Regeneron And Bluebird Team Up In Cell Therapy "Joint Venture"-Style Deal
Executive Summary
Regeneron will make a $100m equity investment in bluebird to collaborate on the discovery of antibodies and T cell receptors, with the hope of building out in immuno-oncology and overcoming some of the early cell therapy challenges. Regeneron's business development chief talks to Scrip about its strategy.
Regeneron Pharmaceuticals Inc. and bluebird bio Inc. are teaming up in a cell therapy collaboration, and they hope together to overcome some of the safety and efficacy challenges that have faced the first generation of chimeric antigen receptor T-cell (CAR-T) therapies.
The two companies announced a deal Aug. 6 to collaborate on the discovery and development of antibodies and T-cell receptors directed against tumor-specific proteins and peptides. Under the arrangement, Regeneron has agreed to make a $100m equity investment in bluebird, at a substantial 59% premium to the $150 closing price on Aug. 3. The $37m premium will be credited against Regeneron's initial 50% funding obligation for collaboration research, after which the partners will fund research equally.
"This is a partnership of equals. We are going to be sharing the costs equally, sharing the labor," Regeneron's Head of Business Development Nouhad Husseini said in an interview. "It will be like a small little company working in this CAR-T field in a joint venture type of fashion."
Regeneron will have the right to opt-in to a co-development and co-commercialization arrangement for certain targets at the IND filing stage, with a 50/50 cost and profit sharing. If Regeneron does not opt-in, the company is eligible to receive milestone payments and royalties from bluebird on any resulting products. The partners have selected six initial targets and may select additional targets over the five-year collaboration term. As this is an early drug discovery collaboration, the partners expect it could take a couple of years for any drugs to reach the clinic.
The companies hope that by combining bluebird's cell therapy experience with Regeneron's VelociSuite technologies for creating antibodies and T-cell receptors that they will be able to overcome some of the initial challenges cell therapies have faced. Regeneron brings expertise in target discovery, where it expects to identify drug targets that are uniquely expressed on the tumor and not on healthy tissue, both intracellular and extracellular.
"This is what got us excited and we said, we need to go out there and make a deal happen," Husseini told Scrip. Bluebird, meanwhile, brings an expertise in cell therapy, manufacturing and approaches to overcoming tumor defense mechanisms, he said.
"The hope is if we can solve both of those problems together, we can unlock a whole array of additional tumors," Husseini added. "We hope that together, Regeneron and bluebird, can really be leaders in this field. "
Despite the first wave of initial breakthroughs in the field by companies like Novartis AG, Kite Pharma Inc. (now Gilead Sciences Inc.) and Juno Therapeutics Inc. (now Celgene Corp.), Regeneron said the field remains nascent, with a big opportunity for new innovation.
The partnership builds on Regeneron's budding immuno-oncology portfolio. The company's first oncology launch is expected later this year in the US. Its PD-1 antibody cemiplumab, partnered with Sanofi, is pending at the US FDA for approval for metastatic cutaneous squamous cell carcinoma (CSCC) with a Oct. 28 user fee date. The companies are also studying cemiplumab in a Phase III trial in non-small cell lung cancer (NSCLC).
Bluebird is also an emerging player in immuno-oncology. The company's second-generation CAR-T therapy bb2121, targeting B-cell maturation antigen (BCMA), is partnered with Celgene and getting some attention on the basis of early data in patients with relapsed/refractory multiple myeloma. The CAR-T therapy has shown encouraging safety and efficacy, including progression-free survival, in patients with multiple myeloma, with positive data presented at the American Society of Hematology meeting last December and the American Society of Clinical Oncology meeting in June. SC123190
Celgene was originally partnered on a broader CAR-T alliance with bluebird but backed out of the arrangement in 2015 when it signed a sweeping alliance with Juno Therapeutics; it later acquired the company outright. (Also see "The Bang For Celgene’s Buck: Looking Inside The Record-Setting Juno Deal" - Pink Sheet, 13 Jul, 2015.)
Regeneron said the deal is one of several investments the company is making to become an important oncology player. "I think immuno-oncology will be a place that Regeneron will invest heavily in going forward," Husseini said.
The deal with bluebird is part of a strategy Regeneron "thought about for a long time" to invest in CAR-T.
"It is a very different space than doing antibodies, and being in the cell therapy field requires a very different expertise, a different infrastructure," Husseini said. "We made that decision awhile back, that if we were going to enter this space than we wanted to this with a partner."
He pointed to a deal two years ago that marked Regeneron's entry into the field, a licensing agreement with off-the-shelf cell therapies developer Adicet Bio for $25m upfront. (Also see "Deal Watch: Roche Aborts But Regeneron, Amgen and Pfizer Sign Up" - Scrip, 8 Aug, 2016.)
The company has signed several other small deals throughout 2017 in IO, including one with Inovio Pharmaceuticals Inc. to study Regeneron/Sanofi's checkpoint inhibitor in combination with Inovio's T-cell activating immunotherapy, and a deal with ISA Pharmaceuticals BV to study it in combination with ISA's immunotherapy targeting human papillomavirus type 16. (Also see "Deal Watch: Sandoz Licenses Posimir For Pain As Durect Generates Data For Resubmission" - Scrip, 11 May, 2017.)