An­nex­on shares fall 33% af­ter pa­tients drop out of Hunt­ing­ton's tri­al; Two Chi­nese biotechs net mod­est fi­nanc­ing rounds

An­nex­on has some dis­ap­point­ing news, and it is ev­i­dent at the Nas­daq.

An­nex­on, which went pub­lic back in 2020, had its share price $AN­NX tum­ble more than 30% down to $7.30 on Wednes­day af­ter sev­er­al pa­tients dis­con­tin­ued treat­ment in a Phase II clin­i­cal tri­al for Hunt­ing­ton’s dis­ease.

The drug can­di­date, ANX005, is a C1q block­er that was be­ing de­signed and test­ed to dis­rupt Hunt­ing­ton’s dis­ease. And while An­nex­on claimed the drug had shown im­prove­ment in more than half of pa­tients af­ter six months, five pa­tients with­drew from the treat­ment — three due to a drug-re­lat­ed ad­verse event, two of which were con­sid­ered se­ri­ous ad­verse events, in­clud­ing sys­temic lu­pus ery­the­mato­sus and id­io­path­ic pneu­moni­tis. An­nex­on said that af­ter post-study drug dis­con­tin­u­a­tion, one pa­tient had symp­toms re­solved and the oth­er pa­tient sta­bi­lized.

While no deaths were re­port­ed, An­nex­on con­firmed that the tri­al re­mains on­go­ing and it ex­pects to have full da­ta by the end of Q2 this year.

Ac­cro Bio­science rais­es $50M+ in Se­ries B round

Ac­cro Bio­science an­nounced yes­ter­day that it has raised over $50 mil­lion in an over­sub­scribed Se­ries B round. The fi­nanc­ing was led by Hong­tai Aplus, along with par­tic­i­pa­tion from South Chi­na Ven­ture Cap­i­tal, Shen­zhen Cap­i­tal Group, Suzhou Oriza Hold­ings and oth­er un­named in­vestors.

The Chi­nese biotech, found­ed in 2017, start­ed out with a Se­ries A from Morn­ing­side Ven­tures and fo­cus­es its re­search on reg­u­lat­ed cell death, lead­ing to em­phases on in­flam­ma­to­ry and au­toim­mune dis­eases along­side can­cer as its main in­di­ca­tions.

Ac­cro co-founder and CEO Xi­ao­hu Zhang ex­pressed op­ti­mism in a pre­pared state­ment, say­ing “we are very pleased with the sup­port and con­fi­dence of our cur­rent and new in­vestors.”

Atom Bio­science rais­es $45 mil­lion in Se­ries C for hy­pe­r­uricemia and gout clin­i­cal tri­al

Chi­nese in­flam­ma­to­ry and meta­bol­ic dis­ease biotech Atom Bio­science closed $45 mil­lion in a Se­ries C round to push its lead can­di­date in­to Phase III.

The Se­ries C, led by Xi­cheng Jin­rui Eq­ui­ty In­vest­ment Fund and Shen­Zhen GT­JA In­vest­ment Group, will push ABP-671 in­to a Phase III clin­i­cal tri­al for hy­pe­r­uricemia and gout. Some of the raise will al­so go in­to pre­clin­i­cal and clin­i­cal de­vel­op­ment of oth­er drugs in Atom’s pipeline.

This is Atom’s biggest cash in­fu­sion to date since its found­ing in 2012, and the round brings the biotech’s to­tal fi­nanc­ing to $87 mil­lion.

Aside from Atom’s lead can­di­date, the biotech has a can­di­date for NASH in pre­clin­i­cal stud­ies along­side three can­di­dates for gas­tric, colon and breast can­cer.

Japan­ese biotech en­ters col­lab­o­ra­tion and li­cens­ing deal with Roche, Genen­tech

Japan pep­tide biotech PRISM Bi­o­Lab an­nounced in a state­ment last night that it has en­tered in­to a re­search col­lab­o­ra­tion and li­cens­ing agree­ment with Roche and Genen­tech.

While de­tails on the deal are still some­what scarce, PRISM will give Roche and Genen­tech ac­cess to its li­brary of pep­tide mimet­ic small mol­e­cules for the biotechs to screen against spe­cif­ic tar­gets. Up­on iden­ti­fi­ca­tion of hit com­pounds, Roche and Genen­tech may elect to fur­ther de­vel­op and com­mer­cial­ize the com­pounds.

PRISM Bi­o­Lab is el­i­gi­ble to re­ceive an up­front pay­ment, suc­cess-based mile­stone pay­ments and roy­al­ties on fu­ture net sales, but those de­tails re­main out of view for now.

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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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.”

EU re­port­ed­ly eye­ing vac­cines deal for mon­key­pox out­break; Nas­daq tells Mereo to get stock price up or face delist­ing

The EU is reportedly working toward a centralized procurement deal for smallpox vaccines to tackle the rising number of cases of monkeypox, according to sources who spoke to the Financial Times.

Andrea Ammon, director of Europe’s CDC, told the FT that the European Commission is “definitely looking at what can be done centrally” and central procurement is “one of the options that are looked at but of course countries are also” looking into bilateral avenues.

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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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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