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.

George Scangos (L) and Marianne De Backer

Pi­o­neer­ing biotech icon George Scan­gos hands in his re­tire­ment pa­pers — and this time it’s for re­al

George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.

The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.

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FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Jeanne Loring, director of the Center for Regenerative Medicine (Credit: Jamie Scott Lytle)

A stem cell pi­o­neer sent an ex­per­i­ment in­to space. Pa­tients are the next fron­tier

Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.

For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.

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In a win for Re­gen­eron, No­var­tis' sy­ringe for AMD drug de­clared 'un­patentable'

Regeneron has won a patent case against Swiss pharma giant Novartis over the delivery system for its eye drug Eylea.

The US Patent Trial and Appeal Board ruled that Novartis’ pre-filled syringe for injecting its eye medication Lucentis was “unpatentable” and handed the victory to Regeneron and its AMD drug Eylea.

In the initial complaint in 2020, Novartis alleged to the US International Trade Commission that certain pre-filled syringes for the intravitreal injection, and ultimately Regeneron’s delivery system for Eylea, were infringing on Novartis’ patent. Regeneron filed a petition to review Novartis’ claims in 2021.

'Tis the sea­son: GSK ad­dress­es win­ter virus surges with celebri­ty and in­flu­encer vac­cine aware­ness cam­paigns

GSK is rounding up the usual suspects this winter — flu, respiratory syncytial and even shingles viruses — for multiple marketing efforts all aimed at encouraging vaccinations.

Mom influencers take center stage in its “Flu is a Family Affair” campaign to reach family decision-makers or “chief health officers.” GSK is asking them in the digital campaign to take care of themselves, and take the family along, when they go to the pharmacy or doctor’s office for a flu vaccine.

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Bris­tol My­ers claims win with CAR-T ther­a­py Breyanzi in leukemia

Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.

The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

FDA takes next step in Tor­rent Phar­ma­ceu­ti­cal­s' trou­bled In­dia plant saga, is­sues OAI

The FDA has handed Torrent Pharmaceuticals an official action indicated (OAI) status for a previously inspected manufacturing facility in India.

Torrent Pharma sent a letter to the National Stock Exchange of India earlier this week with word that the manufacturer has received a “communication from the FDA determining the inspection classification as ‘Official Action Indicated’ (OAI)” for one of its sites. An OAI classification from the FDA comes after the agency has completed an inspection and determines if the facility complies with the applicable laws and regulations. Being given an OAI classification means that regulatory or administrative actions will be recommended to Torrent. However, the details on the recommended actions have not been given.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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