Robert Habib (file photo)

Once laser-fo­cused on liv­er, Mi­NA takes swing at neu­rol­o­gy with Servier's back­ing

Once fo­cused on hard-to-treat liv­er dis­eases, Mi­NA Ther­a­peu­tics is join­ing forces with Servi­er to en­gage its small ac­ti­vat­ing RNA tech­nol­o­gy on an­oth­er dif­fi­cult front: neu­rol­o­gy.

Mi­NA and Servi­er an­nounced a new re­search al­liance Thurs­day cen­tered around neu­ro­log­i­cal dis­or­ders. While the part­ners are keep­ing qui­et about their tar­gets for now, Mi­NA CEO Robert Habib vague­ly re­vealed that the first one was nom­i­nat­ed by Servi­er, which has an op­tion over it. Mi­NA stands to re­ceive up to $266.3 mil­lion (€220 mil­lion) in an up­front pay­ment and mile­stones on that tar­get alone, though they de­clined to break those num­bers down any fur­ther.

In ad­di­tion, Servi­er has ex­clu­siv­i­ty over two more tar­gets, Habib said. Un­der the terms of the deal, Mi­NA will iden­ti­fy po­ten­tial can­di­dates and Servi­er will take the lead on pre­clin­i­cal and clin­i­cal de­vel­op­ment.

“This is sort of our first step in CNS with Servi­er, but it has the po­ten­tial to ex­pand quite sig­nif­i­cant­ly across many tar­gets,” Habib told End­points News.

Mi­NA was co-found­ed in 2008 by Habib’s fa­ther, the promi­nent Im­pe­r­i­al Col­lege Lon­don pro­fes­sor Nagy Habib. Robert left in­vest­ment bank­ing about sev­en years ago to take the helm at his fa­ther’s com­pa­ny, set­ting out on a mis­sion to help treat the “un­drug­gable” — start­ing with liv­er can­cer.

saR­NA is sim­i­lar to RNA in­ter­fer­ence, in that they both re­ly on short strands of RNA and a pro­tein called arg­onaute-2. Ex­cept in­stead of si­lenc­ing genes, saR­NA am­pli­fies.

“We have en­zymes with­in our bod­ies that are re­spon­si­ble for gene reg­u­la­tion. And what we do is we de­sign small RNA se­quences that di­rect those en­zymes to spe­cif­ic re­gions of a gene, which in do­ing so can trig­ger the gene to in­crease tran­scrip­tion, to re­lease more mes­sen­ger RNA and more pro­tein,” Habib ex­plained.

The Lon­don-based biotech’s lead pro­gram goes af­ter CEB­PA — a gene that pro­vides in­struc­tions to make a type of tran­scrip­tion fac­tor pro­tein — in the hopes of re­duc­ing im­mune sup­pres­sion caused by im­ma­ture myeloid cells to im­prove the ef­fi­ca­cy of can­cer ther­a­pies. Its can­di­date, MTL-CEB­PA, is be­ing test­ed as a com­bi­na­tion ther­a­py with Bay­er’s Nex­avar in he­pa­to­cel­lu­lar car­ci­no­ma and Mer­ck’s Keytru­da in ad­vanced sol­id tu­mors. Sev­er­al months ago, Mi­NA land­ed a near­ly $30 mil­lion Se­ries A round to push those pro­grams for­ward.

Habib ex­pects to wrap up the Phase I dose es­ca­la­tion por­tion of the Keytru­da study around the end of this quar­ter, and launch in­to dose ex­pan­sion in Q2. The first da­ta snap­shot could come as ear­ly as the end of this year, he said.

The Servi­er deal al­lows Mi­NA to branch out from liv­er dis­eases and ex­plore new ter­ri­to­ry “ripe for our tech­nol­o­gy,” Habib said. It’s one of sev­er­al col­lab­o­ra­tions that Mi­NA has inked over the last few years, in­clud­ing one with As­traZeneca last Jan­u­ary that gave the phar­ma ne­go­ti­at­ing rights to a li­cens­ing agree­ment af­ter a se­ries of pre­clin­i­cal stud­ies.

Pe­ter Bains

In 2017, So­sei put down about $45 mil­lion for 25.6% of Mi­NA’s eq­ui­ty. Pe­ter Bains, So­sei’s CEO at the time, laid out a $534 mil­lion plan to ac­quire Mi­NA, and thus ex­pand So­sei’s glob­al reach. That same year, Mi­NA signed an up-to $371.9 mil­lion deal with Boehringer In­gel­heim for three liv­er fi­bro­sis tar­gets, in­clud­ing at least one NASH drug. But a year and a half lat­er, So­sei passed on the op­tion, keep­ing its stake.

“The pow­er of saR­NA tech­nol­o­gy is that it is a chem­i­cal drug that works by a tran­sient dose-de­pen­dent mech­a­nism, very much like a chem­i­cal drug. But be­cause it tar­gets gene tran­scrip­tion and can in­crease gene tran­scrip­tion, it can hit tar­gets that are not drug­gable by con­ven­tion­al med­i­cine,” Habib said.

“This is re­al­ly ex­tend­ing the broad­er suc­cess that we’re see­ing in RNA more wide­ly,” CBO Pe­ter Bains said, ref­er­enc­ing com­pa­nies like Al­ny­lam and Mod­er­na. “So this is… an­oth­er modal­i­ty for RNA in­ter­ven­tion.”

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.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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