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.

George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Randy Schatzman, Bolt CEO (Bolt Biotherapeutics)

Bolt Bio­ther­a­peu­tics nabs $93.5M to push Provenge in­ven­tor's new idea deep­er in the clin­ic

A cancer-fighting concept from the inventor of the first cancer vaccine is nearing prime time, and its biotech developer has received a significant new infusion of cash to get it there.

Bolt Biotherapeutics announced a $93.5 million Series C round led by Sofinnova Investments and joined by more than 9 others, including Pfizer Ventures and RA Capital Management. That money will go toward pushing the San Francisco biotech’s platform of innate immune-boosting warheads through its first trial on metastatic solid tumors and into several more.

Josh Cohen, Justin Klee

Armed with pos­i­tive ALS da­ta, Amy­lyx scores $30M in fresh fund­ing to com­plete Alzheimer's PhII

Four years after announcing themselves to the biotech world with a new idea for drugging neurodegeneration, backing by the late Henri Termeer and $5 million from Morningside Venture, the young entrepreneurs at Amylyx are back for round 2.

Morningside continued to lead the $30 million Series B, with participation from Termeer’s widow, Belinda, and other unnamed investors. Having celebrated a topline Phase II win for its lead program in amyotrophic lateral sclerosis, Amylyx expects the cash to fund talks with regulators as well as a separate trial for the same drug in Alzheimer’s — for which they had just finished enrolling.

An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Anthony Johnson, Goldfinch Bio CEO (Goldfinch via YouTube)

Gilead-part­nered Goldfinch Bio lands $100M as it piv­ots to clin­i­cal stage biotech

A year after landing $109 million in cash for an early-stage discovery deal with Gilead, Goldfinch Bio has scored a similar bounty from investors, raising $100 million in the biotech’s first financing round since its 2016 launch.

The new round, led by Eventide Asset Management and joined by 8 other firms, confirms that last year’s Gilead deal began a new, busier, more vocal era for the company. After launching out of Third Rock with $55 million and a plan to tackle kidney disease, they focused on preclinical research and made few material announcements. But the latest press release is full of plans, including their first Phase II study and a new therapy scheduled to enter the clinic next year.