Sci­wind gets li­cens­ing deal with Sanofi for meta­bol­ic dis­ease can­di­dates; Im­mu­ni­ty­Bio and En­Gene­IC reach deal for nano cell tech

Sci­wind Bio­sciences an­nounced last night that it signed an ex­pan­sive li­cense agree­ment with Sanofi to de­vel­op and com­mer­cial­ize Sanofi’s long-last­ing glu­cose-de­pen­dent in­sulinotrop­ic polypep­tide (GIP) re­cep­tor ag­o­nists. Ac­cord­ing to Sci­wind, the lead can­di­date is cur­rent­ly un­der pre­clin­i­cal de­vel­op­ment.

The deal cov­ers all ap­plic­a­ble in­di­ca­tions for the mol­e­cule. Sci­wind plans to de­vel­op the lead GIP re­cep­tor ag­o­nist as part of com­bi­na­tion with XWoo3, its GLP-1 pep­tide can­di­date which is cur­rent­ly be­ing eval­u­at­ed in Phase II stud­ies to po­ten­tial­ly treat di­a­betes, obe­si­ty and NASH.

“We look for­ward to the op­por­tu­ni­ty to com­bine Sanofi’s long-last­ing GIP re­cep­tor ag­o­nist with Sci­wind’s GLP-1 drug can­di­dates which we hope will lead to de­vel­op­ment of more ef­fi­ca­cious and bet­ter tol­er­at­ed com­bi­na­tion ther­a­pies for meta­bol­ic con­di­tions,” said Sci­wind’s founder and CEO Hai Pan in a state­ment.

Aus­tralia’s En­Gene­IC and Soon-Sh­iong’s Im­mu­ni­ty­Bio make a deal

Im­mu­ni­ty­Bio has reached a deal with Aus­tralian biotech En­Gene­IC — for a po­ten­tial treat­ment for Covid-19 and can­cer.

The two com­pa­nies an­nounced a deal on En­Gene­IC’s nano cell tech­nol­o­gy, oth­er­wise known as En­Gene­IC Dream Vec­tor, or EDV. Ear­ly re­sults from an En­Gene­IC clin­i­cal tri­al showed that treat­ing Covid-19 us­ing this tech was able to “neu­tral­ize” Covid-19 and all oth­er vari­ants test­ed, in­clud­ing Delta, the com­pa­ny claimed, al­though they have yet to re­lease any da­ta.

And in terms of its ef­fec­tive­ness against can­cer, Phase I and IIa tri­als in pa­tients with ad­vanced pan­cre­at­ic can­cer is un­der­way, and the FDA re­cent­ly au­tho­rized an­oth­er tri­al in the US.

Now on­to the deal. En­Gene­IC will grant Im­mu­ni­ty­Bio an ex­clu­sive, world­wide li­cense to de­vel­op, man­u­fac­ture and com­mer­cial­ize EDV in com­bi­na­tion with its an­ti-can­cer drugs and COVID-19 vac­cine. Im­mu­ni­ty­Bio al­so agreed to build EDV man­u­fac­tur­ing fa­cil­i­ties in the US and South Africa, and cov­er costs as­so­ci­at­ed with clin­i­cal tri­als and reg­u­la­to­ry ap­provals.

While spe­cif­ic amounts were not dis­closed, En­Gene­IC will al­so re­ceive up­front pay­ments and fees for fu­ture can­cer pro­grams, and the two com­pa­nies agreed to an even split on net prof­it from world­wide sales of EDV-based ther­a­peu­tics.

Tai­ho ex­er­cis­es op­tion with Ar­cus; li­cens­es an­ti-TIG­IT an­ti­bod­ies in Japan and oth­er Asian coun­tries

Back in 2017, Ar­cus Bio­sciences and Tokyo on­col­o­gy biotech Tai­ho Phar­ma­ceu­ti­cal agreed to an op­tion and li­cense agree­ment — and Tai­ho has now ex­er­cised one of its op­tions.

The com­pa­nies an­nounced this morn­ing that Tai­ho ex­er­cised its op­tion for two of Ar­cus’s an­ti-TIG­IT an­ti­bod­ies: dom­vanal­imab and AB308 — to be li­censed by Tai­ho in Japan and cer­tain oth­er ter­ri­to­ries in Asia, ex­clud­ing Chi­na.

This is not Tai­ho’s first time ex­er­cis­ing one of its op­tions to an Ar­cus pro­gram — the Japan­ese biotech has al­ready ob­tained ex­clu­sive rights to etru­madenant (AB928), an adeno­sine A2a/A2b re­cep­tor an­tag­o­nist, and zim­bere­limab (AB122), an an­ti-PD-1 mon­o­clon­al an­ti­body.

In ex­change for the ex­clu­sive li­cense, Tai­ho will make an op­tion ex­er­cise pay­ment, as well as ad­di­tion­al pay­ments up­on achieve­ment of clin­i­cal, reg­u­la­to­ry and com­mer­cial­iza­tion mile­stones, and, if any prod­ucts from the pro­gram are ap­proved, will pay roy­al­ties on net sales of such prod­ucts. De­tails on the spe­cif­ic fi­nan­cials re­main undis­closed.

Con­fo makes drug dis­cov­ery deal with Re­gen­eron

Bel­gian biotech Con­fo Ther­a­peu­tics is go­ing in on a deal with Re­gen­eron.

The biotech will be lever­ag­ing its plat­form, which us­es se­lec­tive VHH an­ti­bod­ies to sta­bi­lize G pro­tein-cou­pled re­cep­tors, to­wards drug dis­cov­ery. Ac­cord­ing to the two com­pa­nies, the plat­form will be used to dis­cov­er new an­ti­body drug can­di­dates for two GPCR tar­gets.

While Con­fo will get an up­front pay­ment along with re­search fund­ing, there’s ad­di­tion­al po­ten­tial clin­i­cal, reg­u­la­to­ry and com­mer­cial pay­ments. Any fur­ther de­tails have not been dis­closed.

“We val­ue this op­por­tu­ni­ty to show­case the strength of this new ad­di­tion to our tech­nol­o­gy suite and par­tic­i­pate in what we hope will be the de­vel­op­ment of suc­cess­ful new an­ti­body-based ther­a­pies,” said Con­fo CSO Chris­tel Menet in a pre­pared state­ment.

Roche fol­lows af­ter Gilead in mak­ing Ama­zon Web Ser­vices its cloud ser­vices provider

Yes­ter­day, Gilead an­nounced that it was mak­ing Ama­zon Web Ser­vices its cloud ser­vices provider. And to­day, it looks like Roche is fol­low­ing suit.

The megaphar­ma an­nounced this morn­ing that it will be us­ing AWS for the ma­jor­i­ty of its work on the cloud to “help Roche ex­tract greater val­ue from its health da­ta.” This may in­clude look­ing at health da­ta re­lat­ed to ge­net­ic make­up of pa­tients, along with drug ef­fi­ca­cy and in­ter­ac­tions, ac­cord­ing to Roche.

Ad­di­tion­al­ly, Roche is cur­rent­ly us­ing dif­fer­ent ser­vices un­der the AWS um­brel­la — such as an­a­lyt­ics ser­vices, smart­phone app plat­forms and even a ma­chine-learn­ing plat­form.

“With AWS, we are bring­ing to­geth­er health da­ta in new ways to bet­ter de­tect, di­ag­nose, treat, mon­i­tor, and man­age dis­eases more ef­fec­tive­ly and ef­fi­cient­ly for the ben­e­fit of pa­tients,” said Roche Group CFO and CIO Alan Hippe in a pre­pared state­ment.

Zai Lab Phase III study meets pri­ma­ry end­point

One of Zai Lab’s Phase III stud­ies has met its pri­ma­ry end­point.

The biotech’s PRIME study of Ze­ju­la (ni­ra­parib) as a main­te­nance ther­a­py “demon­strat­ed a sta­tis­ti­cal­ly sig­nif­i­cant and clin­i­cal­ly mean­ing­ful pro­gres­sion-free sur­vival ben­e­fit,” the com­pa­ny said this morn­ing.

The pa­tients in the study were Chi­nese pa­tients with new­ly di­ag­nosed ad­vanced ep­ithe­lial ovar­i­an, fal­lop­i­an tube, or pri­ma­ry peri­toneal can­cer (col­lec­tive­ly termed as ovar­i­an can­cer), fol­low­ing a re­sponse to plat­inum-based chemother­a­py, re­gard­less of bio­mark­er sta­tus.

“The PRIME clin­i­cal da­ta in Chi­nese pa­tients con­firmed the clin­i­cal pro­file of Ze­ju­la and were con­sis­tent with the re­sults seen in the glob­al PRI­MA study,” said Zai Lab’s pres­i­dent and head of glob­al de­vel­op­ment, on­col­o­gy Alan San­dler.

Vi­s­us Ther­a­peu­tics has 3 pres­by­opia can­di­dates meet clin­i­cal end­point in PhII tri­al

Seat­tle pres­by­opia biotech Vi­s­us Ther­a­peu­tics re­port­ed pos­i­tive topline re­sults this morn­ing from its Phase II tri­al.

The tri­al, which was study­ing three new top­i­cal oph­thalmic for­mu­la­tions un­der in­ves­ti­ga­tion for the treat­ment of pres­by­opia — al­so known as age-re­lat­ed far­sight­ed­ness — achieved the end­point of three lines of im­prove­ment in binoc­u­lar near vi­su­al acu­ity with­out los­ing one line of dis­tance vi­sion with a min­i­mum re­spon­der rate of 83% at one hour. The tri­al stud­ied 85 sub­jects, ages 45 to 80, with two dif­fer­ent types of pres­by­opia at three dif­fer­ent sites in the US.

The biotech said it plans to com­mence Phase III piv­otal tri­als short­ly.

“We are very en­cour­aged by the VIVID study topline clin­i­cal da­ta,” said Vi­s­us co-founder, head of R&D and CMO Rhett Schiff­man in a state­ment. “We are ex­cit­ed to ini­ti­ate our Phase 3 piv­otal tri­als.”

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.