Geron sur­vives, for now, but the ju­ry at J&J is still out on the fu­ture of ime­tel­stat

Geron has sur­vived an­oth­er scrape with dis­as­ter, but it’s still op­er­at­ing un­der a dark cloud.

This morn­ing the biotech an­nounced that J&J’s re­view of the da­ta from two stud­ies of its drug ime­tel­stat war­rant­ed con­tin­ued work in myelodys­plas­tic syn­dromes and myelofi­bro­sis. But the phar­ma gi­ant $JNJ is still re­serv­ing the right to quit if the da­ta don’t hold up lat­er in the year.

That’s not a big vote of con­fi­dence.

In­vestors re­spond­ed to the pos­i­tive, though, send­ing shares of Geron up 17% in pre-mar­ket trad­ing.

The stud­ies for this drug in­clude a Phase II/III study in low-risk myelodys­plas­tic syn­dromes. Now Geron says that they’ll be shar­ing da­ta with the FDA be­fore de­cid­ing whether to launch the sec­ond part of that study, which is be­ing tweaked.

Geron al­so isn’t like­ly to spur much ex­cite­ment with the ob­ser­va­tion that the spleen vol­ume re­sponse in myelofi­bro­sis was less than that seen for oth­er drugs. But Geron hur­ried on to note that there were sev­er­al signs of clin­i­cal ben­e­fit to en­cour­age re­searchers, adding that “the da­ta sug­gest a po­ten­tial over­all sur­vival ben­e­fit as­so­ci­at­ed with ime­tel­stat treat­ment in these pa­tients.”

En­roll­ment in that sec­ond study, though, is still on hold — al­so not an en­cour­ag­ing sign. And the ju­ry is still out:

Geron ex­pects the longer-term da­ta from the tri­al, po­ten­tial health au­thor­i­ty feed­back, and the to­tal­i­ty of ime­tel­stat pro­gram in­for­ma­tion, in­clud­ing an as­sess­ment of the evolv­ing treat­ment land­scape in MF and the po­ten­tial ap­pli­ca­tion of ime­tel­stat in mul­ti­ple hema­to­log­ic ma­lig­nan­cies, in­clud­ing MDS, will in­form Janssen’s de­ci­sion whether to con­tin­ue de­vel­op­ment of ime­tel­stat in re­lapsed or re­frac­to­ry MF.

Geron shares $GERN took a beat­ing last fall af­ter its drug, a telom­erase in­hibitor, ran in­to trou­ble dur­ing its key Phase II tri­al run by J&J. The low dose group — re­lapsed or re­sis­tant to JAK1 ther­a­py — was not see­ing an ad­e­quate re­sponse and in­ves­ti­ga­tors opt­ed to shut that wing of the tri­al down, trans­fer­ring pa­tients over to the high dose. And new en­roll­ment in the high dose arm was sus­pend­ed so in­ves­ti­ga­tors could take a care­ful look at more ma­ture da­ta.

Geron re­or­ga­nized back in 2011, drop­ping its work on stem cell ther­a­pies and re­mak­ing it­self as a can­cer drug de­vel­op­er. The biotech has gone more than two decades, though, with­out find­ing a drug that war­rants ap­proval.

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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Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

Catal­ent to cut about 200 jobs in Mary­land and Texas

Contract manufacturing company Catalent is cutting about 200 jobs in Maryland and Texas, according to WARN notices, trimming back some of its pandemic-era expansion.

The company will cut 77 jobs by Jan. 15 of next year at a cell therapy facility in Webster, TX, just outside of Houston. In Maryland, the company is reducing staff at two locations, with 82 jobs being eliminated at Catalent’s facility in Gaithersburg, and 53 in Rockville. The layoffs go into effect at those locations on Jan. 14.

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Mar­ket­ingRx roundup: Pfiz­er, BioN­Tech re-up iHeartRa­dio hol­i­day spon­sor­ship; WHO re­names mon­key­pox to 'm­pox'

It’s that time of year again for pop music fans with the return of the iHeartRadio Jingle Ball tour — and Pfizer and BioNTech’s sponsorship. For the second year, the Covid-19 vaccine collaborators are the pharma national sponsors among consumer brand partners, including ESPN, Dunkin, M&Ms, Mercedes and Pepsi.

Pfizer and BioNTech are also sponsoring the official Jingle Ball Radio streaming station on iHeart’s network, programmed with music from past and present concert performers. This year they include Lizzo, Dua Lipa, Dove Cameron and Charlie Puth. Pfizer-sponsored radio ads and online video and digital banner ads encourage listeners to get updated Covid-19 booster shots.

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Mark Schneider, Nestlé CEO (AP Images)

Nestlé re­con­sid­ers peanut al­ler­gy pro­gram two years af­ter $2.6B buy­out

It seems Nestlé is experiencing some buyer’s remorse two years after throwing down $2.6 billion for Aimmune Therapeutics and its peanut allergy pill Palforzia.

CEO Mark Schneider announced on Tuesday that Nestlé is “exploring strategic options” for Palforzia following lower-than-expected demand. A company spokesperson declined to confirm whether a potential sale is in consideration.

“The review is expected to be completed in the first half of 2023. Going forward, Nestlé Health Science will sharpen its focus on Consumer Care and Medical Nutrition,” the company said in a news release.

iECURE CEO Joe Truitt and founder Jim Wilson

Jim Wil­son biotech iECURE gets fresh $65M to push pe­di­atric liv­er dis­ease gene ther­a­py in­to the clin­ic

Jim Wilson-founded biotech iECURE has wrapped a $65M Series A extension round to get its lead candidate — a gene replacement therapy for a rare inherited liver disease known as ornithine transcarbamylase deficiency, or OTC — into the clinic.

This round was co-led by Novo Holdings and LYFE Capital, followed by initial investors Versant and OrbiMed as well. In September 2021, iECURE raised a $50 million Series A led by the latter two. The new cash infusion will get iECURE through an initial in-human trial, which CEO Joe Truitt told Endpoints News iECURE hopes to read out in 2024.

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