Takeda Pharmaceutical and Resolve Therapeutics said today they will partner to develop compounds for systemic lupus erythematosus (SLE) and other autoimmune diseases—starting with clinical development later this year of Resolve’s lead compound RSLV-132, a nuclease Fc fusion protein—in a deal that could net Resolve more than $255 million.
Resolve will carry out development work on RSLV-132 until completion of the first Phase Ib/IIa trial in lupus patients, designed to demonstrate proof of biological activity. RSLV-132 is currently in IND-enabling studies and is expected to begin human clinical studies later this year.
After the trial, Takeda has the exclusive option to license the lead compound and all other compounds from the Resolve platform. Additional Resolve clinical candidates in the preclinical proof-of-concept stage target the degradation and elimination of autoantibody-containing immune complexes, thought to be the most proximal pathophysiological trigger of lupus.
Should Takeda exercise its option, it would take lead responsibility for worldwide development and commercialization of the Resolve products.
Takeda will pay Resolve $8 million this fiscal year to fund continued development of RSLV-132. Upon exercising its option, Resolve would additionally receive from Takeda an undisclosed option exercise fee, plus up to $247 million tied to undisclosed development milestones. Resolve is also eligible to receive royalties on product sales.
James Posada, Ph.D., Resolve’s co-founder and CEO, told Xconomy the exercise fee alone was enough for a five-fold return on investment for company shareholders—a multiple that could climb to a 10-fold to 15-fold return on investment, plus ongoing royalties on sales of RSLV-132 if the drug meets all goals.
Since it was spun out of the University of Washington three years ago, Resolve has raised $7.8 million in two financing rounds—the most recent being a $5.8 million Series B private-equity financing disclosed Nov. 1. Resolve said at the time that the financing would allow it to advance RSLV-132 into clinical trials, “which we expect to start in mid-2013.”
The financing was led by previous investor New Science Ventures, with participation from new investor WRF Capital, the venture investment arm of Washington Research Foundation, and previous investor Easton Capital.
According to Resolve, RSLV-132 represents a new approach to eliminating immune complexes, among key and proximal triggers of the inflammatory cascade in lupus.
"This collaboration with Resolve is very exciting as its innovative pipeline of nuclease fusion proteins has the potential to provide a new approach to helping lupus patients," said Tetsuyuki Maruyama (formerly Paul Chapman), Ph.D., general manager of Takeda’s Pharmaceutical Research Division.