NEW YORK – EQRx on Monday said it is reducing staff, terminating license agreements for three programs, and prioritizing development of the CDK4/6 inhibitor lerociclib in hormone receptor-positive, HER2-negative breast cancer and endometrial cancer.
The company will also seek commercial partnership opportunities for its third-generation EGFR inhibitor aumolertinib, which is under review for marketing authorization in EGFR-mutated non-small cell lung cancer in the UK and Europe, with regulators expected to make decisions by the end of 2023. The pipeline pruning plus a companywide reduction of 170 positions is expected to amount to savings of $125 million per year.
The "reset," as EQRx CEO Melanie Nallicheri described it during a conference call to discuss the company's first quarter financial results Monday afternoon, represents a definitive move away from the firm's original plan to disrupt the drug industry by offering competitively priced "fast follower" products like aumolertinib, which beat AstraZeneca's first-generation EGFR inhibitor Iressa (gefitinib) in a head-to-head trial in NSCLC last year.
Nallicheri acknowledged the reorganization was a pivot away from EQRx's original mission. "We tried something groundbreaking, something we all knew was going to be hard," she said, noting that ultimately some risks the company took did not pan out.
EQRx's strategy relied on the US Food and Drug Administration's willingness to accept results from clinical trials conducted in China. The plan took a hit when the agency asked EQRx to conduct a second, US-based Phase III trial for its PD-L1 monoclonal antibody sugemalimab. Now, the company has announced it is terminating license agreements with CStone Pharmaceuticals for sugemalimab and the anti-PD-1 antibody nofazinlimab, as well as with Lynk Pharmaceuticals for the JAK-1 inhibitor EQ-121. EQRx will also spin out a new wholly owned subsidiary that will take over its early-stage immune-inflammatory oncology programs.
The pipeline reorganization leaves lerociclib as EQRx's one remaining drug development program. "Our CDK4/6 inhibitor lerociclib, with its compelling early clinical data and potential for strong financial return, is an exciting starting point from which to build our pipeline, along with some of our early-stage oncology programs," Nallicheri said. "Lerociclib has an opportunity to expand CDK4/6 inhibition into new indications and additional combinations that could be firsts for this class of medicines."
The company that developed lerociclib, G1 Therapeutics, in 2019 reported a 65.2 percent clinical benefit rate and median progression-free survival of 15 months among patients with locally advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer who received lerociclib with fulvestrant in a Phase Ia/IIb trial. The results were consistent with the outcomes seen with other CDK4/6 inhibitors paired with fulvestrant.
EQRx has begun a Phase III trial of lerociclib in endometrial cancer, and Nallicheri said the company is nearly finished enrolling a Phase II open-label trial of the drug in first- and second-line HR-positive HER2-negative advanced breast cancer.