Savara hunts cash af­ter dou­bling down on late-stage res­pi­ra­to­ry drugs

Austin-based Savara Ther­a­peu­tics got start­ed in biotech with a list of an­gel in­vestors and a lead pro­gram that looked to de­vel­op an in­haled dry pow­der for­mu­la­tion of van­comycin for cys­tic fi­bro­sis suf­fer­ers. Now, with its Phase III loom­ing at the end of the year, the com­pa­ny has lined up an­oth­er late-stage ther­a­py, pick­ing up the res­pi­ra­to­ry as­sets of Dan­ish biotech Seren­dex in an ac­qui­si­tion as it hunts up fresh mil­lions to do a con­sid­er­able amount of de­vel­op­ment work.

Rob Neville, CEO Savara

Savara has al­ways tend­ed to keep its cards close to the vest, and isn’t say­ing just what it paid to get the Seren­dex drugs, built by a staff of 11 who will now join Savara’s 7-mem­ber team. It has moved on from the an­gel list to more sub­stan­tial back­ers, ex­ecs say, but they aren’t say­ing who. And while it counts a to­tal of $45 mil­lion raised in in­vest­ments and grant mon­ey – in­clud­ing back­ing from the Cys­tic Fi­bro­sis Foun­da­tion – CEO Rob Neville will now need to raise more mon­ey to push both prod­ucts through to reg­u­la­to­ry sub­mis­sion.

Af­ter rais­ing $20 mil­lion from undis­closed in­vestors a few months ago, he says, the com­pa­ny was ready to start en­rolling pa­tients for the lead Phase III with­out hav­ing all the mon­ey need­ed to fin­ish it. Now with two late-stage ef­forts, he adds, the com­pa­ny reck­ons it will need $45 mil­lion to com­plete the pre-sub­mis­sion ef­fort on both.

Seren­dex delist­ed a few months ago from the Oslo ex­change, part of a process that Neville said was re­quired to al­low the com­pa­nies to merge in a stock deal. And now he’d like to po­si­tion Savara for a mez­za­nine round that might set the stage for an IPO — pro­vid­ed the mar­kets start to look more fa­vor­ably on biotech com­pa­nies.

The lead prod­uct that at­tract­ed Savara’s at­ten­tion is Mol­gradex, an in­haled form of gran­u­lo­cyte-macrophage colony-stim­u­lat­ing fac­tor (GM-CSF) in a Phase II/III tri­al in Eu­rope and Japan for au­toim­mune pul­monary alve­o­lar pro­teinosis (PAP).

This treat­ment in­jects GM-CSF “di­rect­ly in­to the lung al­most as a re­place­ment ther­a­py,” says Savara COO Taneli Jouhikainen. “From pi­lot stud­ies, aca­d­e­m­ic work, we know that the drug works quite nice­ly.”

Neville sees it as a neat fit with Savara’s AeroVanc. The sec­ond prod­uct ac­quired in the deal is a pre­clin­i­cal, in­haled form of Fac­tor VI­Ia, which Savara will take over de­vel­op­ment for a rare lung dis­ease called dif­fuse alve­o­lar he­m­or­rhage (DAH).

“This is a big deal,” says Neville, one that makes Savara a dif­fer­ent kind of com­pa­ny, with a pipeline of what he sees as large­ly de-risked drug pro­grams worth watch­ing. But with­out more trans­paren­cy, that’s not a sen­ti­ment that’s easy to en­dorse.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

A low-pro­file biotech bests Re­gen­eron in high-pro­file patent suit

For nearly a decade now, the low-profile Cambridge biotech Kymab has been battling in US, UK, Japanese and Australian courts with the biotech behemoth Regeneron.

Regeneron has turned itself into a $70 billion company off of a platform of transgenically humanized mice they can use to make antibodies for anything from Ebola to colorectal cancer. The technology took decades and billions to build, 20 years from the company’s founding to the first approved drug. And the company guards and touts it zealously, breaking their production process down into various branded components — Velocimmune, Velocigene, Velocimouse and four other Velocis — and sometimes suing would-be copycats. In 2014, most notably, they sued two Pfizer-backed entities for patent infringement.

Credit: AP Images

Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Bull­ish biotech mar­ket pro­pels Pli­ant to $144M IPO — as No­var­tis pro­vides a $10M boost

After pharma partner Novartis boosted its IPO with a $10 million private placement, Pliant Therapeutics has wrapped its journey to the Nasdaq on a high note.

Pliant had penciled in a $86 million raise back in May. But as has become the norm in recent months, that initial number has turned out to be a mere placeholder, making way for the final haul of $144 million.

The South San Francisco biotech did so by pricing at $16, the high end of the range, while bringing the number of shares offered up to 9 million.

Cameron Durrant, Humanigen CEO (Columbia University Technology Ventures via YouTube)

Cameron Dur­rant hus­tled his way from the OTC side­lines right in­to the Covid-19 drug race. Death or glo­ry lies straight ahead

Over the past few months, Covid-19 has gone from being a monolithic threat to one of the biggest overnight boons the biopharma industry has ever seen. And amid all the furor over Moderna’s swelling stock price, plenty of chatter over what new drugs and vaccines will cost and investors’ uninhibited zeal for all things related to pandemic products, it’s been one little biotech’s golden ticket back from the land of the living dead.

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