Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Am­brx tried to go pub­lic in 2014, they failed and the com­pa­ny’s board switched to a rad­i­cal­ly dif­fer­ent strat­e­gy: They sold them­selves for an undis­closed amount to a syn­di­cate of Chi­nese in­vestors and phar­ma com­pa­nies.

Now, af­ter 5 qui­et years, that syn­di­cate has raised a moun­tain of cash and in­di­cat­ed they’ll soon make an­oth­er bid to go pub­lic.

Ear­li­er this month, Am­brx raised $200 mil­lion in what they billed as a crossover round fi­nanced by Fi­deli­ty, Black­Rock, Cor­morant As­set Man­age­ment, HBM Health­care In­vest­ments, In­vus, Adage Cap­i­tal Part­ners and Su­vret­ta Cap­i­tal Man­age­ment. It’s the largest amount they’ve ever raised and, ac­cord­ing to Crunch­base fig­ures, more than dou­bles the to­tal amount of VC cap­i­tal col­lect­ed since their launch 17 years ago.

“Since mid-2018, our new man­age­ment team, set on a new long term vi­sion, has com­mit­ted to build­ing com­pa­ny fun­da­men­tals and trans­form­ing Am­brx from a tech­nol­o­gy de­vel­op­er to a full-fledged bio­phar­ma­ceu­ti­cal com­pa­ny,” CEO Feng Tian said in a state­ment. “The con­clu­sion of this fi­nanc­ing and the strong da­ta emerg­ing from our on­go­ing clin­i­cal pro­grams, as well as our deep pre­clin­i­cal pipeline of pro­pri­etary drug can­di­dates, po­si­tions the com­pa­ny for rapid growth.”

Am­brx spun out of Scripps Re­search in 20o3 and, over the next decade, racked up part­ner­ships with Mer­ck, Bris­tol My­ers Squibb, Astel­las, and Eli Lil­ly, all of whom want­ed to col­lab­o­rate on an­ti­body-drug con­ju­gates or oth­er as­pects of Am­brx’s pro­tein en­gi­neer­ing tech­nol­o­gy.

But af­ter Shang­hai Fo­s­un Phar­ma­ceu­ti­cal Group, WuXi Phar­mat­e­ch and oth­ers bought them out in 2015, the com­pa­ny turned its at­ten­tion large­ly to­ward Chi­na. Over the fol­low­ing four years, they signed dis­cov­ery deals with BeiGene, Suzhou-based Mab­Space and Shang­hai-based NovoCodex, among oth­ers.

With a $45 mil­lion pri­vate round, they al­so moved their first in-house drug in­to the clin­ic, a HER2 tar­get­ing an­ti­body-drug con­ju­gate called ARX788. Be­yond ARX788, the com­pa­ny now lists 2 oth­er an­ti­body-drug con­ju­gates and 4 dif­fer­ent im­muno-on­col­o­gy an­ti­bod­ies in pre­clin­i­cal de­vel­op­ment, in­clud­ing a CD3 bis­pe­cif­ic.

At the same time, an­ti­body-drug con­ju­gates, have gar­nered new ex­cite­ment around the in­dus­try, as Seagen racks ap­proval af­ter ap­proval with Glax­o­SmithK­line, Dai­ichi Sankyo, and Genen­tech all adding their own.

A cou­ple of the mol­e­cules from some of Am­brx’s big-name part­ner­ships re­main in clin­i­cal de­vel­op­ment. Last year, Bris­tol My­ers paid the biotech a mile­stone for ad­vanc­ing one pro­tein in­to hu­man test­ing for heart fail­ure. Still, the Big Phar­ma has said lit­tle of the an­ti­body they were test­ing in Phase II for NASH, and Astel­las re­cent­ly dis­con­tin­ued a Phase I study in acute myeloid leukemia for an Am­brx-part­nered drug.

Am­brx has reached one ap­proval, though: Im­restor, an an­ti­body they teamed with Eli Lil­ly’s an­i­mal health di­vi­sion on, was OK’d in 2013. It boosts the im­mune sys­tem of dairy cows.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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An Endpoints Zoom meeting; and the email header employees will see if your company is a Premium subscriber

What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Mike Grey, Plexium chairman (Horizon Therapeutics)

Plex­i­um adds in­dus­try vet Mike Grey to the brain trust with new in­vestor cash fund­ing its pro­tein degra­da­tion play

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Covid-19 roundup: Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls; Flood, dead­ly fire threat­en As­traZeneca vac­cine plants

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.

With patent con­cerns loom­ing, Roche gets a new pri­or­i­ty re­view on block­buster IPF drug

Seven years after the FDA first approved Esbriet, the blockbuster Roche IPF drug is getting an expedited review for a second indication.

On Thursday, the agency gave Esbriet priority review for unclassified interstitial lung diseases, or forms of pulmonary inflammation and scarring that don’t fit easily into the over 200 known types of ILD. The move comes 10 months after Esbriet received breakthrough designation and sets Roche up for a decision by May.