Stéphane Bancel, Moderna CEO

Covid-19 roundup: Mod­er­na gets Swiss boost­er OK; Bi­va­lent shots ex­pect US EUA sans com­plete in-hu­man da­ta — re­port

Af­ter Mod­er­na’s bi­va­lent Omi­cron boost­er first got au­tho­rized in the UK, it was on­ly a mat­ter of time be­fore oth­er coun­tries fol­lowed suit. We now know the next coun­try to sign off on it: Switzer­land.

Mod­er­na put out word Mon­day that the reg­u­la­to­ry agency Swissmedic gave a tem­po­rary thumbs up to the mR­NA be­he­moth’s bi­va­lent boost­er vac­cine, mR­NA-1273.214.

Per a press re­lease, the boost­er is on­ly au­tho­rized for adults. Half of the 50 µg vac­cine tar­gets the orig­i­nal virus strain, while the oth­er half tar­gets Omi­cron BA.1.

The de­ci­sion from Swissmedic was based on clin­i­cal tri­al da­ta from a Phase II/III tri­al that were read out in June, where the can­di­date met all pri­ma­ry end­points , in­clud­ing a su­pe­ri­or an­ti­body re­sponse against Omi­cron, when com­pared to base­line in par­tic­i­pants with­out an­ti­bod­ies.

The biotech al­ready got au­tho­riza­tion in the UK two weeks ago and de­ci­sions are still pend­ing in oth­er coun­tries, such as Aus­tralia and Cana­da.

Mod­er­na added that it is work­ing with the Swiss gov­ern­ment and Swissmedic to get the boost­er avail­able in the coun­try by some­time next month.

Omi­cron boost­ers ex­pect­ed to be FDA au­tho­rized be­fore com­ple­tion of in-hu­man tri­als

Covid-19 boost­er shots — ones tar­get­ing the Omi­cron vari­ant — are set to be au­tho­rized by the FDA this week be­fore in-hu­man test­ing is com­plet­ed, ac­cord­ing to a re­port from the Wall Street Jour­nal pub­lished over the week­end.

The re­port not­ed FDA plans to ex­am­ine the shots from a va­ri­ety of oth­er sources out­side of clin­i­cal da­ta, such as pre­clin­i­cal da­ta from mice, the pro­files of the orig­i­nal vac­cines and the per­for­mance of ear­li­er it­er­a­tions of boost­ers.

“Re­al world ev­i­dence from the cur­rent mR­NA Covid-19 vac­cines, which have been ad­min­is­tered to mil­lions of in­di­vid­u­als, show us that the vac­cines are safe,” FDA com­mis­sion­er Rob Califf said in a se­ries of tweets last week. The FDA chief al­so not­ed that strain changes can be done safe­ly, and that the reg­u­la­to­ry agency will not hold an ad­comm to re­view the new sub­mis­sions.

It al­so lines up with biotech and phar­ma ex­pec­ta­tions, af­ter Mod­er­na just fin­ished sub­mit­ting a bi­va­lent Omi­cron can­di­date to the FDA last week. The boost­er, tar­get­ing BA.4 and BA.5 as well as the orig­i­nal strain and called mR­NA-12.73.222, is cur­rent­ly in an on­go­ing Phase II/III tri­al. Pfiz­er and BioN­Tech al­so sub­mit­ted theirs last week to the FDA for EUA.

If the FDA gives these two the green light, then the US will be set for a fall vac­ci­na­tion cam­paign.

Val­ne­va turns over fur­ther pos­i­tive Phase III da­ta for ad­ju­vant­ed Covid-19 vac­cine

Val­ne­va pre­vi­ous­ly re­port­ed a pos­i­tive Phase III read­out for its ad­ju­vant­ed Covid-19 vac­cine can­di­date, VLA2001. Now, it’s got more to share.

The biotech put out word via state­ment Mon­day that ad­di­tion­al read­outs from Val­ne­va’s Phase III tri­al showed “per­sis­tent im­muno­genic­i­ty and first pos­i­tive het­erol­o­gous boost­er re­sults fol­low­ing pri­ma­ry vac­ci­na­tion.” That pri­ma­ry vac­ci­na­tion was with As­traZeneca’s vac­cine ChA­dOx1-S, al­so known as Co­v­ishield.

This is one of the newest de­vel­op­ments for Val­ne­va af­ter its con­tract with Eu­rope for 60 mil­lion dos­es col­lapsed, set­tling for just 1.25 mil­lion dos­es af­ter the com­pa­ny’s reg­u­la­to­ry re­view got stalled. The biotech had al­so fired back af­ter a study late last year — tout­ing some of its own boost­er da­ta af­ter a study pub­lished in the Lancet said that VLA2001 was the on­ly one of 7 dif­fer­ent vac­cines that did not work well as a boost­er for a Pfiz­er or Mod­er­na shot.

Per a re­lease, neu­tral­iz­ing an­ti­body titers in­duced by Val­ne­va’s vac­cine were non-in­fe­ri­or to Co­v­ishield at day 71, in­clud­ing a sim­i­lar lev­el of Covid-19 cas­es be­tween the two vac­cine can­di­dates.

The biotech not­ed that the vac­cine was able to boost im­mu­ni­ty to lev­els re­port­ed to be ef­fi­ca­cious against SARS-CoV-2 — around 90%. On top of that, a boost­er shot of VLA2001 was well tol­er­at­ed in pa­tients who had ei­ther VLA2001 or As­traZeneca’s Co­v­ishield be­fore.

Val­ne­va CMO Juan Car­los Jaramil­lo said in a state­ment that “we be­lieve the ro­bust im­muno­genic­i­ty and safe­ty pro­file of our dif­fer­en­ti­at­ed whole virus, in­ac­ti­vat­ed vac­cine re­mains com­pelling,” and the com­pa­ny looks for­ward to pro­vid­ing fur­ther da­ta.

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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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket en­tire­ly by end of 2024 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.

The decision to not re-commercialize Natpara will be a blow to not only the 2,400 people who were awaiting supplies of their reliable injection since 2019, but also the additional nearly 400 people who were accessing the drugs via the company’s Special Use Program as Takeda sought to resolve these manufacturing issues over the past five years.

Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Andrew Crockett, KalVista CEO

KalVista ends a PhII study ear­ly af­ter pa­tients suf­fer se­vere and life-threat­en­ing side ef­fects

KalVista took a beating Tuesday after announcing it would scrap a Phase II trial for one of its experimental drugs.

The biotech said in an early morning press release that it is terminating the study for KVD824 after multiple patients in every treatment group saw unsafe, elevated levels of certain liver enzymes. By ending the trial now, KalVista hopes to save some money and funnel it toward another study for its lead program, CEO Andrew Crockett said in a statement.

Pen­ny stock play­er to re­view all op­tions to try stay­ing afloat af­ter clin­i­cal tri­al fail

Adamis Pharmaceuticals is slowly tumbling down, and the biotech is looking at all its options.

After a Phase II/III trial failure last month that sent the penny stock player down an additional 50% to just 15 cents a share, the company said Monday that it is examining options to get the best value for its investors. A statement from Adamis indicates that alternatives include anything from a partnership to a sale of Adamis’ two commercial products, Zimhi and Symjepi.