Take­da claims PhI­II suc­cess in dengue vac­cine months af­ter Deng­vax­ia im­plo­sion for ri­val Sanofi

Take­da is one stride clos­er to reach­ing the siz­able mar­ket wait­ing for dengue vac­cines as it re­ports pos­i­tive top-line re­sults from a mas­sive Phase III tri­al.

The analy­sis, which con­sti­tutes the first of a three-part study, con­cludes that the com­pa­ny’s tetrava­lent dengue vac­cine TAK-003 was ef­fi­ca­cious at 15 months in pre­vent­ing dengue fever caused by any of the four serotypes of the virus, there­by meet­ing the pri­ma­ry end­point. And while they are sav­ing the de­tails for a peer-re­viewed jour­nal, Take­da $TAK re­searchers say the vac­cine was “well tol­er­at­ed with no sig­nif­i­cant safe­ty con­cerns to date.”

Ra­jeev Venkayya

The safe­ty el­e­ment is par­tic­u­lar­ly im­por­tant giv­en the fresh mem­o­ries of a pub­lic health con­tro­ver­sy that Sanofi was mired in in­volv­ing the use of its pi­o­neer­ing dengue vac­cine in a ma­jor vac­ci­na­tion cam­paign in the Philip­pines. Giv­en to any­one who had not al­ready been in­fect­ed, Deng­vax­ia left peo­ple vul­ner­a­ble to se­vere, life-threat­en­ing dengue in the event they were sub­se­quent­ly in­fect­ed by wild type dengue. As a re­sult, Sanofi lim­it­ed its use to pro­tect peo­ple who have had a pri­or in­fec­tion — but stopped short of is­su­ing re­funds.

Deng­vax­ia was the first ap­proved vac­cine for the mos­qui­to-borne vi­ral dis­ease, and a block­buster-to-be that cost $1.5 bil­lion over 20 long years to de­vel­op. Ini­tial sales were a dis­ap­point­ment even at its peak in 2016, and in the first 6 months of the year 2018 Sanofi re­port­ed €1 mil­lion in sales rev­enue, down 94.4% from the year be­fore.

Derek Wal­lace

Though care­ful not to draw di­rect com­par­isons, Derek Wal­lace, vice pres­i­dent and glob­al dengue pro­gram head from Take­da, told End­points News that its study was de­signed dif­fer­ent­ly than oth­er dengue vac­cine tri­als so far.

We specif­i­cal­ly de­signed our Phase 3 vac­cine ef­fi­ca­cy tri­al to as­sess the safe­ty and ef­fi­ca­cy against all four serotypes and for both dengue naïve and ex­posed in­di­vid­u­als. Base­line blood sam­ples were col­lect­ed from all in­di­vid­u­als par­tic­i­pat­ing in the tri­al to al­low for eval­u­a­tion of safe­ty and ef­fi­ca­cy based on serosta­tus. The struc­ture of our vac­cine can­di­date, the unique im­muno­genic­i­ty pro­file elicit­ed by it and the rapid de­vel­op­ment of a four-serotype an­ti­body re­sponse fol­low­ing im­mu­niza­tion in most naïve and pre­vi­ous­ly-ex­posed in­di­vid­u­als are rea­sons that we be­lieve TAK-003 has a dif­fer­ent safe­ty and ef­fi­ca­cy pro­file rel­a­tive to the cur­rent­ly-li­censed dengue vac­cine.

While prep­ping a more ex­ten­sive re­view of this da­ta on TAK-003, Ra­jeev Venkayya, pres­i­dent of Take­da’s glob­al vac­cine busi­ness unit, said in a state­ment that they will al­so be “ad­vanc­ing the clin­i­cal de­vel­op­ment, com­mer­cial man­u­fac­tur­ing, and stake­hold­er con­sul­ta­tions to sup­port a po­ten­tial fu­ture glob­al launch of the vac­cine.”

Parts 2 and 3 of the TIDES tri­al — the largest vac­cine tri­al at 20,000 pa­tients, ac­cord­ing to Take­da — will as­sess sec­ondary end­points in six months and longterm safe­ty with three years, re­spec­tive­ly. Tri­al sites are lo­cat­ed in dengue-en­dem­ic ar­eas in Latin Amer­i­ca (Brazil, Colom­bia, Pana­ma, Do­mini­can Re­pub­lic and Nicaragua) and Asia (Philip­pines, Thai­land and Sri Lan­ka).

“We ex­pect key sec­ondary end­point da­ta from the TIDES tri­al in lat­er this year, in­clud­ing safe­ty, ef­fi­ca­cy against hos­pi­tal­iza­tion, and analy­ses of ef­fi­ca­cy by base­line serosta­tus, serotype, and sever­i­ty,” Wal­lace wrote in an email.

Vac­cines was one of four key ar­eas (along­side can­cer, GI and CNS dis­eases) that CEO Christophe We­ber pre­scribed for Take­da in an ef­fort to trans­form the Japan­ese drug­mak­er in­to a glob­al play­er — be­fore vault­ing to the top 10 list via the ac­qui­si­tion of rare dis­ease gi­ant Shire. It re­mains one of three “glob­al busi­ness units,” Wal­lace said, along with on­col­o­gy and plas­ma-de­rived ther­a­pies.

“Take­da fo­cus­es its R&D ef­forts on four ther­a­peu­tic ar­eas: On­col­o­gy, Gas­troen­terol­o­gy (GI), Neu­ro­science and Rare Dis­eases, while we al­so make tar­get­ed R&D in­vest­ments in Plas­ma-De­rived Ther­a­pies and Vac­cines,” he wrote.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: Searching the Pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially,early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

No­var­tis chips in $10M for IPO-bound part­ner Pli­ant; Tenax shares soar on heart drug da­ta

Novartis is coming in with $10 million to help support the looming IPO of a partner. Pliant Therapeutics posted a new filing with the SEC showing that Novartis is buying the shares at $15, the mid-point of the range. It’s adding several million shares to the offering, bringing the total to around $135 million. Biotech companies have been enjoying quite a run on virtual Wall Street, with investors boosting new offerings to some big hauls.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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