Sang­amo's sick­le cell al­liance with Sanofi grinds to a halt as phar­ma gi­ant switch­es fo­cus to al­lo

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.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

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.

In search of elu­sive NASH break­through, Pfiz­er spot­lights com­bo ap­proach

Pfizer’s second crack at steering a NASH candidate through a battered field seems to be going better than the first.

The pharma giant has scored the FDA’s fast track designation for an experimental combination therapy as a treatment for NASH with liver fibrosis. The combo consists of ervogastat, a diacylglycerol O-acyltransferase 2 inhibitor (DGAT2i), and clesacostat, an acetyl-CoA carboxylase inhibitor (ACCi).

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

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.”

AS­CO ab­stracts mint some ear­ly win­ners, but Io­vance, Spring­Works get hit by mas­sive loss­es

Before cancer-focused biotechs start their trek to the first in-person American Society of Clinical Oncology (ASCO) annual conference since the pandemic began, investors have taken a good look at the teasers for the data scheduled to be presented — and started placing bets.

With its power to confer overnight fame, ASCO is a stage where impressive or surprise debut performances can go a long way. On the other hand, disappointing details could be punishing.

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Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Levi Garraway, Roche CMO (Genentech)

Roche's CD20xCD3 does­n't beat Gen­mab at ORR, but sets bar for CR da­ta on lym­phoma drug

On its way to potentially becoming the first to market with a CD20xCD3 bispecific for aggressive lymphoma, Big Pharma’s largest R&D spender has some more data to pad its case with an FDA filing slated for later this year.

Roche dropped some more details from a Phase II expansion study of its fixed-duration glofitamab, to be presented at next week’s ASCO annual meeting, in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The patients had received a median of three prior therapies.

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