CEO Shawn Leland (Elevation)

El­e­va­tion On­col­o­gy bags $65M to push failed Mer­ri­mack drug through PhII

Shawn Le­land hadn’t even heard of NRG1 as an on­col­o­gy tar­get un­til he was sit­ting in a pre­sen­ta­tion at ES­MO 2018 in Mu­nich. Alex Drilon, an on­col­o­gist at the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter in New York, was pre­sent­ing on tar­get­ed ther­a­pies for lung can­cer — and Le­land was en­thralled.

“He put up one slide with­in that pre­sen­ta­tion that de­scribed the tar­get of NRG1 gene fu­sion and the fact that they were po­ten­tial­ly drug­gable with a HER3 mon­o­clon­al an­ti­body ap­proach,” Le­land said.

The wheels be­gan turn­ing. Af­ter the pre­sen­ta­tion, he pulled a bunch of lit­er­a­ture on NRG1 fu­sion and be­gan re­search­ing.

In Ju­ly, Le­land un­veiled a start­up, El­e­va­tion On­col­o­gy, with a $32.5 mil­lion Se­ries A round and a clin­i­cal can­di­date for sol­id tu­mors with NRG1 ge­nom­ic fu­sion. And on Wednes­day, he land­ed a $65 mil­lion Se­ries B to com­plete en­roll­ment in the can­di­date’s Phase II tri­al, and a pro­mo­tion. Le­land’s tak­ing over from in­ter­im CEO Steve Elms, who will re­main chair of El­e­va­tion’s board of di­rec­tors. And Drilon, who in­spired Le­land at ES­MO, is on the biotech’s sci­en­tif­ic ad­vi­so­ry board.

“There is this unique abil­i­ty to go out and get a li­cense or ac­quire a HER3 mon­o­clon­al an­ti­body and re­pur­pose it for this ge­net­i­cal­ly de­fined pa­tient pop­u­la­tion, where a HER3 mon­o­clon­al an­ti­body ap­proach was very much tai­lored to the dis­ease bi­ol­o­gy,” Le­land said.

The biotech ac­quired its lead can­di­date, Mer­ri­mack’s high-pro­file serib­an­tum­ab, last year for up to $58 mil­lion. The drug pre­vi­ous­ly flunked a Phase II tri­al eval­u­at­ing its ef­fi­ca­cy in non-small cell lung can­cer in com­bi­na­tion with do­c­etax­el — but un­like Mer­ri­mack, El­e­va­tion isn’t fo­cused on HER3 am­pli­fi­ca­tions and over­ex­pres­sion. It’s tar­get­ing that NRG1 fu­sion, which Le­land says is more ac­tive in dri­ving tu­mor growth.

“If you’re able to iden­ti­fy … these NRG1 gene fu­sions, it’s high­ly un­like­ly that they have an­oth­er ge­nom­ic aber­ra­tion that may be lead­ing to the growth of their can­cer,” Le­land said.

Mer­ri­mack’s serib­an­tum­ab flop was one of sev­er­al for the com­pa­ny. Af­ter the can­di­date and do­c­etax­el failed to show im­prove­ments in the pro­gres­sion-free sur­vival of NSCLC pa­tients com­pared to do­c­etax­el treat­ments alone, the biotech added it to the scrap heap and slashed 60% of its staff. Last Ju­ly, the com­pa­ny’s ex­ec­u­tives fled the scene.

Le­land is now hop­ing to turn around an ac­cel­er­at­ed ap­proval for serib­an­tum­ab with re­sults from the biotech’s open-la­bel Phase II CRE­STONE study. The Se­ries B will be used to fin­ish en­rolling a to­tal of 75 pa­tients across three co­horts.

The round was led by Cor­morant As­set Man­age­ment, ven­Bio Part­ners, with help from a slate of new and old in­vestors in­clud­ing: Box­er Cap­i­tal of Tavi­s­tock Group, Janus Hen­der­son, Sam­sara Bio­cap­i­tal, and Vi­vo Cap­i­tal, Ais­ling Cap­i­tal, Ver­tex Ven­tures, Qim­ing Ven­ture Part­ners USA, Driehaus Cap­i­tal Man­age­ment, and BVF Part­ners. Back-to-back rais­es and in­volve­ment from Cor­morant, which is known as a crossover play­er, would typ­i­cal­ly in­di­cate an IPO is on the way. But El­e­va­tion re­spond­ed:

A fu­ture IPO is a pos­si­bil­i­ty, al­though the Com­pa­ny has no im­me­di­ate plans to file. The Se­ries B po­si­tions the Com­pa­ny with a strong base of crossover in­vestors to sup­port a pub­lic list­ing if that is the most fa­vor­able route for ad­di­tion­al fund­ing, based on mar­ket con­di­tions at the time.

“There’s lim­it­ed to no op­tions for these pa­tients, and the abil­i­ty for them to get a ther­a­py on a clin­i­cal tri­al, with an agent like serib­an­tum­ab that’s unique­ly tai­lored to this dis­ease bi­ol­o­gy as­so­ci­at­ed with the NRG1 fu­sion, we be­lieve is key,” Le­land said. “I think it’s one of those tar­gets that, you know, caught a lot of at­ten­tion as of late, but up un­til prob­a­bly the past 12 to 24 months pri­or to that, there was very lit­tle known about NRG1.”

El­e­va­tion faces com­pe­ti­tion from Rain Ther­a­peu­tics’ tar­lox­o­tinib and Merus’ MCLA-128, both of which are al­so in Phase II. The race is tight, but Le­land ex­pects to read out in­ter­im da­ta by mid-2021.

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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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

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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Radek Spisek, Sotio CEO (Cellestia)

A qui­et Czech biotech bags $315M to dri­ve its blos­som­ing can­cer pipeline through the clin­ic

In the rather insular world of biotech, most innovation inevitably comes from a cluster of R&D hubs — Cambridge, San Francisco, etc. But sometimes success stories sprout from rocky soil, which is most certainly the case with Prague-based Sotio Biotech and its suddenly jam-packed pipeline of cancer drugs.

After years in quiet development, Sotio now has $315 million in new funds to play with from parent company PPF Group, an investment group founded in the Czech Republic, as the biotech looks to advance its growing pipeline through early- and mid-stage trials.

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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.

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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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.

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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