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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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DEM BioPharma CEO David Donabedian (L) and executive chair Jan Skvarka

Long­wood sets an­oth­er 'don't eat me' biotech in­to gear with help of for­mer Tril­li­um CEO Jan Skvar­ka

Jonathan Weissman and team are out with a cancer-fighting biotech riding the appetite for those so-called “don’t eat me” and “eat me” signals.

The scientific co-founder — alongside fellow Whitehead Institute colleague Kipp Weiskopf and Stanford biologist Michael Bassik — has launched DEM BioPharma with incubator Longwood Fund and a crop of other investors.

In all, the nascent, 10-employee biotech has $70 million to bankroll hematology- and solid tumor-based programs, including a lead asset that could enter human trials in two to three years, CEO David Donabedian told Endpoints News.

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Spanish Prime Minister Pédro Sanchez and European Commission President Ursula von der Leyen (AP Photo/Geert Vanden Wijngaert)

EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

While European companies, including BioNTech, are focused on increasing vaccine access to African countries by setting up vaccine manufacturing facilities, the European Union is looking westward to Latin America and the Caribbean.

Speaking at a press conference with Spanish Prime Minister Pédro Sanchez, EU Commission president Ursula von der Leyen said that the EU is launching a new initiative for vaccines and medicines manufacturing in Latin America, to get drugs to Latin America and the Caribbean faster.

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.