Rhythm CEO Kei­th Gottes­di­ener hits the ex­it; Take­da sets up an AI dis­cov­ery pro­gram at MIT

Rhythm Phar­ma­ceu­ti­cals $RYTM CEO Kei­th Gottes­di­ener is plan­ning to stay at the helm un­til the biotech com­pletes its new drug ap­pli­ca­tion, and then head out. He says it’s the right time to hand over the reins and the com­pa­ny plans to or­ga­nize a search for his re­place­ment. His last task should be done by the end of Q1. “For the more than eight years that I have been CEO, it has been an hon­or to lead the tal­ent­ed Rhythm team, and I am im­mense­ly proud of our work to ad­vance set­melan­otide and bol­ster the un­der­stand­ing of rare ge­net­ic dis­or­ders of obe­si­ty,” said Gottes­di­ener in a state­ment.

→ A cou­ple of years af­ter Cel­gene shrugged off its $44 mil­lion in­vest­ment and op­tion for Phar­mAkea and its fi­bro­sis pipeline projects, the lit­tle biotech is sell­ing off its last re­main­ing drug. There are no terms men­tioned, but Den­mark’s Galec­to is get­ting the LOXL2 as­sets at the San Diego biotech in what is tech­ni­cal­ly be­ing called a merg­er. Last fall Blade bought up Phar­mAkea’s au­to­tax­in in­hibitor project. Xcon­o­my has more of the de­tails here.

Take­da is go­ing to MIT in search of some ex­pert help in shap­ing a new AI ini­tia­tive fo­cused on drug dis­cov­ery and re­lat­ed fields. The glob­al play­er is bankrolling a 3-year plan — with a built-in ex­ten­sion op­por­tu­ni­ty — to set up 6 to 10 projects per year fo­cused on the in­ter­sec­tion of ma­chine learn­ing and health. That gives them an AI al­liance in Cam­bridge neigh­bor­ing their main R&D fa­cil­i­ties un­der Andy Plump. The big idea here is to put MIT pro­fes­sors and stu­dents on a field that has at­tract­ed the rapt at­ten­tion of a phar­ma world in search of a more ef­fi­cient ap­proach to drug de­vel­op­ment.

→ Slow­ly re­cov­er­ing from a Phase IIb dis­as­ter in 2018, Pro­tag­o­nist Ther­a­peu­tics has reached a mile­stone un­der its re­search col­lab­o­ra­tion with J&J’s Janssen to co-de­vel­op oral, gut-re­strict­ed IL-23 re­cep­tor an­tag­o­nist PTG-200 (JNJ-67864238) and sec­ond-gen­er­a­tion pep­tides for all in­di­ca­tions in­clud­ing in­flam­ma­to­ry bow­el dis­ease (IBD). The nom­i­na­tion of a new sec­ond-gen­er­a­tion de­vel­op­ment can­di­date trig­gers a $5 mil­lion mile­stone pay­ment to Pro­tag­o­nist $PGTX.

→ Last Au­gust, Gly­coMimet­icsshares took a nose­dive af­ter Pfiz­er‘s team dis­missed their lead drug as a Phase III fail­ure. The com­pa­ny is now ink­ing a deal with Apol­lomics for the de­vel­op­ment and com­mer­cial­iza­tion of two oth­er drugs, up­ro­le­se­lan and GMI-1687, in Greater Chi­na. Gly­coMimet­ics will re­ceive an up­front cash pay­ment of $9 mil­lion and will be el­i­gi­ble to re­ceive po­ten­tial mile­stone pay­ments to­tal­ing ap­prox­i­mate­ly $180 mil­lion, as well as tiered roy­al­ties on net sales.

→ Dutch biotech Synaf­fix has ex­pand­ed its ex­ist­ing col­lab­o­ra­tion with Shang­hai Miraco­gen — which first tied up in a $125 mil­lion li­cens­ing pact last April — to in­clude a sec­ond prod­uct can­di­date. Fi­nan­cials de­tails were not dis­closed, but Miraco­gen has been grant­ed non-ex­clu­sive rights to Synaf­fix’s pro­pri­etary Gly­co­Con­nect and Hy­dra­Space ADC tech­nolo­gies for use in the sec­ond clin­i­cal can­di­date.

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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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.

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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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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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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