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.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.

Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.