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.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Warren Huff, Reata CEO

Rea­ta sug­gests Friedre­ich's atax­ia pro­gram could be de­layed, send­ing stock plung­ing

Reata Pharmaceuticals $RETA made waves last October when its drug omaveloxolone produced positive trial results in treating a rare neurological disorder, but the candidate’s path forward became much murkier Monday.

In a report of quarterly earnings, the biotech divulged that the FDA is considering delaying omaveloxolone’s NDA pending completion of a second trial. That could push back approval by at least a year given that the target population, individuals with Friedreich’s ataxia, is limited and progression of the hard-to-treat illness is notoriously slow. The Covid-19 pandemic would also hinder Reata’s ability to complete an additional trial.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Eli Lil­ly teams with Pieris on HER2+ tu­mors; Op­di­vo + Yer­voy best chemo in mesothe­lioma

Despite the FDA putting a partial clinical hold on its lead program only a few weeks ago, Boston-based Pieris Pharmaceuticals is plowing forward with a new collaboration.

Pieris will work with Eli Lilly to further advance studies on PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, in combination with the latter’s ramucirumab and paclitaxel for the second-line treatment of patients with HER2-positive gastric cancer in a single-arm, Phase II study.

In­novent and Eli Lil­ly chal­lenge Mer­ck­'s mega-block­buster Keytru­da in non-small cell lung can­cer field

China-based Innovent Biologics and its multinational ally Eli Lilly shared Phase III evidence that their PD-1 inhibitor combo can delay the progression of nonsquamous non-small cell lung cancer.

But the drugmakers will face stiff competition in China from Merck’s Keytruda, the ruling PD-1 which is already approved to treat both squamous and nonsquamous NSCLC and boasts positive overall survival rates.

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