Jeffrey Bluestone, Sonoma co-founder and CEO (Tessa Therapeutics via YouTube)

Jef­frey Blue­stone re­cruits a trio of bio­phar­ma vets to the start­up team at Sono­ma — while adding $30M to the launch round

Jef­frey Blue­stone’s start­up in the Bay Area just added a pack­et of ven­ture mon­ey to its cash re­serves. But more im­por­tant­ly, the ex-chief of the Park­er In­sti­tute for Can­cer Im­munother­a­py re­cruit­ed sev­er­al more ex­pe­ri­enced vets to the ex­ec­u­tive team that will dri­ve new drugs to con­quer au­toim­mune dis­eases like di­a­betes.

On the mon­ey side, Sono­ma Ther­a­peu­tics to­day an­nounced that its syn­di­cate came up with an ex­tra $30 mil­lion for the launch round, bring­ing the to­tal to $70 mil­lion. The cash came from a broad group of in­vestors, led by Rick Klaus­ner’s Lyell and ARCH. Here’s the rest of the crew: 8VC, Life­Force Cap­i­tal, Lil­ly Asia Ven­tures Bio­sciences, Oc­ta­gon Cap­i­tal, Alexan­dria Ven­ture In­vest­ments, the JDRF T1D Fund and ad­di­tion­al undis­closed in­vestors.

That will help fund a team that now in­cludes:

— Leonard Drag­one, the new chief med­ical of­fi­cer. Drag­one is com­ing in from J&J, where he was VP for ear­ly clin­i­cal de­vel­op­ment in in­fec­tious dis­eases. Be­fore that, he had been the ther­a­peu­tic area lead for au­toim­mu­ni­ty, in­flam­ma­tion and oph­thal­mol­o­gy at Mer­ck and ear­li­er com­plet­ed a stint at Genen­tech.

— Se­jal Hall joined the com­pa­ny from Au­dentes, which was re­cent­ly bought out by Astel­las. She steps in as VP, pro­gram, port­fo­lio and al­liance man­age­ment, a role she held ear­li­er at De­nali.

— Ab­b­Vie vet­er­an Su­san Lacy is al­so join­ing the team as head of dis­cov­ery. She worked at the phar­ma gi­ant for the past 20 years.

Blue­stone left the helm of PI­CI and his post at UC San Fran­cis­co to start a biotech that will fo­cus on Tregs in halt­ing au­toim­mune as­saults. Now, in­stead of dri­ving im­mune re­spons­es to van­quish can­cer cells, he’ll be hit­ting the brakes to stop dis­eases like di­a­betes.

Blue­stone’s promi­nence in the West Coast biotech scene has earned some high-pro­file sup­port­ers, in­clud­ing Klaus­ner, the ex­ec­u­tive chair­man at Lyell who al­so chairs the board at Sono­ma.

And he’s aim­ing high. In a re­cent in­ter­view, he told me:

We’ll end up with a cheap­er ther­a­py on­ly hav­ing to do things once, hope­ful­ly, be­cause it’s built on the plat­form of what evo­lu­tion has al­ready cre­at­ed: reg­u­la­to­ry cells as brakes in the im­mune sys­tem.

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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Michel Vounatsos, Biogen CEO (via YouTube)

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.

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 $1 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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CEO Grace Colón (InCarda)

Look­ing to re­pur­pose an old drug to treat ir­reg­u­lar heart­beats, In­Car­da rais­es $30M in first Se­ries C close

A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.

The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.

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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Steve Chen, Cellis Therapeutics president and CMO (Cellics)

UC San Diego spin­out award­ed up to $15M for nanosponge de­signed to soak up sep­sis-caus­ing tox­ins

CARB-X, a global partnership looking to spur the development of new antibacterial drugs, is awarding Cellics Therapeutics $3.94 million to do what president and CMO Steve Chen calls “looking at traditional drug development upside down.”

Instead of going after a target directly — in this case bacterial toxins and inflammatory cytokines that cause sepsis — Cellics researchers “flip it around” to examine the host cells being attacked. The UC San Diego spinout then creates what it calls “nanosponges” — nanoparticles cloaked in the fragments of macrophage cell membranes. Chen says the “sponges” are designed to trap the sepsis-causing endotoxins and cytokines on their cell membranes, neutralizing them.

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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Covid-19 roundup: FDA has fi­nal­ly post­ed dis­cus­sion items for to­mor­row's ad­comm; As­traZeneca could soon re­sume US vac­cine tri­als

It may have come a day late, but the FDA has finally posted the discussion items that its outside experts will review during tomorrow’s adcomm on the new wave of Covid-19 vaccines now in the clinic.

There are no specific vaccines or data to discuss. Instead, the agency wants feedback on its overall approach. And they’re willing to go late into the evening to get it.

Here’s the rundown:

1. Please discuss FDA’s approach to safety and effectiveness data as outlined in the respective guidance documents.

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