Thomas Lingelbach, Valneva CEO

Covid-19 roundup: Val­ne­va runs in­to EMA ques­tions, still ex­pects March au­tho­riza­tion; Cana­da ap­proves first plant-based vac­cine

In Feb­ru­ary 2021, the Eu­ro­pean Med­i­cines Agency be­gan a rolling re­view of French biotech Val­ne­va’s Covid-19 vac­cine, which is a whole virus, in­ac­ti­vat­ed, ad­ju­vant­ed vac­cine.

About a year lat­er, Val­ne­va says the EMA still has ques­tions, al­though the com­pa­ny said Fri­day that it’s “con­fi­dent that it will be able to re­spond to these in the com­ing days. Fol­low­ing the Com­pa­ny’s re­sponse, the EMA will pro­vide a timetable to­wards an­tic­i­pat­ed con­di­tion­al ap­proval.”

Val­ne­va, which ear­li­er ac­knowl­edged that its vac­cine on­ly per­formed well af­ter a pri­ma­ry se­ries of the Val­ne­va vac­cine can­di­date, al­so said it an­tic­i­pates re­ceiv­ing a pos­i­tive CHMP rec­om­men­da­tion for con­di­tion­al ap­proval of its Covid vac­cine can­di­date for adults 18 to 55 years old by the end of March. Fol­low­ing a con­di­tion­al ap­proval, the com­pa­ny said it ex­pects to de­liv­er the first ship­ments of VLA2001 to Eu­ro­pean coun­tries ear­ly in Q2.

The Eu­ro­pean Com­mis­sion signed a sup­ply deal with Val­ne­va in ear­ly No­vem­ber for up to 60 mil­lion dos­es in 2022 and 2023.

Thomas Lin­gel­bach, CEO of Val­ne­va, said in a state­ment, “We are pleased with the ini­tial CHMP as­sess­ment and look for­ward to pro­vid­ing our re­spons­es as soon as pos­si­ble. VLA2001 is the on­ly in­ac­ti­vat­ed COVID-19 vac­cine in clin­i­cal de­vel­op­ment in Eu­rope, and this brings us clos­er to our ob­jec­tive of pro­vid­ing a dif­fer­en­ti­at­ed vac­cine op­tion to the pop­u­la­tion and physi­cians who need it.”

Cana­da ap­proves GSK/Med­ica­go’s plant-based Covid-19 vac­cine

Que­bec-based Med­ica­go and Glax­o­SmithK­line said Thurs­day that Health Cana­da ap­proved its plant-based Covid-19 vac­cine.

This is the first ap­proval for the two com­pa­nies, which paired GSK’s ad­ju­vant with promis­ing anti­gens to de­vel­op the pro­tein-based, re­frig­er­a­tor-sta­ble vac­cine. Known com­mer­cial­ly as Cov­ifenz, the vac­cine is in­di­cat­ed to pre­vent Covid-19 in in­di­vid­u­als 18 to 64 years of age.

The vac­cine showed 71% ef­fi­ca­cy in a late-stage tri­al against all vari­ants of SARS-CoV-2 among more than 24,000 adults in Cana­da, the US, UK, Mex­i­co, Ar­genti­na and Brazil. In Oc­to­ber 2020, the com­pa­ny reached an agree­ment with Cana­da to sup­ply up to 76 mil­lion dos­es of its vac­cine, and Med­ica­go al­so re­ceived $173 mil­lion in fund­ing sup­port from the Gov­ern­ment of Cana­da for its vac­cine R&D.

“We’re al­so grate­ful for the Gov­ern­ment of Cana­da’s sup­port in the de­vel­op­ment of this new vac­cine, and we are man­u­fac­tur­ing dos­es to start ful­fill­ing its or­der,” Takashi Na­gao, pres­i­dent and CEO at Med­ica­go, said in a state­ment.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Up­dat­ing the Covid-19 vac­cine: FDA of­fers a qual­i­fied thumbs-up ahead of ad­comm

The FDA’s adcomm of outside vaccine experts will meet tomorrow to discuss how to protect the US from a likely coming wave of Omicron cases in the fall and winter, and whether to deploy vaccines that specifically target the Omicron variant.

While the data so far are limited, the FDA sounded an upbeat tone in the briefing documents on Pfizer/BioNTech’s candidates, released this weekend ahead of the VRBPAC meeting.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.