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.”

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Kelly Martin, Radius Health CEO

VC firms take os­teo­poro­sis drug­mak­er Ra­dius Health pri­vate for al­most $900M

After attacks from activist investors and disappointing returns on share prices, Radius Health has now agreed to new ownership, a direction resulting in leaving the Nasdaq.

Radius Health, a biotech out of Massachusetts with one approved product in its arsenal, announced Thursday morning that it agreed to be acquired by two VC firms: Gurnet Point Capital and Patient Square Capital. The deal, worth around $890 million, will include debt assumption and the payout of $1 CVR per share for investors. And on top of that, OrbiMed is providing debt financing.

John Leonard, Intellia CEO

In­tel­li­a's CRISPR pro­gram that ed­its genes di­rect­ly in pa­tients shows dura­bil­i­ty in AT­TR amy­loi­do­sis

The first in vivo CRISPR/Cas9 gene editing program has some new durability data showing sustained reduction of a toxic protein in ATTR amyloidosis at all four dose levels in a small 15-patient study.

Intellia Therapeutics presented the much-anticipated data for its Regeneron-collaborated NTLA-2001 Friday morning, adding to the initial Phase I results it first delivered almost a year ago to the day.