No­var­tis ex­pands Covid-19 vac­cine man­u­fac­tur­ing deal with Pfiz­er/BioN­Tech; Exacis links with CCRM for NK cell ther­a­pies

BioN­Tech has signed an agree­ment with No­var­tis to ex­pand fill-fin­ish sup­port for the com­pa­ny’s Covid-19 vac­cine — made in col­lab­o­ra­tion with Pfiz­er in Slove­nia.

The Ljubl­jana, Slove­nia ster­ile man­u­fac­tur­ing site will be used to fill at least 24 mil­lion dos­es in 2022, and un­der the terms of the agree­ment, No­var­tis will take bulk mR­NA ac­tive in­gre­di­ent from BioN­Tech, fill that in­to vials, and ship it back to them for dis­tri­b­u­tion.

The agree­ment fol­lows one signed ear­li­er this year, when No­var­tis start­ed fill­ing for BioN­Tech at its Stein site in Switzer­land in June af­ter gain­ing ap­proval from the EMA.

“No­var­tis con­tin­ues to of­fer its world-class ca­pa­bil­i­ties to oth­er com­pa­nies to take over man­u­fac­tur­ing ac­tiv­i­ties in­clud­ing a va­ri­ety of tech­nolo­gies such as mR­NA pro­duc­tion and oth­ers,” the com­pa­ny said in a state­ment. “The specifics will be dis­closed when we con­clude spe­cif­ic agree­ments.”

Exacis links with CCRM for NK ther­a­pies

An im­muno-on­col­o­gy com­pa­ny based out of Cam­bridge, MA an­nounced a part­ner­ship with the Toron­to-based Cen­tre for Com­mer­cial­iza­tion of Re­gen­er­a­tive Med­i­cine Thurs­day to man­u­fac­ture mR­NA-en­gi­neered nat­ur­al killer cell prod­ucts.

Exacis Bio­ther­a­peu­tics will al­so re­ceive a cash in­vest­ment from CCRM En­ter­pris­es Hold­ings, the for-prof­it arm of CCRM.

“We wel­come CCRM as a key part­ner to al­low us to rapid­ly ad­vance our virus-free man­u­fac­tur­ing process­es to make nov­el NK cell prod­ucts that are en­gi­neered for per­for­mance and to avoid re­jec­tion. CCRM is a rec­og­nized leader in iP­SC-de­rived cell ther­a­py de­vel­op­ment and man­u­fac­tur­ing and we are thrilled to have them as a part­ner,” Exacis CEO Gre­go­ry Fiore said in a state­ment.

Found­ed just last year, Exacis is fo­cused on en­gi­neer­ing off-the-shelf NK and T-cell ther­a­pies that tar­get hema­to­log­ic ma­lig­nan­cies and sol­id tu­mors.

New South Wales to spend $95M on mR­NA man­u­fac­tur­ing

The gov­ern­ment in New South Wales is look­ing to cre­ate a na­tion­al hub for mR­NA vac­cine pro­duc­tion.

Pre­mier Do­minic Per­rot­tet said that the gov­ern­ment will spend $95 mil­lion in a part­ner­ship with the new RNA Bio­sciences Al­liance, which is made up of all the uni­ver­si­ties in NSW.

“We are the first state in Aus­tralia to de­liv­er a pi­lot man­u­fac­tur­ing fa­cil­i­ty to spear­head the es­tab­lish­ment of a lo­cal RNA in­dus­try,” Per­rot­tet said. “The COVID pan­dem­ic has demon­strat­ed to the world that it is crit­i­cal­ly im­por­tant that we have the ca­pa­bil­i­ty to de­vel­op vac­cines quick­ly and for our coun­try to have sov­er­eign ca­pa­bil­i­ty.”

The fa­cil­i­ty will make a po­ten­tial mR­NA man­u­fac­tur­ing in­dus­try pos­si­ble do­mes­ti­cal­ly and gives the po­ten­tial for the fa­cil­i­ty to scale up and down as need­ed for fu­ture pan­demics.

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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