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. 

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Jeb Keiper, Nimbus Therapeutics CEO

PhI­Ib win puts Nim­bus one step clos­er to chal­leng­ing Bris­tol My­ers in TYK2

Bristol Myers Squibb might be the first to clinch an FDA approval for a TYK2 inhibitor, but Nimbus Therapeutics is out to prove that it has the best drug in the class. The biotech says it now has positive mid-stage data to back up those claims — although it’s saving the hard numbers for now.

Topline results from a Phase IIb study involving 259 patients with moderate-to-severe plaque psoriasis showed that Nimbus’ drug, NDI-034858, hit the primary endpoint of helping more patients achieve PASI-75 than placebo at 12 weeks.

Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

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John Carroll with David Chang, Allogene CEO (Credit: Jeff Rumans Photography)

Al­lo­gene takes the stage in New York to go deep on its off-the-shelf cell ther­a­pies — de­clar­ing a first for sol­id tu­mors

NEW YORK — In most cases, a biotech like Allogene would wait until the next big science conference to offer its latest series of snapshots of its data. But most biotechs aren’t like Allogene, where the veteran leaders from Kite garnered a substantial number of kudos over the years for their in-depth reviews of the company’s progress.

So on Tuesday, the leaders at Allogene converged on Manhattan once again to give a detailed breakdown of their latest steps forward, looking to stay out front in the busy off-the-shelf cell therapy arena, keep a clean bill of health on the safety front and prove that they can not only match the autologous pioneers they helped create but make the all-important leap into solid tumors. It’s another step forward in a journey that has a long way to go before even the first big regulatory finish lines appear on the track. But for CEO David Chang, who spent some time with me running through the data ahead of the Tuesday session, it all amounts to forward momentum toward the desired goal.

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UK reg­u­la­tor warns of se­vere eye re­ac­tions fol­low­ing use of Sanofi and Re­gen­eron's Dupix­ent

The UK’s Medicines and Healthcare Regulatory Agency (MHRA) on Tuesday warned of some new and serious eye-related side effects following the use of Sanofi and Regeneron’s atopic dermatitis and asthma treatment Dupixent (dupilumab).

While Dupixent is already associated with cases of conjunctivitis and allergic conjunctivitis, dry eye and with infrequent cases of keratitis and ulcerative keratitis, the MHRA is calling on health professionals to be on the lookout for any of these eye-related side effects as “it is not currently possible to predict who may experience the rarer and most severe ocular adverse reactions, such as ulcerative keratitis.”

Sana, Codex­is lay off staff, reshuf­fle pipeline in bid to fo­cus cell ther­a­py, en­zyme en­gi­neer­ing work

As its market cap shrinks to a fraction of its heyday, flashy cell therapy startup Sana Biotechnology is laying off 15% of its staffers in a move to rejig the pipeline and restructure the company.

Sana is among a growing group of biotechs that, feeling the weight of a broader market downturn and seeing their shares tumble steadily, are tightening the purse strings and adjusting their focus. Also on Tuesday, Codexis, an enzyme engineering company based in California and now helmed by former Sierra Oncology CEO Stephen Dilly, announced it will reduce the workforce by 18%.

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