Vi­en­na-based vac­cine de­vel­op­er Themis signs pact with Mer­ck for 'block­buster in­di­ca­tion'

Months af­ter se­cur­ing up to $21 mil­lion in fund­ing from the Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tions (CEPI) for its Chikun­gun­ya vac­cine — which is be­ing prepped for a late-stage tri­al — Vi­en­na, Aus­tria-based Themis Bio­science en­tered in­to a pact with US drug­mak­er Mer­ck.

The Eu­ro­pean vac­cine de­vel­op­er formed in 2009 and a year lat­er joined forces with the In­sti­tut Pas­teur — gain­ing ex­clu­sive ac­cess to a measles virus vac­cine vec­tor tech­nol­o­gy, which now forms the back­bone of its plat­form.

Con­sid­er­ing it has been used to vac­ci­nate bil­lions of peo­ple, the at­ten­u­at­ed measles virus is one of the most ef­fec­tive and safe vac­cines avail­able, mak­ing it an at­trac­tive can­di­date vec­tor to avert in­fec­tious dis­ease.

In con­trast to oth­er ap­proach­es, Themis has de­vel­oped the tech­nol­o­gy to in­cor­po­rate mul­ti­ple large re­com­bi­nant pro­tein anti­gens in­to the vec­tor, which then acts as a de­liv­ery ve­hi­cle to trans­port the anti­gen pay­load di­rect­ly to macrophages and den­drit­ic cells. Fur­ther, since the vec­tor it­self repli­cates — there­by ex­press­ing anti­gens even af­ter im­mu­niza­tion — Themis’ vac­cine can­di­dates are en­gi­neered to con­fer long-term im­mu­ni­ty, chief Erich Tauber told End­points News.

Apart from its lead ex­per­i­men­tal Chikun­gun­ya vac­cine, Themis has a Zi­ka vac­cine and Las­sa fever in ear­ly-stage de­vel­op­ment. It al­so has a range of pre­clin­i­cal pro­grams, in­clud­ing those for res­pi­ra­to­ry syn­cy­tial virus (RSV), cy­tomegalovirus (CMV), norovirus and Mid­dle East Res­pi­ra­to­ry Syn­drome (MERS).

The vec­tor al­so has the in­trin­sic abil­i­ty to at­tack can­cer cells, which has been demon­strat­ed in var­i­ous pre­clin­i­cal stud­ies, he added. The com­pa­ny is there­fore cap­i­tal­iz­ing on that po­ten­tial by equip­ping the vec­tor with ad­di­tion­al tu­mor-killing pay­loads to de­vel­op on­col­o­gy treat­ments. Themis’s first im­muno-on­col­o­gy vac­cine is set to en­ter the clin­ic this year.

The terms of the Mer­ck $MRK part­ner­ship are shroud­ed in mys­tery. The two will work on a “block­buster in­di­ca­tion” and the New Jer­sey-based drug man­u­fac­tur­er will grant up to $200 mil­lion in mile­stone pay­ments, in ad­di­tion to roy­al­ties. Mer­ck has al­so made an undis­closed eq­ui­ty in­vest­ment in Themis.

Mer­ck, which has been bask­ing in the suc­cess of its flag­ship check­point in­hibitor Keytru­da, caus­ing some to wor­ry it may be lean­ing too heav­i­ly on the block­buster, has sharp­ened its fo­cus on its vac­cine port­fo­lio. In May, its pneu­mo­coc­cal con­ju­gate vac­cine can­di­date aimed at top­pling Pfiz­er’s best­seller, Pre­vnar 13, cleared a mid-stage study — and is al­so be­ing eval­u­at­ed in var­i­ous Phase III tri­als. Mer­ck al­so has a part­ner­ship with mR­NA com­pa­ny Mod­er­na $MR­NA, fo­cused on per­son­al­ized can­cer vac­cines that are cus­tomized for each pa­tient.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Amidst R&D reshuf­fle, Ver­tex ex­pands its pres­ence in Boston, aim­ing to be­come num­ber one

Vertex Pharmaceuticals has been one of the buzzier names in the bustling Boston biotech scene, but now the company is looking to vault to number one status — at least in terms of physical footprint.

At a ribbon cutting on Tuesday for its new Jeffrey Leiden Center for Cell and Genetic Therapies at the Boston Seaport, Vertex announced it would embark on a new project: The company will build a 344,000 square foot facility in the seaport to accommodate the company’s growing R&D needs, especially in its cell and gene therapies program.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

Cheng Zhang, CEO of Character Biosciences (Character)

Ge­nomics biotech un­der­goes a facelift, re­brand­ing from Clover to Char­ac­ter Bio­sciences

Though Clover Therapeutics has a new identity, CEO Cheng Zhang is making one thing clear: the genomics outfit’s goals and mission remain the same. Simply put, “we’re doubling down on it,” Zhang tells Endpoints News.

The San Francisco biotech, originally focused on analyzing reams of healthcare and imaging data to tackle “diseases of aging,” announced its new name late Tuesday morning: Character Biosciences. On top of that, the biotech announced $18 million in new funding via a Series A round.

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Clay Siegall (Photo by Dimitrios Kambouris/Getty Images for Gabrielle's Angel Foundation)

UP­DAT­ED: Clay Sie­gall re­signs from Seagen amid in­ves­ti­ga­tion in­to do­mes­tic vi­o­lence claims

A week after Seagen revealed that longtime CEO Clay Siegall was on leave due to an allegation of domestic violence, he has resigned.

Since that shocking revelation, more details about the claims have emerged into the public eye. As Endpoints News reported, Siegall was arrested on April 23. A police report about that night and a subsequent temporary restraining order described a pattern of abusive behavior against his wife and a physical altercation that left her with multiple bruises. Siegall denied the claims.

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