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.

Their Staying Power Lies in their Patient-Centricity

Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.

Patrick Collison, co-founder of Stripe, has become one of Silicon Valley’s biggest advocates for new forms of funding and conducting science (Matt Winkelmeyer/Getty Images for WIRED)

It’s big days for biology.

The pandemic has seen a series of very public scientific breakthroughs: mRNA vaccine, Covid antibodies, CRISPR as therapy. The minds behind these advancements have graced magazine covers and received prestigious awards.

But the last two years have also, far more quietly, seen a series of new experiments in how to fund the next generation of scientific breakthroughs.

Since March 2020, investors, academics, a significant number of Silicon Valley types, at least one Russian billionaire and two crypto billionaires and, most recently, a few West Coast universities have launched a series of grant programs, institutes, NGOs and companies hoping to change how life science research is done. Though unaffiliated and varying greatly in both size and form, they have broadly promised to evade bureaucracy and misaligned incentives and advance both basic and not-so-basic research in ways they say can’t be done in either conventional academia or profit-focused biotech.

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The FDA this week announced further changes to revamp its structure, this time with alterations to its Office of the Chief Scientist that were agreed to by HHS late last month.

The FDA’s OCS has decided to shift its technology transfer program from the Office of Regulatory Science and Innovation to the OCS Immediate Office to further enhance the effectiveness of the agency’s outside partnership programs.

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Jeff Albers and Kate Haviland (Brad Bahner Photography/PR Newswire)

After a busy 2021 brought Blueprint Medicines its fourth FDA approval, the company is kicking off the new year with plans to shake up its C-suite.

Jeff Albers, Blueprint’s CEO for the past eight years, will be stepping down April 4 and transitioning to the executive chairman position, the biotech announced Wednesday morning. He will be replaced by COO Kate Haviland, who moves into both the chief executive and president roles. Christina Rossi also nabs a promotion from chief commercial officer to COO.

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For anyone who’s been following how the US government has been allocating and shipping supplies of its Covid-19 treatments over the past year, the news has shifted so many times that it can be difficult to keep track of what’s still being shipped and where.

More change is coming this week too, as HHS has now decided to re-start shipments of both Eli Lilly (bamlanivimab plus etesevimab) and Regeneron (casirivimab plus imdevimab) monoclonal antibody products after a short pause because neither product works against the new variant Omicron. Lilly’s combo also was halted last June due to the presence of other variants.

Kicking off 2022, hundreds of pharmaceuticals, including some blockbusters, saw their list prices rise by about 5% on average. But overall, net drug prices (cost after rebates) declined for the fourth year in a row, potentially complicating already stalled drug price reform efforts.

Among the drugs seeing new increases as of Jan. 1 are Gilead’s bevy of blockbuster HIV drugs.

Biktarvy, which pulled in more than $7 billion in worldwide sales in 2020, saw a 4.8% price increase in 2021, and now, another 5.6% increase in 2022, according to a new report from the nonprofit 46brooklyn Research.

All the big R&D trends are on display in this new list of drug approvals for 2021. Plus one.

Add up everything OK’d from CDER and CBER, and you have 60 new drug approvals for last year, topping the 59 in 2020. That’s a close second to the 64 OKs that came out of the FDA in 2018. The dark days of the early 2000s are a distant memory now, with a host of hungry upstarts promising to make their own entries one day as Big Pharmas double down on innovation.

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Tom Riga, Spectrum Pharmaceuticals CEO

Covid-19 has been a rough go for many drugmakers, but few more so than Spectrum Pharmaceuticals, which has seen inspection delays and unwanted CRLs haunt its chance at a first approval. Feeling the sting, Spectrum will now downsize to keep the lights on through the year.

Spectrum will cut 30% of its workforce and pivot its R&D efforts around its two furthest-along drugs as part of a restructuring effort that will pave the company’s cash runway out into next year, it announced Wednesday.

Catalent CEO John Chiminski (Catalent)

If there was one defining theme at Catalent in recent years, it was expansion, as the CDMO upped its operations all over the world, from Baltimore to Japan. It did so under longtime CEO John Chiminski, who has led the Somerset, NJ-based company for 12 years, topped by 2 years of the pandemic. This year will be the last in the C-suite for Chiminski, however, as the company announced plans for a passing of the torch this summer.

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