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.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Joel Dudley, new partner at Innovation Endeavors (Tempus Labs)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs from 2020.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.

Blaise Coleman, Endo International CEO

En­do files for Chap­ter 11 as it looks to fin­ish off its opi­oid lit­i­ga­tion

Irish drugmaker Endo International is entering into bankruptcy as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US.

The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.