Cash-poor Agenus finds itself a generous partner in Gilead, shares surge

December 20, 2018 09:02 AM EST

Cash-poor Agenus finds itself a generous partner in Gilead, shares surge

Natalie Grover

Reporter

Cancer drug developer Agenus had a tough 2017 — it had to amend its antibody deal with Incyte $INCY for a quick cash infusion to overcome a painful trial setback for its lead glioblastoma vaccine, in a series of events that culminated in a restructuring. On Thursday, the Lexington, MA-based company had something to cheer about as Gilead $GILD signed on as a partner on up to five of its immuno-oncology programs. And cheer it did investors, who lifted the stock $AGEN a hefty 57% pre-market.

Under the deal, Agenus gets a much-needed $120 million upfront cash payment and a $30 million equity investment, in addition to up to $1.7 billion in potential future fees and milestones.

Agenus was in desperate need of some cash (and good news). This Gilead deal came at the right moment. Congrats to them.

— Brad Loncar (@bradloncar) December 20, 2018

Gilead will receive exclusive global rights to AGEN1423, which has an estimated IND filing by year-end 2018. The drugmaker will also enjoy the exclusive option to license two additional programs: AGEN1223 and AGEN2373. Agenus has already filed the IND for AGEN1223 and plans to do so for AGEN2373 in the first half of 2019, the companies said.

AGEN1423 is a bispecific antibody with the potential to enhance the anti-tumor activity of myeloid cells, NK cells, T cells, and cancer associated fibroblasts; AGEN1223 is another bispecific antibody; while AGEN2373 is a monoclonal antibody that is designed to boost the immune response to cancer cells by enhancing CD137 signalling in activated immune cells, according to the company’s website.

Gilead turned to the lucrative field of immuno-oncology to replace its waning hep C franchise. Last year, the big biotech swallowed Kite Pharma for nearly $12 billion to gain access to their in CAR-T therapies. More recently, it forked out $50 million upfront to Tango Therapeutics to tap into their I/O engine. With billions of cash in hand, and under new CEO Daniel O’Day who is hoping to steer the ship to greener pastures, we can only expect the trend to continue.

“By year end, our discovery platforms will have resulted in six INDs in 2018 and 13 INDs by the 1H2019,” Agenus CEO Garo Armen said in a statement.

AUTHOR

Natalie Grover

Reporter

natalie@endpointsnews.com @NatalieGrover

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

July 7, 2020 07:49 AM EDTUpdated 08:49 AM

R&D

Coronavirus

OWS shifts spotlight to drugs to fight Covid-19, handing Regeneron $450M to begin large scale manufacturing in the US

John Carroll

Editor & Founder

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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July 8, 2020 08:11 AM EDTUpdated 11:09 AM

R&D

UPDATED: Biogen shares spike as execs complete a delayed pitch for their controversial Alzheimer's drug — the next move belongs to the FDA

John Carroll

Editor & Founder

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

July 5, 2020 02:12 PM EDTUpdated July 6, 06:43 AM

Bioregnum

Pharma

Coronavirus

Which drug developers offer Trump a quick, game-changing ‘solution’ as the pandemic roars back? Eli Lilly and AbCellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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ENDPOINTS CAREERS

Director of Regulatory Affairs

Recursion Pharmaceuticals

Salt Lake City, UT

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

July 8, 2020 03:03 PM EDT

Bioregnum

R&D

Coronavirus

A new study points to $6.5B in public support building the scientific foundation of Gilead's remdesivir. Should that be reflected in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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July 8, 2020 09:24 AM EDT

Regulatory

FDA bars the door — for now — against Merck’s star cancer drug after Roche beat them to the punch

John Carroll

Editor & Founder

Merck has been handed a rare setback at the FDA.

After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

According to Merck:

Ahead of the Prescription Drug User Fee Act action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.

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July 8, 2020 07:45 AM EDTUpdated 04:02 PM

Coronavirus

Covid-19 roundup: Moderna sticks to July for its Phase III as rumors swirl; Following US lead, EU buys up Covid-19 treatments

Max Gelman

Contributing Writer

Jason Mast

Associate Editor

The Phase III might be delayed from its original early July goal, but Moderna says it will still kick off the pivotal study for what could ultimately be the first Covid-19 vaccine before the end of the month.

A day after Reuters reported that squabbling between the Cambridge biotech and government regulators had held up the trial by about two weeks, Moderna released a statement saying that they had completed enrollment of their 650-person Phase II trial and were on track to begin Phase III by the end of the month. The protocol for that study, which is meant to prove whether or not the vaccine can prevent people from becoming sick, has been finalized, they said.

Stephen Hahn, AP

July 8, 2020 02:32 AM EDTUpdated 06:49 PM

Coronavirus

Trump and Navarro press again for hydroxychloroquine. Can the FDA stay independent?

Jason Mast

Associate Editor

Tuesday morning, economist and Trump advisor Peter Navarro walked onto the White House driveway and promptly brought a political cloud back onto the FDA.

Speaking to a White House pool reporter, Navarro said that four Detroit doctors were, based on a single disputed study, filing for the FDA to again issue an emergency authorization for hydroxychloroquine, the anti-malarial pill that President Trump hyped for months as a Covid-19 treatment over the objections of his own scientists. Then, while avoiding directly calling for the FDA to OK the drug, blasted the agency. He said its decision to pull an earlier authorization “was based on bad science” and “had a tremendously negative effect” on doctors and patients.

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Head of Biology

Orum Therapeutics

Cambridge, MA

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Noubar Afeyan, Flagship CEO and Tessera chairman (Victor Boyko/Getty Images)

July 7, 2020 10:41 AM EDT

Startups

Cell/Gene Tx

Flagship execs take a lesson from nature to master ‘gene writing,’ launching a star-studded biotech with big ambitions to cure disease

John Carroll

Editor & Founder

Flagship Pioneering has opened up its deep pockets to fund a biotech upstart out to revolutionize the whole gene therapy/gene editing field — before gene editing has even made it to the market. And they’ve surrounded themselves with some marquee scientists and execs who have crowded around to help shepherd the technology ahead.

The lead player here is Flagship general partner Geoff von Maltzahn, an MIT-trained synthetic biologist who set out in 2018 to do CRISPR — a widely used gene editing tool — and other rival technologies one or two better. Von Maltzahn has been working with Sana co-founder Jake Rubens, another synthetic biology player out of MIT who he describes as his “superstar,” who’s taken the CSO role.

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July 7, 2020 06:56 AM EDTUpdated 11:07 AM

Coronavirus

Covid-19 roundup: Squabbles with government delay Moderna’s PhIII — reports; Novavax secures largest Warp Speed deal yet: $1.6B

Jason Mast

Associate Editor

Amber Tong

Editor

A much-anticipated Phase III trial for Moderna’s Covid-19 vaccine is being held up as the company delayed submitting trial protocols and sparred with government scientists on how to run the study and even what the benchmark for success should be, Reuters reported.

Moderna, the first US company to put their vaccine into human testing, was supposed to enter a 30,000-person study this month in partnership with the NIH to determine whether it can prevent infection. STAT reported last week that the trial was facing delays over the protocol, but that a July start was still possible. Neither the NIH nor Moderna ever disclosed a specific date the trial should start, but Reuters reported that the agency had hoped to begin on July 10.

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