Jacqueline Shea, Inovio CEO

In­ovio agrees to shell out $44M to set­tle Covid-19 vac­cine law­suit

Three months af­ter bring­ing on a new CEO, In­ovio has reached a set­tle­ment with in­vestors over ac­cu­sa­tions that it ex­ag­ger­at­ed progress on its Covid-19 vac­cine can­di­date.

The biotech, once claim­ing to be at the heart of Op­er­a­tion Warp Speed, has agreed to shell out $44 mil­lion in a mix of cash and stock to end a class ac­tion law­suit in which in­vestors al­leged that the com­pa­ny mis­rep­re­sent­ed its ef­forts on INO-4800, caus­ing the biotech’s share price to plunge.

The case dates back to March 2020, when Patrick Mc­Der­mid filed an ini­tial com­plaint. Al­most half a mil­lion pages of doc­u­ments and more than a dozen de­po­si­tions lat­er, the par­ties start­ed look­ing to re­solve the case in Ju­ly 2021, bring­ing in a me­di­a­tor of se­cu­ri­ties class ac­tions and fail­ing. A sec­ond ne­go­ti­a­tion in Feb­ru­ary this year al­so failed.

Ac­cord­ing to court doc­u­ments, the me­di­a­tor, Gre­go­ry Lind­strom, then is­sued a “me­di­a­tor’s pro­pos­al” on May 18, which was ac­cept­ed by all par­ties. The set­tle­ment to­tals $30 mil­lion in cash plus 7 mil­lion shares of $INO at $2 a share. The com­pa­ny’s stock is cur­rent­ly trad­ing at $2.56 a share.

Joseph Kim

An In­ovio spokesper­son told End­points News on Wednes­day that the biotech does not com­ment on on­go­ing lit­i­ga­tion. It’s al­so worth not­ing that the set­tle­ment still has to be ap­proved by a judge be­fore it can go in­to ef­fect and the law­suit of­fi­cial­ly ends.

This new de­vel­op­ment takes place af­ter new CEO Jacque­line Shea an­nounced last month that 18% of the com­pa­ny’s full-time staffers will be let go, plus 86% of all con­trac­tors in a bid to re­duce op­er­a­tional ex­pens­es and ex­tend its cash run­way in­to Q3 of 2024. The pre­vi­ous CEO, Joseph Kim, left the com­pa­ny in May af­ter steer­ing the com­pa­ny for years and claim­ing in the ear­ly days of the pan­dem­ic that In­ovio had “de­vel­oped a vac­cine in a mat­ter of hours.”

Kim was among a se­lect group of CEOs who met with Pres­i­dent Don­ald Trump ear­ly in the Covid-19 pan­dem­ic to dis­cuss the de­vel­op­ment of vac­cines and ther­a­peu­tics against the coro­n­avirus. How­ev­er, In­ovio en­coun­tered hur­dle af­ter hur­dle with its vac­cine can­di­date, in­clud­ing a clin­i­cal hold, fund­ing with­draw­al and a stand­off with con­tract man­u­fac­tur­er VGXI. INO-4800 re­mains in clin­i­cal tri­als, but In­ovio has said it will fo­cus on test­ing it as a boost­er to oth­er vac­cines rather than a pri­ma­ry se­ries vac­cine op­tion.

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.

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.

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.

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.

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.

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.

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.

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.