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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.