A new startup biotech called Thunderbolt has been launched as the brainchild of Baxalta, the Mayo Clinic and Velocity Pharmaceutical Development--and begins life with newly licensed BAFF/APRIL dual antagonists from Astellas.
Thunderbolt is the first company to be launched from the South San Francisco, CA-based Vitesse Biologics--a collaboration model formed by Baxalta ($BXLT), Mayo Clinic and VPD, which is focused on the development of antibody and protein-based therapeutics in the areas of immunology, hematology and oncology.
It begins life by acquiring all the rights to Astellas’ BAFF/APRIL dual antagonist program through an asset purchase agreement. The BAFF/APRIL dual antagonists will be developed for B cell disorders, including systemic lupus erythematosus. Financial details were not disclosed.
All three groups, including the Japanese pharma Astellas, own shares in Thunderbolt.
“With this asset purchase from Astellas and the creation of Thunderbolt, we are excited to begin to accelerate the development of the BAFF/APRIL dual antagonist program with the potential to deliver innovative treatments for patients with unmet needs,” said Dr. John Orloff, head of R&D and chief scientific officer at Baxalta, in a release.
“This is the first company formed under the Vitesse Biologics platform, and we look forward to continuing to build our portfolio to explore new concepts and technologies.”
Dr. Andrew Badley, director of drug discovery and the office of translation to practice, center for clinical and translational science at Mayo Clinic, added: “We are pleased to have created this first company as a result of the novel model in drug development which leverages the basic science and clinical expertise of Mayo Clinic researchers with the drug development and manufacturing expertise of our partners, to accelerate patient therapies for B cell disorders.”
Baxalta, Mayo Clinic and VPD said in a joint statement that they will each contribute to the development costs associated with the program.
Through Vitesse, Baxalta--which is soon to become part of Ireland’s Shire ($SHPG) in a $32 billion deal--will provide global commercialization, antibody and protein development and manufacturing capabilities. Meanwhile, through the Office of Translation to Practice, Mayo Clinic docs and researchers will advise on selection of preclinical candidates, disease indications, and the design and conduct of Phase I clinical trials.
VPD will be responsible for target identification and selection of early stage drug candidates, and will lead the design and execution of preclinical testing and advise the early clinical protocols.
The early-stage biotech will focus on systemic lupus erythematosus (SLE), a difficult-to-treat disease with a number of variations and subpopulations of patients, but one littered with late-stage failures.
A few years ago GlaxoSmithKline ($GSK) became the first drugmaker in more than half a century to gain approval for a new treatment for the disease in the form of Benlysta.
The drug, a human monoclonal antibody that selectively targets B-lymphocyte stimulator, has however struggled to make much of a sales impact for the company since its FDA approval in 2011.
Benlysta has a license for patients with active, autoantibody‑positive SLE who are receiving standard therapy--but brought home just £230 million ($338 million) in 2015.
This is as a result of its modest efficacy, slow onset of action and restrictive label--which does not include patients with severe, active renal and CNS disease. The drugmaker is however currently undertaking new trials aimed at getting the drug to be used as a subcutaneous formulation.
There are also other candidates in the mix, including UCB’s epratuzumab--although this failed two Phase III trials last year after missing its primary endpoints. And Eli Lilly’s ($LLY) tabalumab was axed in 2014 after it too failed several pivotal late-stage studies.
Anthera Pharmaceuticals’ blisibimod is still going in mid- to late-stage studies, which also focuses on anti-BAFF activity in LSE.
- check out the release