As coro­n­avirus out­break reach­es 'tip­ping point,' GSK lends ad­ju­vant tech to Chi­nese part­ner armed with pre­clin­i­cal vac­cine

As the coro­n­avirus orig­i­nat­ing out of Wuhan spreads to South Ko­rea, Italy and Iran, stok­ing al­ready in­tense fears of a pan­dem­ic, Glax­o­SmithK­line has found an­oth­er pair of trust­ed hands to place its ad­ju­vant sys­tem. Chi­na’s Clover Bio­phar­ma­ceu­ti­cals will add the ad­ju­vant to its pre­clin­i­cal, pro­tein-based vac­cine can­di­date against SARS-CoV-2.

Thomas Breuer

Clover, which is based in the in­land city of Cheng­du, boasts of a plat­form dubbed Trimer-Tag that pro­duces co­va­lent­ly-trimer­ized fu­sion pro­teins. Its can­di­date, COVID-19 S-Trimer, re­sem­bles the vi­ral spike (S)-pro­tein found in the virus.

Thomas Breuer, CMO of GSK Vac­cines, praised the re­search as “cut­ting edge” and their pro­pos­al promis­ing.

Ear­li­er this month the phar­ma gi­ant put out word that it’s mak­ing its plat­form avail­able to a net­work of in­ves­ti­ga­tors af­fil­i­at­ed with CEPI, the Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tion in Oslo.

“The use of an ad­ju­vant is of par­tic­u­lar im­por­tance in a pan­dem­ic sit­u­a­tion since it may re­duce the amount of vac­cine pro­tein re­quired per dose, al­low­ing more vac­cine dos­es to be pro­duced and there­fore con­tribut­ing to pro­tect more peo­ple,” Breuer said in a state­ment.

There’s no time­line on when their can­di­date might be ready for a clin­i­cal tri­al, let alone be­com­ing com­mer­cial­ly avail­able. But Clover said it has “one of the largest in-house, com­mer­cial-scale cGMP bio­man­u­fac­tur­ing ca­pa­bil­i­ties in Chi­na,” which would al­low it to rapid­ly scale up pro­duc­tion of a new vac­cine.

Where­as doc­tors in Chi­na and around the world have had some suc­cess treat­ing Covid-19 pa­tients with un­proven but seem­ing­ly ef­fec­tive ther­a­pies — from HIV drugs to a malar­ia med to oth­er ex­per­i­men­tal an­tivi­rals — the plight of Wuhan has demon­strat­ed how the sheer size of the pa­tient pop­u­la­tion can over­whelm med­ical sys­tems and leave many be­hind. These fears are ex­ac­er­bat­ed by the up­dates pour­ing in from Iran, where 50 new deaths have been re­port­ed in one city, as well as Ko­rea, whose case­load has surged to over 800 in a mat­ter of days. Vac­cines re­main the Holy Grail.

Aside from the more tra­di­tion­al ap­proach, CEPI is al­so back­ing new ef­forts to de­vel­op an mR­NA vac­cine, which would hi­jack the cell’s ma­chin­ery and coax the body to make its own anti­gens that then kick up an im­mune re­sponse. Both CEPI part­ner Cure­Vac and Mod­er­na, work­ing with the NIH, have in­di­cat­ed that they will be ready for hu­man test­ing ear­ly this sum­mer — a much faster pace al­beit for a much new­er tech­nol­o­gy.

The abil­i­ty to mass man­u­fac­ture any suc­cess­ful mR­NA vac­cines that emerge, though, still re­mains in ques­tion and the NIH has plead­ed with large drug­mak­ers to step up.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

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With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Goldfinch Bio CEO Tony Johnson (L) and Karuna Therapeutics CEO Bill Meury

Karuna li­cens­es Goldfinch as­sets to com­pete with Boehringer In­gel­heim in neu­ro­science

Karuna Therapeutics is looking to compete with Boehringer Ingelheim on depression and anxiety with a new license to Goldfinch Bio’s assets, starting with $15 million to the shuttered biotech.

Karuna steps into an arena already being tested by Boehringer in multiple Phase II studies — the two are targeting transient receptor potential canonical 4 and 5, or TRPC4/5, which is thought to have a role in neuroscience indications. Goldfinch’s asset went through a Phase II in kidney diseases, but Karuna’s sights are set on mood and anxiety disorders for now.

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Photo: Julia Weeks/AP Images

FDA ax­es re­quire­ment for pos­i­tive Covid test be­fore Paxlovid use

FDA announced today that doctors and pharmacists can now prescribe Paxlovid to patients without a positive test for Covid-19.

CDER Director Patrizia Cavazzoni reissued Paxlovid’s authorization letter Wednesday, saying it has revised the authorization to “no longer require positive results of direct SARS-CoV-2 viral testing.” The EUA now requires instead that adults and kids 12 years of age and older have a “current diagnosis of mild-to-moderate COVID-19.”

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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