Tillman Gerngross (Adagio)

Covid-19 roundup: Ada­gio plans to sub­mit EUA by Q2 in 2022; HIPRA to en­ter PhII tri­als

Ada­gio plans to sub­mit an EUA for its mon­o­clon­al an­ti­body against Covid-19 in Q2 2022, the com­pa­ny an­nounced in its Q3 up­date.

The sub­mis­sion will be based on the com­pa­ny’s STAMP tri­al of new­ly di­ag­nosed Covid-19 pa­tients. The in­ves­ti­ga­tion­al mAb is de­signed to of­fer broad neu­tral­iz­ing ac­tiv­i­ty against  SARS-CoV-2, in­clud­ing many of the dom­i­nat­ing vari­ants.

Ada­gio has al­so tout­ed ADG20 as an al­ter­na­tive treat­ment for those who will be bad can­di­dates for the pills Mer­ck and Pfiz­er have brought for­ward. But new pills brought for­ward from these com­pa­nies have the po­ten­tial to cut in­to its mar­ket. And they’ve not­ed their in­jectable for­mu­la­tions than mon­o­clon­al an­ti­bod­ies that have to be giv­en by IV, al­though ri­vals such as Vir and Re­gen­eron are work­ing on sim­i­lar for­mu­la­tions.

“Our sin­gle in­jec­tion de­liv­ery avoids the in­con­ve­niences as­so­ci­at­ed with IV ad­min­is­tra­tion or mul­ti­ple in­jec­tions,” said CMO Lynn Con­nol­ly in a press re­lease. “The world con­tin­ues to face a host of chal­lenges in ful­ly ad­dress­ing the COVID-19 cri­sis. Al­ter­na­tives or sup­ple­ments to vac­cines for the pre­ven­tion of COVID-19 are need­ed for im­muno­com­pro­mised in­di­vid­u­als and those who re­main hes­i­tant to re­ceive a vac­cine or to vac­ci­nate their chil­dren.

CEO Till­man Gern­gross said in a press re­lease that the com­pa­ny has got­ten clear feed­back from the FDA on a strat­e­gy to sub­mit an EUA, and has ex­pand­ed its clin­i­cal pro­gram to add ad­di­tion­al pa­tient sub­sets, such as in­clud­ing im­muno­com­pro­mised in­di­vid­u­als and chil­dren.

“Our com­mer­cial-readi­ness ef­forts are well un­der­way and with a strong bal­ance sheet, we are ready to move quick­ly to en­able ac­cess to in­di­vid­u­als in need of COVID-19 pre­ven­tion and treat­ment op­tions, if au­tho­riza­tion and/or ap­proval is grant­ed,” he said.

The treat­ment is en­rolling par­tic­i­pants for tri­als eval­u­at­ing the suc­cess at pre­vent­ing the virus as well. As of Sept. 30, Ada­gio is val­ued at $666.3 mil­lion, and R&D ex­pens­es were $49.4 mil­lion, the com­pa­ny re­port­ed.

In Ju­ly, Gern­gross inked a deal to make and com­mer­cial­ize a treat­ment sim­i­lar to ADG20 in south­ern Asia. Ada­gio will pro­vide Bio­con with ma­te­ri­als and know-how to make the ther­a­py, in­clud­ing da­ta from on­go­ing Phase II/III tri­als and ac­cess to its po­ten­tial EUA pack­age.

HIPRA to en­ter PhII tri­als

The Cat­alo­nia-based com­pa­ny HIPRA has got­ten the OK from Span­ish reg­u­la­tors to start a Covid-19 vac­cine tri­al, Spain Prime Min­is­ter Pe­dro Sánchez said Mon­day.

The Phase II tri­al will test the vac­cine in more than 1,000 vol­un­teers in 10 hos­pi­tals across the coun­try. Sánchez called the news of the vac­cine’s de­vel­op­ment “ex­tra­or­di­nary” at an event, and said that the gov­ern­ment has giv­en a 15 mil­lion eu­ro grant to help de­vel­op the drug. Hipra has been work­ing on two Covid-19 shots, one that us­es mR­NA and an­oth­er that us­es a re­com­bi­nant pro­tein sim­i­lar to No­vavax’s jab.

Hipra ex­pects to pro­duce 600 mil­lion dos­es in 2022, Reuters said.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Try­ing to shake up the Parkin­son's par­a­digm, Ab­b­Vie sub­mits NDA for con­tin­u­ous, 24-hour in­fu­sion ther­a­py

AbbVie is approaching the FDA with a new therapy to potentially treat Parkinson’s disease, using prodrugs of two medications commonly used for the condition.

The Big Pharma submitted its NDA for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy, AbbVie announced Friday morning. Researchers are hoping a positive Phase III study that reads out in late October will help move things along quickly at the agency.

Siddhartha Mukherjee (Brian Ach/Getty Images for The New Yorker)

All Blue's $733M bid to ac­quire Zymeworks turns hos­tile as board bat­tles back — af­ter a biotech celebri­ty jumps in

Yesterday, the team at All Blue Capital — bent on the takeover of a badly battered Zymeworks — brought in celebrated oncologist, Pulitzer prize-winning writer and biotech exec Siddhartha Mukherjee to add some glitz to their proposed board. But they’re still not winning over any converts.

This morning, Zymeworks’ board officially turned this acquisition offer into a hostile showdown, rejecting the unsolicited offer and marshaling its forces to prevent a buyout at $10.50 per share.

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Paul Hudson, Sanofi CEO (via Getty)

Sanofi's $20B buy­out of Gen­zyme pays off again with Eu­ro­pean OK for first Nie­mann-Pick drug

Sanofi CEO Paul Hudson has made clear his intention to develop new rare disease drugs and broaden his company’s offerings. That effort leaped forward on Friday with the EMA’s signing off on the company’s — and the EU’s — first drug to treat the non-central nervous system manifestations of the rare and debilitating Niemann-Pick disease.

The enzyme replacement therapy, developed to replace patients’ deficient or defective enzyme, known as acid sphingomyelinase, was first developed by Genzyme, which Sanofi acquired for more than $20 billion in 2011. That acquisition has also helped Sanofi pull in sales in the field of MS.

Proac­tive­ly pre­vent­ing short­ages: New FDA guid­ance spells out which drugs re­quire risk man­age­ment plans

As the majority of drug shortages are still associated with manufacturing-related quality issues, the FDA on Thursday published new draft guidance spelling out how to proactively assess risks to manufacturing processes and supply chains, while understanding the market’s vulnerabilities.

While drug shortages peaked in 2011, the FDA says in its new 18-page draft guidance that the number of new drug shortages “has declined significantly since” that peak, reaching a low in 2015 and 2016, thanks in part to a new law’s enactment, known as FDASIA, which helped the agency better prevent or mitigate drug supply disruptions and shortages, and clarified cGMP requirements.