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.”

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

BREAK­ING: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

FDA's ad­vanced ther­a­pies of­fice pro­vides more clar­i­ty on gene ther­a­py CMC con­sid­er­a­tions

As the Office of Tissue and Advanced Therapies (OTAT) transforms into the Office of Therapeutic Products (OTP), with new user fee funds and “super office” status, the department focused on cell and gene therapies also opened its doors to a town hall Thursday offering clarification on guidance and regulations for manufacturers.

Some of the major concerns from manufacturers were the CMC considerations between first-in-human studies and late-phase studies supporting a marketing approval.

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Pa­tient re­port finds con­sti­pa­tion con­di­tion not well-man­aged, open­ing door for bet­ter ed­u­ca­tion from phar­ma

Advertising for constipation treatments often uses light-hearted humor in an effort to spur open discussions about the sometimes stigmatized topic. However, that may not be enough to get people to take the condition seriously, a new patient report from Phreesia finds.

Fewer than one-fifth (17%) of patients with constipation surveyed understand the longer-term health risks of constipation such as hemorrhoids and bowel incontinence. Many are trying to manage their condition with over-the-counter medicines, but often for much longer than recommended. An equal 68% say they use home remedies or OTC meds to manage constipation. But while 90% understand that OTCs are not intended for long-term use, 50% have used an OTC constipation medicine for more than a year.

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