CEO Lawrence Blatt (Aligos)

With a po­ten­tial $458M per tar­get pay­day, Ali­gos teams up with Mer­ck hop­ing to re­verse biotech's re­cent NASH mal­adies

Just a few months af­ter go­ing pub­lic with a $150 mil­lion IPO, Ali­gos Ther­a­peu­tics $AL­GS is aim­ing to fur­ther cap­i­tal­ize on its mo­men­tum with a new NASH deal.

The biotech has teamed up with Mer­ck to try to de­vel­op oligonu­cleotide ther­a­pies for the dis­ease, a slate that could be worth up to $458 mil­lion in mile­stones per tar­get. Ali­gos and Mer­ck did not dis­close how much would be paid up­front, but not­ed there would be an­oth­er cash pay­ment once the pair de­cides on a sec­ond tar­get.

As part of the deal, Ali­gos will de­sign and pre­pare the can­di­dates for clin­i­cal stud­ies, while Mer­ck will take the lead on the R&D and com­mer­cial­iza­tion ef­forts them­selves. Ali­gos shares ticked up about 9% in ear­ly Mon­day trad­ing.

It’s been a sharp rise for the San Fran­cis­co-based biotech since be­ing found­ed in 2018. Ali­gos is fo­cus­ing the vast ma­jor­i­ty of its ef­forts in liv­er dis­eases like he­pati­tis B and NASH, de­spite the lat­ter field’s propen­si­ty for set­backs.

The com­pa­ny’s lead pro­gram, dubbed ALG-010133, is what Ali­gos calls a STOPS mol­e­cule, or an S-anti­gen trans­port-in­hibit­ing oligonu­cleotide poly­mer. Hav­ing start­ed a Phase I study in Au­gust for chron­ic he­pati­tis B, ALG-010133 aims to sup­press the S-anti­gen in the he­pati­tis B virus it­self.

Ul­ti­mate­ly, Ali­gos says that can boost a pa­tient’s com­pro­mised im­mune sys­tem and im­prove vi­ral clear­ance in chron­ic he­pati­tis B. The com­pa­ny is ex­pect­ing topline re­sults for cer­tain co­horts in the Phase I — mea­sur­ing safe­ty and an­tivi­ral ac­tiv­i­ty in up to 12 week­ly dos­es, both in healthy vol­un­teers and vi­ro­log­i­cal­ly sup­pressed pa­tients with CHB — some­time around the sec­ond half of 2021.

The past 24 months have brought noth­ing but dif­fi­cul­ty for the NASH are­na. Drug de­vel­op­ers have been en­ticed by a po­ten­tial­ly lu­cra­tive mar­ket, with some an­a­lysts pro­ject­ing as much $20 bil­lion in com­bined sales by 2025.

Gilead marked the first high-pro­file dis­ap­point­ments af­ter its three-drug cock­tail fiz­zled back in Dec. 2019, an ef­fort that fol­lowed two oth­er big de­feats ear­li­er in the year. None of the cock­tail reg­i­mens in­duced a sta­tis­ti­cal­ly sig­nif­i­cant in­crease in those tri­als’ pri­ma­ry end­points.

Then this June, the FDA shot down In­ter­cept’s own NASH pro­gram af­ter sev­er­al ad­comm and hear­ing de­lays due to the Covid-19 pan­dem­ic and the agency want­i­ng to see ad­di­tion­al da­ta. Reg­u­la­tors even­tu­al­ly re­ject­ed the drug be­cause they were un­cer­tain if the sur­ro­gate end­point from their Phase III tri­al — re­duc­tion in liv­er fi­bro­sis — would ac­tu­al­ly trans­late in­to ben­e­fit for pa­tients.

In the sub­se­quent months, both Gen­fit and Al­bireo shut down their NASH pro­grams en­tire­ly. Though the for­mer saw its stock price crushed by the flop, the lat­ter emerged rel­a­tive­ly un­scathed giv­en that its pri­ma­ry fo­cus has been on oth­er liv­er dis­eases like bile atre­sia and PF­IC.

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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Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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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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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.

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.