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RTP company’s first FDA-approved therapy aims to help some lung cancer patients

Zachery Eanes
·3 min read

G1 Therapeutics’ first cancer therapy has been approved by the U.S. Food and Drug Administration to help small cell lung cancer patients, and it potentially could treat those with other types of cancer in the future.

The approval is an important milestone for the growing biotechnology company in Research Triangle Park, which is founded off technology from UNC-Chapel Hill.

The approved therapy, Cosela, helps reduce the frequency of bone marrow suppression in adults going through chemotherapy treatments.

Bone marrow helps create white and red blood cells and platelets, which are critical to the functioning of the body’s immune system. But chemotherapy can damage its ability to create those cells, often leading to fatigue and sickness in those with cancer.

Cosela, which is approved for patients with small cell lung cancer, could help protect the bone marrow.

“Chemotherapy is still very effective at killing cancer cells. The challenge is: It’s very indiscriminate, and it also kills the healthy cells in the body,” G1 Therapeutics CEO Jack Bailey said in a video interview. “What our product is able to show ... is a significant reduction” in the destruction of those cells.

“It’s an important milestone,” Bailey added. “Very few biotechnology companies ever actually get to the point of an FDA approval.”

But this could be just the beginning for G1 Therapeutics, Bailey said.

While Cosela is only approved for small cell lung cancer patients, the company plans to submit for approval its use in five other types of cancer, including triple negative breast cancer, colorectal cancer and bladder cancer.

“We really talk about Cosela being almost tumor agnostic,” Bailey said, “that for whatever solid tumor a patient experiences, we believe in the coming years that Cosela will be the product ... that those patients experiencing those different cancer types and undergoing chemotherapy would get.”

Before it received full approval, Cosela was given FDA Priority Review and Breakthrough Therapy designations because it was one of the first treatments of its kind.

Cosela is given via an injection. It currently has a wholesale acquisition cost of $1,471 per vial, and a full treatment will cost about $34,000 per patient on average, G1 Therapeutics said.

Growing the company

The company is now investing into its sales and marketing team around Cosela. Bailey said because it is an innovative product, there will be a lot of education and training that is needed to be done.

“Anytime you have this much of a step up in innovation, education becomes very important,” he said, “both for the oncologist but also folks like the nurses who see these patients.”

The company currently has 125 employees, up from 100 in 2019.

Bailey said future employment growth will depend on the success of Cosela as well as the results from its studies of its effectiveness on other cancers.

G1 Therapeutics is one of the best examples in recent years of how the Triangle’s biotechnology ecosystem can create successful companies.

The company’s treatments are based on discoveries by former UNC Lineberger Comprehensive Cancer Center director Norman E. Sharpless, who is now the director of the National Cancer Institute.

It received important investments from Hatteras Venture Partners, one of the Triangle’s most influential investment firms.

And in 2017, the company raised more than $100 million in an initial public offering.

“It’s one of the true bench-to-bedside success stories coming out of the UNC system,” Bailey said. “I think we represent exactly what UNC and Duke and other institutions want, which is ideas that could translate into products that benefit patients.”

This story was produced with financial support from a coalition of partners led by Innovate Raleigh as part of an independent journalism fellowship program. The N&O maintains full editorial control of the work. Learn more; go to bit.ly/newsinnovate