Act One: An­ti-ag­ing team at Ju­ve­nes­cence adds $50M to the cache as it builds steam on de­vel­op­ment ef­forts

When Ju­ve­nes­cence got start­ed a year ago, the an­ti-ag­ing biotech had some big names at­tached but not big cash. To­day, they’re start­ing to se­ri­ous­ly make up for the gap.

Greg Bai­ley

The com­pa­ny, guid­ed by De­clan Doogan, Greg Bai­ley, An­nal­isa Jenk­ins, Jim Mel­lon and oth­ers, says it has round­ed up $50 mil­lion from an un­spec­i­fied set of “founders, in­sid­ers, in­sti­tu­tion­al in­vestors and fam­i­ly of­fices.” That brings the to­tal raise now to $63 mil­lion.

De­clan Doogan

Ju­ve­nes­cence has been build­ing a set of port­fo­lio col­lab­o­ra­tors that in­cludes In­sil­i­co Med­i­cine, Alex Zha­voronkov’s AI group that just raised some mil­lions of its own. They have al­so struck up a part­ner­ship with the Buck In­sti­tute for Re­search on Ag­ing, and plan to add to some ad­di­tion­al pacts lat­er in the year.

Bai­ley, the CEO of Ju­ve­nes­cence, was one of the ear­ly back­ers of Medi­va­tion, where he was a board di­rec­tor for 7 years — be­fore Pfiz­er stepped in to buy the biotech for $14 bil­lion. De­clan Doogan, a for­mer top Pfiz­er re­search ex­ec, came in as a prin­ci­pal to the new ven­ture along­side bil­lion­aire Mel­lon and Bai­ley.

An­nal­isa Jenk­ins

They’ve brought on An­nal­isa Jenk­ins as the COO. Jenk­ins played a ma­jor role at Bris­tol-My­ers, lat­er jump­ing to head of R&D at Mer­ck KGaA and then on to run her own biotech, which ran in­to trou­ble with the lead pro­gram and was bought out by Ul­tragenyx.

And they’ve all been think­ing big.

Jim Mel­lon

Like a num­ber of up-and-com­ing biotechs, Ju­ve­nes­cence is fo­cused on a med­ley of ther­a­peu­tics, di­ag­nos­tics and de­vices that can start to bat back the ef­fects of ag­ing, of­fer­ing bet­ter liv­ing to a longer life. It’s not go­ing to be easy or fast. But the part­ners def­i­nite­ly want it to be im­pact­ful.

“I think this is go­ing to be the biggest deal I’ve ever done,” Bai­ley told me back in Ju­ly. “It will need repet­i­tive fi­nanc­ing. Five to $600 mil­lion was raised for Medi­va­tion. As we hit in­flec­tion points, we will need to raise a dra­mat­ic amount of mon­ey.”

In an in­ter­view with the Fi­nan­cial Times, Mel­lon not­ed that the biotech plans to raise an­oth­er $100 mil­lion this year and then add on fresh funds from an IPO in 2019.

“We aim to have about 20 shots on this goal — longevi­ty sci­ence — and if we get two or three of them right, there will be a very good re­turn to share­hold­ers,” Mel­lon told the FT.

This isn’t a dra­mat­ic mon­ey sto­ry yet, but it’s pret­ty good for the first act.

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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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.

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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