No thanks: Roche backs out of EGFR-re­lat­ed pro­tein de­graders in re­vised deal with C4

Roche and C4 Ther­a­peu­tics have been col­lab­o­ra­tors since 2016, and the re­la­tion­ship has proved fruit­ful for the biotech that just went pub­lic a lit­tle over a month ago.

But the Swiss Phar­ma is now punt­ing on one of the pro­tein degra­da­tion pro­grams in the part­ner­ship. Roche is hand­ing back the pro­gram tar­get­ing EGFR to C4, the biotech said Thurs­day in re­port­ing its third-quar­ter fi­nan­cials. C4 was orig­i­nal­ly no­ti­fied by Roche in June.

When the com­pa­nies first en­tered in­to their agree­ment, the deal had al­lowed C4 to de­vel­op their pro­tein de­graders for up to 10 tar­gets, with Roche hand­ing over $15 mil­lion up­front. C4 was al­so el­i­gi­ble to re­ceive up to $277 mil­lion in mile­stone pay­ments for each pro­gram Roche de­cid­ed to pick up, as well as up to $150 mil­lion in one-time pay­ments for the first prod­uct to hit a cer­tain lev­el of net sales.

Roche and C4 then re­vised the agree­ment in De­cem­ber 2018, down­siz­ing the num­ber of tar­gets to 6 and se­cur­ing an­oth­er up­front Roche pay­ment of $40 mil­lion. The amend­ed deal al­so called for split­ting de­vel­op­ment costs in re­turn for a larg­er share of fu­ture sales. Ad­di­tion­al­ly, Roche picked up three of the six po­ten­tial tar­gets.

Now though, Roche is re­turn­ing EGFR pro­tein de­graders en­tire­ly to C4. Through the col­lab­o­ra­tion, the com­pa­nies are al­lowed to break off on a pro­gram-by-pro­gram ba­sis and by mode of ac­tion. As such, EGFR in­hibitors are now en­tire­ly Roche prop­er­ty while EGFR de­graders be­long sole­ly to C4.

Noth­ing in C4’s cur­rent pipeline, which con­tains two pre­clin­i­cal can­di­dates and two still in the dis­cov­ery phase, fea­tures an EGFR pro­tein de­grad­er, though it’s un­clear for how long that will re­main. The one pro­gram in C4’s pipeline that’s emerged from this col­lab­o­ra­tion so far is tar­get­ing ge­net­i­cal­ly de­fined re­sis­tant sol­id tu­mors. That mol­e­cule works by bind­ing on one end to the dis­ease-caus­ing tar­get pro­tein with the oth­er end bind­ing to the E3 lig­ase.

Pro­tein degra­da­tion has been a hot top­ic in on­col­o­gy in re­cent years, with C4 com­pet­ing with the likes of Arv­inas and Kymera in the field. Roche al­so has a deal with Arv­inas, signed back in 2015, and paid $135 mil­lion in cash this past May to part­ner with Vi­vid­ion.

But the Swiss phar­ma has de­cid­ed it no longer wants to work on EGFR de­graders with C4.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

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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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

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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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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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

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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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.

FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.