Post-IPO Biotechs Have News, But Big Pharma Drives the ASCO Boat

6/6/14Follow @alexlash

As often happens, industry news from the annual American Society of Clinical Oncology (ASCO) meeting, which ended Wednesday in Chicago, was dominated this year by Big Pharma. It’s not surprising—even with the advent of targeted cancer therapies that promise more precise treatment of smaller patient populations, clinical trials require big budgets.

No drug giant had more to lose than AstraZeneca (NYSE: AZN), which heading into ASCO had just rejected a massive bid from Pfizer (NYSE: PFE). The rationale: Pfizer undervalued its pipeline, so ASCO was a timely venue for AZ to tout the oncology side of its house.

Among its highlights: results from an early-stage study of its PD-L1 inhibitor MEDI4736, and plans to expand its immuno-oncology pipeline with various new combination regimens. AZ also closed the gap with Clovis Oncology (NASDAQ: CLVS) in lung cancer when side effects associated with its AZD9291 compared favorably to those associated with Clovis’s CO-1686.

Its anti-CTLA-4 drug, tremelimumab, is in a pivotal study for mesothelioma that’s expected to produce results in 2016. AstraZeenca is also combining tremelimumab with MEDI4736 in lung cancer, trying to one-up a prospective treatment regimen of Bristol Myers Squibb’s (NYSE: BMY) PD-1 inhibitor nivolumab and CTLA-4 drug ipilimumab (Yervoy). (Bloomberg News kicked off ASCO last week with this solid overview of Big Pharma’s big bet on cancer immunotherapy.)

With the recent flood of biotechs going public the past 24 months, we figured we’d see several members of the “Class of ‘13” (we’re stretching the calendar a few months in either direction) make some noise at ASCO, too. After all, it’s been an unprecedented influx of public money into biotech, and what do public investors want to see more than near-term validation of their investments?

Indeed, several firms from the recent IPO window were on the ASCO docket, but mainly with early-stage news that didn’t move the share-price needle. Redwood City, CA-based OncoMed Pharmaceuticals (NASDAQ: OMED), which has a crowded pipeline, checked in with data from three Phase 1 trials. Karyopharm Therapeutics (NASDAQ: KPTI) discussed data from its lead program selinexor in five different Phase 1 trials. And Cerulean Pharma (NASDAQ: CERU), one of the most recent biotech debuts with an IPO two months ago, had news about its lead candidate, CRX-101, in three different studies.

Among biotechs that enjoyed an ASCO bump was New York-based TG Therapeutics (NASDAQ: TGTX), which has jumped 37 percent since abstracts first came out on May 14. TG presented data from Phase 1 trials of its CD20 antibody, ublituximab, and a P13 kinase inhibitor called TG1202.

Princeton, NJ-based Advaxis (NASDAQ: ADXS) has seen shares rise about 20 percent since the conference began on May 30. Advaxis provided final results from a Phase 2 study of ADX-011, a cancer vaccine, in women with recurrent cervical cancer. The vaccine also recently received orphan drug designation from the FDA.

Not all the news was about drugs. Foundation Medicine (NASDAQ: FMI) has a commercially available cancer diagnostic, FoundationOne, but insurers have yet to be swayed it’s worth reimbursement. So Foundation, which tapped considerable IPO proceeds last September, used ASCO to show that FoundationOne can change treatment outcomes for patients. The company released a couple studies showing that physicians have recommended switching therapies based on the FoundationOne test (27.3 percent, or 36 of 132 patients evaluated with solid tumors), and that the test can pick up new genetic alterations in various pediatric cancers. Foundation said in a statement that it expects those switch rates to increase as more targeted cancer therapies are approved (the trial began in 2011). Whether or not these efforts help patients live longer, of course, is the next step for Foundation.

It’s also important to remember that the clinical cancer world doesn’t always revolve around ASCO. Many members of the recent biotech IPO class, like Epizyme and Agios Pharmaceuticals, didn’t present there. Agios instead will provide an update for one of its lead programs at the European Hematology Association’s annual meeting in a couple weeks.

This story was co-reported by Ben Fidler.

Photo courtesy of Bert Kaufmann via a Creative Commons license.

Alex Lash is Xconomy's National Biotech Editor. He is based in San Francisco. Follow @alexlash

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