Bay­er en­lists Arv­inas on two-pronged pro­tein degra­da­tion ef­fort, for­ay­ing in­to agtech

Arv­inas has inked an­oth­er Big Phar­ma part­ner­ship to get their pro­tein degra­da­tion en­gines revving — for both hu­mans and crops.

All told, the Ger­man con­glom­er­ate is wa­ger­ing $115 mil­lion on the po­ten­tial of Arv­inas’ tech plat­form, which us­es an E3 lig­ase to tag tar­get pro­teins with an ubiq­ui­tin, flush­ing these dis­ease cul­prits down the cell’s nat­ur­al “garbage dis­pos­al.” And Bay­er is in for the whole pack­age, with a col­lab­o­ra­tion, an eq­ui­ty in­vest­ment and a joint ven­ture in play.

A har­bin­ger of the pro­tein degra­da­tion space, Arv­inas comes of age as peers at C4 Ther­a­peu­tics and Kymera al­so gains pop­u­lar­i­ty among the likes of Bio­gen, Ver­tex and Glax­o­SmithK­line. Com­pared to the tra­di­tion­al in­hi­bi­tion ap­proach, get­ting rid of prob­lem­at­ic pro­teins promis­es to be a much more durable so­lu­tion for dis­eases like can­cer.

Jo­erg Moeller Linkedin

“Be­cause PRO­TACs don’t in­hib­it the tar­get pro­tein’s en­zy­mat­ic ac­tiv­i­ty, but bind their tar­gets with high se­lec­tiv­i­ty, it may be pos­si­ble to re­tool pre­vi­ous­ly in­ef­fec­tive in­hibitor mol­e­cules as PRO­TACs for next-gen­er­a­tion med­i­cines for pa­tients,” Jo­erg Moeller, Bay­er’s head of R&D, said in a state­ment.

On the ther­a­peu­tic side, Bay­er’s to­tal com­mit­ment — up­front, R&D sup­port plus eq­ui­ty — amounts to $60 mil­lion. It gets them the rights to nov­el lead struc­tures Arv­inas gen­er­ates in the process but doesn’t cov­er the ad­di­tion­al $685 mil­lion in po­ten­tial mile­stone pay­ments.

The pact will span car­dio­vas­cu­lar, on­co­log­i­cal and gy­ne­co­log­i­cal dis­eases.

The oth­er $55 mil­lion in the deal goes, in the course of six years, to a joint ven­ture set up to ex­plore how Arv­inas’ tech­nol­o­gy can tack­le the weeds, in­sects or dis­eases en­dem­ic in agri­cul­ture. Where pre­vi­ous crop pro­tec­tion ef­forts have suc­cumbed to re­sis­tance, pro­tein degra­da­tion may be able to re­vive them, the part­ners said.

John Hous­ton Arv­inas

“As the first com­pa­ny found­ed to ex­plore tar­get­ed pro­tein degra­da­tion, we’ve been ex­cit­ed about the po­ten­tial to im­prove the lives of pa­tients since our in­cep­tion,” said Arv­inas CEO John Hous­ton. “This col­lab­o­ra­tion en­ables us not on­ly to ex­pand our plat­form in­to new ther­a­peu­tic ar­eas, but al­so be­gins a new jour­ney in ap­ply­ing our ap­proach to agri­cul­ture.”

The cash ex­changed trumps pre­vi­ous part­ner­ships, in which Genen­tech and Pfiz­er paid less to get dis­cov­ery al­liances start­ed but pledged biobucks, great­ly rais­ing Arv­inas’ pro­file be­fore it even got in­to the clin­ic. Its lead ther­a­py in prostate can­cer is now in Phase I tri­als.


Im­age: Shut­ter­stock

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Blueprint CEO Jeff Albers (file photo)

Blue­print plots re­turn to FDA with new Ay­vak­it da­ta in rare con­di­tion — and the an­a­lysts cheer

Over a decade after launch, Blueprint Medicines nabbed the first approval for their first drug earlier this year. Now, as they move forward with a Roche-partnered global launch, they’re touting data that could push them into more patients.

The Jeff Albers-led Cambridge biotech released their full pivotal data for Ayvakit in patients with advanced systemic mastocytosis. In one 53-person study, they showed that 76% of patients responded to the drug, 36% had complete responses and that on average their responses lasted for just over 3 years. A smaller, 32-patient study had a 75% response rate and most were still responding after 10.4 months, the last follow-up.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.

Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,400+ biopharma pros reading Endpoints daily — and it's free.