Cleveland Biolabs Inc. (CLBI), a company that has long seen the potential for additional applications for its acute radiation exposure drug, entolimod, is putting the TLR5 agonist at the center of Genome Protection Inc. (GPI), a new joint venture formed with Everon Biosciences Inc. to develop and commercialize drugs for anti-aging applications, including frailty. Initially funded through a $10.5 million equity financing with venture capital fund Norma Investments Ltd., GPI's portfolio also includes small-molecule and vaccine candidates from Everon intended to protect organisms from the accumulation of cells with damaged DNA that drives aging and multiple age-related diseases, including cancer.

As consideration for the licenses granted to GPI and the assignment of intellectual property to it, the new company issued CLBI and Everon each 1,000 shares of its common stock.

CLBI CEO Yakov Kogan told BioWorld that, by the end of the first quarter of 2019, he expects GPI will move two candidates into the clinic. That advancement could have benefits not just for GPI, but also for CLBI, which has thus far developed entolimod wholly under the FDA's Animal Rule guidance, which calls for animal testing to support Emergency Use Authorization (EUA) for drugs used as medical radiation countermeasures.

For the moment, CLBI is enduring a delay in analytical analyses of a formulation biocomparability study required for its regulatory submissions of entolimod in Europe, which is also temporarily slowing its progress with the FDA. However, presuming it can move past that delay, clinical testing of entolimod in humans by GPI could provide a valuable strategic advantage to CLBI as it advances toward potential approval and commercialization of entolimod for the biodefense market.

On the approval front, Kogan noted that many FDA staffers are trained as medical doctors who have a natural interest in seeing safety data from human subjects as soon as possible. So, while such data are not required for an EUA, they could prove to be a beneficial supplement to the CLBI's regulatory filings. Second, maintainers of the National Stockpile, where entolimod would be stored as a medical countermeasure, appreciate handling medicines with dual use in civilian settings because they can keep batches of those medicines at hand and then rotate them into civilian hospital inventories over time.

To get the new JV off the ground, GPI signed a simple agreement for future equity with Norma, which granted it the right to purchase shares of GPI's capital stock in exchange for the payment of up to $30 million, of which $10.5 million was paid shortly after the execution of the agreement.

Everon and CLBI, both of which are headquartered in Buffalo, N.Y., share a common link in Roswell Park Comprehensive Cancer Center's senior vice president of basic research, Andrei Gudkov, who serves as chief scientific officer at both companies and has been with each since its inception. CLBI was founded in 2003. Everon was founded later, in 2010, with the goal of developing anti-aging medicines from the start. The latter company has since established an R&D program aimed at developing pharmacological agents – both small molecules and immunotherapeutics – that can block or slow down the generation of age-related waste products; restore or facilitate the efficacy of natural mechanisms removing accumulated waste; and create a diagnostic platform to accurately estimate the severity of aging-related frailty and efficacy of anti-aging drugs. In preliminary experiments with one of the company's candidates, treated animals live on average 25 percent to 30 percent longer, it has reported.

In addition to its other contributions to the GPI, CLBI has also assigned certain intellectual property underlying GP-532, a second generation of its entolimod candidate and its entolimod vaccine candidate to the company. GPI then licensed back to the CLBI, on an exclusive basis, the right to develop manufacture, commercialize and sell products relating to those candidates as a medical countermeasure to treat acute radiation exposure or as a cancer treatment.

For now, Kogan is the sole officer and director of GPI. He said the company has yet to select a headquarters for its operations, but is reviewing major U.S. biopharma hubs.

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