Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has land­ed a new first from UNICEF the first-ever con­tract for malar­ia vac­cines, worth up to $170 mil­lion for 18 mil­lion vac­cine dos­es dis­trib­uted over the next three years.

The vac­cine, known as Mosquir­ix or RTS,S, won WHO’s back­ing last Oc­to­ber af­ter a con­tro­ver­sial start, but UNICEF said these dos­es will po­ten­tial­ly save thou­sands of lives every year.

“We hope this is just the be­gin­ning,” Etl­e­va Kadil­li, di­rec­tor of UNICEF’s sup­ply di­vi­sion, said. “Con­tin­ued in­no­va­tion is need­ed to de­vel­op new and next-gen­er­a­tion vac­cines to in­crease avail­able sup­ply, and en­able a health­i­er vac­cine mar­ket. This is a gi­ant step for­ward in our col­lec­tive ef­forts to save chil­dren’s lives and re­duce the bur­den of malar­ia as part of wider malar­ia pre­ven­tion and con­trol pro­grammes.”

GSK’s vac­cine was first ap­proved by the EMA in 2015, but con­cerns arose over the shot’s ef­fi­ca­cy, which in clin­i­cal tri­als reached 50% against se­vere malar­ia af­ter the first year, but fell in sub­se­quent years. Some ex­perts al­so ques­tioned the shot’s abil­i­ty to pre­vent death, giv­en that stud­ies did not di­rect­ly mea­sure mor­tal­i­ty.

But a WHO 2019 pi­lot pro­gram in three coun­tries — Ghana, Kenya and Malawi — in­formed WHO’s rec­om­men­da­tion in Oc­to­ber 2021 and showed that more than two-thirds of chil­dren in the three coun­tries who are not sleep­ing un­der a bed net are ben­e­fit­ing from the vac­cine, lin­ing up wider use of the vac­cine in coun­tries with mod­er­ate to high P. fal­ci­parum malar­ia trans­mis­sion. Two months lat­er, Gavi, the Vac­cine Al­liance said it would pro­vide fund­ing for malar­ia vac­cine pro­grams in el­i­gi­ble coun­tries.

UNICEF al­so said it sup­ports the re­gion­al di­ver­si­fi­ca­tion of vac­cine pro­duc­tion and en­cour­ages GSK and oth­er man­u­fac­tur­ers to con­sid­er part­ner­ing with African com­pa­nies.

Ac­cord­ing to WHO da­ta, more than 30 coun­tries have ar­eas with mod­er­ate to high malar­ia trans­mis­sion, and in 2020, near­ly 500,000 chil­dren died from malar­ia in Africa at a rate of one child death per minute.

“Lives are at stake, every day. WHO wel­comes the progress to se­cure sup­ply and time­ly ac­cess to vac­cine so that more coun­tries can be­gin to in­tro­duce this ad­di­tion­al malar­ia pre­ven­tion tool as rapid­ly as pos­si­ble,” said Kate O’Brien, WHO di­rec­tor of the de­part­ment of im­mu­niza­tion, vac­cines and bi­o­log­i­cals. ”Giv­en the ini­tial lim­it­ed sup­ply, it is cru­cial that chil­dren liv­ing in ar­eas where the risk of dis­ease and need is high­est are pri­or­i­tized first.”

One hitch is that the shot must be ad­min­is­tered in four dos­es, be­gin­ning when chil­dren reach five months of age un­til they turn three years old. Oth­er­wise, some of the best tools to fight malar­ia have been spray­ing in­sec­ti­cides in the home and wrap­ping mat­tress­es with spe­cial nets to ward off the mos­qui­toes that car­ry the par­a­site.

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.

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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Nicklas Westerholm, Egetis Therapeutics CEO

Ac­qui­si­tion talks on­go­ing for Swedish rare dis­ease biotech Egetis, shares up al­most 40%

Shares of the Sweden-based rare disease biotech Egetis Therapeutics skyrocketed on Thursday afternoon as the company said it’s engaged in “ongoing discussion” with external parties regarding a “potential acquisition.”

Egetis confirmed rumors with a statement on Thursday while noting that there is no certainty that a takeover offer will be made.

Nonetheless, the possibility of an acquisition has shot up Egetis’ share price. By the afternoon on Thursday, its stock price was {$EGTX.ST} up over 38%. An Egetis spokesperson told Endpoints News in an email that it has no further comments.

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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.

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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Sen­ate Fi­nance Com­mit­tee lobs more bi­par­ti­san pres­sure on­to PBMs

Congress is honing in on how it wants to overhaul the rules of the road for pharmacy benefit managers, with a Senate Finance Committee hearing Thursday serving as the latest example of the Hill’s readiness to make changes to how pharma middlemen operate.

While pledging to ensure patients and pharmacies “don’t get a raw deal,” Finance Committee Chair Ron Wyden (D-OR) laid out the beginning of what looks like a major bipartisan effort — moves the PBM industry is likely to challenge vigorously.

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Deborah Waterhouse, ViiV Healthcare CEO

MPP re­cruits three gener­ic man­u­fac­tur­ers to ex­pand use of Vi­iV's in­jectable PrEP drug

ViiV Healthcare has teamed up with the UN-backed Medicines Patent Pool and three generic manufacturers to expand access to medicine that can prevent HIV.

ViiV and the Medicines Patent Pool jointly announced Thursday that the MPP signed sub-licensing agreements with Aurobindo, Cipla and Viatris to manufacture generics of a long-acting form of cabotegravir for HIV pre-exposure prophylaxis (PrEP). As a result of the agreement, the manufacturers will be able to develop, manufacture and supply generic versions of cabotegravir LA in 90 countries — subject to regulatory approvals.

Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Cedric Ververken, Confo Therapeutics CEO

Dai­ichi Sankyo inks $183M dis­cov­ery deal with GPCR biotech for CNS tar­get

Belgian biotech Confo Therapeutics has landed $183 million, plus potential royalties, in a drug-discovery deal with Daiichi Sankyo.

Early Thursday, Confo Therapeutics put out word of the deal that will be focused on small molecule antagonists to go after an undisclosed target that the company says is associated with CNS diseases.

Confo CEO Cedric Ververken told Endpoints News that Daiichi originally reached out to learn about the biotech’s technology. He added that Confo, founded in 2015, will use its platform to drug a GPCR target that Daiichi has struggled with internally.