Abzena, the life sciences group providing services and technologies to enable the development and manufacture of biopharmaceutical products, has signed a licensing agreement and a master services and clinical supply agreement with OBI Pharma, a Taiwanese biopharmaceutical company.
The licensing agreement is for Abzena’s novel site-specific ThioBridge antibody drug conjugate (ADC) linker technology to develop OBI’s proprietary ADC, OBI-999 and a series of further ADCs as potential treatments for cancer.
ThioBridge links antibodies and other proteins to drugs. The technology platform is unique in its ability to maintain the stability of the antibody and a consistent Drug-to-Antibody Ratio (DAR), which provides a more uniform product.
OBI-999 specifically targets cancer cells overexpressing the cancer antigen Globo H. The Globo series comprises a group of cancer-associated carbohydrate antigens including Globo H, SSEA3 and SSEA4 that are over-expressed in more than 14 types of cancers, including breast, lung, gastric and colorectal.
By releasing the cytotoxic payload to the targeted cancer cells, the aim is to trigger cancer apoptosis while minimising the drug’s toxicities to normal cells.
OBI has observed encouraging results for OBI-999 in preclinical studies and plans to accelerate the development of OBI-999 and other Globo series ADCs. Phase I IND preparations are underway including Chemistry Manufacturing Control (CMC) planning and toxicology study design.
Concurrent with the signing of the licence agreement, Abzena and OBI have entered into a Master Services and Clinical Supply Agreement for Abzena to provide OBI with further manufacturing process development and GMP manufacture of OBI-999 and further ADCs.
Under the terms of this agreement, OBI will receive a worldwide exclusive licence to use the ThioBridge technology to research, develop and commercialise ADCs targeting the Globo series.
Abzena will receive a small initial up-front payment from OBI and has the potential, subject to successful development, to receive up to £128 million, in aggregate, which may become payable upon achievement of certain development, regulatory and commercialisation milestones. In addition, Abzena will also receive royalties on sales of any approved ADC products that incorporate the ThioBridge technology.
Amy Huang, General Manager of OBI Pharma, Inc., said: “OBI is pleased to collaborate with Abzena for our OBI-999 and other potential pipeline candidates using Abzena’s innovative ThioBridge technology. The collaboration enhances our ADC development programme and we hope to develop effective cancer treatments for patients with cancers that express Globo series antigens.”
Dr John Burt, CEO of Abzena, commented: “This latest licence deal follows on from a successful evaluation programme of the ThioBridge technology for OBI by Abzena. The overall ADC development programme for OBI draws on Abzena’s chemistry research and manufacturing capabilities across the Cambridge (UK) and Bristol (Pennsylvania) facilities, and reaffirms the value of Abzena’s integrated offering.”
“The expansion of our offering to include GMP manufacturing for ADCs has been enabled by our recent fundraising and this deal is a good example of our ability to continue to support our partners with our broader chemistry research services, process development and manufacturing capabilities.”