Dr. Iwao Ojima, center, developed a second-generation taxane formulation that...

Dr. Iwao Ojima, center, developed a second-generation taxane formulation that shows such promise to treat cancer that the compound has been licensed for product development. With Ojima are Sean Boykevisch, PhD, director of Stony Brook University’s Intellectual Property Partners, left, and James E. Egan, CEO of TargaGenix and Recurv.  Credit: Stony Brook University/John Griffin

A global private equity firm has committed up to $24 million to develop a Stony Brook University researcher's cancer drug and put it on a path toward possible acquisition by a major pharmaceuticals company.

TVM Capital Group, headquartered in Munich, Germany, has invested in the chemotherapy drug, developed by Dr. Iwao Ojima at the university, through a newly created company, Recurv Pharma Inc.

Under the funding deal, Recurv will take over development rights to the compound, which has shown promise against colorectal cancer and other solid tumors, said Luc Marengère, managing partner at TVM's Montreal branch.

He described Recurv as a "single-asset entity" whose role is to pursue development of the compound dubbed RP-001 through phase 2 clinical trials.

What to Know

  • A cancer drug candidate developed by Stony Brook University researchers has won backing worth $24 million from a global private-equity firm.
  • A newly created Stony Brook company plans to shepherd the drug through phase 2 clinical trials.
  • Pharmaceutical giant Eli Lilly will have the option to acquire the compound and continue trials in the hope of getting FDA approval.

Should those trials yield positive results, pharmaceutical giant Eli Lilly and Co., an investor in TVM, would have an option to acquire the drug for further development and potential approval by the Food and Drug Administration.

"I call it a turnkey model," Marengère said.

Giving Eli Lilly a voice in the early development of the drug allows the Indianapolis-based drug giant to tailor the trials, avoiding situations where small biotech companies fail to deliver the detailed data required, he said. Meanwhile, Eli Lilly's role as a potential acquirer of the drug mitigates the risk of other investors.

The drug was one of several taxane compounds the university licensed to a spinout, Stony Brook-based TargaGenix Inc., in 2016. But Recurv, based in Newark, Delaware, will spearhead the drug's expected four-year path through the phase 2 trials under a sub-license with TargaGenix.

Both companies are led by chief executive James E. Egan. To execute its plans for human trials, Recurv, with only two employees, plans to rely on specialized pharmaceutical contract research, development and manufacturing organizations.

Taxanes are compounds that were initially found in coniferous trees or shrubs known as yews. Variations on the natural compounds are used in chemotherapy for a variety of solid tumors, including colorectal, breast, prostate and pancreatic cancers.

Widely used taxane chemotherapy drugs include paclitaxel and docetaxel. 

"Taxanes have been a cornerstone of cancer treatment for decades, but they can come with significant side effects, and treated cancers frequently recur," Egan said in a statement. "We are looking to provide a safer, more efficacious treatment option that may be used in combination with immunotherapies and in a far wider range of cancers, even those resistant to current taxanes."

Marengère said the annual market for colorectal cancer drugs alone runs into the billions of dollars. 

In phase 1 clinical trials, small groups of people are given a drug to gauge safety and dosage over several months. In phase 2 trials, efficacy and side effects are studied over a period lasting up to two years in patients who may number up to several hundred.

In phase 3 trials researchers seek to show that a new treatment is at least as safe and effective as existing treatments; the trials may involve thousands of patients. Phase 4 studies are conducted in broad populations after the FDA has approved a treatment and may last for many years.

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