Medicago's vaccine greenhouse (Medicago via YouTube)

Cana­di­an plant-based vac­cine de­vel­op­er Med­ica­go shut­ters months af­ter lay­offs

Plant-based Covid-19 vac­cine de­vel­op­er Med­ica­go shut down this week with lit­tle fan­fare. And its two sub­sidiaries, Med­ica­go R&D and Med­ica­go USA, are al­so clos­ing their doors, ac­cord­ing to a com­pa­ny news re­lease.

The lone share­hold­er left stand­ing, Japan-based Mit­subishi Chem­i­cal Group, “has de­ter­mined not to make fur­ther in­vest­ments in Med­ica­go and to pro­ceed with an or­der­ly wind-up of its busi­ness and op­er­a­tions in Cana­da and in the Unit­ed States.”

Ac­cord­ing to the Mit­subishi re­lease, af­ter a Feb­ru­ary 2022 ap­proval for its vac­cine, Med­ica­go had start­ed prepar­ing for com­mer­cial pro­duc­tion. But af­ter “sig­nif­i­cant changes to the Covid-19 vac­cine land­scape” since ap­proval, it has de­cid­ed to get out of the race.

“In ad­di­tion, the Group judged that it was not vi­able to con­tin­ue to make fur­ther in­vest­ment in the com­mer­cial­iza­tion of Med­ica­go’s de­vel­op­ment prod­ucts,” the state­ment reads.

Toshi­fu­mi Ta­da

The shut­down comes just a lit­tle over three months af­ter Med­ica­go laid off 62 em­ploy­ees at its man­u­fac­tur­ing fa­cil­i­ty in North Car­oli­na. At the time, Med­ica­go CEO Toshi­fu­mi Ta­da, who had just tak­en over the role in May of last year, told End­points News: “We are hard at work on a new ap­proach to de­vel­op­ing and man­u­fac­tur­ing plant-based ther­a­peu­tics that meets the needs of glob­al pub­lic health.”

But the com­pa­ny nev­er re­ceived the green light for its vac­cine from the World Health Or­ga­ni­za­tion, cut­ting Med­ica­go off from a wider base of po­ten­tial pa­tients. The WHO balked at ac­cept­ing an emer­gency use list­ing ap­pli­ca­tion for Med­ica­go’s Covid-19 vac­cine be­cause of the biotech’s ties to the to­bac­co in­dus­try, specif­i­cal­ly part-own­er Philip Mor­ris In­ter­na­tion­al, which man­u­fac­tures Marl­boro cig­a­rettes.

Last March, End­points re­port­ed that the to­bac­co com­pa­ny had a 21% stake in Med­ica­go, down from about a third of shares in 2021. But in De­cem­ber of last year, Philip Mor­ris di­vest­ed the rest of its stake in Med­ica­go.

De­spite ties to Philip Mor­ris, the Cana­di­an gov­ern­ment ap­proved Cov­ifenz a year ago for peo­ple 18 to 64 years old. In Phase III tri­als, it was 71% ef­fec­tive against in­fec­tion across all vari­ants, and over 75% ef­fec­tive against the then-dom­i­nant Delta vari­ant, thanks in part to GSK’s ad­ju­vant tech­nol­o­gy. It could al­so be kept in warmer tem­per­a­tures than the mR­NA vac­cines.

The vac­cine used plant-based virus-like par­ti­cles that mim­ic­ked the spike pro­tein.

GSK li­censed its tech di­rect­ly to the Cana­di­an gov­ern­ment, which back in 2020 gave at least $131 mil­lion to pro­duce Med­ica­go’s vac­cine. Al­so in 2020, it en­tered in­to an agree­ment with Cana­da to sup­ply up to 76 mil­lion dos­es of its vac­cine.

Ac­cord­ing to Med­ica­go’s web­site, it had oth­er can­di­dates in the works, in­clud­ing for the pan­dem­ic and sea­son­al flu, which were in Phase II tri­als and for the ro­tavirus in Phase I. It had a can­di­date for a Covid-19 and flu com­bi­na­tion in the pre­clin­i­cal stage.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Mass­a­chu­setts judge dis­miss­es law­suit against Bio­gen over failed launch of Alzheimer's drug Aduhelm

A Massachusetts federal judge on Wednesday dismissed a class action lawsuit filed by investors against Biogen and several of its current and former executives over the company’s failed Alzheimer’s drug, Aduhelm (aducanumab).

The investors argued that Biogen’s contact with the FDA was unlawful and that the company made 25 false and misleading statements, including statements about the rollout and price of the drug.

Af­ter safe­ty re­view, EMA mir­rors FDA with up­dat­ed rec­om­men­da­tions for JAK in­hibitors

The EMA released updated recommendations today for the use of JAK inhibitors (JAKi) after reviewing data from several clinical trials that showed increased incidents of issues in certain patients who have rheumatoid arthritis and other risk factors.

The EMA noted malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality in some patients.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Ribbon cutting ceremony for Thermo Fisher's new cell therapy manufacturing site in San Francisco

Ther­mo Fish­er moves on cam­pus with new cell man­u­fac­tur­ing site in San Fran­cis­co

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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