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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

NIH re­jects an­oth­er at­tempt to 'march-in' on prostate can­cer drug over ex­ces­sive price

The National Institutes of Health (NIH) has declined to use so-called “march-in” rights to lower the price of Astellas’ prostate cancer drug Xtandi even as the federal government helped to pay for its development.

NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News, the institutes’ analyses found Xtandi “to be widely available to the public” and “given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug.”

Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Vipin Garg, Altimmune CEO

Al­tim­mune’s shares halved af­ter in­ter­im look at PhII weight loss drug da­ta

Altimmune’s attempt to catch up to Novo Nordisk and Eli Lilly’s GLP-1 drugs hit an investor snag Tuesday after the biotech shared interim Phase II weight loss data.

The Maryland biotech’s pemvidutide is a GLP-1/glucagon dual receptor agonist meant to activate GLP-1 receptors to squash appetite and glucagon to ramp up energy use. The 2.4 mg dose showed a placebo-adjusted weight loss of 9.7% at week 24 of 48, which Jefferies analysts said would be comparable to Novo Nordisk’s semaglutide (Wegovy) and Eli Lilly’s tirzepatide (Mounjaro).

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