Sanofi sends a pair of gene therapies back to Oxford Biomedica. Are they salvageable?
The same day Oxford Biomedica signed a 5-year deal to make AstraZeneca’s Covid-19 vaccine, the UK gene therapy company announced they received word Sanofi was sending a couple of decade-old experimental drugs back to them.
In 2009, Sanofi and Biomedica slashed a co-development deal on TroVax, a cancer vaccine that had been one of the centerpieces of the then 14-year-old company. But the pair immediately replaced it with a deal, 8 years before the approval of Spark Therapeutics’ Luxturna, to develop gene therapies for two eye-related disorders.
Now, with little to show for it but a pair of very early studies, Sanofi is kicking the therapies back to Biomedica. The French drugmaker had already announced last year, amid an internal shakeup, that they were not interested in developing the drugs further, but what would happen to the therapies hung in the air.
In some ways, it still does. Biomedica wouldn’t commit to progressing or retiring them. It wasn’t even clear when Biomedica would regain the rights.
“The timing of return of these programs and operational details are yet to be determined,” the biotech said in a statement. “However, when the rights to the two programs are returned, the group will undertake its own internal evaluation to determine the potential future for these programs and decide whether to commit further resources to them.”
Biomedica’s $100 million partnership with Sanofi’s rare blood disorder subsidiary Bioverativ remains intact.
The two gene therapies are SAR422459, for treating a progressive macular disease called Stargardt disease, and SAR421869, for treating Usher’s Syndrome, a disorder that can cause both vision and hearing loss. The Stargardt therapy began a Phase I/II study in France in 2011, but the study was ended prematurely last August after Sanofi reprioritized its pipeline. Although the study was designed to measure biological markers of efficacy, Sanofi included no such data when it posted results on clinicaltrials.gov earlier this year.
The therapy for Usher’s Syndrome entered its Phase I/II study in 2012. That study was suspended in 2017 while Sanofi reviewed its pipeline and then also terminated last year.
If Biomedica considers the therapies to still have potential, it’s likely they will try to out-license them again. The company is built around partnerships, licensing out a few in-house candidates and helping manufacture Novartis’s CAR-T therapy Kymriah and, as of yesterday, AstraZeneca’s Covid-19 vaccine. They are explicitly not a commercial-stage biotech. All of the preclinical candidates on its website are listed as “to be spun out, or out-licensed,” and they run no clinical trials.
So the best question may be not whether Biomedica sees potential, but if anyone else does.