Sanofi keeps foot on the gas, agree­ing to five-year col­lab­o­ra­tion with MD An­der­son

Just four months af­ter scor­ing its first can­cer drug ap­proval in a decade, Sanofi is stay­ing on the on­col­o­gy of­fen­sive.

Dmitri Wieder­schain

The French phar­ma is plan­ning to ac­cel­er­ate the de­vel­op­ment of po­ten­tial treat­ments, part­ner­ing with the Uni­ver­si­ty of Texas MD An­der­son Can­cer Cen­ter in a five-year col­lab­o­ra­tion. By com­bin­ing Sanofi’s pipeline with MD An­der­son’s top-notch clin­i­cal tri­al pro­gram in on­col­o­gy, the pair will launch bio­mark­er-dri­ven clin­i­cal stud­ies to bet­ter un­der­stand which drug cock­tails can ef­fec­tive­ly curb can­cer pro­gres­sion.

“This will help us un­der­stand com­bi­na­tion treat­ments and meth­ods of re­sis­tance that might emerge,” Sanofi’s head of glob­al im­muno-on­col­o­gy Dmitri Wieder­schain told End­points News, not­ing that every pa­tient that comes through MD An­der­son gets a bio­mark­er test­ing. “It’s rep­re­sen­ta­tive of our re­turn to on­col­o­gy.”

Fi­nan­cial terms of the deal be­tween Sanofi and MD An­der­son were not dis­closed, and the first project is ex­pect­ed to be­gin this sum­mer.

Di­et­mar Berg­er

Sanofi is look­ing to build off the suc­cess of its Sar­clisa drug that re­ceived FDA ap­proval in third-line pa­tients in March, be­com­ing the phar­ma’s first in-house can­cer treat­ment to hit the mar­ket since 2010. At the time, de­vel­op­ment chief Di­et­mar Berg­er said gain­ing that green light was “the re-en­try of Sanofi in­to on­col­o­gy,” and this col­lab­o­ra­tion ap­pears to be part of that strat­e­gy.

More good news for Sar­clisa came in May af­ter a Phase III study demon­strat­ed im­proved ef­fi­ca­cy in mul­ti­ple myelo­ma pa­tients when com­bin­ing the drug with Am­gen’s Kypro­lis than when us­ing Kypro­lis alone. Though da­ta were not re­leased, Sanofi said the in­de­pen­dent re­view board stopped the tri­al af­ter the cock­tail pro­longed pro­gres­sion-free sur­vival sig­nif­i­cant­ly.

The ul­ti­mate goal is to take on J&J’s Darza­lex, which has led the third-line mul­ti­ple myelo­ma mar­ket since its ap­proval in 2015.

Paul Hud­son

Sanofi’s re­cent tri­umphs and “re-en­try” in­to on­col­o­gy fol­low a mas­sive re­struc­tur­ing of its game plan and years of R&D mishaps. CEO Paul Hud­son, who took the top job last Sep­tem­ber af­ter be­ing re­cruit­ed from No­var­tis, has dropped the com­pa­ny’s di­a­betes work and new R&D chief John Reed stream­lined the cor­po­rate bu­reau­cra­cy in or­der to move past its his­to­ry of slow-foot­ed clin­i­cal ad­vances.

Ad­di­tion­al­ly, the French phar­ma has been di­vest­ing from long­time part­ner Re­gen­eron for over a year and ac­quired San Diego biotech Syn­thorx for $2.5 bil­lion. That pur­chase added THOR-707 to Sanofi’s pipeline, an IL-2 can­di­date cur­rent­ly in Phase I tri­als that Sanofi hopes can pro­vide the foun­da­tion for fu­ture im­muno-on­col­o­gy com­bi­na­tions.

Wieder­schain said the MD An­der­son part­ner­ship will test a broad fleet of ear­ly de­vel­op­ment pro­grams, but he sin­gled out THOR-707 as par­tic­u­lar­ly promis­ing. The pair will look to see if it can work in a long list of can­cer types.

“There’s a lot to do there, such an ex­cit­ing and promis­ing mol­e­cule that can po­ten­tial­ly be de­vel­oped across a broad range of sol­id tu­mors,” he said. “The bi­ol­o­gy of THOR0707 is so rich and we strong­ly be­lieve that the best way to study it is re­al­ly in pa­tients.”

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

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Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

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Ramy Farid, Schrödinger CEO (Schrödinger)

Bris­tol My­ers fronts new Schrödinger al­liance with $55M up­front, ex­pand­ing pre­ci­sion on­col­o­gy pro­file

Bristol Myers Squibb has a new R&D partner, one to which they’re paying a pretty penny to use their discovery platform.

The pharma company is doling out $55 million upfront to Schrödinger $SDGR to work on up to five small molecules, with the potential for $2.7 billion in milestone payments. Schrödinger’s initial targets include HIF-2 alpha and SOS1/KRAS for a type of kidney cancer and KRAS-driven cancers, respectively.

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As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

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Bahija Jallal (file photo)

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Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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Am­gen sev­ers 14-year Cy­to­ki­net­ics part­ner­ship, bail­ing on ome­cam­tiv af­ter mixed PhI­II re­sults

Amgen is shrugging off a 14-year development alliance and the tens of millions of dollars spent to develop a new heart drug at Cytokinetics after a Phase III trial turned up weak data — leaving Cytokinetics to soldier on alone.

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