Lonza and ImaginAb Announce Successful Completion of Accelerated Minibody Development and Manufacturing Program
Basel (CH) and Inglewood, CA (USA) 15 September 2016 – Lonza, a global leader in biological and chemical manufacturing, and ImaginAb, Inc., a bio-imaging company that designs and develops novel imaging agents, announced today the successful completion of a development and clinical supply program for ImaginAb's lead immuno-oncology imaging candidate, CD8 (IAB22M2C).
In order to meet a key filing date for IND submission, Lonza combined its GS Gene Expression System™, including cell line creation expertise and platform upstream process, with a bespoke downstream process designed around ImaginAb's knowledge of their minibody candidate. This collaboration delivered a customized version of Lonza's Light Path™ Development and Manufacturing program and achieved an accelerated timeline from cell line creation to IND filing in under a year. This enabled ImaginAb to fast-track the start of the Phase 1 clinical trial for its CD8 ImmunoPET, a platform imaging agent that has the potential to expedite the development and market launch of next-generation immuno-modulator treatments.
ImaginAb is an innovative immuno-oncology company developing a pipeline of novel imaging products that give physicians unprecedented insights into the patient's health—potentially enabling better patient selection and treatment monitoring for immuno-oncology therapies. Harnessing the specificity of monoclonal antibodies, ImaginAb engineers small, highly targeted proteins known as minibodies that image important molecular targets using standard Positron Emission Tomography (PET). Our imaging tools help physicians address important clinical questions and improve patient treatment management.
“Our relationship with Lonza is a key to our success. The team's heroic effort in getting us quality product within 10 months has put us in the best position for success. We are grateful to the Lonza organization and look forward to our teamwork going forward,” said Benjamin Chen, PhD, CEO, ImaginAb.
“Our partnership with ImaginAb for the development and manufacture of their novel class of imaging agents has allowed us to utilize our expertise in the areas of cell line development for novel molecules, process development, scale-up and manufacture,” said Karen Fallen, Vice President, Business Unit Head, Clinical Development and Licensing for Lonza. “We are pleased to have been able to work collaboratively to meet our partner's aggressive timeline, and we are looking forward to a long and productive partnership on its pipeline of novel imaging compounds.”