Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Mer­ck — one of the last big phar­ma bas­tions in the be­lea­guered field of an­tibi­ot­ic drug de­vel­op­ment — on Fri­day said the FDA had signed off on us­ing its com­bi­na­tion drug, Re­car­brio, with hos­pi­tal-ac­quired bac­te­r­i­al pneu­mo­nia and ven­ti­la­tor-as­so­ci­at­ed bac­te­r­i­al pneu­mo­nia. The drug could come handy for use in hos­pi­tal­ized pa­tients who are af­flict­ed with Covid-19, who car­ry a high­er risk of con­tract­ing sec­ondary bac­te­r­i­al in­fec­tions. Once SARS-CoV-2, the virus be­hind Covid-19, in­fects the air­ways, it en­gages the im­mune sys­tem, giv­ing oth­er pathogens free rein to pil­lage and plun­der as they please — the is­sue is par­tic­u­lar­ly per­ti­nent in pa­tients on ven­ti­la­tors, which in any case are breed­ing grounds for in­fec­tious bac­te­ria.

Last year, Re­car­brio was ap­proved for use in com­pli­cat­ed uri­nary tract and in­tra-ab­dom­i­nal in­fec­tions — all these ap­provals man­date the use of the treat­ment on­ly when the in­fec­tion is proven or strong­ly sus­pect­ed to be caused by gram-neg­a­tive bac­te­ria.

Mereo is look­ing to add a lit­tle lus­ter to the pipeline with the launch of a Phase Ib tri­al for their an­ti-TIG­IT drug etig­ilimab. TIG­IT quick­ly emerged as one of the hottest tar­gets in can­cer R&D this year, with some val­i­dat­ing da­ta from Roche and a ma­jor al­liance be­tween Ar­cus and Gilead. The UK biotech al­so has the cash to pur­sue its R&D goals on rare dis­ease, adding $70 mil­lion in an eq­ui­ty raise from Or­biMed, Vi­vo Cap­i­tal, Sur­vey­or Cap­i­tal (a Citadel com­pa­ny), Pon­tif­ax Ven­ture Cap­i­tal, Sam­sara Bio­Cap­i­tal, Com­modore Cap­i­tal, and funds man­aged by Janus Hen­der­son In­vestors along­side ex­ist­ing in­vestors Box­er Cap­i­tal of Tavi­s­tock Group and As­pire Cap­i­tal Fund.

Ap­plied Mol­e­c­u­lar Trans­port picked a good time to be short on cash. The biotech, which emerged from stealth mode with lit­tle fan­fare in Sep­tem­ber filed for an IPO last month as they dis­closed  “sub­stan­tial doubt about our abil­i­ty to con­tin­ue as a go­ing con­cern” for the fol­low­ing year. Amid a string of flashy pan­dem­ic IPOs to both promi­nent and lit­tle-known com­pa­nies, they filed for $100 mil­lion. Turns out they got even more, pric­ing at the $14 high end and rais­ing $154 mil­lion to ad­vance their in­flam­ma­to­ry dis­ease pipeline.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,800+ biopharma pros reading Endpoints daily — and it's free.

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%.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 153,800+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.”