Henry Skinner, AMR Action Fund CEO

AMR Ac­tion Fund looks to tack­le an­timi­cro­bial re­sis­tance with first two in­vest­ments — but does the mon­ey ar­rive too late?

The AMR Ac­tion Fund — backed by a hand­ful of heavy­weight phar­ma play­ers in­clud­ing Pfiz­er, Eli Lil­ly, Mer­ck, John­son & John­son, Boehringer In­gel­heim and Glax­o­SmithK­line — has made its first two in­vest­ments in the hopes of ad­dress­ing the loom­ing threat of an­timi­cro­bial re­sis­tance.

But ac­cord­ing to CEO Hen­ry Skin­ner, there’s plen­ty more to go around this year.

AMR has promised to in­vest over $100 mil­lion this year in com­pa­nies de­vel­op­ing an­timi­cro­bials that can over­come re­sis­tance, start­ing with Adap­tive Phage Ther­a­peu­tics (APT) and Ve­na­torx Phar­ma­ceu­ti­cals.

The for­mer was found­ed in 2016 by re­tired NIH sci­en­tist Carl Mer­ril and his son to build on ear­ly work Mer­ril did in phage ther­a­py, or the use of bac­te­rio­phages to treat bac­te­r­i­al in­fec­tions. The com­pa­ny is com­pil­ing a mas­sive li­brary of phages — nat­u­ral­ly oc­cur­ring virus­es that in­fect and kill bac­te­ria — which could po­ten­tial­ly pro­vide pro­tec­tion against high-pri­or­i­ty, an­tibi­ot­ic-re­sis­tant bac­te­ria.

The phages are be­ing test­ed on a range of in­fec­tions, in­clud­ing pros­thet­ic joint in­fec­tions, bone in­fec­tions (os­teomyelitis), and lung in­fec­tions. The Mary­land-based biotech snagged $8 mil­lion from the US De­part­ment of De­fense last Sep­tem­ber (bring­ing the DoD’s to­tal con­tract up to $31.2 mil­lion), and AMR kicked in on a re­cent $61 mil­lion Se­ries B round.

Penn­syl­va­nia-based Ve­na­torx is a bit fur­ther along, with its lead an­tibi­ot­ic — be­ing de­vel­oped for com­pli­cat­ed uri­nary tract in­fec­tions, hos­pi­tal-ac­quired pneu­mo­nia and ven­ti­la­tor-as­so­ci­at­ed bac­te­r­i­al pneu­mo­nia (HABP/VABP) — slat­ed for an NDA fil­ing at the end of this year, ac­cord­ing to the com­pa­ny’s web­site.

Found­ed in 2010, the com­pa­ny’s name comes from the Latin word “ve­na­tor,” mean­ing ‘“hunter,” and “Rx.” AMR led the com­pa­ny’s Se­ries C round. Ve­na­torx didn’t dis­close how much it raised, but it did add that it’s al­so re­ceived in­vest­ments from the NI­AID and BAR­DA.

AMR was launched back in 2020 by the In­ter­na­tion­al Fed­er­a­tion of Phar­ma­ceu­ti­cal Man­u­fac­tur­ers & As­so­ci­a­tions, in col­lab­o­ra­tion with the WHO, and backed by a long list of drug­mak­ers. More than 20 com­pa­nies have chipped in — and with an ini­tial $1 bil­lion, the fund set a goal last year to bring two to four new an­tibi­otics to pa­tients by 2030.

“We will con­tin­ue in­vest­ing in promis­ing biotechs in the years ahead to en­sure that pa­tients around the world have the treat­ments they need,” Skin­ner said in a news re­lease.

But is it too lit­tle, too late? Drug-re­sis­tant bac­te­r­i­al in­fec­tions kill an es­ti­mat­ed 1.27 mil­lion peo­ple an­nu­al­ly, more than HIV/AIDs or malar­ia, ac­cord­ing to Bill Burns, board chair of the AMR Ac­tion Fund. By 2050, ex­perts guess an­timi­cro­bial re­sis­tance could lead to as many as 10 mil­lion deaths per year.

And de­spite the ris­ing threat, Big Phar­ma has re­treat­ed from the risky field, where many an­tibi­otics fail in de­vel­op­ment, while oth­ers “with­er on the vine” due to a lack of avail­able fund­ing. The ones that do get ap­proved are of­ten used spar­ing­ly to pre­serve ef­fec­tive­ness and slow the de­vel­op­ment of fur­ther re­sis­tance.

“Our in­vest­ments are sub­stan­tial, but we alone are not enough to take on the glob­al chal­lenge of AMR,” Skin­ner said. “It is now im­per­a­tive that pol­i­cy­mak­ers around the world en­act mar­ket re­forms to sup­port in­vest­ment in these ur­gent­ly need­ed med­ica­tions.”

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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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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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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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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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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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.

Four community leaders who are living with HIV celebrate life and accomplishments in Theratechnologies' new campaign

Re­al pa­tient ‘cham­pi­ons’ liv­ing with HIV star in Ther­at­e­ch­nolo­gies cam­paign

Over the past several years, people living with HIV have been more often telling Theratechnologies that they wanted more representation. Specifically, they wanted more African American people and more focus on living and thriving versus more typical medication regimen messaging.

So Theratechnologies came up with a new campaign called “I Am A Champion,” initially launched at the US Conference on HIV last year. The initial conference, print and digital media efforts highlight the triumphs of four long-term survivors from across the US.

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