Enbio: Partnered with BioNTech to advance the development of next-generation antibody conjugated drugs (ADCs)

DualityBio announced that it has entered into an exclusive licensing and collaboration agreement with BioNTech for two antibody-coupled drug (ADC) pipelines, DB-1303 and DB-1311. BioNTech will acquire the rights to develop, manufacture and commercialize the two antibody-conjugated AdCs worldwide (excluding Mainland China, Hong Kong and Macau), while DualityBio will retain the rights to develop, manufacture and commercialize the two antibody-conjugated AdCs in mainland China, Hong Kong and Macau.

•DualityBio will receive a total down payment of $170 million and is expected to receive development, registration and commercialization milestone payments totaling more than $1.5 billion, as well as royalty payments in the range of units to double digits of net potential future sales

•BioNTech will receive an exclusive license from DualityBio for two investigational antibody-conjured drug pipelines (DB-1303 and DB-1311) targeting targets widely expressed in human cancer

• This collaboration will add a new class of precision medicine therapies to BioNTech's clinical oncology portfolio, broadening its immunotherapy portfolio with synergistic potential

ADC is a class of effective cancer therapies that combine the selectivity of antibodies with the potent cell-killing effects of chemotherapy or other anticancer agents.

As part of the collaboration, BioNTech will gain access to Enbio's lead drug candidate DB-1303, an ADC product based on topoisomerase-1 inhibitors that target human epidermal growth factor receptor 2 (HER2). Overexpression of this target in many cancers encourages aggressive growth and spread of cancer cells. Antibody therapy targeting HER2 has been shown to be an effective treatment strategy for HER2-expressing cancers. The DB-1303 program has received fast track approval from the United States Food and Drug Administration (" FDA ") and is currently in Phase II clinical trials (NCT05150691) in multiple advanced solid tumors expressing HER2.

BioNTech will also acquire another ADC candidate, DB-1311, based on topoisomerase-1 inhibitors.

Founder and CEO of DualityBio

Dr Zhu Zhongyuan said:

"We are excited to partner with BioNTech, a leading company that is bringing novel treatment options to patients through innovation. This cooperation is not only BioNTech's recognition of Yinen's next-generation ADC platform, but also its R&D capability. Through this collaboration, Inen and BioNTech will work together to advance the development of innovative therapies for the benefit of patients around the world!"

CEO and Co-founder of BioNTech,

UgurSahin Wu Shaxin, MD, said:

"Significant progress has been made in the ADC field over the past few years. The breakthrough of the new technology overcomes some limitations of the original drugs and demonstrates the potential of ADC as a precision medicine drug. ADC could be an alternative to standard chemotherapy. The introduction of two ADC pipelines in collaboration with Inen Bio-will strengthen our tumor immunotherapy portfolio and enhance our ability to treat solid tumor patients."

Under the terms of the agreement, Yingen Bio will receive a total of $170 million in initial payments and is expected to receive a total of more than $1.5 billion in development, registration and commercialization milestone payments. In addition, Yingen will also receive a double-digit percentage of the net potential sales of the two ADC products as royalty. BioNTech will acquire the rights to develop, manufacture and commercialize the two antibody-conjugated AdCs worldwide (excluding Mainland China, Hong Kong and Macau), and Enbio will retain the rights to develop, manufacture and commercialize the two antibody-conjugated ADCs in mainland China, Hong Kong and Macau. As part of the DB-1311 agreement, Enbio has the option to exercise its co-development and co-marketing options for the US market in the future.

About the DB-1303

The DB-1303 is a third generation HER2ADC product based on the unique DITAC technology platform of Enbio. Both HER2-positive and HER2-low tumor models showed strong antitumor activity, excellent safety, and a wide therapeutic window. Existing data from preclinical and early clinical studies indicate that DB-1303 has the potential to address the unmet medical needs of patients with various HER2-expressing tumors.

About the DB-1311

DB-1311 is the third generation ADC product based on the unique DITAC technology platform. It has demonstrated strong antitumor activity in a range of tumor models representing multiple cancer types, and has demonstrated good tolerability and favorable pharmacokinetic characteristics in preclinical safety evaluations. The preclinical antitumor activity and good safety demonstrated that DB-1311 has a broad treatment window in the future application, and it is possible to provide more treatment options for the majority of cancer patients.