Amu­nix grabs $73M from Fra­zier, Omega to fu­el shift to T cell en­gagers

A lit­tle over a year ago, Ang­ie You was run­ning com­mer­cial for a mid-sized Cana­di­an biotech when she got an email from an in­vest­ment firm with an off­beat pro­pos­al.

Ang­ie You

Fra­zier Health Part­ners was giv­ing seed mon­ey to a 15-year-old com­pa­ny called Amu­nix. The biotech had long sup­plied half-life ex­ten­sion tech­nol­o­gy to big-name drug­mak­ers, and now, af­ter the death of one of the founders, Fra­zier was try­ing to turn it around en­tire­ly in­to a biotech that would make its own drugs. The change re­quired not on­ly a shift in tech­nol­o­gy, but al­so a sig­nif­i­cant shift in strat­e­gy. To that point, the com­pa­ny hadn’t tak­en a sin­gle in­vest­ment dol­lar.

Now, in mid­dle-age, they’d have to play the tech start­up game. Fra­zier want­ed to know if You was in­ter­est­ed in stew­ard­ing the tran­si­tion. They showed her the num­bers. They showed how an­oth­er form of the tech had been used in the clin­ic.

“Frankly, I was so drawn to the clin­i­cal val­i­da­tion of the plat­form,” You told End­points News.

And now those in­vest­ment dol­lars are in. Amu­nix an­nounced to­day a $73 mil­lion Se­ries A, led by Omega Funds. Along with a re­cent $40 mil­lion li­cens­ing deal with Roche on their old half-life ex­ten­sion tech­nol­o­gy, the funds will help the com­pa­ny de­vel­op an off-the-shelf al­ter­na­tive to CAR-T treat­ments.

The idea — which co­founder and cur­rent CTO Volk­er Schel­len­berg­er had been work­ing on for a cou­ple of years — is that a re-en­gi­neered form of the half-life ex­ten­sion tech­nol­o­gy can be used to curb the tox­i­c­i­ty of T cell en­gagers. A long list of small and large biotechs, in­clud­ing Am­gen and Genen­tech, have been de­vel­op­ing these an­ti­bod­ies as a less in­va­sive way to get im­mune cells to “see” tu­mors, but they have strug­gled with mak­ing sure the drugs don’t ramp up the im­mune sys­tem across the body and kill oth­er cells.

Amu­nix says its plat­form can es­sen­tial­ly “mask” the an­ti­bod­ies un­til it reach­es the tu­mor mi­cro-en­vi­ron­ment. When it reach­es that area, the spe­cif­ic pro­teas­es en­dem­ic to the mi­cro-en­vi­ron­ment will latch on and cut in­to the an­ti­body, “ac­ti­vat­ing” it.

Otel­lo Stam­pac­chia

Omega Funds founder Otel­lo Stam­pac­chia said the firm had been look­ing for com­pa­nies with T cell en­gage­ment plat­forms. They found the pre­clin­i­cal da­ta on the “mask­ing” ap­proach in­trigu­ing and felt that the shift from a half-life com­pa­ny to full-fledged drug de­vel­op­er could be sped up with an in­jec­tion of funds and know-how.

“A lot of the cred­it goes to the ear­ly work” from the founders, Stam­pac­chia told End­points. “I just think some of the tweak­ing could’ve been done a bit more ef­fi­cient­ly with a dif­fer­ent con­fig­u­ra­tion and a dif­fer­ent fund­ing mod­el.”

The com­pa­ny has been re­luc­tant to give a spe­cif­ic time­line but did an­nounce their lead drug is an an­ti­body against HER2+, and they are try­ing to bring it in­to the clin­ic soon. Al­though the bulk of the plat­form is fo­cused on T cell en­gage­ment, they al­so have a fledg­ing cy­tokine plat­form.

The mask­ing, You ar­gued, should be able to give them more po­tent and thus ef­fec­tive drugs than their ri­vals who are al­ready in the clin­ic.

“Most T cell en­gagers can on­ly dose in the mi­cro­gram, we’re now able to dose at much high­er dos­es.” You said, caveat­ing that it hasn’t yet been test­ed in hu­mans.

Al­so join­ing the round were Fra­zier Health­care Part­ners, Lon­gi­tude Cap­i­tal, Red­mile Group, Po­laris Part­ners, Cas­din Cap­i­tal, Two Riv­er, Ven­rock, and Delian Cap­i­tal.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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iECURE CEO Joe Truitt and founder Jim Wilson

Jim Wil­son biotech iECURE gets fresh $65M to push pe­di­atric liv­er dis­ease gene ther­a­py in­to the clin­ic

Jim Wilson-founded biotech iECURE has wrapped a $65M Series A extension round to get its lead candidate — a gene replacement therapy for a rare inherited liver disease known as ornithine transcarbamylase deficiency, or OTC — into the clinic.

This round was co-led by Novo Holdings and LYFE Capital, followed by initial investors Versant and OrbiMed as well. In September 2021, iECURE raised a $50 million Series A led by the latter two. The new cash infusion will get iECURE through an initial in-human trial, which CEO Joe Truitt told Endpoints News iECURE hopes to read out in 2024.

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John Carroll with David Chang, Allogene CEO (Credit: Jeff Rumans Photography)

Al­lo­gene takes the stage in New York to go deep on its off-the-shelf cell ther­a­pies — de­clar­ing a first for sol­id tu­mors

NEW YORK — In most cases, a biotech like Allogene would wait until the next big science conference to offer its latest series of snapshots of its data. But most biotechs aren’t like Allogene, where the veteran leaders from Kite garnered a substantial number of kudos over the years for their in-depth reviews of the company’s progress.

So on Tuesday, the leaders at Allogene converged on Manhattan once again to give a detailed breakdown of their latest steps forward, looking to stay out front in the busy off-the-shelf cell therapy arena, keep a clean bill of health on the safety front and prove that they can not only match the autologous pioneers they helped create but make the all-important leap into solid tumors. It’s another step forward in a journey that has a long way to go before even the first big regulatory finish lines appear on the track. But for CEO David Chang, who spent some time with me running through the data ahead of the Tuesday session, it all amounts to forward momentum toward the desired goal.

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UK reg­u­la­tor warns of se­vere eye re­ac­tions fol­low­ing use of Sanofi and Re­gen­eron's Dupix­ent

The UK’s Medicines and Healthcare Regulatory Agency (MHRA) on Tuesday warned of some new and serious eye-related side effects following the use of Sanofi and Regeneron’s atopic dermatitis and asthma treatment Dupixent (dupilumab).

While Dupixent is already associated with cases of conjunctivitis and allergic conjunctivitis, dry eye and with infrequent cases of keratitis and ulcerative keratitis, the MHRA is calling on health professionals to be on the lookout for any of these eye-related side effects as “it is not currently possible to predict who may experience the rarer and most severe ocular adverse reactions, such as ulcerative keratitis.”

Catal­ent to cut about 200 jobs in Mary­land and Texas

Contract manufacturing company Catalent is cutting about 200 jobs in Maryland and Texas, according to WARN notices, trimming back some of its pandemic-era expansion.

The company will cut 77 jobs by Jan. 15 of next year at a cell therapy facility in Webster, TX, just outside of Houston. In Maryland, the company is reducing staff at two locations, with 82 jobs being eliminated at Catalent’s facility in Gaithersburg, and 53 in Rockville. The layoffs go into effect at those locations on Jan. 14.

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