Af­ter show­cas­ing clin­i­cal da­ta at #ASH21 for a sick­le cell dis­ease can­di­date, Sanofi has de­cid­ed to throw in the tow­el on its 8-year part­ner­ship with col­lab­o­ra­tor Sang­amo — and re­turn its rights to the can­di­date.

The gene edit­ing biotech an­nounced the “tran­si­tion” this morn­ing, sev­er­al days af­ter Sanofi told Sang­amo that the biotech was back­ing out of the deal. The Paris-based phar­ma gi­ant will be re­turn­ing its rights and oblig­a­tions on SAR445136, a zinc fin­ger nu­cle­ase gene-edit­ed cell ther­a­py back to Sang­amo by the end of June.

Sang­amo had orig­i­nal­ly part­nered up with Bio­gen back in 2014, which then of­floaded the part­ner­ship to Biover­a­tiv, a Bio­gen spin­out that Sanofi ac­quired for over $11 bil­lion back in 2018. Sang­amo re­ceived $20 mil­lion up­front from Bio­gen and had list­ed po­ten­tial­ly $300 mil­lion in mile­stone pay­ments at the time.

At #ASH21, re­searchers pre­sent­ed da­ta on four pa­tients en­rolled in its Phase I/II Pre­cizn-1 study — and while the da­ta seem good on re­duc­ing pain events in pa­tients with sick­le cell dis­ease, it is still a ques­tion of how much po­ten­tial it has against oth­er ri­val treat­ments, such as the CRISPR/CAS9-based CTX001, pre­sent­ed at ASH in 2020 out of CRISPR Ther­a­peu­tics and Ver­tex. And there’s a host of oth­er gene edit­ing play­ers that are in the mid­dle of R&D projects for the dis­ease, as well.

Ac­cord­ing to Sang­amo, Sanofi de­cid­ed to tran­si­tion the SCD pro­gram back to Sang­amo fol­low­ing a re­cent change in Sanofi’s cell ther­a­py strat­e­gy — to go more to­wards al­lo­gene­ics and off the shelf. Sanofi put down more than $350 mil­lion in No­vem­ber 2020 to buy out Kiadis and ac­quire its NK-fo­cused cell ther­a­py plat­form.

John Reed

And as a re­sult, Sang­amo is look­ing for a new col­lab­o­ra­tion part­ner.

Sang­amo said that it ex­pects the Phase I/II study to be com­plet­ed as planned, and al­so ex­pects Sanofi to con­tin­ue pay­ing the costs of the tri­al un­til June 28.

Sanofi R&D Head John Reed said in a state­ment that while the part­ner­ship on that drug is es­sen­tial­ly over, it does not mean that we won’t see the two biotechs col­lab­o­rat­ing again, say­ing that Sanofi “will ex­plore oth­er pos­si­ble col­lab­o­ra­tion op­por­tu­ni­ties.” And it’s cer­tain­ly not the end of the world for Sang­amo — it re­cent­ly signed deals with No­var­tis and Bio­gen worth up to $3 bil­lion to go af­ter var­i­ous neu­ro­log­i­cal con­di­tions.

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”