Andreas Katopodis, Anaveon CEO
There appears to be no shortage of cash for those in the hunt for a better IL-2. On Thursday, Swiss-based Anaveon raked in another $119 million to see its own candidate into a series of Phase II trials — and a new Big Pharma investor is getting on board.
Immunotherapies targeting IL-2 — which stimulates T-cells to multiply and attack tumors — have proven to be quite powerful against cancer over the last couple decades, but are infamous for their toxic side effects. While Proleukin, approved in 1992, helped establish the potency of IL-2, safety issues and a modest half-life thwarted its potential.
Now a broad range of companies are racing to see if they can create a next-generation IL-2 therapy sans the dangerous side effects. Anaveon’s candidate, ANV419, is designed to preferentially signal through the beta/gamma receptor of IL2, excluding the alpha receptor, in the hopes of achieving higher selectivity.
‘It helps the safety because the alpha/beta/gamma is responsible for some of the safety issues,’ CEO and co-founder Andreas Katopodis told Endpoints News. ‘It does not proliferate regulatory cells, which are protecting the cancer, and proliferates only so-called effector cells, which are anti-cancer in this case.’
The approach traces back to research done by the University of Zurich’s Onur Boyman. The Novartis Institutes of Biomedical Research (where Katopodis was director) had been partnering with the university on the project, before Novartis decided to pull out. Boyman and Katopodis launched Anaveon to continue the work in 2017.
The company secured a roughly $35 million Series A round two years later, with the Novartis Venture Fund chipping in. This time around, Pfizer’s venture arm is also hopping on board for the Series B. The round was led by Forbion, with a helping hand from Syncona, the Novartis Venture Fund, Cowen Healthcare Investments, Pfizer Ventures and Pontifax.
ANV419 is currently in a Phase I/II trial in patients with solid tumors, which is expected to read out results at AACR in April. Next up will be a series of Phase II studies in multiple indications, which Katopodis declined to reveal at this time.
‘We are taking the road of trying to do many trials in parallel, and either give a green signal to our molecule early or a red signal, (which) hopefully will never happen,’ the chief executive said. ‘We don’t want to delay the decision-making.’
Anaveon isn’t the only IL-2-focused company to swing a megaround in the last year or so.
Asher Biotherapeutics closed a $108 million Series B just a couple months ago to advance its lead candidate, an engineered IL-2 targeting CD8+ effector T cells, through a proof-of-concept human study. That came just a few months after the company hooked a $55 million Series A. And back in June, Bright Peak Therapeutics nabbed a $107 million B round to launch its IL-2 program into the clinic in 2022.
‘I cannot tell you we’re better than they are, because we don’t know all their data … nor do I know exactly what they’re doing,’ Katopodis said of the competition. ‘In the end, of course, it will be a matter of who shows efficacy and in what indication.’
Sensor-based technology for clinical trial data collection represents the latest medical paradigm shift. There are more than 700 clinical studies involving wearable devices currently underway in the United States. A study from Intel IT projects their inclusion in clinical trials will surge to 70% by 2025.
Apps, biosensors and patient-centered technologies increase visibility of comprehensive patient data. Pharma leaders anticipate the benefits of wearables to include better data (58%), faster results (33%) and lower trial costs (10%).
Crowd gathering at the Westin St. Francis for JPM in 2019 (Endpoints News)
Well, see you in January 2023.
In a surprise about-face, #JPM22 will now be fully virtual after organizers of the popular biotech conference decided to pull the plug on a live event in San Francisco given fears over the Omicron variant and a growing chorus of drugmakers opting out.
The move is no big surprise after reports swirled about some of the industry’s biggest players nixing plans to attend live and pressuring the bank to reconsider the annual meet at the Westin St. Francis. STAT reported Tuesday that Moderna and Amgen, among other large drugmakers, had already pulled out.
Richard Pazdur (via AACR)
There’s no denying that Merck’s Keytruda set a high bar for checkpoint inhibitors in development everywhere. But when it comes to the often redundant development of PD(L)-1 antibodies worldwide, FDA’s top cancer doctors Rick Pazdur and Julia Beaver are calling for more industry coordination.
‘Efforts to corral this enthusiasm should focus on increased international partnerships between sponsors of approved checkpoint inhibitors and those developing novel agents to be used with anti–PD-1 and anti–PD-L1 antibodies rather than developing ‘me too’ drugs,’ Beaver and Pazdur wrote Wednesday in the New England Journal of Medicine.
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The FDA on Wednesday not only approved the first generic versions of the decades-old diabetes insipidus treatment vasopressin, but also simultaneously offered a particularly damning rebuke of a citizen petition attempting to block the generic, while promising to pass along the matter to the Federal Trade Commission.
The response could prove troublesome for the sponsor of the brand name version of the drug, Endo’s Par Sterile Products, which brought in more than $780 million in 2020 for its brand name version of the drug Vasostrict.
Eli Lilly, Gilead, Thermo Fisher and other industry groups and nonprofits like BIO and USP are seeking some slight changes and more clarity from the International Council of Harmonisation on its new guidance related to continuous manufacturing.
The guidance, known as Q13, focuses on continuous manufacturing and its potential to lower manufacturing costs and reduce the physical footprint of manufacturing facilities compared to traditional batch manufacturing, according to USP. Continuous manufacturing also may improve quality control, lower the variability in manufactured products, and provide enhanced flexibility in production quantity and utilization of manufacturing lines.
Karthik Balakrishnan, Nodexus founder and CEO
A new company emerged from stealth this morning in San Francisco Bay, and it’s one focused on research technology.
Nodexus, a bio company that develops automated live cell characterization and isolation technologies, announced its launch this morning with a Series A netting it $30 million.
Even though Nodexus does not develop its own drugs, the Series A was led by major biotech investor RA Capital Management, with participation from California VC fund Section 32 and some previous investors. This comes at the same time Nodexus brings on a new board member: former president at BD Biosciences Bill Rhodes.
Robert Califf (Graeme Sloan/Sipa via AP Images)
As Rob Califf likely makes his return as FDA commissioner next month, his confirmation hearing yesterday offered a peek into some of the larger obstacles he’s going to face in the coming months and years.
The pandemic isn’t going away anytime soon with Omicron, and some vaccines and therapeutics may need to be tweaked or pulled from the market entirely as they prove to be ineffective against the new variant. The FDA, meanwhile, needs to get back on even footing with some longer-term direction.
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A nurse administers a COVID-19 booster shot to Joe Rigdon at a vaccination site in Eastmonte Park, Altamonte Springs. (Photo by Paul Hennessy/SOPA Images/LightRocket via Getty Images)
When Laura Burns went to get her first Covid-19 shot last January, no one had warned her that the vaccines might not work for her.
Burns, the recipient of a double-lung transplant in 2016, knew to be careful about the medicines she took. She consulted with her transplant team when the Pfizer and Moderna shots were authorized and only signed up after being told the vaccines would likely be safe for her, which they were.
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Jay Bradner, President, Novartis Institutes for BioMedical Research
John Carroll: Well, hello everybody. This is John Carroll. I’m the editor of Endpoints News, the editor and founder of Endpoints News. I’m here with Jay Bradner, the president of the Novartis Institutes for BioMedical Research. Jay, we’re going to be talking about ASH in just a second, but you’ve just recently celebrated your sixth anniversary as president of NIBR. And I’m curious, it’s such a significant amount of time for anybody to spend in one career phase. And looking back over the last six years, is everything fundamentally different about the research process and the translational arena that you’re in?
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https://endpts.com/the-next-gen-il-2-race-heats-up-as-anaveon-secures-a-megaround-with-its-sights-set-on-mid-stage-tests/
