Angie You (file photo)

With $117M in fresh cash, Amu­nix paves path to the clin­ic for 'u­ni­ver­sal mask' pro­drug on the hunt for HER2 tu­mors

De­spite all the ex­cite­ment over the pos­si­bil­i­ty of T cell ther­a­pies to crack the code against sol­id tu­mors, ear­ly safe­ty da­ta have lim­it­ed the bur­geon­ing field’s promise. A clutch of play­ers hope to solve that prob­lem by “mask­ing” their drugs, and now one of those out­fits has snared fresh in­vestor cash to take its shot in the clin­ic.

Amu­nix closed a $117 mil­lion Se­ries B to guide AMX-818, a masked pro­tease-ac­ti­vat­ed T cell en­gager for HER2 ex­press­ing tu­mors, to the clin­ic as well as shep­herd­ing its bustling pipeline of tu­mor hunters through the pre­clin­i­cal stage, the com­pa­ny said Thurs­day.

A 15-year-old firm that on­ly re­cent­ly piv­ot­ed its drug half-life ex­tend­ing plat­form in­to next-gen on­col­o­gy de­vel­op­ment, Amu­nix is one of a suite of com­pa­nies us­ing mask­ing an­ti­bod­ies to sneak ther­a­pies di­rect­ly in­to the tu­mor mi­croen­vi­ron­ment with­out the se­ri­ous safe­ty risks com­mon to oth­er im­munother­a­pies.

What sep­a­rates Amu­nix from the pack? For one, the biotech is us­ing a “uni­ver­sal mask” for its im­munother­a­py drugs, CEO Ang­ie You told End­points News, which al­lows the team to “plug and play” against dif­fer­ent tar­gets where oth­er com­pa­nies are forced to de­sign cus­tom cloaks for each tar­get.

“The tar­get uni­verse is huge, and our strat­e­gy is ‘look, we’re not lim­it­ed by good tar­gets,'” You said.

The biotech’s lead can­di­date, for in­stance, tar­gets HER2 — a high­ly val­i­dat­ed and com­mon­ly tar­get­ed growth fac­tor pro­tein — but Amu­nix is al­so test­ing four ad­di­tion­al can­di­dates “in par­al­lel” to tar­get TROP2, PS­MA and EGFR, You said. Those pro­grams are less de­vel­oped, but Amu­nix still plans to nom­i­nate a sec­ond can­di­date for hu­man test­ing by the end of the year, she added.

The first im­me­di­ate mile­stone for You’s team is tak­ing AMX-818 in­to the clin­ic. Amu­nix will ini­tial­ly launch its first hu­man tri­al in Spain and is scop­ing a CTA sub­mis­sion with the EMA by the end of the year to en­able pa­tient en­roll­ment by ear­ly 2022, You said.

Go­ing af­ter HER2 is a bit of a dou­ble-edged sword: It’s a high­ly val­i­dat­ed tar­get but one with a ton of es­tab­lished com­pe­ti­tion. But You ar­gued all of those drugs tar­get tu­mors with high ex­pres­sion of HER2, leav­ing an un­tapped mar­ket in pa­tients with low- or mid-HER2 ex­pres­sion that are “over­ex­pressed” or am­pli­fied.

“Some peo­ple have a knee jerk re­ac­tion like ‘it’s so crowd­ed,'” You said. “What’s emerg­ing is a lot of in­sti­tu­tions are screen­ing their pa­tients for HER2 be­cause it seems to be a mech­a­nism of re­ac­tion. We think there’s a lot of op­por­tu­ni­ty there.”

In mouse da­ta pre­sent­ed in De­cem­ber, AMX-818 spurred com­plete re­spons­es even for tu­mors with low HER2 ex­pres­sion. That could of­fer a clue that AMX-818’s high po­ten­cy will of­fer a clin­i­cal ben­e­fit across the HER2 spec­trum, You said.

But it’s not just T cell en­gagers on Amu­nix’s dock­et. The biotech is al­so chas­ing a pro­gram for masked, pro­tease-ac­ti­vat­ed cy­tokines that avoid T cells al­to­geth­er. That pro­gram is still “re­al­ly ear­ly,” You said, but could of­fer a nov­el path to cut­ting down tu­mors.

With so much in the works, Amu­nix will look to great­ly ex­pand its team of 50 based in South San Fran­cis­co, You said. The biotech is al­so work­ing on part­nered drugs with Sanofi and 9 Me­ters, in­clud­ing a Fac­tor VI­II clot­ting drug with the French drug­mak­er that is cur­rent­ly in Phase III.

Thurs­day’s round was led by Viking Glob­al Cap­i­tal and joined by new in­vestors in Bain Cap­i­tal Life Sci­ences, Black­Rock, Franklin Tem­ple­ton, Janus Hen­der­son In­vestors, Ar­row­Mark­Part­ners, Avid­i­ty Part­ners, Clough Cap­i­tal, and CaaS Cap­i­tal Man­age­ment. Ex­ist­ing in­vestors that jumped on board the new round in­clud­ed Red­mile Group, Ven­rock, Cas­din Cap­i­tal, Omega Funds, Fra­zier Health­care Part­ners, Lon­gi­tude Cap­i­tal and Po­laris Part­ners.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

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Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

A T-cell play­er with back­ing from Roche takes next big step for BiTE drugs with 'on-of­f' switch to avoid tox­i­c­i­ty

The bispecific T cell engager field is absolutely packed with big-name players who have crowded in despite some high-profile failures in the class. Now, a Bay Area biotech thinks it may have the key to tackling BiTE toxicity, using an old “on-off switch” idea to give doctors more control of the drugs’ effect on patients.

San Francisco-based Soteria Biotherapeutics uncloaked Monday with a $42 million Series A co-led by Roche Venture Fund and 5AM Ventures with participation from the Novartis Venture Fund to advance its bispecific T cell engagers with an “on-off” switch the founders think can avoid some of the dire safety flags endemic to the class.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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