As mon­key­pox quick­ly spreads, a hand­ful of biotechs spring to ac­tion

At the be­gin­ning of the week, many peo­ple hadn’t ever heard of mon­key­pox. By Fri­day, that all changed — and now a hand­ful of biotech com­pa­nies are reap­ing the ben­e­fits.

Emer­gent Bioso­lu­tions’ $EBS stock jumped more than 10% on Fri­day, four days af­ter the com­pa­ny plumped down $225 mil­lion for the rights to Chimerix’s small­pox vac­cine. Chimerix’s stock $CM­RX was up more than 3.8% on Fri­day. And Bavar­i­an Nordic $BVN­RY — which closed a $119 mil­lion deal with BAR­DA to pro­vide the US gov­ern­ment with freeze-dried dos­es of the Jyn­neos vac­cine — was up near­ly 2.5%.

The news comes just a cou­ple days af­ter the first mon­key­pox case was de­tect­ed in the US, and on Fri­day the CDC re­vealed it’s mon­i­tor­ing at least six oth­er Amer­i­cans af­ter they came in close con­tact with an in­fect­ed trav­el­er ear­li­er this month. Cas­es are surg­ing in Eu­rope, where Spain has now iden­ti­fied 30 cas­es, and neigh­bor­ing Por­tu­gal has re­port­ed 23.

Make no mis­take, though: The cur­rent sit­u­a­tion is noth­ing like Covid, ac­cord­ing to Nor­man Bay­lor, who once di­rect­ed the FDA’s Of­fice of Vac­cines Re­search and Re­view and now serves as a con­sul­tant.

“The good news is we have a vac­cine. Re­mem­ber with Covid, we had noth­ing. We were start­ing from scratch,” he said.

Mon­key­pox has been around since 1958, when two out­breaks oc­curred in colonies of re­search mon­keys (hence the name). How­ev­er, the first hu­man case wasn’t re­port­ed un­til over a decade lat­er in the De­mo­c­ra­t­ic Re­pub­lic of Con­go. The US saw an out­break back in 2003, af­ter re­ceiv­ing a ship­ment of an­i­mals from Ghana, which was con­tained with test­ing and vac­ci­na­tion, ac­cord­ing to the CDC.

Be­cause mon­key­pox is sim­i­lar to (but milder than) small­pox, cur­rent­ly ap­proved small­pox vac­cines like Chimerix’s Tem­blex should of­fer some pro­tec­tion against mon­key­pox, ac­cord­ing to Daniel Ku­ritzkes, chief of in­fec­tious dis­eases at Brigham and Women’s Hos­pi­tal in Boston. In fact, most old­er adults are al­ready vac­ci­nat­ed (rou­tine vac­ci­na­tion end­ed in 1972 af­ter the dis­ease was erad­i­cat­ed in the US).

Even though a large pop­u­la­tion re­mains un­vac­ci­nat­ed, both Bay­lor and Ku­ritzkes doubt that the US will need to roll out a wide­spread vac­cine cam­paign to con­tain the cur­rent out­break.

Nev­er­the­less, BAR­DA is pay­ing Bavar­i­an Nordic $119 mil­lion to ex­er­cise op­tions for a freeze-dried stock­pile of Jyn­neos, which cov­ers both mon­key­pox and small­pox. Ad­di­tion­al op­tions for an­oth­er 13 mil­lion dos­es through 2024 and 2025 would add up to $180 mil­lion.

Paul Chap­lin, CEO of Bavar­i­an Nordic, said in an in­ter­view with End­points News that the com­pa­ny has had a long-stand­ing re­la­tion­ship with BAR­DA and is ready for what­ev­er comes next.

BAR­DA’s new op­tion for the Jyn­neos vac­cine is part of a years-old col­lab­o­ra­tion with Bavar­i­an Nordic to cre­ate a vac­cine with a longer shelf-life. So the new deal is quite co­in­ci­den­tal con­sid­er­ing what’s hap­pen­ing in the world, Chap­lin said.

How­ev­er, he was quick to em­pha­size that Bavar­i­an Nordic has an im­me­di­ate stock­pile and the ca­pa­bil­i­ty to pro­duce more. It has over a mil­lion dos­es in stock cur­rent­ly for BAR­DA, most of which is stored at their fa­cil­i­ty in Den­mark.

The com­pa­ny usu­al­ly sells Jyn­neos on an on­go­ing ba­sis, typ­i­cal­ly man­u­fac­tur­ing for or­der as there hasn’t been much in­ter­est in stock­pil­ing for small­pox. How­ev­er, Chap­lin said he ex­pects to be­gin sup­ply­ing EU coun­tries in the com­ing days and is man­u­fac­tur­ing more dos­es as we speak, though he didn’t dis­close any of the de­tails.

“I think gov­ern­ments are tak­ing the emer­gence of new in­fec­tious dis­eases ex­treme­ly se­ri­ous­ly. So I think that’s one thing, which is a pos­i­tive sign,” he said. “There are a num­ber of gov­ern­ments, Cana­da, the Unit­ed States, and ac­tu­al­ly a few coun­tries in Eu­rope [that] have ac­tu­al­ly pre­vi­ous­ly pur­chased Jyn­neos to stock­pile.”

Mean­while, Emer­gent snagged the rights to Tem­bexa, a small­pox treat­ment for all ages that was ap­proved in 2021, with an an­tic­i­pat­ed BAR­DA con­tract in the wings. The com­pa­ny is ea­ger for a come­back af­ter a re­port from the US House se­lect sub­com­mit­tee re­vealed that around 400 mil­lion Covid-19 vac­cine dos­es were like­ly tossed due to cross con­t­a­m­i­na­tion prob­lems at its Bal­ti­more plant.

Should the US need to roll out vac­cines, the re­al ques­tion will be who gets them first, Bay­lor said. British au­thor­i­ties re­cent­ly prompt­ed health­care work­ers and oth­ers who were ex­posed to get vac­ci­nat­ed, ac­cord­ing to a Reuters re­port.

“The sup­ply is not enough to roll out to every­body,” he said. “That would re­al­ly need some dis­cus­sion, and we’re not at that point yet.”

Aa­dia Rana, an as­so­ciate pro­fes­sor of med­i­cine at the Uni­ver­si­ty of Al­aba­ma-Birm­ing­ham, told End­points that it’s un­clear whether those who have been vac­ci­nat­ed against small­pox in the past will need to be re­vac­ci­nat­ed. How­ev­er, William Schaffn­er, an in­fec­tious dis­ease ex­pert from Van­der­bilt Uni­ver­si­ty, point­ed out that small­pox vac­cines can pro­vide long-term pro­tec­tion. Like any vac­cine, though, pro­tec­tion di­min­ish­es over time.

“I am re­al­ly quite con­fi­dent that the pub­lic health au­thor­i­ties in the US and Cana­da and in Eu­rope will rather quick­ly bring these var­i­ous chains of trans­mis­sion to a close and it’s an ex­ot­ic event,” Schaffn­er said. “It’s an­oth­er in­di­ca­tion that we live to­geth­er on a very small globe, and that strange in­fec­tions can ap­pear very dis­tant­ly, and all of a sud­den show up in your neigh­bor­hood.”

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Mi­rati’s drug sitra­va­tinib flops PhI­II in com­bo with Op­di­vo for cer­tain lung can­cer

Mirati Therapeutics’ path to a second drug approval will likely have to wait. The San Diego biotech company said Wednesday that its investigational lung cancer drug failed a Phase III trial testing it in combination with Bristol Myers Squibb’s Opdivo.

The drug, sitravatinib, and Opdivo weren’t better than the chemo drug docetaxel at keeping patients alive, Mirati said in a press release. The spectrum-selective kinase inhibitor missed the primary goal of overall survival in patients with second- or third-line advanced non-squamous, non-small cell lung cancer.

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End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

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EMA rec­om­mends re­vok­ing au­tho­riza­tion of No­var­tis' sick­le cell drug

The European Medicines Agency’s committee for medicinal products for human use (CHMP) on Friday recommended revoking the marketing authorization for Novartis’ treatment for a painful complication related to sickle cell, after a recent study did not confirm its clinical benefit.

CHMP’s review looked at results of the STAND study, finding that Adakveo (crizanlizumab) did not reduce the number of painful crises leading to a healthcare visit, and patients treated with Adakveo had slightly more painful crises on average, with a subsequent healthcare visit, over the first year of treatment, compared with those on placebo.

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