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.

Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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CEO Marco Taglietti (Scynexis)

'N­ev­er been more ur­gent:' Scynex­is looks to tack­le su­per­bug cri­sis with late-stage read­out for an­ti­fun­gal hope­ful

As the superbug crisis heats up around the world, Scynexis says it has new data from two interim analyses that prove its antifungal has the potential to treat a broad range of infections.

“The need for new anti-infectives capable of fighting the most resistant pathogens has never been more urgent as we confront the ongoing COVID-19 global pandemic,” CEO Marco Taglietti said in a statement.

A spot­light schiz­o­phre­nia drug in Neu­ro­crine's $2B Take­da deal flunks its first ma­jor test. But it's not giv­ing up yet

When Takeda spun out a pipeline of experimental psychiatry drugs to Neurocrine in a $2 billion deal amid a post-merger shakeout, R&D chief Andy Plump described the therapies as “very interesting but still difficult.”

On Tuesday, we got some idea of how difficult.

San Diego-based Neurocrine revealed that one of the three spotlight clinical programs they’d acquired failed the primary endpoint in a Phase II trial for schizophrenia, registering a negative outcome on the change from baseline in the positive and negative syndrome scale/negative symptom factor score (PANSS NSFS).

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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