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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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Peter Thompson, Terremoto Biosciences interim CEO

For­mer Prin­cip­ia team looks to shake up co­va­lent small mol­e­cules again, this time at 'earthquake' scale

Terremoto Biosciences goes back a long ways, in a sense, to about a dozen years ago when Principia Biopharma was founded by UCSF professor Jack Taunton. Peter Thompson initially helmed the biotech.

The company helped expand covalent small molecule inhibitors beyond oncology and into autoimmune disease by targeting cystine. But that amino acid is uncommon in a lot of proteins, offering fewer drug targets than, say, lysine, which is present in most proteins of interest. So, over the years, Taunton went back to the drawing board to check out that second amino acid.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Simba Gill, CEO of Evelo Biosciences

While down 87% YOY, Evelo gets Flag­ship and oth­ers to in­fuse new cap­i­tal for come­back hope

Just four years after Flagship spinout Evelo Biosciences went public in an IPO worth $85 million, the biotech has seen its share price tank from $13 a share this time last year (ultimately reaching a peak of over $17) to now under $1.50. And today, it looks like Flagship still thinks the fledging biotech, in a down market, is still worth something after initial pre-IPO backing from the likes of Google’s GV, Celgene, Mayo Clinic and Alexandria Venture.

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