Covid-19 roundup: Eu­ro­pean gov­ern­ments push to rene­go­ti­ate vac­cine con­tracts — re­port; As PhII da­ta dis­ap­point, PureTech pulls long Covid pro­gram

Be­fore the first Covid-19 vac­cines be­came avail­able, coun­tries scram­bled to se­cure ac­cess to the shots, clam­or­ing for sup­ply deals. But as sup­ply now far out­strips de­mand, gov­ern­ments in the Eu­ro­pean Union are push­ing to rene­go­ti­ate those deals.

Ex­ist­ing con­tracts would oblige them to buy vac­cines that will just go to waste, they ar­gue.

EU health min­is­ters are meet­ing to dis­cuss the is­sue, Reuters re­port­ed, cit­ing com­ments French min­is­ter Brigitte Bourgignon made to re­porters.

Most of these pur­chase agree­ments would in­volve Pfiz­er and BioN­Tech, which have al­ready shipped more than a bil­lion dos­es of their part­nered mR­NA vac­cine world­wide.

Poland is the lead­ing coun­try in this at­tempt to re­vise con­tracts and re­duce re­quired or­ders, Reuters added, as it still has more than 30 mil­lion shots in stock and is on the hook to buy an­oth­er 70 mil­lion un­der con­trac­tu­al agree­ments. The coun­try has a pop­u­la­tion of about 38 mil­lion, about 60% of whom are ful­ly vac­ci­nat­ed.

Pfiz­er said it’s made changes to de­liv­ery sched­ules to adapt. But it’s un­clear what so­lu­tion the min­is­ters will be look­ing for — or how they plan to en­force it.

As PhII da­ta dis­ap­point, PureTech pulls long Covid pro­gram

PureTech is throw­ing in the tow­el on ef­forts to de­vel­op its lead drug, LYT-100, for long Covid af­ter a Phase II study sug­gest­ed there was no treat­ment ef­fect.

“Ear­ly in the Covid-19 pan­dem­ic, we iden­ti­fied a po­ten­tial ap­pli­ca­tion for LYT-100 giv­en the hy­poth­e­sis that in­flam­ma­tion and fi­bro­sis may play a role in pro­long­ing res­pi­ra­to­ry symp­toms ex­pe­ri­enced by many pa­tients,” CEO Daphne Zo­har said in a state­ment. “We un­der­took this ex­plorato­ry study, guid­ed by a de­sire to ad­dress this emerg­ing need, while fur­ther ex­pand­ing the safe­ty and tol­er­a­bil­i­ty da­ta for our LYT-100 de­vel­op­ment pro­gram at large.”

What the re­sults do sup­port, ac­cord­ing to the com­pa­ny, is con­tin­ued de­vel­op­ment in oth­er in­di­ca­tions due to its “im­proved tol­er­a­bil­i­ty.”

The tri­al en­rolled 177 pa­tients with the av­er­age age of 55 who con­tin­ued to have res­pi­ra­to­ry com­pli­ca­tions fol­low­ing hos­pi­tal­iza­tion for se­vere acute Covid-19 in­fec­tion.

For the pri­ma­ry ef­fi­ca­cy end­point, in­ves­ti­ga­tors looked at a three-month change from base­line on the six-minute walk test dis­tance, and couldn’t see a dif­fer­ence be­tween drug and place­bo.

LYT-100 is a se­lec­tive­ly deuter­at­ed form of pir­fenidone, an an­ti-in­flam­ma­to­ry drug that’s used to treat id­io­path­ic pul­monary fi­bro­sis. PureTech will be start­ing a reg­is­tra­tion-en­abling pro­gram for the same dis­ease lat­er this month.

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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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Merdad Parsey, Gilead CMO

Four months af­ter CRL due to con­t­a­m­i­nant wor­ries, Gilead re­turns to FDA for next-gen HIV drug

Just shy of four months ago, Gilead’s next-gen HIV drug candidate lenacapavir got hit with a CRL over CMC issues involving the type of vials planned for use. Now, the pharma is headed back to the FDA for round two.

Gilead announced Monday afternoon that it had refiled its NDA submission filled with new CMC data after the FDA essentially balked at borosilicate glass vials, originally used for the non-oral form of lenacapavir. The drug candidate, which recently won a positive opinion from Europe’s CHMP, is being developed for HIV-1 infection “in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.”

Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

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.