Nancy Whiting, Recludix CEO

For­mer Blue­print vets take their new biotech out of stealth, with STAT3 in their sights

A new biotech go­ing af­ter STAT mu­ta­tions through a pre­vi­ous­ly un­drug­gable tar­get emerged from stealth and se­cured its first fundraise Mon­day, in­tro­duc­ing its fresh­ly mint­ed CEO in the process.

Re­cludix Phar­ma, a San Diego biotech launched by a found­ing team of Blue­print Med­i­cines vets, pulled in a $60 mil­lion Se­ries A on Mon­day, promis­ing in­vestors a path to the holy grail STAT3 mu­ta­tion through what’s called the SH2 do­main. Tak­ing over as chief ex­ec­u­tive is Nan­cy Whit­ing, ar­riv­ing af­ter a 15-year run at Seagen that saw her run cor­po­rate strat­e­gy and late-stage de­vel­op­ment at var­i­ous points.

In­vestors in the round in­clud­ed NEA, West­lake Vil­lage BioPart­ners, and Ac­cess In­dus­tries.

Re­cludix’s founders had worked to­geth­er be­fore Blue­print, but came to­geth­er to de­vel­op the biotech’s “ki­nome scan” tech­nol­o­gy and ap­ply it to drug dis­cov­ery, Whit­ing told End­points News. Led by Blue­print sci­en­tif­ic founder Nick Ly­don, the group thought it could use a sim­i­lar tech­nol­o­gy while in­te­grat­ing a new se­lec­tiv­i­ty tool and en­cod­ed DNA li­braries, al­low­ing for much deep­er analy­ses.

Whit­ing said the process is an it­er­a­tive de­sign, al­low­ing the biotech to de­cide where and how ex­act­ly to mod­i­fy dif­fer­ent mol­e­cules. The team can screen any­where from one mil­lion to one bil­lion mol­e­cules at once, she said.

Thus Re­cludix was birthed, ini­tial­ly get­ting off the ground in De­cem­ber 2019. The com­pa­ny’s main fo­cus is de­vel­op­ing SH2 do­main in­hibitors, found in a group of about 120 dif­fer­ent hu­man pro­teins. Re­searchers have pre­vi­ous­ly pegged the do­main as a “re­al­ly good tar­get to drug,” Whit­ing said, but faced some chal­lenges along the way.

“It’s kind of a flat pro­tein, there’s not a lot of nooks and cran­nies for a drug to find in­side and hook in­to,” Whit­ing said in an in­ter­view.

Chief among the pro­teins im­pli­cat­ed by SH2 is the STAT fam­i­ly, which in­cludes the STAT3 can­cer mu­ta­tion long con­sid­ered a holy grail tar­get — Whit­ing said 70% of all can­cers have that STAT3 mu­ta­tion. But Re­cludix will al­so spend time look­ing at oth­er in­flam­ma­to­ry and au­toim­mune dis­eases where STAT might prove im­por­tant, she stressed.

Re­cludix is launch­ing with three dis­cov­ery pro­grams, two of which are planned to tar­get STAT3 and STAT6. The third can­di­date will be de­vel­oped for a non-STAT tar­get, but Whit­ing isn’t re­veal­ing much more at this point. While she not­ed the STAT can­di­dates are in the lead op­ti­miza­tion phase, they’re not quite ready for INDs.

The CEO al­so said the Se­ries A like­ly won’t be enough to get the pro­grams in­to the clin­ic and that Re­cludix isn’t dis­clos­ing how much run­way this raise will give.

Ini­tial­ly, though, the goal will be de­vel­op­ing oral­ly avail­able com­pounds for these tough-to-treat dis­eases. Re­cludix’s plan is to start in lat­er-line pa­tients whose can­cers have pro­gressed on the stan­dard of care, but it’s still too ear­ly to make any sweep­ing con­clu­sions.

Though it’s tack­ling STAT through SH2, Re­cludix will join a slate of biotechs try­ing to solve the holy grail puz­zle. The Hous­ton start­up Tvar­di nabbed a $74 mil­lion Se­ries B back in June to ad­vance its STAT3 ef­forts, and the Sanofi-part­nered Kymera and Medicxi’s Jan­pix, now part of Centes­sa, are un­der­tak­ing sim­i­lar projects.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

BREAK­ING: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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Marcelo Bigal, Ventus Therapeutics CEO

No­vo Nordisk joins No­var­tis, Roche in NL­RP3 are­na, bet­ting $70M cash on NASH, car­diometa­bol­ic us­es

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

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