Henry Daniell (Credit: Penn Dental Medicine)

Can a spe­cial chew­ing gum slick away Covid-19 from sali­va? Penn re­searchers start clin­i­cal tri­al to find out

Re­searchers from the Uni­ver­si­ty of Penn­syl­va­nia have be­gun a small clin­i­cal tri­al to test whether a cin­na­mon-fla­vored gum (no, not Wrigley’s Big Red) could re­duce the amount of Covid-19 in sali­va — a po­ten­tial way to cut trans­mis­sion of the virus.

The gum, de­signed by Penn School of Den­tal Med­i­cine’s Hen­ry Daniell, is made from let­tuce plant cells that were al­tered to ex­press ACE2 — the re­cep­tor that the Covid-19 virus binds to in the body — which en­ables the gum to trap Covid-19 vi­ral par­ti­cles.

In Ju­ly, Daniell and col­leagues pub­lished a pa­per de­scrib­ing the de­sign of their virus-trap­ping gums for var­i­ous strains of Covid as well as the flu. But this isn’t the first gum they’ve made.

Daniell’s lab has long stud­ied the oral de­liv­ery of plant-based drugs, but in re­cent years has al­so been look­ing at plant-based oral drugs for the mouth it­self. Pre­vi­ous­ly, they cre­at­ed a chew­ing gum that con­tained en­zymes that could break down plaque buildup on teeth, Daniell told End­points News, an al­ter­na­tive to get­ting it painstak­ing­ly scraped off by your den­tist. “And then came the pan­dem­ic,” Daniell said.

So they piv­ot­ed to make a virus-trap­ping gum.

In an ear­li­er pa­per, Daniell and col­leagues showed that their ACE2 chew­ing gum could sub­stan­tial­ly re­duce Covid-19 virus count in sali­va sam­ples — a re­sult they repli­cat­ed with var­i­ous strains of the Covid virus and two strains of the flu virus in the Ju­ly pa­per. To move their prod­uct for­ward, they got an IND in May to test the gum in peo­ple and be­gan the clin­i­cal tri­al this month, as first re­port­ed in Penn To­day.

The Phase I/II tri­al will en­roll 40 em­ploy­ees from Penn who have Covid-19, but aren’t get­ting any an­tivi­rals or hos­pi­tal care for it. The em­ploy­ees will have to chew the gum for 10 min­utes four times every day for three days, and col­lect mul­ti­ple sali­va sam­ples over the course of their tri­al pe­ri­od.

The goal of the study is to (1) test the safe­ty of the gum, as with all ear­ly-stage tri­als, and (2) see whether it can ac­tu­al­ly re­duce the vi­ral load in the sali­va of the par­tic­i­pants.

The study is set to fin­ish ear­ly next year, ac­cord­ing to clin­i­cal­tri­als.gov.

“Even though our en­tire tri­al is done with Covid-19 pa­tients, the gum is re­al­ly not in­tend­ed for peo­ple af­ter in­fec­tion. And this is be­cause no­body knows when they get in­fect­ed, so this will be launched as a pro­phy­lax­is prod­uct,” Daniell said, mean­ing that it would be used to pre­vent dis­ease.

The Covid-19 chew­ing gum could pro­vide an af­ford­able al­ter­na­tive in ar­eas where the vac­cine isn’t read­i­ly avail­able, and it could al­so pro­tect health­care work­ers while they per­form oral or den­tal care on un­masked pa­tients, the re­searchers sug­gest in the Ju­ly pa­per.

The the­o­ry be­hind the gum is that cut­ting the amount of virus in sali­va damp­ens the risk of Covid-19 trans­mis­sion and vi­ral load. Covid-19 is trans­mit­ted through flu­ids from the mouth, nose, and eyes, and stud­ies have sug­gest­ed that the sali­va con­tains es­pe­cial­ly high vi­ral loads. But what hap­pens once you spit out the gum? Does the ef­fect last?

That’s an­oth­er thing the re­searchers want to find out from the tri­al. “It is not known how long it takes for a pa­tient to re­build the virus in their mouth and in their sali­va — in spite of hun­dreds of thou­sands of pub­li­ca­tions, no­body has tried it,” Daniell said, though the cur­rent pro­jec­tion his team is run­ning with is four hours.

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.