Sanofi terminates blood disorder gene-editing alliance with Sangamo

FRANCE – Sanofi is terminating a long-running collaboration to develop haemoglobinopathies therapeutics based on Sangamo’s zinc finger nuclease (ZFN) genome-editing technology.

Sangamo said in a regulatory filing in the United States that it was notified of the move by Sanofi late last month, noting that the decision stems from the French drugmaker’s shift to focus on off-the-shelf genomic medicine approaches rather than autologous cell therapies.

Sanofi is also relinquishing rights to SAR445136, a ZFN gene-edited cell therapy candidate for the treatment of sickle cell disease (SCD) that the companies were developing as part of the collaboration. The transfer will occur in the first half of 2022.

We remain committed to progressing this programme,” said Sangamo CEO Sandy Macrae, adding “we will vigorously investigate alternative options to bring this genomic medicine forward to patients,” including seeking a new collaboration partner.

The collaboration agreement was first signed in 2014 by Sangamo and Biogen. Bioverativ, which was acquired by Sanofi in 2018 for US$11.6 billion, was formed after Biogen spun off its hemophilia business.

As part of the agreement, Sangamo received a US$20 million upfront license payment and would have been entitled to an additional US$276.3 million if all specified milestones were met.

According to the company’s regulatory filing, US$13.5 million in milestones have been met to date. According to the filing, the termination will take effect on June 28. Sanofi will transfer data, information, and regulatory materials to Sangamo between now and then.

Positive early results

Sanofi’s termination notice to Sangamo comes just weeks after encouraging preliminary data were presented at the American Society of Hematology’s annual meeting.

So far, none of the four patients who have received the therapy have required blood transfusions, and total hemoglobin levels have stabilized by week 26.

In addition, all four patients had an increase in fetal hemoglobin levels. There were no reported adverse events associated with the experimental therapy.

Sangamo reported at last month’s American Society for Hematology (ASH) meeting that all four treated patients experienced increases in total hemoglobin, fetal hemoglobin, and percent F cells, and that none required blood transfusions following engraftment.

Sangamo expects Sanofi to continue to pay the costs of the study until the agreement officially expires in June. Sanofi is leaving the alliance before it becomes liable for any significant payments to Sangamo.

According to the biotech, the Phase 1/2 sickle cell study will be completed on time, with the final patients being dosed in the third quarter of this year.

“Discussions regarding potential future clinical trials [of SAR445136 will] continue with health authorities,” Macrae added.

Meanwhile, Sanofi last year paid up to US$470 million for Tidal Therapeutics, claiming that the startup’s “next-generation, off-the-shelf approach has the potential to bring CAR-T cell therapy to a much broader patient population.”

Prior to that, it paid around €308 million (US$348 million) for Kiadis Pharma, giving the French drugmaker access to allogeneic Natural Killer cell-based therapies being developed for various tumor types.

Other genomic medicines are in Sangamo’s pipeline, some of which are collaborative. A gene therapy for hemophilia A has reached late-stage development as part of a collaboration with Pfizer, though the study is currently on hold.

Preclinical programs for a variety of conditions are being developed with partners such as Novartis, Takeda Pharmaceutical, Biogen, and Gilead Sciences.

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