Au­rinia gets two new as­sets in ac­qui­si­tion, li­cens­ing deal; Shorla preps T-cell leukemia drug for com­mer­cial­iza­tion

Au­rinia has ac­quired two new pipeline as­sets through a buy­out and re­search col­lab­o­ra­tion, the Cana­di­an biotech an­nounced Tues­day.

The first new com­pound comes from Thun­der­bolt Phar­ma, which Au­rinia ac­quired in an all-stock deal. Au­rinia’s new pro­gram is a re­com­bi­nant Fc fu­sion pro­tein de­signed to specif­i­cal­ly block B-cell Ac­ti­vat­ing Fac­tor, known as BAFF, and A Pro­lif­er­a­tion-In­duc­ing Lig­and, known as APRIL. The biotech hopes the pro­gram can treat au­toim­mune and nephrol­o­gy con­di­tions.

To ac­quire the com­pa­ny and the com­pound, now called AUR200, Au­rinia paid Thun­der­bolt share­hold­ers $750,000. An IND is ex­pect­ed by the end of 2022.

The sec­ond new as­set, dubbed AUR300, comes from a li­cens­ing deal with Rip­tide Bio­science. It’s a pep­tide that mod­u­lates M2 macrophages via the macrophage man­nose re­cep­tor CD206, Au­rinia said. The goal here is to re­duce cy­tokine re­spons­es in au­toim­mune and fi­brot­ic dis­eases.

For this col­lab­o­ra­tion, Au­rinia paid Rip­tide $6 mil­lion up­front and has promised an undis­closed amount of mile­stones. AUR300 is ex­pect­ed to en­ter clin­i­cal tri­als in the first half of 2023.

“These trans­ac­tions are trans­for­ma­tion­al for Au­rinia as they al­low us to lever­age our ex­ist­ing R&D ca­pa­bil­i­ties and com­mer­cial ex­pe­ri­ence to sup­port a bal­anced pipeline and ad­vance in­no­v­a­tive ther­a­peu­tic so­lu­tions to help peo­ple liv­ing with rare au­toim­mune dis­eases,” CEO Pe­ter Green­leaf said in a state­ment.

Ahead of PDU­FA, Shorla preps com­mer­cial­iza­tion for T-cell leukemia pro­gram

As Shorla Phar­ma’s T-cell leukemia pro­gram sits be­fore the FDA in the pri­or­i­ty re­view lane, the biotech is prep­ping for the po­ten­tial ap­proval with a new part­ner­ship Tues­day.

Shorla is team­ing with com­mer­cial ser­vices com­pa­ny Ever­sana to sup­port mar­ket­ing of the pro­gram, known as SH-111, the biotech an­nounced. While Shorla will main­tain own­er­ship of SH-111 and be re­spon­si­ble for fi­nan­cial, le­gal, reg­u­la­to­ry and man­u­fac­tur­ing con­cerns, Ever­sana nabs the ex­clu­sive right to sup­port all com­mer­cial­iza­tion ac­tiv­i­ties for the drug.

“This part­ner­ship will pro­vide us with a ful­ly in­te­grat­ed com­mer­cial or­ga­ni­za­tion to sup­port the launch of SH-111,” Shorla CEO Sharon Cun­ning­ham said in a state­ment. “New ther­a­pies for women and chil­dren are of­ten over­looked or in short sup­ply. Our goal is to bring to mar­ket prod­ucts that rep­re­sent a new stan­dard of treat­ment for these pa­tients.”

In April, the FDA grant­ed pri­or­i­ty re­view to SH-111, Shorla’s mys­tery can­di­date for the third-line treat­ment of adults and chil­dren with T-cell acute lym­phoblas­tic leukemia and T-cell lym­phoblas­tic lym­phoma. While most leukemias tar­get old­er peo­ple, T-cell leukemia is an ag­gres­sive blood and bone mar­row can­cer that’s most com­mon among chil­dren.

AD­HD video game mak­er signs new deal to ex­pand to younger chil­dren

Ak­ili In­ter­ac­tive, mak­ers of the first FDA-ap­proved video game to treat AD­HD, has en­list­ed a new part­ner to broad­en its port­fo­lio.

The PureTech-found­ed and Boston-based com­pa­ny is team­ing up with Aus­tralian dig­i­tal health com­pa­ny TALi, the en­ti­ties an­nounced Tues­day, in an ef­fort to ad­dress ad­di­tion­al ear­ly child­hood at­ten­tion im­pair­ments. There was no ap­par­ent up­front pay­ment in­volved in the deal, but Ak­ili has promised up to $37.5 mil­lion in mile­stones.

“Fo­cused on ear­ly child­hood in­ter­ven­tion tar­get­ing at­ten­tion, TALi’s im­pres­sive tech­nol­o­gy is an ide­al ad­di­tion to Ak­ili’s port­fo­lio,” Ak­ili CEO Ed­die Mar­tuc­ci said in a state­ment. “We are com­mit­ted to chang­ing the way peo­ple think about med­i­cine, and strate­gic agree­ments like this will al­low us to ex­pand our vi­sion to treat cog­ni­tive im­pair­ments in en­tire­ly new ways.”

TALi’s pro­grams stem from over 25 years of re­search, the com­pa­nies say, and tar­get chil­dren aged 3 to 8 years old with an “en­gag­ing video game ex­pe­ri­ence” to try to im­prove at­ten­tion. The com­pa­nies say they will work to­geth­er on clin­i­cal tri­als of the TALi tech­nol­o­gy in pe­di­atric AD­HD and pur­sue FDA ap­proval.

Ak­ili’s cur­rent video game, En­deav­or­Rx, is thus far on­ly ap­proved to treat AD­HD in chil­dren aged eight to 12.

Cana­di­an CRO buys out ri­val for $37M+

A Cana­di­an CRO has bought out one of its com­peti­tors to be­come the largest such firm in the coun­try.

NuChem Sci­ences ac­quired OmegaChem on Tues­day, the com­pa­nies an­nounced, merg­ing to be­come what they say is Cana­da’s largest CRO in drug dis­cov­ery and chem­istry. The deal to­taled $37.6 mil­lion and came from back­ers Fonds de sol­i­dar­ité FTQ ($17.4 mil­lion), In­vestisse­ment Québec ($10.1 mil­lion) and BDC Cap­i­tal ($10.1 mil­lion).

“We’re proud to join forces with OmegaChem to cre­ate the largest CRO in drug dis­cov­ery and chem­istry in Cana­da, with 200 ex­pe­ri­enced sci­en­tists and sup­port staff,” said NuChem pres­i­dent Marc LeBel in a state­ment. “The new group will strength­en the po­si­tion of both com­pa­nies as they con­tin­ue har­ness­ing their ex­per­tise to run their op­er­a­tions.”

Arthrosi sets sights on Chi­na with new joint ven­ture

San Diego biotech Arthrosi Ther­a­peu­tics has a new deal in hand to launch an in-house drug in Chi­na.

Arthrosi is en­gag­ing in a joint ven­ture with Chi­nese biotech Guangzhou Ruiao Bio­phar­ma­ceu­ti­cal Tech­nol­o­gy to form Guangzhou Ruian­bo Phar­ma­ceu­ti­cal Tech­nol­o­gy, which will seek to de­vel­op and com­mer­cial­ize AR882 for gout and topha­ceous gout in Chi­na and its sur­round­ing re­gions.

The ven­ture is ex­pect­ed to re­sult in a $34.3 mil­lion in­vest­ment for de­vel­op­ment in the greater Chi­na area, and an­oth­er $25 mil­lion to par­tic­i­pate in Arthrosi’s Se­ries C round.

In ad­di­tion, the joint ven­ture will al­low Arthrosi to move AR035, a po­tent EGFR ex­on 20 in­hibitor tar­get­ing non-small cell lung can­cer, in­to the IND-en­abling stage, Arthrosi said.

“We are en­thu­si­as­tic about this op­por­tu­ni­ty to bring two drug de­vel­op­ment pro­grams to the Chi­na mar­ket while col­lab­o­rat­ing with a lead­ing Chi­nese phar­ma­ceu­ti­cal com­pa­ny with strong re­search, mar­ket­ing, and sales ca­pa­bil­i­ties,” said Litain Yeh, CEO of Arthrosi, in a state­ment.

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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