BIO Roundup: Agenus, FDA, Merck’s Frazier and Much More


With more than 16,000 attendees from 67 countries and hundreds, even thousands of presentations, it can be difficult to get a real grip on everything that went on at the 2019 BIO International Convention held in Philadelphia. Here’s a look at just a few of the highlights.

Agenus’ COO Speaks on the Next Level of Immuno-Oncology

At an Education Session, Jennifer Buell, chief operating officer of Agenus, spoke on the trends and obstacles in immuno-oncology. The talk was moderated by Jeffrey Bockman, executive vice president of Oncology Practice for Cello Health BioConsulting and joined by Asthika Goonewardene, senior biotechnology analyst for Bloomberg Intelligence, Bibhash Mukhopadhyay, principal, New Enterprise Associates, and Drew Pardoll, Abeloff Professor of Oncology, Medicine, Pathology and Molecular Biology and Genetics at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center.

Buell told BioSpace, “We are at a transformative phase in immuno-oncology. Let’s embrace the reality and believe in immunotherapy combination therapies aided by cutting-edge technology that brings the word ‘cure’ to cancer patients.”

She emphasizes that as the world learns more about cancer biology and tumor escape mechanisms, “we will identify new novel combination approaches offering potential to expand how many patients benefit.” For example, she said at Agenus, “we built a robust pipeline for optimal combinations for optimal efficiency—in combination with foundational I-O agents such as CTLA-4 and PD-1. These approaches have the potential to change the I-O landscape. Also, our ‘antibody engineering’ tools may bring curative benefit to a large population of patients who are not served by currently available antibodies.”

Agenus recently indicated that enrollment in two trials in cervical cancer has been faster than expected. As a result, clinical data might come by the end of this year or early in 2020. “Which means,” Buell told BioSpace, “we may be able to file our first BLA earlier than anticipated in 2020. Secondly, enrollment in our second-generation CTLA-4 trial is also proceeding.”

Buell also discussed what she sees as obstacles to broader implementation of immunotherapies, which begins with access to drugs. “At Agenus,” she says, “we have the capabilities to overcome this challenge. Our robust pipeline and integrated capabilities, allow us the flexibility to design combinations in-house, with a greater commercial flexibility.”

She also notes that there aren’t enough established biomarkers to strategize and design smart clinical trials, or predictive markers for treatment outcome. Agenus and others are utilizing artificial intelligence (AI)-based approaches to overcome those challenges.

Ultimately, Buell says, “Believe in the science and the mission. Obstacles are the given. Taking smart risks is the only way I-O will demonstrate its key to patient therapeutic success.”

States, Territories and Countries Target the Biopharma Industry

For example, Delaware Gov. John Carney spent an hour in a Q&A session about the state’s biotech sector, which includes the biotech company Incyte. Carney noted that the state had cut taxes to keep DuPont Co. and farm-supply company Corteva from leaving the state. Carney had a little extra time to speak, because he was supposed to take part in an event that also included New Jersey Gov. Phil Murphy and Pennsylvania Gov. Tom Wolf, but they were no-shows. Manuel Laboy, economic development secretary for the government of Puerto Rico spent a lot of time meeting with company representatives. For example, he told The Philadelphia Inquirer, “I met with Boehringer Ingelheim—they are one of our German companies—we want them to expand their pet healthcare operations in Barceloneta. And I’m going to see AbbVie this afternoon.”

JPMorgan CHASE’S Jamie Dimon Gives Keynote Address

On June 5, Jamie Dimon, chairman and chief executive officer of JPMorgan Chase gave the keynote address. He also had a wide-ranging chat with Jim Greenwood, president and chief executive officer of BIO, about drug pricing and healthcare costs. “U.S. healthcare costs are now almost 20% of GDP—more than twice the amount per person compared with most developing nations. Yet our outcomes are not twice as good,” Dimon noted. He noted that most of the world’s healthcare is around 9% of GDP. And while the U.S. has some of the best healthcare, it has some of the worst outcomes.

Acting FDA Commissioner Sharpless Weighs in on RWE, Drug Pricing, and Talent

In a speech, the U.S. Food and Drug Administration (FDA) acting Commissioner Ned Sharpless said that the agency is “open for business” in taking into consideration real-world evidence (RWE) for new cancer drugs. “The FDA is always going to want to see really well-designed beautiful trials with convincing endpoints,” Sharpless said in his talk. “If you can do a large [randomized controlled trial] with overall survival as your outcome, there is nothing better.”

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And in a bit of a surprise move for an FDA commissioner, Sharpless responded to a question of drug pricing, saying he was “a little disappointed” in the coverage Novartis’ gene therapy for spinal muscular atrophy, Zolgensma, received, with the focus on the $2.12 million, five-year installment-plan price tag. “This is a completely novel, almost magical miracle that ends a devastating disease for lots of little kids and the thing you care the most about is the price? I mean, really? If you’re so cynical you can’t see how wonderful and great that is […] you need to re-wear your happy hat.”

Sharpless also said that recruiting top scientists is the FDA’s greatest concern. “The FDA is well-supported to do what we need to do today,” he said. “But the problem is we are being asked to take on a lot of new stuff.”

For example, regulating software, 3D printed medical devices, e-cigarettes, and increasingly individualized therapies. “And all of those innovative areas require new expertise and knowledge,” he said.

Merck’s Frazier Defends Capitalism and Free Trade

In an on-stage interview, Ken Frazier, chief executive officer of Merck & Co., gave a strong defense of capitalism and free trade. “We have to defend capitalism in this world,” Frazier said. “We have to be able to say to people, look, you cannot have a system that develops new drugs unless you can get access to the capital. And you can’t get access to the capital unless you get a return on investment that is commensurate with the huge risk we are taking in this business.”

And Frazier went on to say that it was his job to “optimize patient access to medicine and optimize a return on investment, not to maximize either. I get criticized by people on the left, because I don’t maximize the amount of drugs I can get to people. I can’t do that and be able to raise money. And people on the right will say, why are you giving the Ebola vaccine away? I’m not trying to maximize profit.”

Phillie Goes All in on Sales Pitch

As the host of BIO, Philadelphia took the opportunity to sell itself as a great location for biopharma companies. One event was a breakout session emceed by NBC10 Philadelphia anchor Vai Sikahema that included Carl June of the University of Pennsylvania, Herve Hoppenot, chief executive officer of Incyte, Bradley Campbell, chief operating officer of Amicus Therapeutics, Maria Fardis of Iovance Biotherapeutics, and Jeff Marrazzo, co-founder and chief executive officer of Spark Therapeutics.

June noticed that with 85 hospitals and clinics, about 20% of Philadelphia’s workforce is employed in the healthcare sector. “I think what we’ve done is we’ve gone through a tipping point,” he said. “A lot of ideas used to die because we didn’t have the money to test. Now, that’s over. I think we are past that tipping point and there’s going to be this huge change in health care.”

BIO Released Bioscience Economic Development Guide

During the convention, BIO released, “Transforming Ideas into Advances: Best Practices in State and Regional Bioscience Economic Development Initiatives.” It is the fifth edition of the Best Practices Guide and reviewed all 50 states and their attempts to support the bioscience companies. It highlights key examples of state efforts and emphasizes the importance of trained workforces.

“Nationwide, our industry directly employs more than 1.7 million people,” stated BIO president and chief executive officer Jim Greenwood. “These are high-quality jobs, paying substantially more than the average U.S. wage.”

UK Unveiled Newest Life Sciences Asset

The UK Department for International Trade, Invest Northern Ireland, the Welsh Government, BIA, AstraZeneca and the British American Business Counsil of Greater Philadelphia hosted an invent, where they presented the Health Innovation Research Alliance Northern Ireland (HIRANI). HIRANI is a collaboration between academic, local government, clinical and life science organizations with plans to stimulate Northern Ireland’s life sciences ecosystem.

“We are delighted that HRANI will provide the infrastructure to ensure that the life science community can work as a collective within Northern Ireland to then raise its profile internationally and play its leading role in global collaboration,” stated Association of British HealthTech Industries (ABHI) chief executive officer Peter Ellingworth.

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