Laura Shawver (Silverback Therapeutics)

Fol­low­ing a hefty Se­ries B, Sil­ver­back Ther­a­peu­tics quick­ly pulls in $85M for 'an im­por­tant growth phase'

Months af­ter reel­ing in a $78 mil­lion Se­ries B round, Sil­ver­back Ther­a­peu­tics has hooked an even larg­er Se­ries C.

The Seat­tle-based com­pa­ny an­nounced Wednes­day that it net­ted $85 mil­lion from a slate of new and pre­vi­ous in­vestors. The quick boost could be a sign that an IPO is on the way.

In an email, Sil­ver­back CEO Lau­ra Shawver told me she was “not able to pro­vide any ad­di­tion­al com­ments about Sil­ver­back” be­yond what was shared in the com­pa­ny’s news re­lease. In the pre­pared state­ment, she said the com­pa­ny is at “an im­por­tant growth phase.”

In March, around the time of its Se­ries B an­nounce­ment, Sil­ver­back laid out plans to re-con­cep­tu­al­ize an­ti­body-drug con­ju­gates. Where­as oth­er AD­Cs de­liv­er can­cer-killing tox­ins, Sil­ver­back is us­ing the tech to de­liv­er im­mune-stim­u­la­to­ry agents. Its lead can­di­date, SBT6050, de­liv­ers a TLR8 ag­o­nist to HER2-ex­press­ing tu­mors in the hopes of ac­ti­vat­ing and re­pro­gram­ming myeloid cells to dri­ve an im­mune re­sponse. The com­pa­ny says it will use its lat­est round to ad­vance the drug, which is in Phase I test­ing, as well as oth­er ADC can­di­dates.

Va­lerie Ode­gard

“TLR8 is the in­nate im­mune re­cep­tor ex­pressed in hu­man myeloid cells, and the abil­i­ty then to sys­tem­i­cal­ly de­liv­er an agent, whose ac­tiv­i­ty is lo­cal­ized to the site of the tu­mor and on­ly ac­ti­vates myeloid cells in the tu­mor is a very ex­cit­ing ther­a­peu­tic,” CSO Va­lerie Ode­gard told End­points News back in March.

The Se­ries C saw some help from re­turn­ing in­vestors Or­biMed Ad­vi­sors, US Ven­ture Part­ners, Nex­tech In­vest, Hunt Tech­nol­o­gy Ven­tures, and Pon­tif­ax Ven­ture Cap­i­tal. New in­vestors Box­er Cap­i­tal of Tavi­s­tock Group, Fi­deli­ty Man­age­ment & Re­search Com­pa­ny, Nan­ta­ha­la Cap­i­tal Man­age­ment, and RA Cap­i­tal chipped in. EcoR1 Cap­i­tal led the round.

Sil­ver­back al­so seized the op­por­tu­ni­ty to an­nounce two pro­mo­tions: Ode­gard, who’s been the com­pa­ny’s CSO for two years, is adding pres­i­dent to her ti­tle. And Nao­mi Hun­der jumped from se­nior VP of clin­i­cal re­search and de­vel­op­ment, where she’s been for about a year and a half, to CMO.

“We are at an im­por­tant growth phase for the com­pa­ny and their on­go­ing lead­er­ship will be crit­i­cal as we progress SBT6050 through clin­i­cal de­vel­op­ment, as well as ad­vance our ro­bust pre­clin­i­cal pipeline,” Shawver said in a state­ment.

The can­cer space is abound with AD­Cs, in­clud­ing Im­munomedics’ Trodelvy, which was re­cent­ly ap­proved for metasta­t­ic triple-neg­a­tive breast can­cer. The biotech, which is set to be ac­quired by Gilead, pre­sent­ed pos­i­tive new da­ta at vir­tu­al ES­MO 2020, and is rac­ing to­ward ap­proval in urothe­lial can­cer, where it will com­pete with Seat­tle Ge­net­ics’ ADC Pad­cev.

Ear­li­er this year, Dai­ichi Sankyo and As­traZeneca’s En­her­tu was ap­proved for breast can­cer — months ahead of sched­ule. And Roche’s Kad­cy­la, ap­proved for HER-2 pos­i­tive breast can­cer, scored huge sales last year.

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.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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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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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.

Fast on Glax­o­SmithK­line's heels, Au­rinia wins OK to steer a sec­ond lu­pus nephri­tis drug straight to the mar­ket

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

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.

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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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Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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