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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Eli Lil­ly and Te­va pre­pare for court bat­tle over mi­graine med ri­val­ry

It looks like Eli Lilly and Teva Pharmaceuticals are going to trial.

A federal appeals court on Monday refused to invalidate three of Teva’s patents for its migraine treatment Ajovy, while also declining to issue a summary judgment in favor of either company, which would effectively end the case without a full trial.

Teva filed suit against Lilly back in 2018, alleging that the company infringed upon nine patents with its rival migraine drug Emgality. The rival drugs were both approved in September 2018 for the preventative treatment of migraine, and are designed to block calcitonin gene-related peptide (CGRP), a protein associated with the onset of migraine pain.

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Rep. Vern Buchanan (R-FL) (Bill Clark/CQ Roll Call via AP Images)

Af­ter cov­er­age re­stric­tions for Alzheimer's drugs, bi­par­ti­san House bill would force CMS to re­view drugs in­di­vid­u­al­ly

When Biogen’s controversial Alzheimer’s drug Aduhelm was hit with a national decision from CMS that restricted coverage to only randomized trials, practically guaranteeing a commercial flop in the near term, questions surfaced over why CMS also included all amyloid-targeted monoclonal antibodies for Alzheimer’s disease.

With Eisai and Biogen’s second Alzheimer’s drug, lecanemab, now showing it can slow the rate of cognitive decline versus placebo, lining up for a likely full approval next spring, the question now turns to whether that data, which is being presented at the Clinical Trials on Alzheimer’s Congress in San Francisco in late November, will be enough for CMS when it asks, “Does the anti-amyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients in broad community practice?”

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FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA on Wednesday set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, meaning regulators aren’t likely to meet the Nov. 30 PDUFA date that was previously set.

The drug, known as omecamtiv mecarbil, read out its first Phase III in November 2020, hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

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David Cory, Eiger BioPharmaceuticals CEO (via MultiVu)

FDA re­jects Eiger's emer­gency use re­quest for re­pur­posed Covid-19 treat­ment

Eiger BioPharmaceuticals is no longer planning to submit an emergency use application to the FDA.

The Palo Alto, CA-based biotech had hoped to repurpose its hepatitis D treatment, peginterferon lambda, for mild-to-moderate Covid-19 — submitting a request to the FDA for a pre-EUA meeting back in September with data from a Phase III platform trial in hand.

However, that meeting was rejected by federal regulators because of “concerns about the conduct of the TOGETHER study,” per an Eiger statement.

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