GTL003 (Empty Vaxiclase vector used as a Pertussis antigen)
GTL003 can be used as an antigen of Bordetella pertussis, causative agent of whooping cough in the development of acellular multivalent pertussis vaccines.
This latest application was licensed to Serum Institute of India Pvt. Ltd. (Serum Institute) in February 2015.
Improving pertussis vaccines
Former cellular Pertussis vaccines were efficacious but not well tolerated. In turn, current acellular Pertussis vaccines (aP) are very well tolerated but with an insufficient duration of efficacy. As a result, there is a marked global resurgence of pertussis cases worldwide observed by WHO1.
GTL003 (Vaxiclase as a pertussis antigen) can potentially improve the duration of protection of aP vaccines but with good tolerability2.
The estimated global market for combination vaccines DTaP and Tdap containing aP exceeds $2 billion per year.
The agreement with Serum Insititute of India Pvt. Ltd.
In February 2015, Genticel licensed to Serum Institute of India Pvt. Ltd. (Serum Institute)GTL003, its Vaxiclase technology for use as an antigenin the development of acellular multivalent combination vaccines containing pertussis antigens.
Serum Institute (www.seruminstitute.com) is a private company valued at over $12 billion and the world's largest producer of the Measles and DTP group of vaccines. Two of every three children immunized globally are vaccinated with a product manufactured by Serum Institute.
The license granted by Genticel to Serum Institute provides GTL003 for its inclusion in multivalent vaccines that also protect against Bordetella pertussis, the causative agent of whooping cough. The license covers all countries of the world except major pharmaceutical markets, in particular the USA, Canada, New Zealand, Australia, Japan, Israel, Turkey and greater Europe.
In exchange for the access and use of GTL003 in the licensed indication, Genticel is eligible for up to $57 million in upfront, development & sales milestone payments from Serum Institute, as well as single digit royalties on net sales.
In November 2016, the last preclinical milestone in the partnership was reached, opening the path to formal preclinical testing prior to clinical development and subsequent commercialization.
- WHO: Weekly epidemiological record, 85, 2010 (www.who.int/wer); Klein et al., New England Journal of Medicine, 367(11), 2012
- Koepke, Journal of Infectious Disease, 210, 2014;  Cheung et al., Infection and Immunity, 74(12), 2006.