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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Radek Spisek, Sotio CEO (Cellestia)

A qui­et Czech biotech bags $315M to dri­ve its blos­som­ing can­cer pipeline through the clin­ic

In the rather insular world of biotech, most innovation inevitably comes from a cluster of R&D hubs — Cambridge, San Francisco, etc. But sometimes success stories sprout from rocky soil, which is most certainly the case with Prague-based Sotio Biotech and its suddenly jam-packed pipeline of cancer drugs.

After years in quiet development, Sotio now has $315 million in new funds to play with from parent company PPF Group, an investment group founded in the Czech Republic, as the biotech looks to advance its growing pipeline through early- and mid-stage trials.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.