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.

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.