David Perlin (L) and Charles Rice

'Vac­cines alone are in­suf­fi­cien­t': Mer­ck, Ali­gos work with aca­d­e­m­ic ex­perts to find Covid an­tivi­rals as part of $65M NIH grant

Mer­ck is throw­ing its weight be­hind a new con­sor­tium of aca­d­e­m­ic, non­prof­it and biotech sci­en­tists to dis­cov­er oral an­tivi­rals that can fight Covid-19 — and pan­dem­ic virus­es of the fu­ture.

The NIH and the NI­AID will pro­vide $65 mil­lion over three years to fund the The Met­ro­pol­i­tan An­tiVi­ral Drug Ac­cel­er­a­tor, or MAV­DA, as it works to find and test small mol­e­cule drugs to tar­get coro­n­avirus­es. With an em­pha­sis on SARS-CoV-2 and one or more se­lect RNA virus­es with pan­dem­ic po­ten­tial, the goal is to make oral treat­ments that can be giv­en in an out­pa­tient set­ting.

MAV­DA ap­pears to be part of an NIH cam­paign to cre­ate an­tivi­ral drug dis­cov­ery cen­ters, whose main goals are to do the pre­clin­i­cal dis­cov­ery work for Covid-19 drugs and oth­er virus­es with high pan­dem­ic po­ten­tial. But here, the part­ners will look to take it a step fur­ther by hav­ing the bio­phar­ma part­ners rapid­ly trans­late the find­ings.

Vi­rol­o­gists and aca­d­e­m­ic drug find­ers at Rock­e­feller Uni­ver­si­ty, Co­lum­bia Uni­ver­si­ty, Memo­r­i­al Sloan-Ket­ter­ing Can­cer Cen­ter in New York City, as well as Hack­en­sack Merid­i­an Cen­ter for Dis­cov­ery and In­no­va­tion (CDI) and Rut­gers Uni­ver­si­ty in New Jer­sey will join hands with drug de­vel­op­ers at Mer­ck, Ali­gos Ther­a­peu­tics and the non­prof­it Tri-In­sti­tu­tion­al Ther­a­peu­tics Dis­cov­ery In­sti­tute for the ini­tia­tive.

David Per­lin, the CSO and se­nior vice pres­i­dent of the CDI, is co-lead­ing the pro­gram with Rock­e­feller Uni­ver­si­ty vi­rol­o­gist and No­bel lau­re­ate Charles Rice.

“This pub­lic-pri­vate part­ner­ship is how sci­ence can pre­pare for the next phase of SARS-CoV-2 — as well as oth­er cur­rent and new vi­ral threats,” Per­lin said in a state­ment. “Vac­cines were a ter­rif­ic break­through to help stem COVID-19 af­ter the ini­tial spread — but as we have learned with COVID-19 and oth­er pan­dem­ic dis­eases, vac­cines alone are in­suf­fi­cient. We need ef­fec­tive drugs that can be used ear­ly and dis­trib­uted wide­ly to di­verse pop­u­la­tions around the world.”

Oth­er big names — cov­er­ing di­verse fields like vi­rol­o­gy, struc­tur­al bi­ol­o­gy, drug dis­cov­ery, med­i­c­i­nal chem­istry and drug screen­ing — in­clude Co­lum­bia’s David Ho, Stephen Goff, Jingyue Ju and Lawrence Shapiro; Rock­e­feller’s Tom Tuschl and Fras­er Glick­man; MSK’s Din­shaw Pa­tel; CDI’s James Balkovec and Veronique Dar­tois; and Rut­gers’ Joel Fre­undlich.

“We need to think dif­fer­ent­ly,” Rice added. “Bring­ing all this ex­pe­ri­ence and ex­per­tise in­to the same pro­gram, and hav­ing every­one ‘pull’ in the same di­rec­tion, can pro­duce some great re­sults.”

Hav­ing worked to­geth­er on oth­er projects, the sci­en­tists have put to­geth­er a plan to go five dif­fer­ent di­rec­tions. Six phar­ma-style “cores” will com­ple­ment each oth­er as they work on those projects.

With SARS-CoV-2, MAV­DA wants to look at eight mol­e­c­u­lar fea­tures in the virus which have crit­i­cal roles in vi­ral repli­ca­tion, mat­u­ra­tion and im­mune-sys­tem eva­sion. Chief among them is 3CL­pro, which is the virus’ main pro­tease for repli­ca­tion.

Ali­gos will be con­tribut­ing its 3CL­pro in­hibitor as one of the can­di­dates be­ing test­ed.

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.