Moncef Slaoui, Operation Warp Speed chief (AP Images)

Covid-19 roundup: In­ovio nabs $3 mil­lion and a de­vel­op­ment part­ner for its vac­cine that's still on par­tial hold; Slaoui pro­pos­es halv­ing Mod­er­na vac­cine dos­es as dis­tri­b­u­tion lags

With its vac­cine can­di­date fi­nal­ly in Phase II, In­ovio is bag­ging $3 mil­lion in a part­ner­ship deal with Ad­vac­cine Bio­phar­ma­ceu­ti­cals Suzhou to de­vel­op and com­mer­cial­ize the can­di­date in Greater Chi­na.

Ad­vac­cine and In­ovio shook hands on a deal for ex­clu­sive rights to de­vel­op, man­u­fac­ture and com­mer­cial­ize the can­di­date, INO-4800, in Main­land Chi­na, Hong Kong, Macao and Tai­wan. In ad­di­tion to $3 mil­lion up­front, Ad­vac­cine is sweet­en­ing the deal with up to $108 mil­lion in mile­stone pay­ments. In re­turn, it stands to earn a “high sin­gle-dig­it per­cent­age” of an­nu­al net sales in each re­gion with­in Greater Chi­na. The com­pa­ny is al­so li­cens­ing its plas­mid man­u­fac­tur­ing process to In­ovio, with the right to sub­li­cense to In­ovio’s man­u­fac­tur­ing part­ners.

The news comes about a month af­ter In­ovio be­gan dos­ing pa­tients in the Phase II por­tion of a Phase II/III tri­al, which was slapped with a par­tial clin­i­cal hold back in Sep­tem­ber. The Phase III por­tion is still on hold, due to re­main­ing ques­tions about the de­vice that will be used to de­liv­er the shot di­rect­ly to the skin. Ac­cord­ing to a state­ment, it plans on an­swer­ing those re­main­ing ques­tions in the Phase II.

A few weeks ago, In­ovio tapped Japan’s Kane­ka Eu­ro­gen­tec as a man­u­fac­tur­ing part­ner to hit its goal of pro­duc­ing hun­dreds of mil­lions of dos­es. Kane­ka is tasked with fill­ing the role of Ko­re­an con­tract man­u­fac­tur­er VGX, which In­ovio is in a le­gal stand­off with. Tthe com­pa­ny re­mains op­ti­mistic, though it hasn’t had a prod­uct can­di­date ap­proval in over 40 years. — Nicole De­Feud­is

Slaoui pro­pos­es halv­ing Mod­er­na vac­cine dos­es as dis­tri­b­u­tion lags

As Covid-19 vac­cine dis­tri­b­u­tion lags be­hind pro­jec­tions, there has been much de­bate about how to in­crease in­oc­u­la­tions over the last cou­ple weeks. And on Sun­day, OWS chief Mon­cef Slaoui gave his two cents.

Slaoui pro­posed cut­ting the Mod­er­na vac­cine dose in half to po­ten­tial­ly al­low more peo­ple ac­cess to the shots, he said on Face the Na­tion. He cit­ed da­ta from the biotech’s clin­i­cal tri­als that showed adults aged 18 to 55 who re­ceived two 50 μg dos­es showed an “iden­ti­cal im­mune re­sponse” to the stan­dard of two 100 μg dos­es.

Dur­ing the in­ter­view, Slaoui was pressed on what the fed­er­al gov­ern­ment could do to help the states speed up vac­ci­na­tions and said halv­ing the Mod­er­na dos­es was a po­ten­tial al­ter­na­tive com­pared to spread­ing out the dos­es longer than orig­i­nal­ly planned in their late-stage tri­als.

“If we leave peo­ple a month, two months, three months with maybe in­com­plete im­mu­ni­ty, wan­ing im­mu­ni­ty, maybe even the wrong kind of im­mune re­sponse in­duced, that is then cor­rect­ed by the sec­ond dose,” Slaoui told Face the Na­tion. “Chang­ing the de­ci­sions made, the choic­es made … with­out any da­ta I think would not be re­spon­si­ble.”

Should the FDA de­cide to move for­ward with this plan, the two im­mu­niza­tions would still oc­cur 28 days apart. Slaoui said OWS is in dis­cus­sions with the agency and Mod­er­na over whether im­ple­ment­ing this pro­pos­al would be pos­si­ble. Mod­er­na won an EUA for its Covid-19 vac­cine last month for the 100-μg dos­es, the same dosage lev­el used in their Phase III study.

Get­ting shots in arms has proved a chal­leng­ing task as vac­cine roll­out has start­ed. Fed­er­al pro­jec­tions had aimed to dis­trib­ute 20 mil­lion dos­es by the end of 2020 as re­cent­ly as last month, but on­ly 4.2 mil­lion Amer­i­cans had re­ceived their first shots as of Sat­ur­day, per the CDC. Those num­bers are like­ly high­er in ac­tu­al­i­ty giv­en re­port­ing lags, how­ev­er.

The ob­sta­cles have launched a de­bate among health of­fi­cials over the best way to ac­cel­er­ate dis­tri­b­u­tion. With a new, more con­ta­gious coro­n­avirus vari­ant spread­ing, the UK has al­ready an­nounced plans to de­lay the sec­ond dose of the Pfiz­er/BioN­Tech and As­traZeneca vac­cines — the lat­ter of which is not yet au­tho­rized in the U.S.

Ac­cord­ing to the coun­try’s Joint Com­mit­tee of Vac­ci­na­tion and Im­mu­niza­tion, this de­ci­sion was made based on da­ta show­ing the first Pfiz­er shot can grant par­tial im­mu­ni­ty and that longer in­ter­vals be­tween As­traZeneca shots can pro­vide stronger im­mu­ni­ty. The plan has some back­ers to em­u­late the plan in the US, giv­en the sup­ply con­straint and new mu­ta­tion.

UCSF de­part­ment of med­i­cine chair Robert Wachter and Brown Uni­ver­si­ty School of Pub­lic Health dean Ashish Jha vouched for a US ver­sion of the plan in an op-ed in the Wash­ing­ton Post on Sun­day, writ­ing in part:

Hun­dreds of thou­sands of peo­ple are be­ing in­fect­ed and thou­sands are dy­ing every day. Any high-risk per­son who isn’t vac­ci­nat­ed to­day could be in­fect­ed to­mor­row and die in a month. But we are hold­ing back half of the dos­es in re­serve for peo­ple to get their sec­ond shots. That slows things down.

But there still doesn’t ap­pear to be a con­sen­sus on the mat­ter, as some top Amer­i­can of­fi­cials are op­posed to the de­ferred shot method.

“I would not be in fa­vor of that,” NI­AID chief An­tho­ny Fau­ci told CNN on Fri­day. “We’re go­ing to keep do­ing what we’re do­ing.”

— Max Gel­man

FDA re­jects Re­lief Ther­a­peu­tics and Neu­roRx’s bid for an EUA

The FDA shot down last week an emer­gency use ap­pli­ca­tion for half-cen­tu­ry-old avip­tadil in Covid-19, which Swiss biotech Re­lief Ther­a­peu­tics and their US part­ner Neu­roRx sub­mit­ted back in Sep­tem­ber based on a study in which on­ly 21 pa­tients were treat­ed.

The part­ners an­nounced Sept. 23 that they filed for an EUA based on a case-con­trol study with 21 pa­tients in the treat­ment arm and an­oth­er group who re­ceived max­i­mal stan­dard-of-care treat­ment in the same ICU. Neu­roRx came un­der fire ear­li­er that month af­ter Politi­co re­port­ed the com­pa­ny tapped a Re­pub­li­can con­gress­man with close ties to its CEO and a his­to­ry of mask skep­ti­cism to their Da­ta and Safe­ty Mon­i­tor­ing Board.

Up­on fil­ing, Neu­roRx an­nounced that pa­tients in the treat­ment arm had “demon­strat­ed a 3-fold ad­van­tage in sur­vival, re­cov­ery from res­pi­ra­to­ry fail­ure, and oth­er pa­ra­me­ters.” Su­san El­len­berg, a for­mer FDA re­view­er and a bio­sta­tis­ti­cian at the Uni­ver­si­ty of Penn­syl­va­nia Perel­man School of Med­i­cine, told End­points that an EUA based on such lim­it­ed da­ta could be pos­si­ble, but on­ly if the ev­i­dence was over­whelm­ing.

“The FDA did not agree to grant EUA, as ap­plied for in Sep­tem­ber,” Neu­roRx CEO Jonathan Javitt said in a state­ment.

Re­lief’s $RLFTF stock plunged on the news, falling from about 40 cents on Dec. 29 to 31 cents on Dec. 30.

Javitt cush­ioned the bad news by adding the part­ners had com­plet­ed en­roll­ment in a 165-pa­tient Phase IIb/III tri­al, with topline da­ta ex­pect­ed in late Jan­u­ary or ear­ly Feb­ru­ary. At the end of No­vem­ber, the part­ners an­nounced a 72% sur­vival rate in more than 175 pa­tients with crit­i­cal Covid-19, res­pi­ra­to­ry fail­ure and a se­vere co­mor­bid­i­ty who were stud­ied through an ex­pand­ed ac­cess pro­to­col in the US. Of the 90 pa­tients who had reached a 28-day fol­low-up, 72% sur­vived.

Javitt an­nounced the com­pa­nies will con­tin­ue to work with the FDA, which “will prompt­ly re­view the forth­com­ing da­ta” from the Phase IIb/III. — Nicole De­Feud­is

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,500+ biopharma pros reading Endpoints daily — and it's free.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,500+ biopharma pros reading Endpoints daily — and it's free.

Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.