With a potential FDA approval looming, G1 Therapeutics taps ex-GSK US president Jack Bailey as new CEO
There’s never a perfect time to step down from a leadership position, G1 Therapeutics CEO Mark Velleca said. But to him, this felt like the right one.
On January 1 — a month before the FDA rules on what could be the biotech’s first approved drug — Velleca will pass the torch to GSK vet John “Jack” Bailey, who joined G1’s board in March. Bailey stepped down at GSK’s US president last year, where he gained considerable experience on the sales side.
“I very much feel like I’ve accomplished what I was originally cast to do,” Velleca said.
In August, the North Carolina-based company announced priority review for its drug trilaciclib, which is designed to proactively reduce the side effects of chemotherapy. The drug’s PDUFA date is February 15, and if approved, G1 hopes to roll it out early next year.
“It’s very clear what we need to do,” Bailey said. The biotech is already working on other indications, including colorectal cancer. The company anticipates a global Phase III trial in about 300 patients with colorectal cancer will begin “very soon,” which would produce data in 2023, Velleca said.
In June, G1 entered a marketing agreement with Boehringer Ingelheim. Velleca said G1 offered Boehringer a “modest” upfront payment, and will put down more in revenue-based payments over the course of the three-year deal, which is only for small cell lung cancer. BI stood out to the team at G1 because they’ve been in oncology for years, and have “well-established relationships specific for lung cancer,” Bailey said.
The new CEO said he’s been “admiring (G1) from afar” since it was launched by NCI chief Ned Sharpless in 2008. He comes by way of GlaxoSmithKline, where he worked as president of their pharmaceuticals and vaccines business in the US. He also spent 18 years at Eli Lilly, serving a number of roles including senior vice president of account-based markets, general manager of Eli Lilly South Africa, and area director for the sub-Saharan region.
Trilaciclib — which Velleca described as Sharpless’ “brainchild” in an August interview with Endpoints News — entered the clinic in 2014. It snagged a breakthrough designation in 2019, and G1 submitted an NDA this June. The drug is meant to preserve bone marrow and immune functions in patients on chemotherapy. It works by temporarily arresting bone marrow cells and preventing them from dividing while the chemo fights tumor cells.
It’s a proactive treatment, as opposed to “rescue interventions” performed after the damage is already done, Velleca said.
The current CEO said back in August that he believes the drug could prove effective in “any patient with a solid tumor” receiving myelosuppressant chemotherapy. “This is a fundamentally new way to spare patients from myelosuppresion,” he added on Thursday. After surrendering his top spot, Velleca will stick around as senior advisor.
G1 spokesman Jeff Macdonald did not disclose the anticipated price of trilaciclib, but said it will likely come in above Neulasta, which has a list price of $6,231 per dose.