Fresh off Servier’s acquisition of Agios Pharmaceuticals’ oncology business, the company’s new targeted cancer med Tibsovo scored an FDA nod and posted a phase 3 trial win. And the company has no plans to slow down.
Looking to capitalize on the momentum, Servier’s U.S. CEO David Lee plans to scout more M&A and partnership deals and invest heavily in internal R&D to fuel growth, he said in an interview.
Servier Pharmaceuticals, the U.S. branch of France’s Servier Group, formed in mid-2018 after the French pharma bought Shire’s oncology business. Lee joined Servier after orchestrating the deal from the Shire side.
Over the past three years, the company has been beefing up its portfolio with multiple deals; its latest, the Agios oncology buyout, brought Tibsovo into the fray. As a key part of Servier’s oncology push, the IDH inhibitor recently chalked up two back-to-back wins: an FDA nod for tough-to-treat bile duct cancer and a phase 3 trial success in newly diagnosed acute myeloid leukemia (AML).
Aiming high with dealmaking
When working to identify the best new home for the Shire oncology portfolio back in 2018, Lee aimed to find a buyer that wanted to become an oncology leader. And that meant looking beyond financials.
Strategy “really matters,” he said. “I wanted a company that could actually resource this portfolio well and wanted to grow in oncology.”
Servier is “highly motivated” to invest in oncology, Lee points out. In fact, more than half of the company’s total R&D budget goes into oncology.
To reach its oncology ambitions, Servier has been building its portfolio through dealmaking around three pillars—cellular metabolism, immuno-oncology and apoptosis, or programmed cell death—through dealmaking.
Agios and its IDH focus fit within the cellular metabolism pathway. Servier’s partnership with Novartis on MCL-1 and BCL-2 inhibitors falls in the apoptosis group. Immuno-oncology is a much larger category than the others.
In that department, Servier is working with Pieris Pharmaceuticals on a 4-1BB/PD-L1 bispecific antibody, though the French drugmaker only has ex-U.S. commercial rights to that candidate.
Those aren't the only deals Servier has worked up in recent years, either.
Last April, the company took over Danish biotech Symphogen for its antibody drug capabilities, which would essentially enable Sevier to develop its own drug candidates. Last March, it expanded a partnership with Cellectis on CD19 allogeneic CAR-T cell therapies. On the flip side, Servier recently sent rights to allogeneic, or off-the-shelf, CAR-T programs back to Precision BioSciences.
Currently approved CAR-T therapies require collecting and modifying a patient’s own T cells. By comparison, allogeneic CAR-Ts are made from donor T cells and are viewed as a way to address the manufacturing challenges of existing autologous CAR-Ts.
“We do think allogenic CAR-Ts can be quite tricky, and we want to make sure we truly understand where we want to play in this [field],” Lee explained. He said Servier kept certain opt-in rights with Precision, “but the idea right now is to really see how this plays out” and to be able to “make quick [business development] pivots around data.”
Servier is signing more deals than an average midsized pharma company, Lee acknowledged, and more could be on the way.
For its next dealmaking target, Lee said he would like to consider late-stage candidates or even commercial assets if possible. Servier would also consider earlier-stage programs if they're “truly innovative” and fit within Servier’s three focus areas, Lee added.
“Of course, revenue matters … but that’s generally not my definition of true leadership,” Lee said. “Leadership is around innovation and what difference you really make in patients.”
Tibsovo grows with eyes on competition
Before Lee makes his next big M&A move, the company's immediate focus is on digesting the Agios franchise after closing the $1.8 billion deal in April.
The pickup brought the first-in-class IDH1 inhibitor Tibsovo that’s approved to treat relapsed or refractory IDH1-mutated AML and certain newly diagnosed patients who aren’t suitable for intensive induction chemotherapy. With a headline win from the phase 3 Agile trial, the drug looks on track to add front-line use alongside Bristol Myers Squibb’s Vidaza for chemo-ineligible patients, as well.
The regimen bested placebo on a composite endpoint that measures time to treatment failure, relapse from remission or death. What’s more, the trial also hit all secondary endpoints, including showing Tibsovo and Vidaza could extend patients’ lives.
The drug's prior owner said Tibsovo could reach around $160 million to $170 million in 2021 sales. As a private company, Servier doesn’t share financial performance, but Lee said the drug is tracking “very well” with Agios' statements and Servier's own expectations.
The drug could face competition down the line from Forma Therapeutics’ olutasidenib, which has posted tumor shrinkage data similar to Tibsovo’s in its own trial. Lee argued that AGILE, as the first double-blinded randomized trial with an IDH inhibitor, could bolster Tibsovo’s performance in the face of upcoming competition. It could take a while before olutasidenib posts that kind of controlled data, he noted.
Next up, a phase 3 trial dubbed HOVON150AML is pairing Tibsovo with chemo in front-line AML or myedysplastic syndrome among patients who are eligible for chemo. That study also involves IDH2 inhibitor Idhifa, which Agios developed and licensed to Bristol Myers.
Also with the Agios deal, Servier picked up a dual IDH1/2 inhibitor called vorasidenib. Early phase 1 data showed a response rate of 18% in recurrent or progressive IDH1/2-mutant disease. The drug is in phase 3 testing for low-grade glioma, but Lee noted that the company doesn’t expect a meaningful readout until four or five years from now.