Agreements

Date: 2016-06-23

Type of information: Production agreement

Compound: ADC-1013

Company: Alligator Bioscience (Sweden) Cobra Biologics (UK)

Therapeutic area: Cancer - Oncology

Type agreement: production - manufacturing

Action mechanism:

monoclonal antibody. ADC-1013 is an agonistic fully human monoclonal antibody targeting CD40, an immunostimulatory receptor found on antigen-presenting cells such as dendritic cells. ADC-1013 has been developed in close collaboration with Professor Thomas Tötterman, Uppsala University, Sweden. Professor Tötterman is a pioneer in directed immunotherapy of cancer, a concept where the immune system is selectively activated locally in the tumor microenvironment in order to reduce systemic side effects while optimizing systemic anti-tumor effects. Professor Tötterman´s group has performed a number of successful in-vivo experiments demonstrating the powerful immune mediated anti-tumor effects of ADC-1013. The pre-clinical assessment of ADC-1013 indicates a favorable tolerability profile, which is likely to be further improved by the intratumoral route of administration in the first clinical trial. Manufacturing of ADC-1013 was performed by Cobra Biologics, using the maxXpress platform and the Ubiquitous Chromatin Opening Element (UCOE) technology, and by BioInvent International, who performed process development and manufacturing of the non-GMP and GMP batches.

Disease: cancer

Details:

• On June 12, 2012, Cobra Biologics has announced the signing of a manufacturing services and supply agreement with Alligator Bioscience for the production of monoclonal antibody drug substance and drug product for pre-clinical studies and Phase I-II clinical trials. Under the terms of the agreement, Cobra will be providing cell line development through its maxXpress service, GMP cell banking, analytical and process development, scale-up, toxicology and GMP supplies, as well as stability studies and QP release for clinical trials.
Alligator will be taking advantage of Cobra’s maxXpress service, which combines the UCOE protein expression technology with the experience and expertise of Cobra Biologics’ cell line development team and the Cello™ robotic clone selection system, to enable rapid clone selection and production of the monoclonal antibody.

Financial terms:

Latest news:

• On April 3, 2017, Cobra Biologics announced that ADC-1013 manufactured as part of the company’s cell line development programme for Alligator Bioscience has completed its first Phase 1 clinical trial.
• On June 23, 2016, Cobra Biologics has been contracted to develop a second cell line for Alligator Bioscience. Alligator has requested further support from the team at Cobra to develop the cell line for production of new drug candidate ADC-1015, a bispecific immune activator developed to induce superior immune activation. Cobra is using their expression system maxXpress, along with a historically documented master cell bank (CHO-S) and chemically defined media.
• On May 28, 2015, Cobra Biologics announced that the company has developed a cell line for Alligator Bioscience, expressing monoclonal antibodies for a phase 1 clinical trial which commenced in April 2015. Development of the cell line expressing the antibodies for CD40 Agonistic Immuno-Oncology ADC-1013 was performed by Cobra using the maxXpress platform which harnesses the power of Ubiquitous Chromatin Opening Element (UCOE) technology. The study, led by Alligator Bioscience, will determine the safety, pharmacokinetics and pharmacodynamics of intratumourally administered ADC-1013, enrolling up to 40 patients during the dose escalation and expansion phases at five centres in the United Kingdom, Denmark and Sweden.