Sanofi eyes a gene therapy prospect and commits $60M for a stake, potential rights

 

Sanofi’s gene therapy pipeline is not as deep as that of some of its industry peers, and the company has been shuffling programs in the past year as it tries to find the right mix. The France-based pharmaceutical giant has found a possible new piece. A deal gives it an equity stake in a clinical-stage company and a shot at that gene therapy developer’s lead therapeutic candidate.

According to terms announced Monday, Sanofi is committing up to $60 million to Gyroscope Therapeutics, breaking down to $40 million now and the rest coming in a future investment round. Meanwhile, the U.K.-based biotech gets additional cash to apply toward clinical development of GT005, which the company is developing as a treatment for patients who have genetic variants that drive vision loss.

Gyroscope’s initial focus is the “dry” form of age-related macular degeneration, in which the macula, which is a part of the retina, deteriorates. Dry AMD can progress to geographic atrophy, characterized by a loss of central vision. Gyroscope points to research showing that the disease is associated with activity of the complement system, a part of the immune system. The company’s gene therapy candidate is intended to increase production of a protein that regulates the complement system, restoring balance to complement system overactivity that is associated with the progression of geographic atrophy. Gyroscope has said that this approach could reduce inflammation, and in turn preserve vision.

In the announcement of the deal, Gyroscope CEO Khurem Farooq said his company believes GT005 has the potential to become the first gene therapy for geographic atrophy. The Gyroscope gene therapy is currently in mid-stage clinical development. Sanofi’s investment in the company comes a little more than a month after Gyroscope presented encouraging data for the gene therapy at the annual scientific meeting of the Retina Society. In a time-span ranging from seven months to nearly two years following initial treatment, Gyroscope reported that biomarker data in 13 patients continued to show increases in the complement system protein compared to baseline levels.

Gyroscope also reported that there were sustained decreases in downstream proteins that are associated with complement system activation. The one-time therapy has been well tolerated by patients and no serious adverse events related to treatment were reported. Furthermore, an analysis showed no increase in levels of the complement system protein circulating in the blood, which Gyroscope said suggests that GT005’s effects remain localized to the eye.

Earlier deals Sanofi reached for eye disease gene therapies have not progressed far. Last year, the pharma giant conducted a companywide portfolio review after which it returned to Oxford Biomedica the rights to gene therapy candidates for two rare genetic eye disorders, Stargardt disease and Usher syndrome type 1b. Soon after, Sanofi turned over to Atsena Therapeutics the rights to a Leber congenital amaurosis gene therapy candidate in Phase 1/2 testing.

Gene therapy partnerships in other therapeutic areas had also not borne fruit for Sanofi. In 2015, Sanofi began an alliance with Voyager Therapeutics focused on developing gene therapies for neurological disorders. In 2019, the pharma giant returned to Voyager rights to programs in Huntington’s disease and Friedreich’s ataxia.

Earlier this year, Gyroscope was preparing to join the wave of biotech companies going public. It withdrew those plans in May, citing market conditions. As of the end of the first quarter of this year, Gyroscope has reported a cash position of $117 million. The company last raised money in March, a $148 million financing. Gyroscope said Monday that Sanofi’s investment comes at a premium to that Series C round of funding.

In addition to providing the biotech with fresh cash, Sanofi’s agreement with Gyroscope allows the pharma giant to place a Sanofi executive on the biotech’s clinical advisory board to advise on the development of GT0005. In addition, the agreement gives Sanofi an exclusive right of first refusal to negotiate future transactions involving the Gyroscope’s lead gene therapy in certain geographic regions. Those regions were not specified.

Photo: Karen Bleier/AFP, via Getty Images

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