Mark Gold­smith Rev­o­lu­tion

Gilead is jump­ing on board the pro­tein degra­da­tion band­wag­on. And they’re turn­ing to a low-pro­file Third Rock start­up for the ex­per­tise. But if you were look­ing for a trans­for­ma­tion­al deal to kick up fresh en­thu­si­asm for Gilead, you’ll have to re­main pa­tient.

This one will have a long way to go be­fore they get in­to the clin­ic.

The big biotech said Wednes­day morn­ing that it is pay­ing $45 mil­lion up­front and re­serv­ing a whop­ping $2.3 bil­lion in biotech bucks if San Fran­cis­co-based Nurix can point the way to new can­cer ther­a­pies, as well as drugs for oth­er, un­spec­i­fied dis­eases.

John McHutchi­son Gilead

Still in the pre­clin­i­cal phase 5 years af­ter Mark Gold­smith — dis­patched by Third Rock to launch West Coast biotechs and now CEO at Rev­o­lu­tion — boot­ed up the com­pa­ny with an un­usu­al­ly lean $25 mil­lion ven­ture round, Nurix quick­ly picked up an im­pres­sive $150 mil­lion up­front from a new deal back in 2015 with the then pro­lif­ic Cel­gene. It has 2 pre­clin­i­cal ef­forts un­der­way, one in house and a CDL-B pro­gram paired with Cel­gene, which will soon mi­grate to Bris­tol-My­ers Squibb.

Gilead CSO John McHutchi­son counts him­self as an ad­mir­er of Nurix’s tech plat­form, hop­ing it pans out “as we con­tin­ue to build a pipeline of small mol­e­cule ther­a­peu­tics for pa­tients with can­cers and oth­er dis­eases.”

Jay Brad­ner No­var­tis

The fo­cus at Nurix, and now Gilead, is the ubiq­ui­tin sys­tem and key en­zymes called E3 lig­as­es. Pro­tein degra­da­tion has proved a promis­ing ap­proach in on­col­o­gy, at­tract­ing a group of play­ers to the field. Arv­inas is one of the most promi­nent, adding an ag deal with Bay­er a few days ago with $115 mil­lion built-in up­front. But it is by no means play­ing so­lo in the sec­ond-gen pro­tein degra­da­tion field. Ri­vals to the pro­tein degra­da­tion ti­tle in­clude C4 Ther­a­peu­tics — out of Jay Brad­ner’s lab at Dana Far­ber be­fore he took the helm at NI­BR — and the start­up Kymera. And not sur­pris­ing­ly, Brad­ner — who now runs NI­BR — re­cent­ly forged a close re­la­tion­ship with UC Berke­ley on pro­tein degra­da­tion as well.

Nurix gets a chance to co-pro­mote drugs in the deal they did with Gilead, pro­vid­ed they pick up half the de­vel­op­ment costs.

So­cial im­age: Er­ic Ris­berg, AP Im­ages

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Rare diseases often have more than just physical effects on patients — especially when it comes to chronic conditions. In the case of the rare slow-growing blood cancer chronic lymphocytic leukemia (CLL), AbbVie wanted to try to assess the mental and emotional toll on patients.

So it surveyed more than 300 CLL patients, caregivers and physicians. While each group differed in how they felt — caregivers overwhelmingly (81%) felt positive about their role, for instance — patients described a “roller coaster” of emotions traversing diagnosis to treatment to remission and even relapse for some.

Sarepta’s research agreement with the Broad Institute is taking the next step Monday.

The biotech will license a new group of adeno-associated viruses from the institute for an undisclosed upfront payment and milestone promises, the pair announced Monday morning. Under the agreement, Sarepta will have the rights to five neuromuscular and cardiac indications, including Duchenne muscular dystrophy, where it’s already well-versed.