No­var­tis backs $30M round for can­cer biotech; Bay­er drug makes a ‘break­through’ at FDA

Ay­ala Ther­a­peu­tics — which fo­cus­es on rare can­cers that oc­cur due to dys­reg­u­la­tion of the Notch-ac­ti­vat­ing path­way — has raised $30 mil­lion in a round of fi­nanc­ing led by part­ner No­var­tis.

The funds, which al­so came from in­vestors in­clud­ing SBI JI In­no­va­tion Fund, Is­rael Biotech Fund, aMoon and Harel In­sur­ance & Fi­nance Group, will be used to fu­el the de­vel­op­ment of its lead drug, AL101. The pan-Notch in­hibitor is cur­rent­ly be­ing eval­u­at­ed for ade­noid cys­tic car­ci­no­ma (ACC) in a Phase II tri­al, and the com­pa­ny is al­so plan­ning to in­ves­ti­gate its use in a mid-stage study in triple neg­a­tive breast can­cer.

In 2017, Ay­ala inked a deal with Bris­tol-My­ers Squibb $BMY to de­vel­op treat­ments for can­cers with al­tered Notch genes. The fol­low­ing year, it joined forces with No­var­tis to de­vel­op and mar­ket an­oth­er drug, AL102, in com­bi­na­tion with BC­MA-tar­get­ing agents for mul­ti­ple myelo­ma pa­tients.

The Is­raeli biotech raised $17 mil­lion in its first round of fi­nanc­ing in April 2018.

→ The FDA grant­ed Bay­er’s Aliqopa (co­pan­lis­ib) — used for the treat­ment of adult pa­tients with re­lapsed mar­gin­al zone lym­phoma (MZL) who have re­ceived at least two oth­er ther­a­pies pri­or — break­through ther­a­py des­ig­na­tion based on over­all re­sponse rate (ORR) from its piv­otal Phase II CHRONOS-1 study. The com­pa­ny says that it “is con­duct­ing two ad­di­tion­al Phase III stud­ies to eval­u­ate the ef­fi­ca­cy and safe­ty of Aliqopa in com­bi­na­tion with oth­er ther­a­pies with iNHL (in­clud­ing MZL) who have re­lapsed fol­low­ing one or more pri­or ther­a­pies.”

→ Ger­man-based Bay­er $BAYRY and Foun­da­tion Med­i­cine $FMI are en­ter­ing a glob­al col­lab­o­ra­tion for the de­vel­op­ment and com­mer­cial­iza­tion of NGS-based com­pan­ion di­ag­nos­tic tests, which help find a pos­si­ble can­cer treat­ment ther­a­py via mol­e­c­u­lar in­for­ma­tion from a pa­tient’s tu­mor genome. Bay­er will al­so have ac­cess to Foun­da­tionOne CDx — Foun­da­tion Med­i­cine’s se­quenc­ing based in vit­ro di­ag­nos­tic de­vice.

The first project that will be un­der­tak­en is de­vel­op­ing a com­pan­ion di­ag­nos­tic for Vi­t­rakvi (larotrec­tinib), the first and on­ly TRK in­hibitor ap­proved in the US for adult and pe­di­atric pa­tients with “sol­id tu­mors that have a neu­rotroph­ic tropomyosin re­cep­tor ki­nase (NTRK) gene fu­sion with­out a known ac­quired re­sis­tance mu­ta­tion that are ei­ther metasta­t­ic or where sur­gi­cal re­sec­tion will like­ly re­sult in se­vere mor­bid­i­ty, and have no sat­is­fac­to­ry al­ter­na­tive treat­ments or that have pro­gressed fol­low­ing treat­ment.”

As­traZeneca spin­out Viela Bio has notched a com­mer­cial deal with sea­soned Chi­nese phar­ma Han­soh cen­tered around inebi­lizum­ab, the lead drug among six as­sets from the phar­ma gi­ant. The an­ti-CD19 drug treats neu­romyelitis op­ti­ca spec­trum dis­or­der, a rare dis­ease that af­fects the eye and spine. All told, the deal is worth up to $220 mil­lion in­clud­ing up­front and mile­stones.

The Park­er In­sti­tute is em­bark­ing on a new re­search jour­ney to find out why some pa­tients de­vel­op au­toim­mune dis­or­ders fol­low­ing can­cer im­munother­a­py. To­geth­er with two oth­er non­prof­its (ded­i­cat­ed to di­a­betes and health­care re­spec­tive­ly), it’s pledg­ing $10 mil­lion over three years to sup­port re­searchers at Yale, UCSF, Vir­ginia Ma­son and Dana-Far­ber. The hope is to both ad­vance can­cer treat­ment and bet­ter un­der­stand how type 1 di­a­betes de­vel­ops in gen­er­al.

→ In 2015, In­ovio joined forces with As­traZeneca’s $AZN Med­Im­mune unit for $27.5 mil­lion up­front, as well as an­oth­er po­ten­tial $700 mil­lion in mile­stone pay­ments — for the ex­clu­sive rights to In­ovio’s im­munother­a­py, de­signed to tar­get can­cers caused by hu­man pa­pil­lo­mavirus (HPV), in ad­di­tion to two ad­di­tion­al DNA-based can­cer vac­cine prod­ucts. On Wednes­day, In­ovio in a fil­ing dis­closed that Med­Im­mune was re­tain­ing its rights to the HPV im­munother­a­py, ME­DI0457 (pre­vi­ous­ly called INO-3112), but walk­ing away from the rest.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Bomb squad called to As­traZeneca vac­cine plant; Lu­men nabs CARB-X award for low-cost an­tidiar­rheal

A plant located in Wrexham, Wales that is packing the Oxford/AstraZeneca Covid-19 vaccine into vials was surrounded by a bomb squad after officials called police to report a suspicious package.

The alert caused a partial evacuation of the plant, the BBC was among those to report Wednesday. The owner of the plant, British drugmaker Wockhardt UK, said it was cooperating with local authorities and that there were no reports of any injuries.

Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Florian Brand (L) and Srinivas Rao (ATAI)

Psy­che­del­ic biotech ATAI hopes to ex­pand port­fo­lio through re­search part­ner­ship with Mass Gen­er­al

Psychedelics have made a comeback for mental health research, with companies like startup biotech ATAI Life Sciences raising millions and earning the backing of prominent investors like Peter Thiel, but there’s a hole at the heart of the resurgence: Researchers still don’t fully understand how they work.

A new partnership between ATAI and world-renowned Mass General Hospital hopes to change that.