Eli Lil­ly part­ner Ab­Cellera ac­quires bis­pe­cif­ic plat­form; Te­va faces more law­suits, this time over opi­oid mar­ket­ing

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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sergio Traversa, Relmada Therapeutics CEO

Rel­ma­da makes 'crit­i­cal changes' to PhI­II tri­al to try and save de­pres­sion drug

Relmada Therapeutics is making changes to its Phase III study of its lead drug for major depressive disorder, in an attempt to avoid problems with a prior trial that showed little difference between the drug and a placebo.

That failure in October wiped 80% from Relmada’s stock price, and was followed by another negative readout a few months later. In both cases, the company said that there had been trial sites that were associated with what it called surprising placebo effects that skewed the results compared with the drug, REL-1017.

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Paul Song, NKGen Biotech CEO

NK cell ther­a­py-fo­cused biotech eyes SPAC deal

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.

In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

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.”

Peter Hecht, Cyclerion Therapeutics CEO

Hard pressed for cash, Cy­cle­ri­on looks for help fund­ing rare dis­ease drug

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.

Three­'s a crowd as an­oth­er Kite ex­ec hits the ex­it; Surf­ing tough wa­ters, Celyad On­col­o­gy picks up new CEO

Kite Pharma is losing another exec, as Francesco Marincola leaves his post to join Flagship startup Sonata Therapeutics as CSO. Marincola served as Kite’s SVP and global head of cell therapy research, having joined the company in 2021 after a stint as CSO at Refuge Biotechnologies. Marincola has also served as a distinguished research fellow at AbbVie and spent more than two decades at the NIH and NCI. Marincola’s exit from Kite marks the third, following CEO Christi Shaw and Tecartus global program clinical lead Behzad Kharabi, who both left last month.

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