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G1, Out to Shield Body From Chemo, Heads to First Clinical Test

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damage to the bone marrow during treatment and allow the body to resume production of healthy cells more quickly after a chemotherapy blast than it otherwise would.

The two scientists formed G1 (named after the phase of the cell cycle in which they’re aiming to pause healthy cells) in late 2012, and advanced the company with the help of around $5 million in government funding from various local sources like the Small Business Innovation Research program, UNC’s University Cancer Research Fund, the Carolina Kickstart Program, and the North Carolina Biotechnology Center. The company then got its big funding break in October, when MedImmune Ventures, the VC arm of AstraZeneca, led a $12.5 million round Series A round, with help from Hatteras Venture Partners and Mountain Group Capital. G1 has since hired a full management team, led by Velleca, and including chief medical officer Raj Malik (formerly of Agennix), chief business officer Greg Mossinghoff (a veteran of Inspire Pharmaceuticals), and chief scientific officer Jay Strum (an ex-GlaxoSmithKline executive).

The big hook here is that by taking G1T28-1 with chemo, cancer patients could theoretically avoid the side effects that come from damage to the bone marrow. These include anemia, neutropenia, and thrombocytopenia—dangerous reductions in red blood cells, white blood cells, and platelets, respectively, that leave patients weak and vulnerable to infection and bleeding. Chemo-induced anemia can be treated with recombinant forms of erythropoietin, which signals to the bone marrow to make more blood cells, but it’s not used nearly as much as it used to be because of safety hazards. So-called granulocyte colony-stimulating factors like Amgen’s Neupogen and Neulasta are widely used to treat neutropenia, but Velleca contends that those types of treatments become less and less effective after the bone marrow gets exhausted by multiple rounds of chemo. Velleca contends, meanwhile, that G1’s drug has the potential to eliminate the need for such drugs.

“That is clearly the market we’re going after,” he says.

Velleca says that potential market could be big, and would include patients taking chemotherapy for tumors like small cell lung cancer or triple-negative breast cancer that don’t need CDK4/6 to grow. G1’s approach wouldn’t be appropriate for cancers that depend on CDK4/6, of course, because then it would shield the tumor cells along with the healthy ones, but Velleca says that the majority of cancers do not rely on CDK4/6.

Still, this is all early, speculative talk so far. G1 is only has animal data to support its claims right now, and so really doesn’t know what type of effects, good or bad, G1T28-1 is going to cause when it’s put in humans. As Velleca concedes, there’s always a risk when a new drug candidate is administered to people for the first time.

G1 will get a glimpse of the drug’s prospects when it begins its first trial in healthy volunteers during the third quarter. Velleca expects the company to announce its first data early next year. But it’ll see what G1T28-1 is really made of afterwards—likely in the second quarter of 2015—when the company expects to begin testing the drug in real cancer patients. Meanwhile, if all goes well, G1 hopes to close a Series B round next year, according to Velleca.

“I think we’ll know very quickly when we’re in cancer patients next year whether the drug is doing what it’s supposed to do, as far as protecting the marrow,” he says.

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