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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Top gene ther­a­py deals, M&A pacts in 2020 high­light an­oth­er big year in one of the hottest fields in bio­phar­ma

Chris Dokomajilar at DealForma has been crunching the numbers on gene therapy deals over the last 2 years and came away with a few key observations.

Both the upfront cash and deal totals last year backed off a bit from the record high hit in 2019, but the totals are still running well ahead of anything we’ve seen in the years prior to 2019/2020.
2020 R&D partnerships came in at 23 deals, with $1.1 billion in disclosed upfront cash and equity and more than $8.5 billion in total deal value. Looking at 2019-2020 M&A, Dokomajilar found: 9 Acquisitions, with over $11.1 billion in disclosed upfront cash and equity and more than $13.4 billion in total M&A value.

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Janet Woodcock (AP Images)

Ad­vo­ca­cy groups don't want Janet Wood­cock to head the FDA, blast­ing ‘reg­u­la­to­ry fail­ures’ in opi­oid cri­sis

It turns out the controversies around Janet Woodcock’s regulatory legacy weren’t limited to Sarepta’s eteplirsen.

A coalition of advocacy groups dedicated to the opioid crisis urged Norris Cochran and Xavier Becerra — the acting and designated HHS secretary, respectively — to keep her reign as interim FDA chief a “very short transition.” During her lengthy tenure as CDER, they add, Woodcock presided over “one of the worst regulatory agency failures in U.S. history.”

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Bob Nelsen (Michael Kovac/Getty Images)

ARCH an­nounces largest fund yet, rais­ing $1.85B to back men­tal health, cell and gene edit­ing ap­proach­es

Nearly a year ago, as the pandemic encroached and the stock market cratered, Flagship and ARCH Venture announced three mega-funds worth a combined $2.6 billion. They wanted, ARCH’s Bob Nelsen said, to restore confidence “that there was money out there and a lot of it” to invest in biotech.

Since then, the stock market has returned — almost frighteningly so — and Nelsen has kept raising and spending cash. On Thursday, he announced a new fund, worth $1.85 billion. It’s the largest pot yet for a VC famous for its deep pockets.

Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Dean Li kicks off Mer­ck­'s post-Roger Perl­mut­ter era by team­ing with Arti­va and its off-the-shelf CAR-NK tech

Even though Dean Li has now officially taken over for Roger Perlmutter as R&D chief, Merck’s appetite for dealmaking continues to be ravenous.

Li struck his first big deal at the helm Thursday morning, hammering out a collaboration with Artiva Biotherapeutics that could earn the biotech nearly $1.9 billion when all is said and done. It’s a quick rise and validation for Artiva, which just last June launched with a $78 million Series A.

Take­da earns win for its TKI in­hibitor in tiny lung can­cer group — but GI side ef­fects could be an ear­ly red flag

Japanese drugmaker Takeda has made a big push in recent years to build a hand in oncology, particularly in the next-gen cancer space. One of those candidates, tyrosine kinase inhibitor (TKI) mobocertinib, recently earned the FDA’s interest in a small section of untreated lung cancer patients, but will severe GI side effects be a roadblock?

Takeda’s oral mobocertinib posted clinically significant objective response rates in a Phase I/II adaptive trial drugging metastatic non-small cell lung cancer patients with EGFR exon 20 gene mutations who had previously undergone platinum-based chemotherapy, according to data presented Thursday at the virtual World Conference on Lung Cancer.

Covid-19 roundup: Con­tro­ver­sy around colchicine per­co­lates af­ter study fail­ure; As­traZeneca's meet­ing with EU was 'con­struc­tive,' but did­n't solve much

A group of researchers at the Montreal Heart Institute has spelled out what they had called positive results suggesting that colchicine, an inexpensive oral anti-inflammatory drug commonly used to treat gout, could prevent Covid-19 complications in newly diagnosed patients.

The study failed its primary endpoint. But the latest scientific debate around treatments for the coronavirus is just beginning to brew.

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