Thomas De Beer, RheaVita

A Bel­gian man­u­fac­tur­er looks to pit its freeze dry­ing process against mR­NA — and be­yond

When the Covid-19 vac­cine was first rolled out by drug­mak­ers, Dip­pin’ Dots was on the minds of sci­en­tists. Not be­cause they were ex­cit­ed to eat the “ice cream of the fu­ture” at base­ball games and coun­ty fairs again, but be­cause the bead­ed dessert must be stored at -49 de­grees Fahren­heit, sim­i­lar to the dos­es of Pfiz­er and Mod­er­na’s mR­NA vac­cine. In a crunch, Dip­pin’ Dots was called up­on to help trans­port the first of the vac­cine dos­es be­fore freez­ers were more wide­ly avail­able.

RheaV­i­ta CEO Thomas De Beer has nev­er heard of Dip­pin’ Dots, and his com­pa­ny has an­oth­er so­lu­tion to the prob­lem: de­vel­op­ing those vac­cines through a freeze-dried process. Near­ly half of EMA- and FDA-ap­proved prod­ucts are freeze-dried to ex­tend shelf life with­out the need for an ex­pen­sive cold chain.

On Wednes­day, De Beer’s com­pa­ny, RheaV­i­ta, se­cured a sweet $3 mil­lion in Se­ries A fi­nanc­ing. The round was co-led by VC No­valis Biotech Ac­cel­er­a­tion and in­vest­ment com­pa­ny Par­tic­i­patie Maatschap­pij Vlaan­deren.

The com­pa­ny, which was de­vel­oped in 2018 as a spin0ut from Ghent Uni­ver­si­ty, has de­vel­oped the world’s first end-to-end freeze-dry­ing so­lu­tion for prod­uct de­vel­op­ment, sup­ply and man­u­fac­tur­ing. Its tech­nol­o­gy crunch­es the man­u­fac­tur­ing process in­to a con­tin­u­ous pro­duc­tion line, al­low­ing for quick de­vel­op­ment and ef­fi­cient man­u­fac­tur­ing, the firm claims.

The com­pa­ny’s tech is ca­pa­ble of be­ing used for sev­er­al types of treat­ment — gene ther­a­py, an­ti­bod­ies, bi­o­log­i­cal ther­a­pies —  but mR­NA has emerged on to the main­stream through the pop­u­lar­i­ty and ne­ces­si­ty of Pfiz­er and Mod­er­na’s Covid-19 vac­cines.

“We’re so much more than just that. I see RNA is hot at this mo­ment, I un­der­stand,” De Beer said in an in­ter­view with End­points News. “But what I can say is at this mo­ment, we have done over 20 stud­ies with dif­fer­ent phar­ma­ceu­ti­cal com­pa­nies through a very wide range of prod­ucts and in all of them we have been suc­cess­ful.”

The com­pa­ny’s con­tin­u­ous freeze-dry­ing tech avoids scal­ing is­sues, re­duces cy­cle times and re­duces the time it takes for a prod­uct to get to mar­ket, the com­pa­ny said. Cur­rent­ly, it has a sin­gle-vial sys­tem and a non-GMP pro­to­type avail­able to test. With its Se­ries A fund­ing, De Beer and his team will be able to fi­nal­ize and as­sem­ble the GMP com­pli­ant freeze-dry­er. It will al­so ac­cel­er­ate the com­mer­cial­iza­tion and grow its team, De Beer said.

“What I want to em­pha­size is that we don’t sell stain­less steel. We sell man­u­fac­tur­ing so­lu­tions,”  he said. “So that this is ac­tu­al­ly a com­bi­na­tion of man­u­fac­tur­ing equip­ment but al­so to­geth­er with the ser­vices that are need­ed to prop­er­ly and, in a fast way, de­vel­op func­tion­al prod­ucts.”

No­valis’ Kjell Morti­er and Ste­fan De Waele of PMV will join the com­pa­ny’s board of di­rec­tors as a part of the deal.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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As it ex­pands its foot­print, Mod­er­na reach­es deal to man­u­fac­ture Covid-19 vac­cine dos­es in Mid­dle East

While the UAE leads the world with the highest percentage of residents vaccinated, neighboring Saudi Arabia — home to nearly 35 million people — has lagged behind significantly. On Friday, Moderna announced that it has partnered with the Saudi pharmaceutical company Tabuk to manufacture its jab and future variant-specific boosters in the country.

Tabuk will hold marketing authorization for the vaccine in Saudi Arabia, and the agreement gives them the possibility of distributing future Moderna mRNA products.

FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Months af­ter FDA re­jec­tion, Sanofi touts piv­otal win for rare dis­ease drug su­tim­limab as it preps to re­file

One of the pillar drugs of Sanofi’s $11.6 billion pickup of Bioverativ hit a big setback late last year when the FDA sent its application for approval back. Now, as Sanofi gears up to resubmit the drug for review, the drugmaker is touting pivotal data it hopes will help take it over the finish line.

Sanofi’s sutimlimab nailed all three of its primary endpoints in its Phase III CADENZA study for patients with cold agglutinin disease, a rare disorder that can cause severe anemia, without a recent history of blood transfusion, the French drugmaker said Friday. The topline results will be presented at this weekend’s virtual EHA meeting.

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Sadasivan Vidyasagar (Credit: University of Florida)

An API firm with a his­to­ry of J&J fund­ing scores a ma­jor loan to ad­vance its port­fo­lio

A Massachusetts-based company that manufactures APIs closed its Series A and B fundraising, with J&J among the list of investors. Now, the company is announcing another $49 million loan to help boost operations.

Entrinsic Bioscience — or EBS — expects to use the loan to fund programs for GI, airway and skin diseases. CEO Stephen Gatto called these programs a “blueprint for serial innovation” in a press release.