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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Sanofi, Re­gen­eron boast PhI­II win with Dupix­ent in COPD, clear­ing first bar for ex­pan­sion

Dupixent, the blockbuster anti-inflammatory drug from Sanofi and Regeneron, has cleared a high-stakes Phase III study in chronic obstructive pulmonary disease, the companies announced Thursday morning.

If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Genen­tech to stop com­mer­cial man­u­fac­tur­ing at Cal­i­for­nia head­quar­ters

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

The move is the result of a decision Genentech made in 2007 to relocate manufacturing operations from its South San Francisco headquarters location to other facilities or move the work to CDMOs, said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech has made changes in capabilities and invested more in technology, so it doesn’t need as many large-scale manufacturing facilities as it did in the past, she said.

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In­cyte wins ac­cel­er­at­ed ap­proval for PD-1 in rare skin can­cer

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.

A new study finds that many patient influencers are sharing prescription drug experiences along with health information.

So­cial me­dia pa­tient in­flu­encers ‘danc­ing in the gray’ of phar­ma mar­ket­ing, more clar­i­ty need­ed, re­searcher says

It’s no surprise that patient influencers are talking about their health conditions on social media. However, what’s less clear is what role pharma companies are playing, how big the patient influencer industry is, and just how is information about prescription drugs from influencers relayed — and received — on social media.

While University of Colorado associate professor Erin Willis can’t answer all those questions, she’s been researching the issue for several years and recently published new research digging into the communication styles, strategies and thinking of patient influencers, many of whom partner with pharma companies.

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Drug short­age so­lu­tions brought be­fore Sen­ate Home­land Se­cu­ri­ty com­mit­tee

With more than 300 active drug shortages, the Senate Committee on Homeland Security and Governmental Affairs had its hands full on Wednesday with multiple experts testifying on drug shortages and possible solutions.

A picture of the shortage situation. presented by Erin Fox, an adjunct professor at the College of Pharmacy at the University of Utah, explained how some patients have died due to drug shortages, including with medication errors when substitutes were dosed incorrectly or when an emergency product was not available.

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