Tony Liu, CBMG CEO

A new­ly pri­vate No­var­tis part­ner bags a megaround on its first go to tur­bocharge CAR-T, cell ther­a­py pipeline

An ear­ly fore­run­ner of Chi­nese biotech’s grow­ing in­flu­ence glob­al­ly, Cel­lu­lar Bio­med­i­cine — or CB­MG – ap­peared to be tak­ing two steps back­ward when it delist­ed on Nas­daq and went pri­vate ear­ly this year. But the biotech had its eyes set on the fu­ture, and a new megaround of fundrais­ing with big-name back­ers on board could put its plans back on the right track.

CB­MG Hold­ings closed a $120 mil­lion Se­ries A with back­ing from a group of promi­nent phar­ma play­ers to dri­ve its lead CAR-T ther­a­pies through the clin­ic and juice up its bud­ding cell ther­a­py pipeline, the com­pa­ny said Thurs­day. The round was co-led by the As­traZeneca-CI­CC Fund, Se­quoia Cap­i­tal Chi­na and Yun­feng Cap­i­tal with par­tic­i­pa­tion from new and ex­ist­ing in­vestors, in­clud­ing No­var­tis, GIC and TF Cap­i­tal, CB­MG said in a re­lease.

New­ly pri­vate af­ter its delist­ing in Feb­ru­ary, CB­MG’s lead can­di­dates are a bis­pe­cif­ic an­ti-CD19/CD20 CAR-T for re­lapsed/re­frac­to­ry non-Hodgkin lym­phoma, dubbed C-CAR039, and a BC­MA tar­get­ing CAR-T for mul­ti­ple myelo­ma, dubbed C-CAR088.

Mean­while, the biotech has a bud­ding pipeline of more CAR-Ts and tu­mor-in­fil­trat­ing lym­pho­cytes (TIL) for sol­id tu­mors, CB­MG said, as well as a broad stem cell plat­form it’s test­ing against in­di­ca­tions as di­verse as acute res­pi­ra­to­ry dis­tress syn­drome (ARDS) and knee os­teoarthri­tis.

The new fund­ing is a nice change of pace of CB­MG, one of the ear­li­est Chi­nese biotechs to list on Nas­daq way back in 2014 and a sign of where the field was head­ing de­spite its own short­com­ings. In 2018, No­var­tis en­list­ed CB­MG to man­u­fac­ture and sup­ply the CAR-T ther­a­py Kym­ri­ah in Chi­na, while bag­ging a world­wide li­cense to some of the biotech’s own CAR-T work.

In 2020, the biotech de­cid­ed to delist as part of a $383 mil­lion deal with debt ac­cu­mu­lat­ing and open loans cast­ing doubt on the com­pa­ny’s abil­i­ty to con­tin­ue.

But now, CB­MG ap­pears poised for growth with man­u­fac­tur­ing fa­cil­i­ties in Rockville, MD, its fu­ture head­quar­ters site, as well as in Chi­na, where it has fo­cused much of its R&D ef­forts. At this year’s AS­CO, CB­MG rolled out da­ta for C-CAR039 show­ing an 84% com­plete re­sponse rate in ear­ly pa­tients.

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

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.

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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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