Xuefeng Yu, CanSino Biologics CEO (Imaginechina via AP Images)

Covid-19 roundup: CanSi­no’s in­haled vac­cine gets thumbs-up from Chi­nese reg­u­la­tors; Sino­vac gets go-ahead for boost­er tri­al in Chile

While the world has been fo­cused on in­jectable boost­er shots to ad­dress the Omi­cron vari­ant, one com­pa­ny fo­cused on a dif­fer­ent ap­proach has seen its prod­uct take a ma­jor step for­ward.

Chi­nese biotech CanSi­no Bi­o­log­ics has re­ceived ap­proval from the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion of Chi­na for its in­haled Covid-19 vac­cine, dubbed Con­vide­cia Air, to be used as a boost­er.

The com­pa­ny said that its boost­er us­es an ade­n­ovirus vec­tor plat­form and it tout­ed the non-in­va­sive na­ture of the vac­cine, as com­pared to in­jectable jabs al­ready on the mar­ket. The boost­er dose us­es a neb­u­liz­er to change liq­uid in­to an aerosol so it can be in­haled via the mouth.

In 2020, CanSi­no pre­sent­ed the vac­cine’s ef­fec­tive­ness in The Lancet, along with sev­er­al ex­perts giv­ing the spray a pos­i­tive re­view.

The Lancet’s re­port on Phase II of the vac­cine in 2021 showed that it had in­duced over 85% of vol­un­teers to cre­ate an­ti­bod­ies for the nov­el coro­n­avirus and a T-cell re­sponse with­in 14 days of re­ceiv­ing the vac­cine. There were al­so no se­ri­ous ad­verse events re­port­ed.

While the ap­proval is good news for CanSi­no, it needs a pick me up as the com­pa­ny has been star­ing down an 82% drop in its stock price since Sep­tem­ber of last year.

Clover Bio­ther­a­peu­tics un­veils PhI­II da­ta for its Covid-19 boost­er

As boost­er vac­cines to counter the Omi­cron vari­ant are be­gin­ning to roll out, oth­er biotechs are not giv­ing up the ship in pre­sent­ing re­sults for its can­di­dates.

Clover Bio­ther­a­peu­tics on Tues­day pre­sent­ed da­ta from its Phase III tri­al for its vac­cine can­di­date SCB-2019, as a uni­ver­sal boost­er for the virus.

The da­ta from its study, which was con­duct­ed in the Philip­pines, showed that a boost­er dose of SCB-2019 in par­tic­i­pants who had re­ceived two dos­es of the in­ac­ti­vat­ed vac­cine did have an im­mune re­sponse against both the orig­i­nal strain as well as the Omi­cron vari­ants BA.1 and BA.2.

Pa­tients with low pre-boost­er an­ti­body lev­els showed that the boost­er can­di­date gave a 17-fold in­crease in an­ti­bod­ies against the orig­i­nal strain, with the geo­met­ric mean titers (GMT) of an­ti­bod­ies in­creas­ing from 44 to 733.

The boost­er al­so had a 6-fold in­crease in an­ti­bod­ies against BA.1 and an 8-fold boost against BA.2. How­ev­er, no re­sults were giv­en against the BA.5 vari­ant. Ac­cord­ing to the com­pa­ny, those da­ta are ex­pect­ed to be re­leased soon, but no time­line was giv­en.

The com­pa­ny is al­so look­ing to en­roll a co­hort to in­ves­ti­gate the ef­fects of a fourth dose of the boost­er can­di­date, as well.

Sino­vac gets the green light to in­ves­ti­gate its omi­cron vac­cine can­di­date in Chile

While Sino­vac has hit stum­bling blocks in South Amer­i­ca pre­vi­ous­ly — with Brazil halt­ing over 12 mil­lion dos­es last year af­ter its man­u­fac­tur­ing site was not ap­proved for emer­gency use — the com­pa­ny is go­ing ahead with a clin­i­cal tri­al in an­oth­er coun­try on the con­ti­nent.

The Chilean Pub­lic Health In­sti­tute has giv­en the Chi­nese phar­ma the go-ahead to con­duct a Phase II tri­al for its Omi­cron strain Covid-19 vac­cine and triva­lent vac­cine, which is de­signed to counter the orig­i­nal strain as well as all Delta and Omi­cron vari­ants, the com­pa­ny an­nounced on Tues­day.

The tri­al will eval­u­ate the safe­ty and im­muno­genic­i­ty of one boost­er dose of the two can­di­dates in adults who have al­ready re­ceived two vac­cine dos­es, the com­pa­ny said. The dou­ble-blind Phase II aims to en­roll 826 pa­tients.

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.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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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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User fees in ac­tion: FDA un­veils new short­ened sup­ple­ment re­view, rare dis­ease pi­lots

Thanks to PDUFA VII, signed into law last Friday by President Joe Biden, the FDA this week unveiled two new industry-friendly pilot programs to advance new rare disease endpoints via additional meetings, and to shorten FDA review times for supplemental apps aimed at unmet medical needs.

The agency this week released eagerly-awaited details behind the shortened pilot, known as the Split Real Time Application Review or STAR pilot program, which will speed up certain FDA reviews of efficacy supplements across all therapeutic areas (thanks to earlier submissions of data), but only for those that propose addressing an unmet medical need.

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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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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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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, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.