Cameron Durrant, Humanigen CEO (Columbia University Technology Ventures via YouTube)

Hu­mani­gen crash­es as FDA shoots down its Covid-19 drug EUA

Hu­mani­gen, once led by the im­pris­oned Mar­tin Shkre­li, is find­ing it­self in a sim­i­lar­ly con­fined space.

On Thurs­day, the com­pa­ny said the FDA de­clined its re­quest for an EUA for its lead drug lenzilum­ab to treat new­ly hos­pi­tal­ized Covid-19 pa­tients, send­ing shares of the com­pa­ny’s stock $HGEN down by more than 50% pre-mar­ket.

Why ex­act­ly the FDA re­ject­ed the EUA re­mains large­ly un­known as the com­pa­ny of­fered few specifics.

“In its let­ter, FDA stat­ed that it was un­able to con­clude that the known and po­ten­tial ben­e­fits of lenzilum­ab out­weigh the known and po­ten­tial risks of its use as a treat­ment for COVID-19,” the com­pa­ny said in a state­ment, while not­ing that it can sub­mit ad­di­tion­al da­ta as it be­comes avail­able.

The NIH is still test­ing lenzilum­ab in com­bi­na­tion with Gilead’s remde­sivir in its AC­TIV-5/BET-B study, which Hu­mani­gen said could pro­vide fur­ther da­ta to sup­port a new EUA re­quest.

Those re­sults will be cru­cial for the com­pa­ny, which said that as of June 30, it had cash and cash equiv­a­lents of about $121 mil­lion. The long-suf­fer­ing biotech was a pen­ny stock play­er in the OTC mar­ket when Covid-19 came along and lift­ed its prospects, fu­el­ing a steep rise in share price and re­viv­ing its prospects with in­vestors. Hu­mani­gen burned through more than $100 mil­lion in cash in the first half of 2021, com­pared to about $20 mil­lion in the first half of 2020.

Hu­mani­gen CEO Cameron Dur­rant, who took the reins of then-bank­rupt Hu­mani­gen — known pre­vi­ous­ly as Kalo­Bios — from Shkre­li, said in a state­ment, “We be­lieve the on­go­ing AC­TIV-5/BET-B tri­al, which has been ad­vanced to en­roll up to 500 pa­tients, may pro­vide ad­di­tion­al safe­ty and ef­fi­ca­cy da­ta suf­fi­cient to sup­port our ef­forts to ob­tain an EUA to treat hos­pi­tal­ized COVID-19 pa­tients.”

The re­jec­tion is an about-face for the com­pa­ny, which in March tout­ed pos­i­tive re­sults from a 520-per­son, place­bo-con­trolled study that found lenzilum­ab im­proved the odds of ven­ti­la­tor-free sur­vival by 54%.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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.

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.

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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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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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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Vas Narasimhan, Novartis CEO (Gian Ehrenzeller/Keystone via AP)

No­var­tis pulls the plug on UK-based car­dio­vas­cu­lar study

Novartis is calling off a UK-based trial for Leqvio in the primary prevention of cardiovascular events in patients with high cholesterol, the company confirmed on Wednesday.

The Swiss pharma giant made the decision after “careful evaluation,” a spokesperson told Endpoints News via email. The trial, dubbed ORION-17, was planned in partnership with England’s National Health Service (NHS) and was part of the company’s strategy to establish Leqvio as a standard of care in cardiovascular disease management.

Senate health committee chair Bernie Sanders (D-VT) and Moderna CEO Stéphane Bancel (Tom Williams/CQ Roll Call via AP Images)

Mod­er­na CEO de­fends Covid-19 vac­cine price change at Sen­ate com­mit­tee grilling

Moderna CEO Stéphane Bancel faced a barrage of questions from the Senate health committee on Wednesday but emerged mostly unscathed as he defended the quadrupling of the price of the company’s blockbuster Covid-19 vaccine in the US, from about $26 per dose to $130 per dose.

What’s behind that rise in price, many senators on both sides of the aisle questioned, and Bancel offered a variety of reasons. First and foremost, the company is expecting a 90% reduction in demand for its vaccine next fall, when the FDA is likely to roll out another booster campaign to fight Covid-19.

FDA re­jects Ab­b­Vie's in­fu­sion ther­a­py for Parkin­son's, re­quests more in­fo on pump de­vice

The FDA rejected AbbVie’s 24-hour infusion therapy for Parkinson’s, saying it needs more information on a device used to administer the treatment before it can clear it.

The Chicago-area drugmaker said in a press release that the complete response letter from the agency didn’t include any requests for more efficacy or safety trials related to the drug, known as ABBV-951. The company said it aims to “resubmit the NDA as soon as possible.”

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