Sean McCarthy, CytomX CEO

Reel­ing from PhII flop, Cy­tomX lays off 40% as ex­ecs go back to draw­ing board, seek new deals

Just days af­ter putting a lead drug on the back­burn­er in the wake of a Phase II flop, Cy­tomX has set­tled on a makeover plan.

The South San Fran­cis­co biotech is lay­ing off around 40% of its staffers as part of a re­vamp in­tend­ed to pri­or­i­tize in­ter­nal work on its pre­clin­i­cal and ear­ly clin­i­cal pipeline — hit­ting hard­est on the de­vel­op­ment and gen­er­al and ad­min­is­tra­tive teams. At the end of 2021, Cy­tomX re­port­ed it had 174 full-time em­ploy­ees.

Amy Pe­ter­son

Among those de­part­ing will be pres­i­dent and COO Amy Pe­ter­son, CFO Car­los Cam­poy and CMO Al­i­son Han­nah.

In ad­di­tion to praluzatam­ab rav­tan­sine, the CD166-di­rect­ed an­ti­body-drug con­ju­gate that de­liv­ered dis­ap­point­ing re­sults in breast can­cer, the biotech says it will al­so de­pri­or­i­tize a DM21-con­ju­gat­ed Ep­CAM-di­rect­ed ADC dubbed CX-2043.

Car­los Cam­poy

For now, all the clin­i­cal-stage pro­grams in the pipeline come from its Big Phar­ma pacts: CX-904, the Am­gen-al­lied Phase I T cell-en­gag­ing bis­pe­cif­ic; CX-2029, the Ab­b­Vie-part­nered Phase II ADC; as well as BMS-986249 and BMS-986288, con­di­tion­al­ly ac­ti­vat­ed ver­sions of Bris­tol My­ers Squibb’s Yer­voy be­ing de­vel­oped by the phar­ma gi­ant.

While all of Cy­tomX’s own can­di­dates re­main pre­clin­i­cal, it does plan to file INDs in 2023 for an IFN al­pha-2b cy­tokine and a sep­a­rate Ep­CAM-di­rect­ed ADC.

The learn­ings from its clin­i­cal ex­pe­ri­ence — which hasn’t seen much suc­cess so far — will in­form the next wave of can­di­dates, CEO Sean Mc­Carthy said.

“In the con­text of the chal­leng­ing cur­rent in­vest­ment cli­mate for biotech­nol­o­gy, we are mak­ing a se­ries of changes to en­sure Cy­tomX re­mains well po­si­tioned for the fu­ture,” he added.

As the re­struc­tur­ing ex­tends the cash run­way from 2024 to 2025, it should al­so buy time for more busi­ness de­vel­op­ment around their Pro­body tech­nol­o­gy. Lever­ag­ing a mask­ing pep­tide, the idea is that its spe­cial­ly de­signed drugs would on­ly be ac­ti­vat­ed un­der the right con­di­tions, the­o­ret­i­cal­ly al­le­vi­at­ing safe­ty con­cerns.

“Part­ner­ships have been formed in rapid suc­ces­sion, par­tic­u­lar­ly 2016 through 2017, though there is lit­tle vis­i­bil­i­ty on tim­ing as the last part­ner­ship oc­curred in 2020,” Mizuho an­a­lysts not­ed.

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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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.

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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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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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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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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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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