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. 

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology

ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development

CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources.