Bo Ying, Abogen founder (Xi'an Jiaotong-Liverpool University)

Chi­na’s top mR­NA con­tender is ready to go. And Soft­Bank just led a cash in­fu­sion push­ing it over the $1B line

With Mod­er­na and BioN­Tech of­fer­ing a mod­el — in the US and Eu­rope, re­spec­tive­ly — for how mR­NA biotechs can en­joy a me­te­oric rise to prof­it and fame with just one suc­cess­ful Covid-19 vac­cine, a Chi­nese play­er is ready to put it­self on the map.

Abo­gen, which set a record just three months ago with a $720 mil­lion Se­ries C, has now raised an­oth­er $300 mil­lion as it pre­pares to file its vac­cine can­di­date for au­tho­riza­tion. Part­nered with Wal­vax and Chi­na’s mil­i­tary, ABO-028M first en­tered clin­i­cal test­ing in the sum­mer of 2020 and is now in Phase III tri­als in Mex­i­co, In­done­sia and Nepal.

The com­pa­ny has kept it­self large­ly se­cre­tive since be­ing found­ed in Jan­u­ary 2019 — its web­site is near­ly en­tire­ly blank, save for an email ad­dress and a two-sen­tence de­scrip­tion of the com­pa­ny. But one key dif­fer­en­ti­at­ing fac­tor ap­pears to be greater sta­bil­i­ty of its mR­NA vac­cine at warm tem­per­a­tures.

Soft­Bank Vi­sion Fund and 5Y Cap­i­tal co-led the new raise, which is be­ing brand­ed a Se­ries C+, and oth­er in­vestors in­clude Chimera Abu Dhabi, For­tune Ocean and Mi­rae As­set Fi­nan­cial Group.

As BioN­Tech’s jab, part­nered with Fo­s­un on de­vel­op­ment and dis­tri­b­u­tion, re­mains in lim­bo in Chi­na, pub­lic health of­fi­cials and reg­u­la­to­ry au­thor­i­ties have been talk­ing up the prospects of a rapid ap­proval for a do­mes­tic shot.

In an ef­fort to speed up the an­tic­i­pat­ed roll­out, Abo­gen and Wal­vax said on Mon­day they will en­list con­tract man­u­fac­tur­er Gen­Script Pro­Bio to pro­duce the plas­mids that will go in­to their com­mer­cial batch­es.

“The pan­dem­ic is still rag­ing,” said Bri­an Min, CEO of Gen­Script Pro­Bio. “Abo­gen Bio­sciences had launched the project since the very be­gin­ning of the out­break of COVID-19.”

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Phil Sharp, Nobel Prize laureate (L), and John Carroll, Endpoints News co-CEO (via Michael Last)

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

The following Q&A has been edited for length and clarity.

John Carroll:

We’ve had a chance to talk a little bit before here about some of the things that you’ve done. Just really remarkably, a lot of the things that you’ve done early in your career puts you in the path with some amazing science that has had an absolutely huge impact in terms of what we’re seeing now on drug development and some of the new technologies that are coming out here, and not only the new technologies, but also some of the most remarkable people ever.

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Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.