Ex-Den­dreon chief Mitch Gold steers his way back to the pub­lic mar­kets, look­ing to jump­start a new clin­i­cal pro­gram

Mitch Gold is com­ing back to the helm of a pub­lic biotech com­pa­ny.

The for­mer Den­dreon CEO — and cur­rent ven­ture cap­i­tal­ist — who was forced out of that com­pa­ny as Provenge slow­ly de­railed, is get­ting back in­to the pub­lic eye with con­sid­er­ably less fan­fare this time around.

Af­ter Ni­valis’ drug failed in a dis­as­trous at­tempt to come up with an add-on to Ver­tex’s cys­tic fi­bro­sis com­bo, about the on­ly thing left af­ter the in­evitable slash and burn on staff and costs was a vir­tu­al­ly emp­ty pub­lic shell.

Mitch Gold

Ni­valis had man­aged to catch one of the last waves in the old IPO boom in cash­ing in on in­vestors’ in­ter­est in biotech. But by the time the mar­ket closed to­day the mar­ket cap had shrunk down to a mere $41.3 mil­lion. And now Gold’s Alpine Im­mune Sys­tem is tak­ing that over in a re­verse merg­er that will scoot it out in­to the pub­lic mar­ket.

One of the big ideas at Alpine is to of­fer cus­tom en­gi­neer­ing work for the cell ther­a­pies now in the pipeline. Kite, crosstown Seat­tle biotech Juno and oth­ers have been adapt­ing T cells in­to can­cer weapons. And Alpine’s top sci­en­tists — Ryan Swan­son and Michael Ko­r­nack­er, who both left Am­gen af­ter the big biotech opt­ed to shut­ter its Seat­tle cam­pus — have come up with some new tech that they be­lieve can make CAR-Ts and TCRs bet­ter equipped to hunt down and de­stroy can­cer cells.

The com­pa­ny has al­so been work­ing on pro­teins that can ei­ther amp up or tamp down on an im­mune re­sponse, and Alpine is plan­ning to get start­ed in the clin­ic with a Phase I study for a dual ICOS/CD28 an­tag­o­nist en­gi­neered for use in au­toim­mune and in­flam­ma­to­ry dis­eases in the sec­ond half of 2018.

To get the deal done, Fra­zier Health­care Part­ners, Gold’s Alpine BioVen­tures, and Or­biMed Ad­vi­sors will in­vest a com­bined ad­di­tion­al $17 mil­lion in­to Alpine Im­mune Sci­ences. The cash Alpine Im­mune brings to the ta­ble, com­bined with the $44 mil­lion that Ni­valis has left, will give the com­pa­ny $90 mil­lion in cash. And Ni­valis share­hold­ers will hang on to 26% of the merged op­er­a­tions.

Long­time biotech ob­servers will re­mem­ber — or can’t for­get — that Den­dreon was once one of the high fly­ers in the in­dus­try. Af­ter the FDA fi­nal­ly got around to ap­prov­ing Provenge, though, new ther­a­pies were lin­ing up to claim the bulk of the mar­ket it aimed for. But Gold made out well, cash­ing in $29 mil­lion in stock on the ap­proval news and stock spike.

“This merg­er pro­vides a unique op­por­tu­ni­ty to ac­cel­er­ate the de­vel­op­ment of our nov­el im­munother­a­py plat­form fo­cused on both in­flam­ma­tion and im­muno-on­col­o­gy,” said Gold in a state­ment. “We look for­ward to build­ing on our ear­ly suc­cess by tak­ing mul­ti­ple nov­el pro­grams in­to the clin­ic to help pa­tients with sig­nif­i­cant med­ical needs.”

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Luciana Borio (Susan Walsh/AP Images)

UP­DAT­ED: Bob Nelsen's ARCH adds FDA, biode­fense ex­per­tise with ap­point­ment of Lu­ciana Bo­rio

Once vetted by the Biden team to lead the FDA as commissioner, Luciana Borio is now compiling quite the résumé.

Borio has now been named a venture partner at Bob Nelsen’s ARCH Venture Partners, and Nelsen told Endpoints News, “She will be involved in projects across the portfolio, including ongoing projects in manufacturing, clinical trials, gene therapy and gene editing, cell therapy, and delivery. We are exploring multiple projects in infectious disease, and next generation manufacturing.”

Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Andrea Pfeifer, AC Immune CEO (AC Immune)

Look­ing to repli­cate Covid-19 suc­cess in neu­ro, BioN­Tech back­ers bet on AC Im­mune and its new­ly-ac­quired Parkin­son's vac­cine

The German billionaires behind BioNTech have found a new vaccine project to back.

Through their family office Athos Service, twin brothers Thomas and Andreas Strüngmann are leading a $25 million private placement into Switzerland’s AC Immune — which concurrently announced that it’s shelling out $58.7 million worth of stock to acquire Affiris’ portfolio of therapies targeting alpha-synuclein, including a vaccine candidate, for Parkinson’s disease.

Rajiv Shukla, Constellation Alpha Holdings

Can­del gets busy IPO week mov­ing with down­sized raise as Ra­jiv Shuk­la's third SPAC goes pub­lic

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

In a week that’s expected to see several biotechs price their IPOs, Candel Therapeutics got things kicked off Tuesday with a muted opener.

The company helmed by former GlaxoSmithKline vet Paul Peter Tak made its way to Nasdaq thanks to a $72 million raise, which was downsized by about 15% than originally anticipated, according to Renaissance Capital. Candel priced at $8 per share after initially seeking to launch in the $13 to $15 range.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.