehringer Ingelheim can be found at www.boehringer-ingelheim.com or in our annual report http://annualreport.boehringer-ingelheim.com.

Boehringer Ingelheim in Oncology

Cancer takes. Takes away time. Takes away loved ones. At Boehringer Ingelheim Oncology, we are giving patients new hope, by taking cancer on. We are dedicated to collaborating with the oncology community on a shared journey to deliver leading science. Our primary focus is in lung and gastrointestinal cancers, with the goal of delivering breakthrough, first-in-class treatments that can help win the fight against cancer. Our commitment to innovation has resulted in pioneering treatments for lung cancer and we are advancing a unique pipeline of cancer cell directed agents, immuno-oncology therapies and intelligent combination approaches to help combat many cancers.

About Enara Bio

Enara Bio (formerly Ervaxx) is a science-led company targeting the T-cell/cancer-cell interface (the “immune synapse”) to develop new targeted cancer immunotherapies designed to treat a broad patient population. Enara Bio is exploring the hidden depths of cancer and T-cell biology to discover and characterize novel immunotherapy targets, such as Dark Antigens™ and MR1-presented ligands. We are pioneering approaches to exploit these targets with TCR-directed T-cell immunotherapy and therapeutic vaccines. To achieve our mission, we are leveraging our differentiated Dark Antigen™ and TCR discovery platforms that integrate bioinformatics, immunopeptidomics, metabolomics and immunology in our Oxford, UK-based research lab. Enara Bio is backed by leading life science investors, including SV Health Investors. We have partnerships with world-class academic institutions, including the Francis Crick Institute, Cardiff University, Johns Hopkins School of Medicine and the University of Oxford, to help drive the leading edge of these new areas of science.

For more information visit: www.enarabio.com