Ankit Mahadevia, Spero Therapeutics CEO

Two strug­gling biotechs fall un­der bear mar­ket in­flu­ence, as Spero sharply re­duces staff and Sesen seeks sale

As the bear mar­ket con­tin­ues bat­ter­ing the biotech sec­tor, Spero Ther­a­peu­tics and Sesen Bio are seek­ing ways to mit­i­gate loss­es.

Spero is un­der­go­ing an “im­me­di­ate ces­sa­tion” of com­mer­cial­iza­tion work on its com­pli­cat­ed uri­nary tract in­fec­tion drug, known as tebipen­em HBr, fol­low­ing feed­back from the FDA last week. The treat­ment is like­ly out the door as the an­tibi­otics biotech will let its med­ical and op­er­at­ing chiefs go in a sweep­ing com­pa­ny­wide lay­off.

And sep­a­rate­ly, Sesen said Tues­day it kicked off a strate­gic re­view process to ex­plore a sale, merg­er, ac­qui­si­tion, busi­ness com­bi­na­tion, di­vesti­ture, li­cens­ing or oth­er op­tions.

The agency is still re­view­ing Spero’s med, but the com­pa­ny said “the dis­cus­sion sug­gest­ed that the da­ta pack­age may be in­suf­fi­cient to sup­port ap­proval dur­ing this re­view cy­cle,” in a Tues­day press re­lease.

Spero linked arms with in­vestor Health­Care Roy­al­ty Part­ners last Sep­tem­ber for $50 mil­lion to pre­pare for mar­ket launch, an­oth­er $50 mil­lion up­on FDA green light and an­oth­er $25 mil­lion up­on com­mer­cial mile­stone.

“We are dis­ap­point­ed that the FDA has iden­ti­fied sub­stan­tive re­view is­sues, and we strong­ly be­lieve that tebipen­em HBr would of­fer health­care providers, pay­ers and pa­tients an im­por­tant oral an­tibi­ot­ic al­ter­na­tive to IV treat­ment for cU­TI for pa­tients with lim­it­ed oral treat­ment op­tions,” Spero CEO Ankit Ma­hade­via said in the press re­lease.

“We be­lieve that there is a path for­ward to po­ten­tial FDA ap­proval for tebipen­em HBr, though ad­di­tion­al analy­sis or clin­i­cal study may be re­quired. We are con­tin­u­ing our di­a­logue with the agency,” Ma­hade­via said in an in­vestor call.

Spero will lay off 75% of its work­force, which com­prised 146 peo­ple at the end of 2021, as Spero fo­cus­es on the drug it bought from Ver­tex and a Pfiz­er-sup­port­ed an­tibi­ot­ic.

The lay­offs add to the long-run­ning list of biotechs and phar­mas that have been hit by clin­i­cal fail­ures, drug re­jec­tions, pipeline re­or­ga­ni­za­tions and a bear mar­ket that has left no stone un­turned. The Spero lay­offs im­pact­ed the C-suite, in­clud­ing CMO David Mel­nick and COO Cristi­na Larkin, ac­cord­ing to an SEC fil­ing.

The move should free up Spero’s cash re­serves to keep the lights on through late 2023. The com­pa­ny end­ed 2021 with $146.4 mil­lion in cash, which should bankroll Phase II mile­stones for the two drugs now at the top of Spero’s pri­or­i­ty list.

The for­mer Ver­tex drug, SPR720, was un­der an FDA clin­i­cal hold for near­ly a year af­ter sci­en­tists had un­cov­ered deaths in a tox­i­col­o­gy study in­volv­ing non-hu­man pri­mates. The hold was lift­ed in Jan­u­ary of this year and the mid-stage study is slat­ed for a start in the sec­ond half of this year for non-tu­ber­cu­lous my­cobac­te­r­i­al dis­ease. FDA has giv­en the med or­phan drug and qual­i­fied in­fec­tious dis­ease prod­uct des­ig­na­tions.

SPR206 was de­vel­oped in-house and is tar­get­ed at gram neg­a­tive MDR bac­te­r­i­al in­fec­tions. Pfiz­er bought up Spero stock last Ju­ly, promised sin­gle-dig­it roy­al­ties and $80 mil­lion in biobucks in ex­change for ex-US and ex-Asia rights. Ever­est bought the Asian rights in 2019.

Thomas Can­nell

Mean­while, Sesen is con­tin­u­ing its de­vel­op­ment work but its “strong cash po­si­tion pro­vides us the op­por­tu­ni­ty to care­ful­ly con­sid­er a wide range of po­ten­tial strate­gic al­ter­na­tives,” CEO Thomas Can­nell said in a press re­lease.

The com­pa­ny’s non-mus­cle in­va­sive blad­der can­cer drug was re­ject­ed by the FDA last Au­gust. Sesen in­tends to re­quest a meet­ing with the agency in the com­ing weeks to “align on the re­main­ing out­stand­ing items re­lat­ed to an ad­di­tion­al Phase 3 clin­i­cal tri­al.”

Sesen had $169.8 mil­lion as of March 31.

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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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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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.”