Pierre d’Epenoux, ImCheck CEO

Im­Check adds $7.1M to Se­ries B, boost­ing de­vel­op­ment of gam­ma delta T cell pro­grams

Nine months af­ter first an­nounc­ing a Se­ries B, French biotech Im­Check re­turned to the ven­ture cap­i­tal well seek­ing a bit more cash.

The com­pa­ny found what it was look­ing for, seal­ing the deal on an ad­di­tion­al $7.1 mil­lion in­vest­ment and clos­ing the Se­ries B at a to­tal of $64 mil­lion. New fund­ing comes sole­ly from BB Pure­os Bioven­tures and will help sup­port an on­go­ing tri­al for its lead can­di­date, as well as boost de­vel­op­ment of the com­pa­ny’s pre­clin­i­cal port­fo­lio of an­ti­body can­di­dates in im­muno-on­col­o­gy, au­toim­mune and in­fec­tious dis­ease in­di­ca­tions.

Last De­cem­ber, Im­Check re­vealed the ini­tial round at $53 mil­lion, and the ex­tend­ed Se­ries B now brings the to­tal mon­ey raised by Im­check to $91 mil­lion in a lit­tle over three years.

Im­Check had pre­vi­ous­ly com­mit­ted that most of its Se­ries B fund­ing would help fund a Phase I/IIa study for its lead im­muno-on­col­o­gy pro­gram, ICT01. The tri­al start­ed in Feb­ru­ary and re­ceived ap­proval to be­gin dos­ing the sec­ond co­hort of pa­tients last week. It is ex­pect­ed to be com­plet­ed to­ward the end of 2022.

ICT01 cen­ters around a spe­cif­ic kind of T cell called a gam­ma delta T cell, which re­searchers hope are more ef­fec­tive than CAR-T ther­a­pies har­ness­ing al­pha be­ta cells at break­ing in­to a tu­mor’s mi­croen­vi­ron­ment. Where the treat­ments dif­fer is in how gam­ma delta T cells do not re­ly on spe­cif­ic anti­gens, but in­stead kill their tar­gets when pre­sent­ed with gener­ic ex­pres­sions of in­fec­tion or dis­ease.

Ad­di­tion­al­ly, CAR-T treat­ments on­ly work in blood can­cers and come with sev­er­al lim­i­ta­tions, name­ly tox­i­c­i­ty. They are al­so ex­treme­ly ex­pen­sive to man­u­fac­ture and pro­duce, lead­ing to high price tags for con­sumers and un­der­whelm­ing sales.

The ICT01 pro­gram, though, stems from the idea that the mere pres­ence of gam­ma delta T cells with­in a tu­mor mi­croen­vi­ron­ment is linked to a bet­ter prog­no­sis. But rather than ex­tract­ing the cells, Im­Check has de­vel­oped a method us­ing bu­ty­rophilin (BTN) mol­e­cules to boost the ac­tiv­i­ty of cer­tain gam­ma delta T cells al­ready at hand.

Im­Check sci­en­tists hope their pro­gram can do two things: point the gam­ma delta T cells in the blood­stream to­ward in­fect­ed cells or tu­mors and ac­ti­vate the gam­ma delta T cells al­ready in a tu­mor’s mi­croen­vi­ron­ment. CEO Pierre d’Epe­noux sug­gest­ed to End­points News in an in­ter­view last De­cem­ber that ICT01 is the on­ly mon­o­clon­al an­ti­body pro­gram among those try­ing to har­ness the po­ten­tial of gam­ma delta T cells.

That com­pe­ti­tion has grown steadi­ly over the years, with some of the biggest play­ers in­clud­ing Gam­maDelta Ther­a­peu­tics and its spin­off Adap­tate, Re­gen­eron-backed Adicet Bio, Nether­lands-based Gade­ta, and Scot­land’s TC Bio­Pharm.

Eli Lilly CSO Dan Skovronsky (file photo)

#ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

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#ES­MO20: It’s not just Keytru­da any­more — Mer­ck spot­lights 3 top ear­ly-stage can­cer drugs

Any $12 billion megablockbuster in the portfolio tends to overshadow everything else in the pipeline. Which is something Merck can tell you a little bit about.

Keytruda not only dominates the PD-(L)1 field, it looms over everything Merck does, to the point some analysts wonder if Merck is a one-trick pony.

There’s no shortage of Keytruda data on display at ESMO this weekend, but now the focus is shifting to the future role of new drugs and combos in maintaining that lead position for years to come. And the pharma giant has a special focus for 3 early-stage efforts where Roger Perlmutter’s oncology team is placing some big bets.

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Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA have vowed not to let politics get in the way of science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped health agencies under his purview — including the FDA — of their rulemaking ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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Greg Friberg (File photo)

#ES­MO20: Am­gen team nails down sol­id ear­ly ev­i­dence of AMG 510’s po­ten­tial for NSCLC, un­lock­ing the door to a wave of KRAS pro­grams

The first time I sat down with Amgen’s Greg Friberg to talk about the pharma giant’s KRAS G12C program for sotorasib (AMG 510) at ASCO a little more than a year ago, there was high excitement about the first glimpse of efficacy from their Phase I study, with 5 of 10 evaluable non-small cell lung cancer patients demonstrating a response to the drug.

After decades of failure targeting KRAS, sotorasib offered the first positive look at a new approach that promised to open a door to a whole new approach by targeting a particular mutation to a big target that had remained “undruggable” for decades.

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#ES­MO20: Out to beat Tagris­so, J&J touts 100% ORR for EGFR bis­pe­cif­ic/TKI com­bo — fu­el­ing a quick leap to PhI­II

J&J’s one-two punch on EGFR-mutant non-small cell lung cancer has turned up some promising — although decidedly early — results, fueling the idea that there’s yet room to one up on third-generation tyrosine kinase inhibitors.

Twenty out of 20 advanced NSCLC patients had a response after taking a combination of an in-house TKI dubbed lazertinib and amivantamab, a bispecific antibody targeting both EGFR and cMET engineered on partner Genmab’s platform, J&J reported at ESMO. All were treatment-naïve, and none has seen their cancer progress at a median follow-up of seven months.

#ES­MO20: Trodelvy da­ta show that Gilead­'s $21B buy­out may have been worth the big pre­mi­um

Gilead CEO Dan O’Day has been on a shopping spree. And while some analysts gawked at the biotech’s recent $21 billion Immunomedics buyout, new data released at virtual ESMO 2020 suggest the acquisition may have been worth the hefty price.

The deal, announced last weekend, will give California-based Gilead $GILD Trodelvy, which was recently approved for metastatic triple-negative breast cancer (mTNBC).

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#ES­MO20: As­traZeneca bur­nish­es Tagris­so's ad­ju­vant NSCLC pro­file with 'un­prece­dent­ed' re­duc­tion in brain mets. Can they win over skep­tics?

When AstraZeneca trumpeted “momentous” and “transformative” results for Tagrisso earlier this year at ASCO, some practitioners threw cold water on the ADAURA fervor. Sure, the disease-free survival data look good, but overall survival is the endpoint that matters when it comes to choosing adjuvant therapy for non-small cell lung cancer patients, the experts said.

The OS data still aren’t here, but AstraZeneca is back at ESMO to bolster their case with a look at brain metastasis data.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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