Date: 2016-05-20
Type of information: Milestone
Compound: bispecific antibodies using DuoBody™ technology
Company: Genmab (Denmark) Janssen Biotech - J&J (USA)
Therapeutic area: Autoimmune diseases - Inflammatory diseases - Cancer - Oncology
Type agreement: R&D
development
Action mechanism: bispecific antibody. The DuoBody platform is a platform for the discovery and development of bispecific antibodies that may improve antibody therapy of cancer, autoimmune, infectious and central nervous system disease. Bispecific antibodies bind to two different epitopes either on the same, or on different targets (also known as dual-targeting) which may improve the antibodies' specificity and efficacy in inactivating the disease targets. DuoBody molecules are unique in combining the benefits of bispecificity with the strengths of conventional antibodies which allows DuoBody molecules to be administered and dosed as other antibody therapeutics. Genmab's DuoBody platform generates bispecific antibodies via a fast and broadly applicable process which is easily performed at standard bench, as well as commercial, manufacturing scale.
Disease: undisclosed
Details: * On July 12, 2012, Genmab has entered into a collaboration with Janssen Biotech to create and develop bispecific antibodies using its DuoBody technology platform. Genmab will create panels of bispecific antibodies to multiple disease target combinations identified by Janssen, who will in turn fully fund research at Genmab. Under the terms of the agreement, Genmab and Janssen will collaborate on the research of up to 10 DuoBody programs.
Financial terms: Genmab will receive an upfront payment of $3.5 million (DKK 21 million) from Janssen and all research by Genmab will be fully funded by Janssen. In addition, Genmab will potentially be entitled to milestone and license payments of up to approximately $175 million (DKK 1,062 million) for each product as well as royalties on any commercialized products.
* Under the expansion of the agreement announced in December 2013, Genmab will receive an initial payment of $2 million (approximately DKK 11 million) from Janssen. For each of the ten additional programs that Janssen successfully initiates, develops and commercializes, Genmab will potentially be entitled to milestone and license payments of up to approximately $174 million (DKK 956 million) to $219 million (DKK 1.2 billion), depending on the date each program is initiated. In the most favorable scenario in which all ten additional programs are successfully initiated, developed and commercialized, Genmab would receive average milestone and license payments of approximately $191 million (DKK 1.0 billion) for each of the ten programs. In addition, Genmab will be entitled to royalties on sales of any commercialized products.
Latest news: * On May 20, 2016, Genmab announced that the first participants have been dosed in a clinical study of a DuoBody® bispecific antibody under Genmab’s DuoBody technology platform collaboration with Janssen Biotech. The Phase I study investigates the human bispecific antibody JNJ-61178104, which is directed to two inflammatory disease targets, for potential use in treating autoimmune disorders. Genmab will receive a $2 million milestone payment for the progress in the study. A total of 12 programs have been activated through this collaboration. Seven clinical candidates have been selected for development by Janssen and three DuoBody programs are entering the clinic. * On December 21, 2015, Genmab announced it has achieved a $3 million milestone in its DuoBody technology platform collaboration with Janssen Biotech. The milestone is triggered by Janssen's selection of a clinical candidate for the seventh program in the collaboration. Janssen has optioned 11 programs out of a total of 20 programs under the bispecific DuoBody platform collaboration with Genmab. * On December 18, 2015, Genmab announced it has achieved a $3 million milestone in its DuoBody technology platform collaboration with Janssen Biotech. The milestone is triggered by Janssen's selection of a clinical candidate for the sixth program in the collaboration. At the same time, a $500,000 milestone was achieved for pre-clinical progress in the same program. Janssen has optioned 11 programs out of a total of 20 programs under the bispecific DuoBody platform collaboration with Genmab. * On October 5, 2015, Genmab announced it has reached a milestone in its DuoBody technology platform collaboration with Janssen Biotech, triggering a $3 million milestone payment. The milestone payment is for pre-clinical progress with a DuoBody product candidate targeting cancer. Janssen has optioned 11 programs out of a total of 20 programs under the bispecific DuoBody platform collaboration with Genmab. * On July 14, 2014, Genmab announced it has reached a milestone in its DuoBody technology platform collaboration with Janssen Biotech, triggering a $3 million milestone payment. The milestone payment is for pre-clinical progress with a DuoBody product candidate targeting two inflammatory mediators, proteins which play a key role in major autoimmune diseases. * On December 4, 2013, Genmab has announced an expansion of its collaboration with Janssen Biotech to create and develop bispecific antibodies using the DuoBody technology platform. The original agreement entitled Janssen to work on up to ten DuoBody programs. Under the terms of the amendment, Janssen is entitled to work on up to ten additional programs. Genmab will receive an initial payment of $2 million (€1.47 million) from Janssen. For each of the ten additional programs that Janssen successfully initiates, develops and commercializes, Genmab will potentially be entitled to milestone and license payments of up to approximately $174 million (€127.8 million) to $219 million (€160.9 million), depending on the date each program is initiated. In the most favorable scenario in which all ten additional programs are successfully initiated, developed and commercialized, Genmab would receive average milestone and license payments of approximately $191 million (€140 million) for each of the ten programs. In addition, Genmab will be entitled to royalties on sales of any commercialized products. * On August 26, 2013, Genmab has announced that it has reached another milestone in its DuoBody technology platform collaboration with Janssen Biotech, triggering a $1 million payment. The milestone is for achieving technical proof-of-concept for the second DuoBody product candidate. * On December 11, 2012, Genmab announced it has reached a key milestone in its DuoBody technology platform collaboration with Janssen Biotech, triggering a $ 2 million payment. The milestone is for achieving technical proof-of-concept for the first DuoBody product candidate.
