Genen­tech inks $650M deal with pro­tein degra­da­tion pi­o­neer Arv­inas

Genen­tech is dou­bling down on its com­mit­ment to New Haven biotech Arv­inas, ex­tend­ing the duo’s part­ner­ship and tack­ing an ad­di­tion­al $350 mil­lion on­to the to­tal deal val­ue.

The com­pa­nies have been work­ing to­geth­er since 2015, with Genen­tech li­cens­ing Arv­inas’ plat­form for pro­tein degra­da­tion to do some se­cre­tive R&D. Back then, Genen­tech wasn’t dis­clos­ing its dis­ease tar­gets, and it still isn’t. They’re on­ly telling us that the new deal in­cludes ad­di­tion­al tar­gets in “mul­ti­ple ther­a­peu­tic ar­eas.”

Un­der the re­vised terms, Arv­inas can re­ceive mile­stone pay­ments in ex­cess of $650 mil­lion. When the deal was first an­nounced, the pack­age in­clud­ed $300 mil­lion in po­ten­tial mile­stones.

John Hous­ton

What has Genen­tech so in­ter­est­ed? Arv­inas is a bit of a pi­o­neer in a new modal­i­ty called pro­tein degra­da­tion. Arv­inas’ CEO John Hous­ton tells me the com­pa­ny was the first to take the con­cept be­yond acad­e­mia. The sci­ence has since gained pop­u­lar­i­ty, with com­pa­nies like C4 Ther­a­peu­tics and Kymera jump­ing on board. Even ma­jor phar­mas like Cel­gene, Take­da, GSK and No­var­tis have ef­forts in the space.

The con­cept be­hind pro­tein degra­da­tion is sim­ple enough. Where pro­tein in­hi­bi­tion has led to some ad­vanced med­i­cines, de­grad­ing pro­teins could prove a much more durable so­lu­tion. In short, Arv­inas plans to tag cer­tain dis­ease-caus­ing pro­teins for de­struc­tion by re­cruit­ing an E3 lig­ase to the tar­get, there­by send­ing the pro­tein to the cell’s nat­ur­al “garbage dis­pos­al” called the ubiq­ui­tin-pro­tea­some sys­tem.

Hous­ton said the plat­form, in the­o­ry, could be wide­ly ap­plic­a­ble to sev­er­al dis­eases.

“We’re not lim­it­ed by dis­ease area, as al­most any dis­ease with a cell you want to de­grade could be tar­get­ed,” Hous­ton said.

Still, the com­pa­ny is start­ing with two main pro­grams for an­dro­gen and es­tro­gen re­cep­tor degra­da­tion for prostate and breast can­cer. They’re work­ing on a pair of INDs and look­ing to get in­to the clin­ic by 2018, al­though the com­pa­ny’s breast can­cer pro­gram may get there a tad ear­li­er.

Hous­ton said af­ter these two tar­gets, Arv­inas may pur­sue lung can­cer and melanoma. Fur­ther in the fu­ture, Hous­ton (who used to run neu­ro­sciences at Bris­tol-My­ers) said he’d like to see the com­pa­ny take on neu­rode­gen­er­a­tion, as well.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Roche finds a home for a new, $500M man­u­fac­tur­ing lo­gis­tics hub, promis­ing 500 jobs

Roche is pouring $500 million into its Canadian headquarters in Mississauga, Ontario to set up a new hub that will coordinate logistics for its global supply chain.

Over the 5-year investment, the Swiss pharma giant expects to add 200 jobs over next year and another 300 by the end of 2023.

Introduced as a $190 million global pharmaceutical development site in 2011, the campus currently houses Roche’s Canadian commercial unit as well as product development, global procurement and pharma informatics. The new expansion will see it organize manufacturing across 13 plants and 11 sites, according to FiercePharma.

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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Years af­ter a ma­jor tri­al set­back, No­var­tis switch­es gears with SMA drug. This time they're try­ing it for Hunt­ing­ton's

Four years after a Phase I/II setback in spinal muscular atrophy (SMA), Novartis is hoping its drug branaplam will find more success in a new neurological indication: Huntington’s disease.

The decision was announced a year after the head of research, Jay Bradner, said he did not see a “big opportunity” in SMA, according to Reuters. Novartis says it has preclinical data showing that branaplam reduces levels of mutant huntingtin protein, and SMA data showing patients on the drug had reductions in huntingtin mRNA. The FDA gave branaplam their orphan drug designation, and Novartis plans to move forth with a Phase IIb trial next year.

Glax­o­SmithK­line's vac­cines group aims for a first as it kicks off PhI­II RSV stud­ies

One of GlaxoSmithKline’s big projects at its global vaccine R&D center in Rockville, MD is set to enter Phase III after passing early-stage tests with flying colors.

Eyeing the wide-open respiratory syncytial virus (RSV) space, GSK is pushing two different vaccine candidates: GSK3888550A is designed to confer protection to infants via maternal immunization, while GSK3844766A is meant for the elderly.