Ugur Sahin, AP Images

As pres­sure to share tech­nol­o­gy mounts, BioN­Tech se­lects Rwan­da for lat­est vac­cine site

BioN­Tech’s first mR­NA-based vac­cine site in Africa will call Rwan­da home, and con­struc­tion is set to start in mid-2022, the com­pa­ny an­nounced Tues­day at a pub­lic health fo­rum.

The Ger­man com­pa­ny signed a mem­o­ran­dum of un­der­stand­ing, af­ter a meet­ing be­tween Rwan­da’s Min­is­ter of Health, Daniel Ngami­je, Sene­gal’s Min­is­ter of For­eign Af­fairs Aïs­sa­ta Tall Sall, and se­nior BioN­Tech of­fi­cials. Con­struc­tion plans have been fi­nal­ized, and as­sets have been or­dered. The agree­ment will help bring end-to-end man­u­fac­tur­ing to Africa, and as many as sev­er­al hun­dred mil­lion dos­es of vac­cines per year, though ini­tial pro­duc­tion will be more mod­est.

The move comes as pres­sure mounts on Mod­er­na and BioN­Tech (and its part­ner Pfiz­er) to make their Covid-19 vac­cine more ac­ces­si­ble to the vast swaths of the globe still des­per­ate for dos­es. That’s in­clud­ed calls for the com­pa­nies to share their in­tel­lec­tu­al prop­er­ty, which the drug­mak­ers view as anath­e­ma.

Both have now an­nounced plans to open plants in Africa, al­though each of the pro­pos­als has faced crit­i­cism that they won’t help slow this pan­dem­ic. And al­though BioN­Tech un­veiled its plans in co­or­di­na­tion with the WHO and lo­cal gov­ern­ments, Mod­er­na faced crit­i­cism that its plan wasn’t suf­fi­cient­ly thought out: When it made its an­nounce­ment, the com­pa­ny hadn’t de­cid­ed which of the con­ti­nent’s 55 coun­tries to place their site in.

Both moves al­so come as the com­pa­nies ig­nore an mR­NA tech­nol­o­gy hub set up by the WHO, prompt­ing the or­ga­ni­za­tion to try and re­verse en­gi­neer Mod­er­na’s vac­cine.

Al­so on Tues­day, in what could per­haps one of the most an­tic­i­pat­ed an­nounce­ments Mod­er­na has made in re­cent months, the Cam­bridge, MA biotech will sup­ply up to 110 mil­lion dos­es of its Covid-19 vac­cine to the African Union, the com­pa­ny an­nounced Tues­day. CEO Stephane Ban­cel said it is just the first step.

“We rec­og­nize that ac­cess to COVID-19 vac­cines con­tin­ues to be a chal­lenge in many parts of the world and we re­main com­mit­ted to help­ing to pro­tect as many peo­ple as pos­si­ble around the globe,” he said in a state­ment.

The first 15 mil­lion dos­es will come in Q4 of 2021, with an­oth­er 35 mil­lion in Q1 of 2022 and up to 60 mil­lion in Q2 2022.

As of mid-Oc­to­ber, just nine African coun­tries had met the goal of vac­ci­nat­ing 10% of their pop­u­la­tions by the end of Sep­tem­ber, ac­cord­ing to the World Health Or­ga­ni­za­tion. The con­ti­nent has large­ly been left be­hind amid vac­ci­na­tion ef­forts, with rough­ly 4% of its to­tal pop­u­la­tion vac­ci­nat­ed. Even as the US pumped $200 mil­lion in­to a Gqe­ber­ha, South Africa plant owned by As­pen Phar­ma­ceu­ti­cal to in­crease the sup­ply of J&J shots, those dos­es were ini­tial­ly shipped back over­seas to Eu­rope.

“Bring­ing end-to-end vac­cine man­u­fac­tur­ing of bi­o­log­i­cals to Africa is es­sen­tial for our con­ti­nent’s health se­cu­ri­ty and pros­per­i­ty,” Ngami­je said in a press re­lease. “Rwan­da is com­mit­ted to work­ing with the African Union, the Eu­ro­pean Union, BioN­Tech, and oth­er tech­nol­o­gy part­ners to make this a re­al­i­ty as quick­ly as pos­si­ble.”

BioN­Tech will staff, own and op­er­ate the site at first, to help safe­ly ramp up pro­duc­tion. Then, it will trans­fer knowl­edge to lo­cal part­ners. The Rwan­da De­vel­op­ment Board and In­sti­tut Pas­teur de Dakar in Sene­gal have both agreed to quick­ly build up its hu­man re­sources op­er­a­tions to take over own­er­ship.

Sierk Po­et­ting

BioN­Tech is us­ing its fa­cil­i­ty in Mar­burg, Ger­many site as an ex­am­ple for the Rwan­dan site. Ca­pac­i­ty will start at 50 mil­lion dos­es a year, then in­crease se­quen­tial­ly by adding man­u­fac­tur­ing lines and sites as the project pro­gress­es.

“We aim to ac­cel­er­ate the build­ing of a GMP-cer­ti­fied man­u­fac­tur­ing fa­cil­i­ty and plan to be­gin the con­struc­tion on site in mid-2022. The MoU un­der­lines that time is a crit­i­cal suc­cess fac­tor in the de­vel­op­ment of sus­tain­able vac­cine pro­duc­tion for the African Union,” COO Sierk Po­et­ting said in a press re­lease. “We have fi­nal­ized the plan­ning and ini­tial as­sets for the new fa­cil­i­ty have al­ready been or­dered.”

BioN­Tech CEO Ugur Sahin had met with Paul Kagame, the pres­i­dent of Rwan­da, as well as Sene­galese Pres­i­dent Macky Sall and EC Pres­i­dent Ur­su­la von der Leyen in Au­gust to dis­cuss a pos­si­ble site for its new man­u­fac­tur­ing op­er­a­tions.

The com­pa­ny was among the first to pub­licly an­nounce stage two of its man­u­fac­tur­ing plan, once the need for Covid-19 vac­cine and treat­ment man­u­fac­tur­ing dies down. BioN­Tech will spin its pro­duc­tion in­to malar­ia and tu­ber­cu­lo­sis vac­cines when the time is right. But be­fore then, it will up its ca­pac­i­ty across the board, as the vac­cine is al­ready be­ing man­u­fac­tured on three con­ti­nents and in 20 sites. It’s all part of the plan to have a 4 bil­lion dose ca­pac­i­ty in 2022.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

One work­er at a Lat­vian man­u­fac­tur­er is dead af­ter a fire breaks out at fa­cil­i­ty

A press release referred to it as simply, “the incident.” But a fire at an Olainfarm site in Latvia last week has left one person dead, and injured another, the company announced Monday.

Just before midnight Nov. 26, a fire broke out in the production building of JSC Olainfarm,  as the result of an “accident,” a company spokesperson said in an email to Endpoints News. The two victims were both company employees, and the causes of the accident are still being determined.

Fu­ji­film Diosynth dumps an­oth­er $454M in­to its sup­ply chain, this time at a fa­cil­i­ty in the UK

Fujifilm Diosynth Biotechnologies is in the middle of a monumental point in the company’s 10-year history, and the CDMO is about to grow even more, as it sets out to be the “beating heart” of the UK’s North East Life Sciences ecosystem.

A site in Billingham, Teeside, UK will receive a $453.72 million investment package from the manufacturer to double the existing footprint and create the largest multi-modal biopharmaceutical manufacturing site in the UK, bringing another 350 jobs to the region by late 2023.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,600+ biopharma pros reading Endpoints daily — and it's free.

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.