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.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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