An Eli Lil­ly part­ner help­ing de­vel­op a lead­ing Covid-19 project has just scored a new ac­qui­si­tion.

Tim Ja­cobs

Ab­Cellera, a small but well-con­nect­ed biotech out of Van­cou­ver, an­nounced it has pur­chased a plat­form from Du­a­log­ics called Or­thomab, which en­gi­neers pro­teins to cre­ate IgG-like bis­pe­cif­ic an­ti­bod­ies from any two an­ti­body se­quences. The trans­ac­tion fur­thers the deal­ings be­tween the two com­pa­nies, as Du­a­log­ics CTO Tim Ja­cobs joined Ab­Cellera in ear­ly Au­gust.

Thurs­day’s agree­ment gives Ab­Cellera full rights to the Or­thoMab plat­form while Du­a­log­ics re­tains the abil­i­ty to de­vel­op ex­ist­ing pro­grams and com­plete ex­ist­ing part­ner­ships.

The biotech emerged from rel­a­tive ob­scu­ri­ty dur­ing the Covid-19 pan­dem­ic thanks to its “lab-on-a-chip” tech­nol­o­gy that iso­lates an­ti­body-pro­duc­ing cells from blood sam­ples and us­es ma­chine learn­ing to pro­cure the best ones. Af­ter ob­tain­ing a sam­ple from a Covid-19 sur­vivor in Feb­ru­ary, Ab­Cellera part­nered with Eli Lil­ly the next month and then pulled in a hefty $105 mil­lion Se­ries B fundraise.

They’re not de­vel­op­ing a vac­cine, but Ab­Cellera has made waves with their po­ten­tial treat­ment, pick­ing up steam in Busi­ness­week and MIT Tech­nol­o­gy Re­view. Vir and Re­gen­eron are al­so work­ing on sim­i­lar clin­i­cal stud­ies.

New York sues Te­va and Al­ler­gan over roles in opi­oid epi­dem­ic

On the heels of fed­er­al pros­e­cu­tors ac­cus­ing Te­va of de­fraud­ing the Medicare sys­tem, the Is­raeli drug­mak­er is fac­ing more le­gal pro­ceed­ings.

New York State has launched its own in­quiry in­to Te­va’s deal­ings re­gard­ing the opi­oid cri­sis, gov­er­nor An­drew Cuo­mo’s of­fice an­nounced Tues­day, al­leg­ing that the com­pa­ny “know­ing­ly fur­thered false nar­ra­tives” in or­der to boost sales of its drugs. Cuo­mo al­so in­clud­ed Al­ler­gan, which was left out of the fed­er­al com­plaint, in the state’s law­suit. A hear­ing will take place on Oc­to­ber 26.

Among the most se­ri­ous al­le­ga­tions is that Te­va mis­rep­re­sent­ed the risks of fen­tanyl and mar­ket­ed such drugs for off-la­bel use. The law­suit cites the FDA ap­proval of Ac­tiq in can­cer pa­tients as proof this strat­e­gy suc­ceed­ed, boost­ing sales of the drug from $16 mil­lion in 2000 to $590 mil­lion by 2006.

The com­plaint al­so dinged the com­pa­nies for uti­liz­ing key opin­ion lead­ers to im­prop­er­ly dis­sem­i­nate mis­in­for­ma­tion about opi­oids in med­ical in­for­ma­tion cours­es and pam­phlets, tar­get­ing pa­tients and pre­scribers.

Tues­day’s fed­er­al suit dealt with price fix­ing, as the gov­ern­ment said Te­va paid hun­dreds of mil­lions of dol­lars to two foun­da­tions to boost sales for the mul­ti­ple scle­ro­sis drug Co­pax­one.

Evotec ex­pands deal with Cen­to­gene to in­clude Gauch­er re­search

Ger­man drug dis­cov­ery com­pa­ny Evotec is ex­pand­ing an ex­ist­ing part­ner­ship with a com­pa­ny fo­cused on min­ing da­ta from pa­tients with rare dis­eases.

The scope of the col­lab­o­ra­tion with Cen­to­gene, based in Cam­bridge, MA, will broad­en in­to pro­duc­ing treat­ments for Gauch­er dis­ease, a ge­net­ic dis­or­der caused by mu­ta­tions in the glu­co­cere­brosi­dase gene. Re­searchers will look to tar­get GBA by com­bin­ing Evotec’s stem cell plat­form with Cen­to­gene’s rare dis­ease plat­form.

The two com­pa­nies orig­i­nal­ly en­tered in­to the part­ner­ship in 2018 with the goal to de­vel­op ther­a­pies for rare hered­i­tary meta­bol­ic dis­eases.

Gauch­er dis­ease is an in­her­it­ed dis­or­der and can af­fect the cen­tral ner­vous sys­tem. Signs and symp­toms can vary wide­ly among af­fect­ed in­di­vid­u­als, rang­ing from the en­large­ment of the liv­er and spleen, ane­mia and lung dis­ease in Type 1 to seizures and brain dam­age in Types 2 and 3.

The most com­mon of the lyso­so­mal dis­eases, Gauch­er is of­ten treat­ed with imiglucerase, a re­com­bi­nant form of the de­fi­cient en­zyme, al­though sev­er­al new treat­ments have been ap­proved in re­cent years.

Proces­sa li­cens­es gas­troin­testi­nal can­di­date from South Ko­re­an phar­ma

A South Ko­re­an phar­ma is li­cens­ing out a lead­ing gas­troin­testi­nal treat­ment to a US part­ner.

Yuhan Corp will sell ex­clu­sive glob­al de­vel­op­ment and com­mer­cial­iza­tion rights, with the ex­cep­tion of Ko­rea, to Proces­sa Phar­ma­ceu­ti­cals for YH12852. The deal nets Yuhan up to $415 mil­lion and $2 mil­lion in Proces­sa shares as a down pay­ment.

Cur­rent­ly, the can­di­date is be­ing eval­u­at­ed for the treat­ment of dys­pep­sia and con­sti­pa­tion, but a Phase II study in Ko­rea was sus­pend­ed last Sep­tem­ber with Yuhan need­ing to re­con­fig­ure its dosage.

YH12852 works by stim­u­lat­ing the 5-HT4 re­cep­tor, which plays an es­sen­tial role in the reg­u­la­tion of in­testi­nal move­ment. The com­pa­ny hopes it can com­pete with cis­apride-based drugs in gas­troin­testi­nal in­di­ca­tions, aim­ing to show few­er car­dio­vas­cu­lar side ef­fects than cur­rent­ly li­censed drugs.

Proces­sa is plan­ning its own Phase II study for oth­er gas­troin­testi­nal motil­i­ty dis­eases, such as post­op­er­a­tive in­testi­nal ob­struc­tion or opi­oid-in­duced con­sti­pa­tion, be­gin­ning in 2021 pend­ing guid­ance from the FDA.

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.