Phillip Gomez, Siga Technologies CEO

Siga nabs $10.7M from the US gov­ern­ment in deal for its mon­key­pox an­tivi­ral

The US gov­ern­ment is all set to buy $10.7 mil­lion worth of Siga Tech­nolo­gies’ mon­key­pox oral an­tivi­ral, the com­pa­ny an­nounced Thurs­day.

Of the to­tal dos­es, $5.1 mil­lion worth of oral an­tivi­rals called Tpoxx (tecovir­i­mat) will be de­liv­ered this year, with the US De­part­ment of De­fense hav­ing the op­tion of buy­ing the rest at a lat­er point.

The new con­tract fol­lows an ear­li­er one in which the gov­ern­ment had pur­chased $7.4 mil­lion worth of Tpoxx from the com­pa­ny.

Ear­li­er this month, the CDC ex­pand­ed its guide­lines for ex­pand­ed use of Tpoxx to cur­tail the spread of mon­key­pox. The drug is cur­rent­ly on­ly FDA-ap­proved for the treat­ment of small­pox.

An­tho­ny Fau­ci

How­ev­er, there haven’t been enough stud­ies con­duct­ed to con­firm Tpoxx’s ef­fi­ca­cy for mon­key­pox, so tri­als are un­der­way. The Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases (NI­AID) and the UK have start­ed Phase III tri­als look­ing to en­roll more than 500 par­tic­i­pants each.

“We cur­rent­ly lack ef­fi­ca­cy da­ta that would help us un­der­stand how well this drug may mit­i­gate painful mon­key­pox symp­toms and pre­vent se­ri­ous out­comes. This clin­i­cal tri­al was de­signed to an­swer those im­por­tant ques­tions,” NI­AID di­rec­tor An­tho­ny Fau­ci said in a CDC press state­ment.

Mean­while, the FDA has sug­gest­ed that doc­tors use Tpoxx ju­di­cious­ly, fear­ing that the virus may be­come re­sis­tant to the drug. A small change to the vi­ral pro­tein, which Tpoxx tar­gets, “could have a large im­pact on the an­tivi­ral ac­tiv­i­ty of TPOXX,” the FDA said on its web­site.

Al­though mon­key­pox cas­es have been en­dem­ic in parts of Africa, the dis­ease start­ed spread­ing glob­al­ly in May 2022, prompt­ing the WHO to de­clare the out­break as a glob­al emer­gency on Ju­ly 23. Most cas­es have been in men who have sex with men, al­though women and chil­dren can be­come in­fect­ed, ac­cord­ing to the WHO.

Rochelle Walen­sky

Cur­rent­ly, a two-shot vac­cine called Jyn­neos, man­u­fac­tured by the Dan­ish drug­mak­er Bavar­i­an Nordic, is the on­ly avail­able pro­tec­tion against the dis­ease. Re­cent da­ta by the CDC, how­ev­er, showed that a sin­gle dose of the vac­cine of­fers pro­tec­tion against the virus.

“These new da­ta pro­vide us with a lev­el of cau­tious op­ti­mism that the vac­cine is work­ing as in­tend­ed,” CDC di­rec­tor Rochelle Walen­sky said in a press con­fer­ence on Wednes­day.

Mon­key­pox cas­es have shown a grad­ual de­cline in the US with dai­ly in­fec­tions av­er­ag­ing around 200 this week, as op­posed to 450 cas­es in mid-Au­gust.

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.