Blue­print maps plans for $150M raise; Glax­o­SmithK­line cre­ates dis­cov­ery pact with Warp Dri­ve

Blue­print Med­i­cines $BPMC has filed to raise $150 mil­lion in a new stock of­fer­ing. Most of the new mon­ey is be­ing ear­marked for up­com­ing clin­i­cal tri­als of its pipeline drugs. And the com­pa­ny says it will add to the $268 mil­lion al­ready in re­serves at the end of 2016, stretch­ing its run­way to the mid­dle of 2019.

→ Cam­bridge, MA-based Warp Dri­ve Bio has set up a dis­cov­ery deal with Glax­o­SmithK­line, cre­at­ing a cus­tom DNA-tagged SMART li­brary that GSK will build and screen against a set of ‘un­drug­gable’ tar­gets re­lat­ed to dis­eases of high un­met med­ical need. Among the Warp Dri­ve tar­gets are RAS, SHP2 and Cbl-b. “This unique col­lab­o­ra­tion with GSK of­fers an in­valu­able op­por­tu­ni­ty to com­bine two pow­er­ful plat­forms to cre­ate an un­prece­dent­ed li­brary of up to 200 mil­lion di­verse SMART com­pounds for the dis­cov­ery of lead chem­i­cal mat­ter against a set of cur­rent­ly-in­ac­ces­si­ble tar­gets,” said Alan Rig­by, Ph.D., chief sci­en­tif­ic of­fi­cer of Warp Dri­ve Bio.

→ There’s been a change at the helm of the em­bat­tled De­pomed. The com­pa­ny, un­der as­sault by an ac­tivist in­vestor, says CEO James Schoe­neck is out, re­placed by ex-Bay­er CEO Arthur Hig­gins. The switch comes with a shake­up of the board. Gavin Mo­linel­li, part­ner of Star­board, who’s been push­ing for change, says he’s sat­is­fied with the re­or­ga­ni­za­tion.

Acor­da says it’s mak­ing good progress with long-term safe­ty stud­ies of its Parkin­son’s drug CVT-301. “We are de­light­ed with these re­sults, and plan to move for­ward with our NDA fil­ing for CVT-301. These two stud­ies, which in­clude ap­prox­i­mate­ly 700 par­tic­i­pants, rep­re­sent the largest safe­ty data­base eval­u­at­ing long-term pul­monary func­tion in peo­ple with Parkin­son’s,” said Burkhard Blank, the CMO at Acor­da.

→ Ko­rea’s Sam­sung Bi­o­Log­ics has blitzed its way to a lead­ing spot in the emerg­ing biosim­i­lars mar­ket. And it’s been build­ing up its man­u­fac­tur­ing mus­cle with its pipeline. Now a top ex­ec says the com­pa­ny is look­ing to Eu­rope or the US for the site of its next big man­u­fac­tur­ing site.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

Endpoints News writer Nicole DeFeudis has posted a snapshot of all the companies, universities and hospital-based groups now racing through the clinic, ranking them according to their place in the pipeline as well as the latest remarks available on timelines. And we’ll keep this lineup updated right through the end of the year, as the checkered flags start to fall, possibly as early as October.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Har­mo­ny Bio­sciences sets terms on $100M IPO; FDA ac­cepts a Pro­tal­ix BLA for re­view

Paragon portfolio company Harmony Biosciences announced its IPO terms on Tuesday, which set a range of $20 and $23 a share.

The Pennsylvania-based company, which initially filed for a $100 million IPO weeks ago, plans on offering 4.7 million shares. It seeks to raise roughly $100 million, which will fund the clinical advancement of its drug pitolisant.

Jeff Aronin — who serves as chairman of the Harmony board — stirred up controversy several years ago when he directed an old steroid he picked up cheap to Duchenne MD patients for $89,000. But that isn’t the only drama on the executive board — former CEO Bob Repella pled guilty to mail fraud in May in a college admissions scandal.

Eisai moves to 200 Metro Blvd. by late 2021 (ON3)

Ei­sai is cre­at­ing a new US cor­po­rate, R&D HQ in Roche’s old Nut­ley, NJ cam­pus

Eight years after Roche pulled up stakes from Nutley, NJ in a major R&D reorganization, Japan’s Eisai is moving its US corporate and research hub into their old campus.

Now the ON3 property, Eisai — a longtime Biogen partner focused on neurodegenerative disorders like Alzheimer’s — will bring together a staff of up to 1,200 employees. And execs are pitching the move to the New Jersey campus as a cultural game-changer.

Ugur Sahin, BioNTech CEO

Covid-19 roundup: Pfiz­er-backed BioN­Tech plans to seek FDA OK for a new vac­cine 'as ear­ly as' Oc­to­ber — ahead of the elec­tion

BioNTech execs say they’re on track to get their late-stage data on a Covid-19 vaccine — partnered with Pfizer — into the hands of regulators as early as October.

In their Q2 release Tuesday morning, the biotech reported that investigators could have late-stage data as early as October, and they won’t be wasting any time in hustling that over to the FDA.

“I am incredibly proud of our team, who has worked tirelessly to initiate our BNT162 Phase 2b/3 trial in record time and put us in a position to seek regulatory review as early as October of this year, if our trials are successful,” said Ugur Sahin, BioNTech’s CEO and co-founder.

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DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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