Eli Lilly is turning to executives from Loxo Oncology, the biotech it bought in January for $8 billion, to lead a major reorganization of its cancer research efforts.
Josh Bilenker, formerly Loxo's CEO, as well as two members of the biotech's leadership team, Jacob Van Naarden and Nisha Nanda, will head up a merged group that combines Lilly's cancer laboratories with Loxo's.
The new unit, dubbed Loxo Oncology at Lilly, will be tasked with recasting the pharma's research and development more in the mold of the nimbler biotech, known for its success with genetically targeted cancer drugs.
"We're prioritizing the biology that's ready to be exploited therapeutically, rather than contorting a pipeline towards themes we wish were true," said Bilenker in an interview.
David Hyman, head of early drug development at Memorial Sloan Kettering Cancer Center, will join the new team as chief medical officer. Hyman led the clinical study which supported the U.S. approval of Loxo's Vitrakvi, the second drug ever cleared for use against cancers with a specific genetic signature, regardless of tumor site. (Bayer holds rights to Vitrakvi.)
The Loxo Oncology at Lilly team will report to Daniel Skovronsky, Lilly's chief scientific officer.
Alongside the organizational and leadership changes, Lilly will prioritize development of four drugs — two of which come from Loxo — and wind down testing of several unspecified early-stage cancer therapies in Lilly's pipeline.
Chief among the medicines Lilly plans to emphasize is selpercatinib, a Loxo-developed targeted treatment for tumors with uncommon abnormalities in a gene known as RET.
Recent study results were promising, showing the drug shrank tumors in 68% of patients with lung cancer, many of whom had been previously treated with drugs like Merck & Co.'s immunotherapy Keytruda. Lilly said it plans to file the drug for U.S. approval by the end of the year, a timeline that Van Naarden reiterated to BioPharma Dive.
Also in focus are LOXO-305, which works similarly to AbbVie's and Janssen's Imbruvica, as well as two Lilly-developed targeted drugs. Initial data on LOXO-305 will be presented this weekend at the American Society of Hematology's annual meeting.
Loxo Oncology at Lilly will be responsible for discovery research as well as clinical testing and regulatory affairs — a wide remit that Bilenker says reflects the current state of play in oncology.
"You can go from product concept to Phase 1 proof of concept in a genomically defined set of patients ... and you can have a lot of confidence that you might be working with an approvable drug," he said. "That collapses a lot of historically sequestered activities like regulatory, commercial or manufacturing scale-up."
"What this realignment tries to do is say when we get a signal like that, that's an all hands on deck moment," he added, suggesting LOXO-305 could turn out to be such an opportunity, as selpercatinib was before it.
Once experimental medicines are sufficiently advanced, Lilly's existing oncology business unit will handle further development and marketing. Expanding approvals for already on-market drugs like Lilly's breast cancer drug Verzenio will be done by the oncology business unit, currently led by Anne White.
The organizational structure Lilly created to incorporate Loxo only came together over time, said Van Naarden, noting in an interview the speed at which the initial deal was struck.
"The acquisition of the company came out of nowhere," he said. "We had to get to know each other."
A decision in late summer by Levi Garraway, previously Lilly's head of oncology research, to depart for a position at Roche then sparked new discussions, Van Naarden said.
"That created a moment in time for us to look at each other and say, 'should we have a broader conversation?'"
While it happened fast, buying Loxo was the largest acquisition ever completed by Lilly. The second biggest, a 2008 deal for ImClone Systems, was similarly aimed at making Lilly a top cancer drugmaker.
But that vision never fully materialized, and Lilly's current portfolio is missing the immunotherapies that have made Merck and Bristol-Myers Squibb leading companies in the field. Recent trial setbacks for its sarcoma drug Latruvo and the experimental therapy pegilodecakin have hurt, too.
With Loxo, Lilly is hoping it can scale more widely the biotech's expertise in developing genetic-based medicines.
"In the past, we were successful one drug at a time," said Bilenker. "We hope to be doing that by multiples moving forward."
Lilly doesn't appear done with business development, either. In announcing the restructuring, the pharma left the door open to further additions to its business, indicating the new group will pursue acquisitions as well as licensing deals.