Shawn Leland, Elevation Oncology founder

El­e­va­tion On­col­o­gy launch­es with $32.5 mil­lion Se­ries A, gives new life to for­mer Mer­ri­mack pro­gram

Al­most two years ago, Mer­ri­mack’s high-pro­file serib­an­tum­ab pro­gram flopped in a tri­al that at­tempt­ed to treat non-small cell lung can­cer in com­bi­na­tion with an­oth­er drug. Now, that pro­gram is get­ting a sec­ond chance.

El­e­va­tion On­col­o­gy an­nounced its launch Tues­day with $32.5 mil­lion in Se­ries A fund­ing and serib­an­tum­ab as its lead can­di­date. Rather than fo­cus­ing on NSCLCs like Mer­ri­mack, El­e­va­tion will aim to use the com­pound to treat sol­id tu­mors with the rare NRG1 ge­nom­ic fu­sion.

The fund­ing was led by Ais­ling Cap­i­tal, and oth­er in­vestors in­clud­ed Ver­tex Ven­tures, Qim­ing Ven­ture Part­ners USA, Driehaus Cap­i­tal Man­age­ment and BVF Part­ners.

First ac­quired by El­e­va­tion in Ju­ly 2019 for up to $58 mil­lion, serib­an­tum­ab is a mon­o­clon­al an­ti­body that binds to hu­man epi­der­mal growth fac­tor re­cep­tor 3, or Her3. The can­di­date was just one in a long string of clin­i­cal busts for Mer­ri­mack, ul­ti­mate­ly re­sult­ing in the biotech sell­ing sev­er­al as­sets and lay­ing off all its staff and ex­ec­u­tives. Mer­ri­mack test­ed serib­an­tum­ab specif­i­cal­ly in com­bi­na­tion with do­c­etax­el and failed to show im­prove­ments in pro­gres­sion-free sur­vival com­pared to do­c­etax­el treat­ments alone.

But El­e­va­tion and its founder, Shawn Le­land, are fo­cused on a dif­fer­ent ap­proach for their own pro­gram. Where­as Mer­ri­mack re­searched how serib­an­tum­ab can treat pa­tients with Her3 am­pli­fi­ca­tions and over­ex­pres­sion, El­e­va­tion is re­pur­pos­ing the com­pound to set its sights on the NRG1 fu­sion that is more ac­tive in dri­ving tu­mor growth, Le­land said.

Af­ter run­ning its due dili­gence, El­e­va­tion de­ter­mined serib­an­tum­ab would be a good fit for the biotech from both a “bi­o­log­i­cal and op­er­a­tional per­spec­tive,” Le­land said. The com­pa­ny want­ed a can­di­date that had po­ten­tial to treat these fu­sions and had pre­vi­ous­ly been test­ed in Her3 pa­tients, and serib­an­tum­ab fit Le­land’s bill.

As part of its launch, El­e­va­tion al­so ini­ti­at­ed a Phase II study to re­search the ef­fi­ca­cy of serib­an­tum­ab in these new NRG1 tar­gets. The study, dubbed CRE­STONE, is al­ready en­rolling pa­tients, and the key thing for Le­land is the en­roll­ment of any pa­tient with an NRG1-ex­press­ing sol­id tu­mor, re­gard­less of which kind of can­cer they have.

Though the NRG1 fu­sion on­ly ap­pears in 0.2% of pa­tients with sol­id tu­mors, it is most com­mon­ly ex­pressed in cer­tain types of lung and pan­cre­at­ic can­cers. Le­land said he be­lieves these pa­tients will bet­ter ben­e­fit from El­e­va­tion’s serib­an­tum­ab pro­gram be­cause, un­like a typ­i­cal T cell im­munother­a­py treat­ment, the study is more honed in on spe­cif­ic tu­mors.

“The whole de­sire here is to be able to iden­ti­fy pa­tients most like­ly to ben­e­fit up­front … and then treat them with the drug that we know is bi­o­log­i­cal­ly tai­lored to their dis­ease,” Le­land said. “And based up­on that bi­ol­o­gy, that should shut down the sig­nal­ing and growth of their can­cer cells.”

In terms of com­peti­tors in the NRG1 fu­sion field, El­e­va­tion is mea­sur­ing it­self against Rain Ther­a­peu­tics’ tar­lox­o­tinib and Merus’ MCLA-128. Both of these pro­grams have reached the Phase I/II stage, putting CRE­STONE at or near the same point in de­vel­op­ment. Pre­clin­i­cal da­ta from CRE­STONE will be sub­mit­ted for pub­li­ca­tion lat­er this year.

But giv­en that it’s still ear­ly for these pro­grams, right now it’s any­body’s game. In the mean­time, El­e­va­tion hopes to add sim­i­lar can­di­dates as it ex­pands its port­fo­lio and con­tin­ues CRE­STONE test­ing with its NRG1-fo­cused re­cruit­ment.

“By hav­ing those next-gen­er­a­tion se­quenc­ing re­sults, it al­lows you to un­der­stand your tu­mor and what’s caus­ing it to grow, and we be­lieve every pa­tient should be en­ti­tled to that,” Le­land said.

Noubar Afeyan, Flagship founder and CEO (Victor Boyko/Getty Images)

Flag­ship launch­es Sen­da Bio­sciences with an $88M back­ing, look­ing to pi­o­neer the field of 'In­ter­sys­tems Bi­ol­o­gy'

Flagship Pioneering has a fresh company out this week, one that aims to lay the groundwork for a whole new discipline.

Senda Biosciences launched Wednesday with $88 million in Flagship cash. The goal? Gain insights into the molecular connections between people and coevolved nonhuman species like plants and bacteria, paving the way for “Intersystems Biology.”

Guillaume Pfefer has been tapped to run the show, a 25-year biotech veteran who comes from GSK after leading the development of the company’s shingles vaccine.

Q32 Bio grabs $60M to kick off hu­man stud­ies for next-gen com­ple­ment drugs — with some Covid-19 tweaks along the way

For a company that launched in the early months of the pandemic, Q32 Bio had its fair share of run-ins with the new normals under Covid-19.

The original plan, for instance, was to conduct first-in-human studies of the IL-7 receptor antibody it licensed from Bristol Myers Squibb in the Netherlands. But they realized shortly after that while the country was beginning to open up clinical trials, there were additional restrictions on drugs that tampered with immunological mechanisms.

Daphne Koller, Getty

Bris­tol My­er­s' Richard Har­g­reaves pays $70M to launch a neu­rode­gen­er­a­tion al­liance with a star play­er in the ma­chine learn­ing world

Bristol Myers Squibb is turning to one of the star upstarts in the machine learning world to go back to the drawing board and come up with the disease models needed to find drugs that can work against two of the toughest targets in the neuro world.

Daphne Koller’s well-funded insitro is getting $70 million in cash and near-term milestones to use their machine learning platform to create induced pluripotent stem cell-derived disease models for ALS and frontotemporal dementia.

Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

Eli Lil­ly lines up a block­buster deal for Covid-19 an­ti­body, right af­ter it failed a NI­AID tri­al

Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized Covid-19 patients, the US government is preparing to make it a blockbuster.

The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $812 million.

Konstantin Poukalov

Per­cep­tive re­cruits A-list in­vestors to back its in-house Chi­na start­up with a mam­moth $310M raise

It took two years for Perceptive Advisors to conceive and boot up LianBio, its big bet on a new kind of in-licensing model for China, seeding it with enough cash to set up two anchoring deals with MyoKardia and BridgeBio. The result was a startup that was all ready to go, reaping $310 million just a little over two months after official launch.

Homegrown Chinese biotechs — many of them boasting of US ties and execs with overseas credentials — have been raking in mega-venture rounds in 2020, both from influential local backers and overseas VC firms that have been loading up new cash. As with IPOs, the deal flow might be slower but the amounts are often more staggering. LianBio’s latest round, unusually, is branded both a Series A and crossover.

Ar­cus and As­traZeneca part­ner on a high stakes an­ti-TIG­IT/PD-L1 PhI­II can­cer study, look­ing to im­prove on a stan­dard of care

For AstraZeneca, the PACIFIC trial in Stage III non-small cell lung cancer remains one of the big triumphs for AstraZeneca’s oncology R&D group. It not only made their PD-L1 Imfinzi a franchise player with a solid advance in a large niche of the lung cancer market, the study — which continues to offer data on the long-range efficacy of their drug — also helped salve the vicious sting of the failure of the CTLA-4 combo in the MYSTIC study.

No­var­tis buys a new gene ther­a­py for vi­sion loss, and this is one pre­clin­i­cal ven­ture that did­n't come cheap

Cyrus Mozayeni got excited when he began to explore the academic work of Ehud Isacoff and John G. Flannery at UC Berkeley.

Together, they were engaged in finding a gene therapy approach to pan-genotypic vision restoration in patients with photoreceptor-based blindness, potentially restoring the vision of a broad group of patients. And they did it by using a vector to deliver the genetic sequence for light sensing proteins.

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CMO Merdad Parsey (Gilead)

Gilead hits the brakes on a tri­fec­ta of mid- and late-stage stud­ies for their trou­bled fil­go­tinib pro­gram. It's up to the FDA now

Gilead $GILD execs haven’t decided exactly what to do with filgotinib in the wake of the slapdown at the FDA on their rheumatoid arthritis application, but they’re taking a time out for a slate of studies until they can gain some clarity from the agency. And without encouraging guidance, this drug could clearly be axed from the pipeline.

In their Q3 report out Wednesday afternoon, the company says researchers have “paused” a Phase III study for psoriatic arthritis along with a pair of Phase II trials for ankylosing spondylitis and uveitis. Late-stage studies for ulcerative colitis and Crohn’s are continuing, but you can see for yourself how big a hole this leaves in the inflammatory disease pipeline, with obvious implications if the company abandons filgo altogether.

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Managing partner Stefan Fischer (TVM)

Eli Lil­ly part­ner TVM Cap­i­tal rais­es $478M for their new life sci­ences fund, a 'sub­stan­tial' over­sub­scrip­tion

A German-Canadian VC fund and high-profile Eli Lilly partner has nearly half a billion dollars in new cash to play with.

TVM Capital Life Science, based out of Munich and Montreal, announced the closing of its second and latest fund Tuesday with $478 million in hand. That total represents a “substantial” oversubscription, managing partner Stefan Fischer said, and a good 36.5% more than the $350 million initially expected.