Ex­e­Vir dos­es first pa­tients with lla­ma-de­rived an­ti-Covid an­ti­body

A lit­tle over five months af­ter pulling in a $50 mil­lion Se­ries A, Ex­e­Vir is ready to take the next step with its lla­ma-de­rived Covid-19 an­ti­bod­ies.

The Bel­gium-based biotech is of­fi­cial­ly launch­ing a Phase I study in healthy vol­un­teers for the lla­ma an­ti­body pro­gram, known as XVR011, an­nounc­ing the dos­ing of its first pa­tients Wednes­day morn­ing. Look­ing at the safe­ty pro­file and phar­ma­co­ki­net­ics of the can­di­date, the study will ex­am­ine three as­cend­ing dos­es of an IV for­mu­la­tion in a ran­dom­ized and dou­ble-blind­ed set­ting.

Torsten Mum­men­brauer

Giv­en Ex­e­Vir launched on­ly in June 2020, CEO Torsten Mum­men­brauer told End­points News the tri­al launch marks an im­por­tant mile­stone.

“We’re damn proud,” Mum­men­brauer said in an in­ter­view.

The quick rise ac­tu­al­ly stems from re­search re­gard­ing the SARS out­break in the ear­ly 2000s, al­so known as the SARS-CoV-1 virus. Sci­en­tists who helped launch Ex­e­Vir stud­ied the lla­ma an­ti­body in SARS about five years ago, giv­ing the biotech a sol­id base to co­a­lesce around Covid-19.

“In Feb­ru­ary 2020, when the se­quence was pub­lished, they were able to im­me­di­ate­ly set up an as­say for the new virus,” Mum­men­brauer said.

There are two key as­pects in which the lla­ma an­ti­body is dif­fer­ent from oth­er Covid-19 an­ti­bod­ies that are out there, Mum­men­brauer said. The first is sim­ply that the an­ti­bod­ies are much small­er, al­low­ing for bind­ing in very small groups on the spike pro­tein.

And sec­ond, Ex­e­Vir has iden­ti­fied a “spe­cial epi­tope” hid­den with­in the spike pro­tein that al­lows for an ad­di­tion­al mech­a­nism of ac­tion. Pre­clin­i­cal da­ta have shown high con­ser­va­tion of the epi­tope, Mum­men­brauer said, re­duc­ing the risk of vi­ral es­cape across the orig­i­nal strain of the coro­n­avirus and the four most promi­nent vari­ants that first orig­i­nat­ed in the UK (Al­pha), South Africa (Be­ta), Brazil (Gam­ma) and In­dia (Delta).

For now, the plan is to re­cruit healthy vol­un­teers through the end of Oc­to­ber and ran­dom­ize them in­to three dosage groups: 250 mg, 500 mg and 1 gram. The biotech is al­so run­ning a Phase Ib study in par­al­lel look­ing at hos­pi­tal­ized pa­tients.

Even­tu­al­ly, how­ev­er, Ex­e­Vir has ideas for a sub­cu­ta­neous for­mu­la­tion of the an­ti­body, which could po­ten­tial­ly al­low for a pro­phy­lac­tic use. That’s a bit far­ther off in­to the fu­ture, Mum­men­brauer said, and will come as part of their sec­ond-gen push, once Ex­e­Vir gets the IV for­mu­la­tion across the fin­ish line.

“In this set­ting we have si­lenced the Fc el­e­ment of the an­ti­body to avoid an in­crease in dis­ease in pa­tients,” Mum­men­brauer said. “We are work­ing on sec­ond-gen, and there the tech al­so al­lows us to do a bi­na­ry mol­e­cule where we fuse two dif­fer­ent an­ti­bod­ies and are mim­ic­k­ing the com­bi­na­tion ap­proach of Eli Lil­ly in one mol­e­cule.”

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

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; 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.

The slate of products we’re offering here at Endpoints is continuing to grow, and it’s not just limited to editorial. If you haven’t, do visit your reader profile to see if there are any other weekly newsletters you’re interested in — as each comes with its own exclusive content. And don’t miss the publisher’s note from Arsalan Arif on Endpoints Studio, our latest avenue for advertising on Endpoints.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

Covid-19 roundup: Ugur Sahin says new shots like­ly need­ed for Omi­cron; UK ful­ly ap­proves Vir/Glax­o­SmithK­line an­ti­body

Despite Ugur Sahin’s calls for calm over the Omicron variant — making a much more measured appeal than Moderna CEO Stéphane Bancel — the BioNTech chief is already predicting the potential need for new Covid-19 vaccines.

In comments made at a conference hosted Friday morning by Reuters, Sahin said that even though vaccinated individuals would likely still be protected from severe disease, Omicron could see greater numbers of breakthrough infections than other variants. The mutations mean Covid shots will probably become necessary every year, similar to the flu.