Ali­gos Ther­a­peu­tics, de­vel­op­ing sev­er­al dif­fer­ent hep B and NASH treat­ments, files for $100M IPO raise

An­oth­er biotech filed to go pub­lic late Fri­day as the 2020 IPO par­ty rages on.

Ali­gos Ther­a­peu­tics, fo­cus­ing on chron­ic he­pati­tis B and NASH, sub­mit­ted its S-1 pa­per­work to the SEC with a goal of rais­ing $100 mil­lion. The com­pa­ny’s lead can­di­date is known as a STOPS mol­e­cule, or an S-anti­gen trans­port-in­hibit­ing oligonu­cleotide poly­mer, and start­ed a Phase I study for CHB in Au­gust.

Through late Au­gust, the in­dus­try as a whole had raised $11 bil­lion-plus across four dozen IPOs, per in­de­pen­dent an­a­lyst Brad Lon­car, sur­pass­ing the amount from all of 2019.

Af­ter four oth­er biotechs priced their shares last Fri­day, the to­tal num­ber of in­dus­try IPOs in 2020 reached 56, Nas­daq’s head of health­care list­ings Jor­dan Saxe told End­points News at the time. Nas­daq has count­ed $11.3 bil­lion raised for those 56 biotechs through Fri­day. Saxe’s tal­ly al­so match­es Lon­car’s to­tal from 2018, which made 2020 tied for the most biotech IPOs seen since at least 2017.

The the­o­ry be­hind the lead pro­gram, dubbed ALG-010133, is that sup­press­ing the S-anti­gen in the he­pati­tis B virus can boost the pa­tients’ com­pro­mised im­mune sys­tems and im­prove vi­ral clear­ance in chron­ic he­pati­tis B. Ali­gos’ Phase I study will mea­sure safe­ty and an­tivi­ral ac­tiv­i­ty in up to 12 week­ly dos­es, both in healthy vol­un­teers and vi­ro­log­i­cal­ly sup­pressed pa­tients with CHB.

Ac­cord­ing to a state­ment at the time, ALG-010133 will first be eval­u­at­ed as a monother­a­py but Ali­gos said it has seen some po­ten­tial that it could be used in com­bi­na­tion ther­a­pies.

Topline re­sults for some co­horts are ex­pect­ed in the sec­ond half of 2021, and the first pa­tients were dosed at a tri­al site in New Zealand. Oth­er sites across Asia and Eu­rope have not be­gun dos­ing as of yet.

Ali­gos has three oth­er pre­clin­i­cal pro­grams try­ing to hit the chron­ic he­pati­tis B in­di­ca­tion, each with dif­fer­ent mech­a­nisms of ac­tion. The first is with cap­sid as­sem­bly mod­u­la­tors, which are small mol­e­cules that in­ter­fere with HBV cap­sid dis­as­sem­bly and vi­ral repli­ca­tion. This pro­gram, called ALG-000184, is ex­pect­ed to be­gin clin­i­cal tri­als be­fore the end of the year.

The com­pa­ny’s oth­er two CHB pre­clin­i­cal pro­grams both can in­hib­it the virus’s mR­NA that en­codes S-anti­gens, Ali­gos says. These two meth­ods are through an an­ti­sense oligonu­cleotide, as well as a small in­ter­fer­ing RNA. Ad­di­tion­al­ly, the biotech’s NASH pro­gram — al­so in pre­clin­i­cal stud­ies — is a THB-be­ta ag­o­nist.

Ali­gos’ S-1 did not give much de­tail about how it ex­pects to divvy up the funds from the IPO raise, on­ly that the mon­ey would main­ly go to­wards fund­ing these five pro­grams.

Al­so on Fri­day, a 5AM Ven­tures-backed blank check com­pa­ny filed to go pub­lic, seek­ing an $80 mil­lion raise. The com­pa­ny, called 5:01 Ac­qui­si­tion, is not plan­ning on op­er­at­ing like a nor­mal SPAC in that it’s not of­fer­ing war­rants that would be­come ex­er­cis­able fol­low­ing com­ple­tion of the ini­tial busi­ness com­bi­na­tion, per Re­nais­sance Cap­i­tal.

5:01 Ac­qui­si­tion did not spec­i­fy with which biotech it plans to con­duct a re­verse merg­er.

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

Up­dat­ed: 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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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.

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.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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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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Marcelo Bigal, Ventus Therapeutics CEO

No­vo Nordisk joins No­var­tis, Roche in NL­RP3 are­na, bet­ting $70M cash on NASH, car­diometa­bol­ic us­es

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

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