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.”

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.

Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Vi­iV Health­care looks to make long-act­ing HIV pre­ven­tion shot ac­ces­si­ble in low- and mid­dle-in­come coun­tries

The Joint United Nations Programme on HIV and AIDS set a lofty goal back in 2019 to end the HIV epidemic by 2030. But according to the World Health Organization, infection rates are not falling rapidly enough to meet that target.

GSK’s ViiV Healthcare thinks it can help change that.

On Friday, ViiV announced that it’s in talks with the UN-backed Medicines Patent Pool (MPP) for patent rights to its cabotegravir long-acting HIV injectable for pre-exposure prophylaxis (PrEP) in low- and middle-income countries.