6 months af­ter ar­riv­ing at Sanofi R&D, John Reed gam­bles $125M on De­nali’s RIPK1 work

Sanofi’s new R&D chief, John Reed, is on the march. 

New­ly ar­rived from Roche, Reed is hand­ing over $125 mil­lion in cash to part­ner with De­nali $DNLI on a RIPK1 ap­proach to tamp­ing down in­flam­ma­tion. And in the deal — which in­cludes more than a bil­lion dol­lars in mile­stones — the French phar­ma gi­ant is grab­bing sys­temic in­flam­ma­to­ry dis­eases while the De­nali team con­tin­ues to lead the charge on the blood-brain bar­ri­er and neu­ro dis­eases.

Alex Schuth

De­nali dived in­to RIP1 a lit­tle more than 2 years ago, buy­ing out In­cro and bag­ging one of their top drugs — which ini­tial­ly came out of Har­vard — for the pipeline. That ap­proach to in­flam­ma­tion, pro­vid­ed they could get it in­to the brain prop­er­ly, has po­ten­tial in ALS, mul­ti­ple scle­ro­sis and Alzheimer’s. And it’s pay­ing some quick div­i­dends af­ter a key play­er took care­ful no­tice of their work.

“John Reed was a cham­pi­on of this deal,” De­nali chief op­er­at­ing of­fi­cer Alex Schuth tells me, cit­ing some of the team play­ers around Reed who helped close the deal.

Reed is com­mit­ting his re­search group to the RIP1 tar­gets out­side the brain. Sanofi will take over the de­vel­op­ment work of DNL758 for tar­gets such as rheuma­toid arthri­tis and pso­ri­a­sis while fund­ing the Phase Ib/II costs for DNL747 for ALS, MS and oth­er con­di­tions — oth­er than Alzheimer’s, where De­nali re­tains re­spon­si­bil­i­ty for costs. Sanofi then will cov­er 70% of the costs in the piv­otal neu­ro work.

The com­pa­nies plan to share prof­its and loss­es in the US and Chi­na on 747, while Sanofi will pay roy­al­ties on 747 from the rest of the world and on all 758 sales. Sanofi al­so gets rights to pre­clin­i­cal RIPK1 in­hibitor mol­e­cules.

This is one of the first new deals to be struck by John Reed since he made the leap to Sanofi 6 months ago, with Elias Zer­houni on the way out. A deeply re­spect­ed sci­en­tist, Reed made lit­tle pub­lic progress while he was run­ning the show at pRED based in Basel.

Sanofi, mean­while, has earned a poor rep­u­ta­tion for in-house in­no­va­tion. But it has a great rep for col­lab­o­ra­tions, with a high-pro­file al­liance with Re­gen­eron that was re­cent­ly down­grad­ed at the gi­ant phar­ma com­pa­ny.

Steve Krognes

De­nali has man­aged to en­joy con­sid­er­able cred­i­bil­i­ty while walk­ing a mine field of risk. The ex­ec­u­tive team out of Genen­tech has some of the best re­sumes in the field, and their tar­get­ed, ge­net­ics-based ap­proach to CNS has won sig­nif­i­cant back­ing as they built the over­all staff to 175, with a new HQ un­der con­struc­tion right next to their cur­rent site in South San Fran­cis­co’s Oys­ter Point.

Steve Krognes, the CFO at De­nali, is hap­py to talk about the staffing (grow­ing), the new HQ (ready for move-in in March) and the mon­ey re­serves (sig­nif­i­cant). De­nali struck an­oth­er ma­jor col­lab­o­ra­tion with Take­da at the be­gin­ning of this year for Alzheimer’s and near that de­liv­ered $155 mil­lion in cash and an eq­ui­ty stake.

But he and Schuth are al­so a lit­tle low key about some of the timeta­bles and the ex­act chem­i­cal prop­er­ties that make these drugs best-in-class con­tenders.

We can find out more about that as da­ta are as­sem­bled.

They’re not alone in RIP1, by any means. Just a cou­ple of weeks ago Hal Bar­ron sin­gled out a mid-stage pro­gram at GSK, which he char­ac­ter­ized as a high-risk, high-re­ward drug that might need some work ahead of any piv­otal test.


Im­age: John Reed. 

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

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FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

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In a win for Re­gen­eron, No­var­tis' sy­ringe for AMD drug de­clared 'un­patentable'

Regeneron has won a patent case against Swiss pharma giant Novartis over the delivery system for its eye drug Eylea.

The US Patent Trial and Appeal Board ruled that Novartis’ pre-filled syringe for injecting its eye medication Lucentis was “unpatentable” and handed the victory to Regeneron and its AMD drug Eylea.

In the initial complaint in 2020, Novartis alleged to the US International Trade Commission that certain pre-filled syringes for the intravitreal injection, and ultimately Regeneron’s delivery system for Eylea, were infringing on Novartis’ patent. Regeneron filed a petition to review Novartis’ claims in 2021.

'Tis the sea­son: GSK ad­dress­es win­ter virus surges with celebri­ty and in­flu­encer vac­cine aware­ness cam­paigns

GSK is rounding up the usual suspects this winter — flu, respiratory syncytial and even shingles viruses — for multiple marketing efforts all aimed at encouraging vaccinations.

Mom influencers take center stage in its “Flu is a Family Affair” campaign to reach family decision-makers or “chief health officers.” GSK is asking them in the digital campaign to take care of themselves, and take the family along, when they go to the pharmacy or doctor’s office for a flu vaccine.

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Bris­tol My­ers claims win with CAR-T ther­a­py Breyanzi in leukemia

Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.

The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

FDA takes next step in Tor­rent Phar­ma­ceu­ti­cal­s' trou­bled In­dia plant saga, is­sues OAI

The FDA has handed Torrent Pharmaceuticals an official action indicated (OAI) status for a previously inspected manufacturing facility in India.

Torrent Pharma sent a letter to the National Stock Exchange of India earlier this week with word that the manufacturer has received a “communication from the FDA determining the inspection classification as ‘Official Action Indicated’ (OAI)” for one of its sites. An OAI classification from the FDA comes after the agency has completed an inspection and determines if the facility complies with the applicable laws and regulations. Being given an OAI classification means that regulatory or administrative actions will be recommended to Torrent. However, the details on the recommended actions have not been given.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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