Hans van Houte (Nurix)

Part­nered with Gilead and Sanofi, pro­tein degra­da­tion spe­cial­ist Nurix bags $120M to chart its own clin­i­cal path

The race to steer the first pro­tein degra­da­tion drugs to the clin­ic is on.

On the same day that Cam­bridge, MA-based Kymera Ther­a­peu­tics un­veiled a $102 mil­lion round to en­ter in­to de­vel­op­ment phase, Nurix said it has raised $120 mil­lion to do the same out of San Fran­cis­co’s Mis­sion Bay.

Michael Rome

Fore­site Cap­i­tal led the round. Red­mile Group, a co-leader in Kymera’s Se­ries C, par­tic­i­pat­ed along­side Bain Cap­i­tal Life Sci­ences, Box­er Cap­i­tal (Tavi­s­tock Group), EcoR1 Cap­i­tal, Welling­ton Man­age­ment Com­pa­ny and an undis­closed in­vestor, as well as found­ing in­vestors The Col­umn Group and Third Rock Ven­tures.

In­vest­ing out of its $668 mil­lion Fund IV, Fore­site is in­ter­est­ed in any new modal­i­ties for drug dis­cov­ery. Hav­ing fol­lowed Nurix since at least 2017, stay­ing in touch with CEO Arthur Sands and his team through the years, part­ner Michael Rome said now is the per­fect time to get in­volved.

“What’s re­al­ly unique about the com­pa­ny is they spent sev­er­al years de­vel­op­ing their plat­form tech­nol­o­gy, whether that’s their DNA en­cod­ed li­braries, or their spe­cif­ic CTM mol­e­cules,” he said, re­fer­ring to its chimeric tar­get­ing mol­e­cules har­ness­ing E3 lig­as­es.

Arthur Sands

That deep dive in­to the bi­ol­o­gy of E3 lig­as­es — the ubiq­ui­tin tag that tells the cell’s garbage dis­pos­al sys­tem that a cer­tain pro­tein is up for degra­da­tion — has al­lowed Nurix to go be­yond sim­ply reap­pro­pri­at­ing the nat­ur­al ma­chin­ery. There are cer­tain E3 lig­as­es, it turned out, that de­grade pro­teins nec­es­sary for the im­mune sys­tem to mount an at­tack on can­cer. Block­ing them can un­leash the body’s full de­fense.

“They’re very com­plex pro­tein struc­tures,” Nurix CFO Hans van Houte told End­points News. “It turns out that there are prob­a­bly over 600 E3 lig­as­es in the hu­man genome, and they all have cer­tain roles to play in terms of reg­u­lat­ing pro­tein lev­els them­selves.”

Ac­cord­ing to him, it gives them an edge over ri­vals at Kymera, C4 and even Arv­inas (which is in a Phase I tri­al for prostate can­cer).

The promise of the tech­nol­o­gy has first en­ticed Cel­gene, then Gilead and Sanofi. Both came on board last year look­ing for new drugs to hit dif­fi­cult-to-ad­dress tar­gets.

Van Houte made a clear dis­tinc­tion be­tween deal mon­ey — $100 mil­lion in up­front to­tal and $4.5 bil­lion in po­ten­tial mile­stones — and the new fi­nanc­ing. While the for­mer is help­ing beef up its re­search or­ga­ni­za­tion, the lat­ter is strict­ly re­served for bring­ing the two whol­ly-owned fran­chis­es (with two pro­grams each) in­to hu­man test­ing in the next 12 to 18 months.

Jean Chang

The first aims to de­grade BTK, the ki­nase tar­get for mar­ket­ed drugs like J&J/Ab­b­Vie’s Im­bru­vi­ca, As­traZeneca’s Calquence and BeiGene’s Brukin­sa. But tu­mors can de­vel­op a re­sis­tance to these ther­a­pies. Nurix hopes that by fol­low­ing a dif­fer­ent mech­a­nism of ac­tion, its CTM can by­pass the re­sis­tance mu­ta­tions and in­duce deep­er and more durable re­sponse.

An­oth­er has to do with a type of E3 lig­ase dubbed CBL-B, which is found to neg­a­tive­ly reg­u­late T cell ac­ti­va­tion. In­hibit­ing it, van Houte said, trig­gers the se­cre­tion of the pow­er­ful cy­tokine IL-2.

Nurix re­cent­ly re­cruit­ed biotech vet Jean Chang as VP of pro­gram man­age­ment and as­set strat­e­gy as part of a plan to build out the de­vel­op­ment team on top of its cur­rent 95-strong work­force. It ex­pects to file an IND by the end of the year.

The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Af­ter de­cou­pling from Re­gen­eron, Sanofi says it’s time to sell the $13B stake picked up in the mar­riage

With Regeneron shares going for a peak price — after doubling from last fall — Sanofi is putting a $13 billion stake in their longtime partner on the auction block. And Regeneron is taking $5 billion of that action for themselves.

Sanofi — which has been decoupling from Regeneron for more than a year now — bought in big in early 2013, back when Regeneron’s stock was going for around $165 a share. Small investors flocked to the deal, buzzing about an imminent takeover. The buyout chatter wound down long ago.

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Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

Covid-19 roundup: Hit with new con­flict ac­cu­sa­tions, Janet Wood­cock steps out of the agen­cy's Covid-19 chain of com­mand

Two weeks ago, FDA drug chieftain Janet Woodcock was assuring a top Wall Street analyst that any vaccine approved for combating Covid-19 would have to meet high agency standards on safety and efficacy before it’s approved. But over the weekend, after she and Peter Marks took top positions with the public-private operation meant to speed a new vaccine to lightning-fast approvals — they both recused themselves from the review process after an advocacy group argued their roles close to the White House could pose a conflict of interest.

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Eric Edwards, Phlow president and CEO (PR Newswire)

BAR­DA of­fers a tiny start­up up to $812M to cre­ate a US-based drug man­u­fac­tur­er — and the CEO comes with a price goug­ing con­tro­ver­sy on his ré­sumé

BARDA has tapped a largely unknown startup to ramp up production of a list of drugs that may be at risk of running short in the US. And the deal, which comes with up to $812 million in federal funds, was inked by a CEO who found himself in the middle of an ugly price gouging controversy a few years ago.

The feds’ new partner — called Phlow — won a 4-year “base” contract of $354 million, with another $458 million that’s on the table in potential options to sustain the outfit. That would make it one of the largest awards in BARDA’s history.

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Re­searchers de­fine ex­act­ly what they saw in the first pos­i­tive remde­sivir study for Covid-19. But what's that worth to Gilead?

Remdesivir can work in fighting Covid-19, particularly for patients with less severe cases, but this is just a first step in the journey to finding combos that can do the job much better,

That’s the bottom line from Gilead’s randomized study published in the New England Journal of Medicine. Analysts were quick to draw conclusions about how the big biotech could turn this into a profitable advantage — with widespread expectation of considerable pricing restraint on Gilead’s part. Anyone looking for a new mountain of cash to count as the world grapples with the pandemic is likely to come away disappointed.

Jean-Pierre Sommadossi, Atea Pharmaceuticals CEO (Atea)

Phar­mas­set co-founder jumps in­to Covid-19 fight, with a new com­pa­ny and $215 mil­lion to get there

For 7 years, Atea Pharmaceuticals hummed along, another biotech in a city full of them, filing patents, quietly picking up a few small funding rounds for molecules targeting hepatitis, Dengue and RSV — some of the few infectious diseases that could still generate investor interest.

Then Covid-19 struck and now they’ve raised $215 million in a single round from over a dozen investors, including Bain Capital and RA Capital. They’ll use it to launch a cross-country Phase II trial testing their lead drug, AT-527, as the latest new antiviral to go up against the coronavirus.

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An­oth­er NASH de­lay for In­ter­cept frus­trates in­vestors, shares wilt

A previous FDA advisory committee delay for Intercept’s NASH drug may have dampened spirits, but investors perked up after French rival Genfit recently failed to best a placebo with its offering in a keenly anticipated pivotal study. In yet another twist on Friday, the New York drugmaker said the FDA is postponing its adcom again to accommodate the review of additional data it has asked the company to furnish.

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FDA ap­proves the first gener­ic for Amar­in's Vas­cepa — but is a fish oil price war im­mi­nent?

Late last year, enthusiasm for Amarin’s fish-oil pill Vascepa burgeoned when the FDA signed off on expanding the cholesterol fighter’s label to include the drug’s beneficial impact on cardiovascular risk, but months later the exuberance for the blockbuster-to-be took a big hit when a judge invalidated key patents protecting Vascepa.

Despite Amarin’s $AMRN pledge to appeal — a process that could take months — the ruling opened the door for generic competition. Hikma Pharmaceuticals, one of three challengers in the Nevada suit, on Friday said that its generic copy of pure EPA, the omega-3 fatty acid that constitutes Vascepa, has been approved by the FDA.

Covid-19 roundup: CanSi­no beats Mod­er­na to pub­li­ca­tion of first-in-hu­man da­ta for a coro­n­avirus vac­cine

China’s CanSino Biologics has released results from the Phase I trial of its Covid-19 vaccine — data that have propelled its entry into Phase II more than a month ago.

In a paper published in the Lancet, the biotech reported that their adenovirus-based vaccine was “tolerable and immunogenic at 28 days post-vaccination” among the 195 volunteers enrolled in the trial. In addition to antibody responses, T cell responses were also observed.

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