Vincent Milano, Idera Pharmaceuticals CEO

Idera Phar­ma­ceu­ti­cal­s' stock tanks af­ter Ab­b­Vie cuts en­roll­ment ear­ly in a PhIb tri­al

When Idera Phar­ma­ceu­ti­cals flunked a Phase III melanoma tri­al with its Toll-like re­cep­tor 9 ag­o­nist tilso­tolimod back in March, ex­ec­u­tives clung to the hope that sep­a­rate tri­als in oth­er can­cers would turn up bet­ter re­sults.

With­out the re­sults it was hop­ing for, Idera says it’s now dis­con­tin­u­ing en­roll­ment in a key Phase II study and con­sid­er­ing out-li­cens­ing the can­di­date. Ab­b­Vie’s al­so cut­ting re­cruit­ment short in an ear­li­er-stage part­nered study — caus­ing Idera’s stock $IDRA, al­ready worth less than a $1, to tank more than 27% on Wednes­day af­ter­noon.

“While our clin­i­cal tri­als with tilso­tolimod have not yet trans­lat­ed in­to a new treat­ment al­ter­na­tive for pa­tients, da­ta sup­port­ing tilso­tolimod’s mech­a­nism of ac­tion and en­cour­ag­ing safe­ty pro­file from across the ar­ray of pre-clin­i­cal and clin­i­cal work to date, to­geth­er with its in­tel­lec­tu­al prop­er­ty pro­tec­tion, are note­wor­thy,” CEO Vin­cent Mi­lano said in a state­ment.

“As a re­sult, we will con­sid­er an out-li­cens­ing arrange­ment for tilso­tolimod so that its full po­ten­tial may con­tin­ue to be ex­plored on be­half of pa­tients who do not re­spond to tra­di­tion­al im­munother­a­py,” he added.

The first set of bad news on Wednes­day came from the sec­ond 10 pa­tients in the safe­ty co­hort of IL­LU­MI­NATE-206, a Phase II tri­al test­ing tilso­tolimod in com­bi­na­tion with Bris­tol My­ers Squibb’s Op­di­vo and Yer­voy in mi­crosatel­lite-sta­ble col­orec­tal can­cer. Of eight pa­tients who had a post-base­line dis­ease as­sess­ment, on­ly one saw sta­ble dis­ease, and the rest saw pro­gres­sion of their can­cer, Idera said. How­ev­er, that in­cludes one pa­tient who ex­pe­ri­enced a pseu­do-pro­gres­sion, mean­ing that the ini­tial in­crease from base­line in tu­mor bur­den was fol­lowed by a de­crease, which is con­sid­ered an im­mune-re­lat­ed par­tial re­sponse on an­oth­er scale.

Idera says it won’t en­roll any more pa­tients in IL­LU­MI­NATE-206. Ac­cord­ing to clin­i­cal tri­, the study was sup­posed to en­roll 30 pa­tients to­tal.

En­roll­ment is al­so be­ing dis­con­tin­ued in an Ab­b­Vie-spon­sored tri­al for re­cur­rent or metasta­t­ic head and neck squa­mous cell car­ci­no­ma, look­ing at tilso­tolimod in sev­er­al com­bi­na­tions with Ab­b­Vie can­di­dates.

The Phase Ib study, which was an­nounced back in 2019, was test­ing three sep­a­rate arms: An OX40 ag­o­nist called AB­BV-368 plus tilso­tolimod; AB­BV-368 plus tilso­tolimod and chemother­a­py (nab-pa­cli­tax­el); and AB­BV-368 plus tilso­tolimod, nab-pa­cli­tax­el and a PD-1 an­tag­o­nist called AB­BV-181.

Idera says the dis­con­tin­u­a­tion “was not re­lat­ed to safe­ty con­cerns,” and that cur­rent treat­ment and fol­low-up is on­go­ing. Ab­b­Vie wasn’t avail­able for com­ment as of press time.

This isn’t the first time a Big Phar­ma part­ner­ship with tilso­tolimod didn’t work out. Back in May, Idera said it wouldn’t fin­ish a Bris­tol My­ers Squibb-part­nered tri­al as­sess­ing tilso­tolimod in com­bi­na­tion with ip­il­i­mum­ab ver­sus ip­il­i­mum­ab alone in pa­tients with an­ti-PD-1 re­frac­to­ry ad­vanced melanoma.

“Our con­clu­sion is that the to­tal­i­ty of the da­ta, with all pa­tients hav­ing com­plet­ed the study treat­ment, does not sup­port the like­li­hood that the com­bi­na­tion of tilso­tolimod with ip­il­i­mum­ab would achieve a sta­tis­ti­cal­ly sig­nif­i­cant OS ben­e­fit over ip­il­i­mum­ab alone,” Mi­lano said in a state­ment at the time.

Ac­cord­ing to Idera’s web­site, it ap­pears that tilso­tolimod is the on­ly can­di­date in the com­pa­ny’s pipeline.

The com­pa­ny says there are still two in­ves­ti­ga­tor-spon­sored stud­ies of tilso­tolimod on­go­ing at the VU Uni­ver­si­ty Med­ical Cen­ter (VUmc) Am­s­ter­dam and the Gus­tave Roussy Can­cer Cam­pus in Paris, as a monother­a­py in melanoma and a com­bi­na­tion ther­a­py with Op­di­vo and Yer­voy in ad­vanced can­cers, re­spec­tive­ly.

“We al­so con­tin­ue both to pre­serve cash and to iden­ti­fy and ex­plore po­ten­tial de­vel­op­ment or com­mer­cial-stage as­sets for Idera’s port­fo­lio, and we are en­cour­aged by the op­por­tu­ni­ties pre­sent­ed to us,” Mi­lano said.

Cor­rec­tion: Idera made the de­ci­sion to end its BMS-part­nered tri­al, not BMS. 

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Mi­rati’s drug sitra­va­tinib flops PhI­II in com­bo with Op­di­vo for cer­tain lung can­cer

Mirati Therapeutics’ path to a second drug approval will likely have to wait. The San Diego biotech company said Wednesday that its investigational lung cancer drug failed a Phase III trial testing it in combination with Bristol Myers Squibb’s Opdivo.

The drug, sitravatinib, and Opdivo weren’t better than the chemo drug docetaxel at keeping patients alive, Mirati said in a press release. The spectrum-selective kinase inhibitor missed the primary goal of overall survival in patients with second- or third-line advanced non-squamous, non-small cell lung cancer.

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End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; 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.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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Teresa Bitetti, Takeda's president of the global oncology business unit

Take­da wins pri­or­i­ty re­view for $400M col­orec­tal can­cer drug, li­censed from Hutchmed in Jan­u­ary

Takeda and Hutchmed scored a priority review Thursday afternoon for a colorectal cancer drug, the companies announced.

The experimental drug in question is fruquintinib, previously approved in China in 2018 to treat metastatic colorectal cancer. Takeda and Hutchmed are aiming to bring fruquintinib to the US and other countries outside China in the same indication, and the FDA set its decision date for Nov. 30 of this year.

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David Ricks, Eli Lilly CEO (Carolyn Kaster/AP Images)

Lil­ly gears up trio of PhI­II tri­als for its oral GLP-1 amid No­vo Nordisk, Pfiz­er com­pe­ti­tion

As Novo Nordisk and Pfizer disclose some data on their oral weight loss drugs in Phase III and II, respectively, Eli Lilly is beefing up its stance in the obesity field with three late-stage clinical trials of its next-generation GLP-1 agonist orforglipron.

The moves, disclosed in updates to the federal clinical trials database this week, put the Indianapolis drugmaker ahead of Pfizer, whose science chief has said the company will “cherry-pick” which of its mid-stage candidates to take deeper into the clinic after data late this year or early next.

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Douglas Love, Annexon CEO

An­nex­on’s GA drug miss­es on pri­ma­ry goal but win on vi­su­al acu­ity will be fo­cus of planned late-stage tri­al

Annexon’s complement inhibitor didn’t prove better than sham at reducing lesion growth in a leading cause of blindness, but the biotech still plans to move forward on the back of secondary endpoints showing visual acuity preservation, which will “certainly” be the primary goal in a late-stage trial to be discussed shortly with the FDA, CEO Douglas Love told Endpoints News. 

The California biotech’s ANX007 was not statistically significant compared to pooled sham, the comparator, at 12 months in patients with geographic atrophy, per a Wednesday presentation. In every-month dosing, the GA lesion area changed about 6.2% from baseline (p=0.526) and 1.3% (p=0.896) in the every-other-month group. In a March note, Jefferies analyst Suji Jeong said a reduction of 20% to 30% would be “encouraging.”

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