Pro­tein degra­da­tion pi­o­neer C4 Ther­a­peu­tics nabs $170M; Barcelona start­up has €30M to go af­ter can­cer metas­tases

→ Pro­tein degra­da­tion has been good to C4 Ther­a­peu­tics. The Wa­ter­town, MA-based biotech just raised $170 mil­lion. That in­cludes a $150 mil­lion B round as well as $20 mil­lion in ven­ture debt from Per­cep­tive. “This fund­ing comes at a sig­nif­i­cant junc­ture, as our com­pa­ny is mov­ing to a clin­i­cal stage,” says CEO Marc Co­hen. “We plan on fil­ing our first IND by the end of this year and ex­pect to have four drug can­di­dates in the clin­ic by the end of 2022.” The syn­di­cate is big. The round was co-led by ex­ist­ing in­vestor Co­bro Ven­tures and new in­vestor Per­cep­tive Ad­vi­sors. New eq­ui­ty in­vestors in the round in­clud­ed Adage Cap­i­tal Man­age­ment, Ax­il Cap­i­tal, Bain Cap­i­tal Life Sci­ences, Com­modore Cap­i­tal, 3E Bioven­tures Cap­i­tal, HBM Health­care In­vest­ments, Lightchain Cap­i­tal, Lo­gos Cap­i­tal, Mizuho Se­cu­ri­ties Prin­ci­pal In­vest­ment, Nex­tech, RA Cap­i­tal Man­age­ment, RTW In­vest­ments, Sphera Funds Man­age­ment, Tai­wa­nia Cap­i­tal Man­age­ment, Yon­jin Ven­ture, and funds and ac­counts man­aged by T. Rowe Price As­so­ci­ates and Janus Hen­der­son In­vestors. Ex­ist­ing in­vestors al­so par­tic­i­pat­ed.

→ A Barcelona-based start­up with its own ap­proach to metas­ta­sis has just raised a €30 mil­lion launch round. Ona Ther­a­peu­tics has round­ed up the mon­ey from Asabys Part­ners and new in­vestors Al­ta Life Sci­ences, Bpifrance – In­no­Bio 2, Fund+ and Ys­ios Cap­i­tal. The biotech is found­ing on key find­ings by co-founder Sal­vador Az­nar-Ben­i­tah, who showed that metasta­t­ic cells are ad­dict­ed to fat — un­like pri­ma­ry tu­mors, which feasts most­ly on sug­ar. While many can­cer drug de­vel­op­ers have tend­ed to lump pri­ma­ry tu­mors and metas­tases to­geth­er, “we see it as a dif­fer­ent type of beast,” CEO Va­lerie Van­hooren told End­points News. The Abl­ynx vet ex­pects the cash to take them through a large proof-of-con­cept bas­ket tri­al in­volv­ing up to 150 pa­tients, from which Ona will se­lect the most promis­ing in­di­ca­tions to pur­sue for its an­ti­bod­ies.

→ Hop­ping on the SPAC band­wag­on, RA Cap­i­tal has filed for a $100 mil­lion IPO for its blank check com­pa­ny. Pe­ter Kolchin­sky is Ther­a­peu­tics Ac­qui­si­tion’s CEO and chair­man — which in ef­fect means he will lead the search for a promis­ing biotech to buy and flip to the Nas­daq. Spe­cial pur­pose ac­qui­si­tion com­pa­nies have be­come a trendy ve­hi­cle among mar­quee health­care in­vestors, with Chardan and RTW al­ready ex­e­cut­ed the merg­ers that their SPACs were set up for.

→ Shen­zhen, Chi­na-based Im­mvi­ra has raised $58 mil­lion to fund de­vel­op­ment of its on­colyt­ic virus­es, which promis­es to repli­cate bet­ter, kill can­cer cells more ef­fec­tive­ly, and in­duce more im­mune re­sponse than the pre­vi­ous gen­er­a­tion. Its lead can­di­date has launched clin­i­cal stud­ies in Aus­tralia, Chi­na and the US. Hua­gai Cap­i­tal led the round, with par­tic­i­pa­tion from Apri­cot Cap­i­tal and Cowin Cap­i­tal.

→ Can CAR-T be part of the an­swer to an HIV cure? A group of UCLA re­searchers have re­ceived a $13.65 mil­lion grant from the NIH to find out. By mod­i­fy­ing a pa­tient’s own stem cells to re­sist HIV in­fec­tion and hunt down in­fect­ed cells, the treat­ment would ide­al­ly repli­cate the ef­fect of a stem cell trans­plan­ta­tion.

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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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.

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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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC deal 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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Pur­due Phar­ma signs guilty plea, preps $8B+ set­tle­ment on Oxy con­tro­ver­sy — re­port; Flag­ship brings in a comms chief

Purdue Pharma may soon be signing off on a guilty plea and an $8 million-plus settlement to wrap up its controversial role distributing OxyContin.

The AP has the breaking story this morning.

Purdue filed for bankruptcy last year, along with Insys and followed by Mallinckrodt, as it navigated its way through a blizzard of litigation surrounding Oxy, which triggered an epidemic of abuse around the country.

Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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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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UP­DAT­ED: Brazil­ian vol­un­teer in As­traZeneca Covid-19 vac­cine tri­al has died in the place­bo arm — re­ports

A volunteer in AstraZeneca’s Covid-19 vaccine trial in Brazil has died, Brazilian health authorities said Wednesday, triggering fresh alarms over the future of the Oxford program. But later reports noted that the death was in the placebo group and AstraZeneca issued word that there were no concerns about continuing the study.

The Brazilian health agency Anvisa said it had received data from an investigation into the issue, per a Reuters report. The report was then updated citing a Brazilian newspaper with unnamed sources saying that the volunteer was in the placebo arm of the trial.

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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