Bristol Myers Squibb continues to build out its portfolio of oncology treatments, this time by signing a co-development and co-commercialization agreement with Eisai on MORAb-202.
The potential therapeutic is an antibody drug conjugate (ADC) that marks Eisai’s first such development in the space. Eisai will be hoping for a similar success to the one that brought the company, alongside Biogen, another first – the approval of their jointly developed Alzheimer’s therapy.
So far, Eisai has taken MORAb-202 through to the clinic, with a Phase I clinical study in Japan and a Phase I/II study in the US on-going. The ADC itself is a combination of an anti-folate receptor alpha (FRα) antibody and eribulin, an anticancer agent, which are joined by an enzyme cleavable linker. The trials are investigating the potential therapies’ uses in FRα-positive solid tumors.
BMS was prepared to pay $650m (€547m) in upfront payments, plus a potential $2.45bn (€2.07bn) in future milestones, to gain co-development rights to the ADC.
In return, BMS will be responsible for sales of MORAb-202 in the US and Canada, paying a royalty fee on sales, while Eisai will have exclusive sales rights in Japan, China, and countries in the Asia-Pacific region, Europe and Russia. Both partners will share profits, research and development and commercialization costs in collaboration territories.
The partners plan to move into the registrational stage of development for the potential therapy early next year. Eisai will be responsible for the manufacture and supply of MORAb-202 globally.
In terms of how Eisai manages the manufacturing process, a spokesperson told BioPharma-Reporter that “currently, the production of MORAb-202 as an investigational drug (eribulin) is outsourced to a CMO (contract manufacturing organization) depending on the process, but the antibody is manufactured at our Exton, Pennsylvania production site. We assume a similar manufacturing scheme for commercial production.”
Next generation of ADCs
Eisai’s spokesperson referred to the drug candidate as one of the ‘next generation’ of ADCs, which are differentiated from earlier examples by containing a ‘softer payload’. They expanded on this to say that eribulin “demonstrates not only direct cancer cell killing activity but also ‘bystander effect’ to modulate tumor microenvironment around cancer cells.”
The secondary effect sees eribulin externalized from the cancer cells, causing this bystander effect, that leads to tumor vasculature remodeling, cancer-associated fibroblast (CAF) suppression and immune activation.
ADCs growing in popularity
For BMS, this represents another ADC candidate to enter its pipeline. With BCMA ADC being investigated in Phase I trials in multiple myeloma, and CD22 ADC also in Phase I, but being investigated against lymphoma.
BMS and Eisai are just two of a number of companies that are looking into the ADC area, as development in the space continues to grow. In April, ADC Therapeutics received approval for its ADC therapy for patients with B-cell lymphoma. While earlier this month, Iksuda Therapeutics managed to raise $47m to take its pipeline of ADC candidates further through the clinic.
As such, the interest in contract development and manufacturing organization (CDMO) services in the space is also growing in line with the developing pipeline of ADC therapies. Earlier this year, Sterling Pharma acquired such an ADC-focused CDMO, in the form of ADC Bio.