UPDATED: ASCO abstracts reveal added appeal for key cancer drug prospects

Posted under Array BioPharma, ASCO, AVEO Pharmaceuticals, Blog, Cancer, Cancer Drugs, Companies, Diagnostics, Funding, kidney cancer, Medical Devices, Medical Supply, Nexavar, Pfizer, Pharmaceuticals, Pipeline, rilotumumab, selumetinib, Startups, tivozanib, Universities, Videos by john

The avalanche of ASCO abstracts last night triggered a flurry of news reports about the most notable new data on experimental therapies to be revealed ahead of next month's big meeting in Chicago. Here are a few of the highlights:

Aveo Pharmaceuticals

Aveo Pharmaceuticals ($AVEO) is concentrating on new safety data to make the case that tivozanib will be superior to Nexavar in treating kidney cancer. Investigators already announced that patients taking the treatment gained several months of progression-free survival over Nexavar. Now the biotech's abstract reveals that the experimental therapy triggered fewer cases of serious hand-foot syndrome. And the company took the initiative to tout the fact that 35% of Nexavar patients had to interrupt treatment, compared to 18% in the tivozanib crowd. 

"I think the important point is that this is a next-generation VEGF TKI with a cleaner mechanism of action that's focused more intensely on the VEGF receptor, and the VEGF pathway appears to be the most critical pathway in kidney cancer, so if you can more selectively focus on that you can produce equivalent or better efficacy with less toxicity. That's the real potential value of tivozanib," Dr. Michael Atkins, a TIVO-1 study investigator and deputy director of the Georgetown Lombardi Comprehensive Cancer Center in Washington, DC, tells FierceBiotech Executive Editor Ryan McBride.

Pfizer

The data dump included a look at some positive new mid-stage results for Pfizer's ($PFE) dacomitinib, an experimental lung cancer therapy. Three out of four patients in the study demonstrated a response to the treatment, according to Reuters. The preliminary median  progression-free survival rate for patients with advanced cases was an impressive 17 months. Three of the 92 patients in the study had to stop therapy due to toxicity. The drug inhibits a variety of proteins that spur cell division and the pharma giant has a number of studies underway to determine its overall potential.

 

Buzz: Is Bayer looking to buy Onyx Pharma?

Posted under Bayer, Blog, carfilzomib, Companies, Diagnostics, Funding, M&A, Medical Devices, Medical Supply, Nexavar, Onyx Pharmaceuticals, Pharmaceuticals, regorafenib, Startups, Universities, Videos by john

Reuters reported today that Bayer is looking to close a multibillion-euro acquisition deal, quoting sources who say that an announcement could be "imminent." And investors took one look at the news and started to bid up the share price of Onyx Pharmaceuticals--a close partner of Bayer's on Nexavar with a big stake in some promising late-stage cancer drugs.

San Francisco-based Onyx ($ONXX) has been at the center of persistent buyout rumors since last fall, when it reportedly brought in bankers to scout a strategic deal. And it would be a perfect fit for Bayer, which would like to have carfilzomib in its portfolio when the FDA hits the July 27 PDUFA date on the potential blockbuster multiple myeloma drug. Bayer also was forced to settle up with Onyx on regorafenib, a close cousin to Nexavar that Onyx now has a 20% stake in.

It's pure speculation, of course, but it's a sensible enough theory to investors, who bid up Onyx shares 8.5% today.

Bayer CEO Marijn Dekkers has done nothing to squelch the buyout rumors in recent months. "Every company of our size is looking for acquisition opportunities," he told reporters recently. "You have to do it to remain competitive."

M&A has been a key theme in the past few weeks, with GlaxoSmithKline ($GSK) looking to acquire Human Genome Sciences ($HGSI), Roche ($RHHBY) wrestling with a frustrated bid for Illumina ($ILMN), a much discussed but never confirmed attempt by Bristol-Myers Squibb to acquire Amylin and AstraZeneca's ($AZN) move to snap up Ardea Biosciences ($RDEA) in a scramble for new drug programs. There's no sign of the wave evaporating anytime soon.

Carfilzomib has an interesting history. Originally developed at Proteolix, a biotech run by Susan Molineaux, Onyx acquired it in an $851 million deal. Onyx also lists PD 0332991, a mid-stage drug, in its pipeline. 

- here's the story from Reuters

Special Report: Carfilzomib – Top 10 Late-Stage Cancer Drugs – 2012

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Aveo on a hiring spree as it preps for the launch of tivozanib

Posted under Astellas Pharma, AVEO Pharmaceuticals, Blog, Companies, Diagnostics, Funding, Kyowa Hakko Kirin, Medical Devices, Medical Supply, Nexavar, Pharmaceuticals, Pipeline, Startups, TIVO-1, tivozanib, Universities, Videos by john

Early this year, when Aveo Pharmaceuticals published the data from its head-to-head matchup between its experimental kidney cancer drug tivozanib and industry standard Nexavar, analysts were so unimpressed by Aveo's ($AVEO) margin of victory on disease progression that the company's shares took a beating. But the Cambridge, MA-based biotech has been consistently upbeat about its market potential in the lead-up to its regulatory filing, and Aveo is going full steam ahead on its expansion plans.

The fast-growing developer tells The Boston Globe that it plans to hire 120 new staffers this year in preparation for the likely upcoming launch of tivozanib, which delivered a median PFS rate of 11.9 months compared with Nexavar's 9.1 month rate in a late-stage study. Tuan Ha-Ngoc, president and chief executive officer of Aveo, also pronounced himself "delighted with the favorable safety profile observed in TIVO-1."

Despite the mixed reception, tivozanib remains one of the most closely watched late-stage cancer drugs in the industry. Its success at the FDA would mark a key turning point for Aveo, as it transforms itself from a developer into a more mature company with a drug to sell.

Aveo in-licensed tivozanib from Japan's Kyowa Hakko Kirin and partnered on the program with Astellas Pharma. Now it plans to file for an approval in the third quarter, setting up the prospects of a likely launch next year. At that point Aveo can find out just how well tivozanib can do against the market competition.

- here's the story from The Boston Globe

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Bayer bolsters blockbuster case for regorafenib with new PhIII data

Posted under Bayer, Blog, Cancer, Clinical Trials, colorectal cancer, Companies, Diagnostics, Funding, gastrointestinal tumors, Medical Devices, Medical Supply, Nexavar, Onyx Pharmaceuticals, Pharmaceuticals, Phase III, Pipeline, regorafenib, Startups, Universities, Videos by john

Bayer has racked up a fresh set of preliminary late-stage data that will bolster its plans to market regorafenib for a range of cancers. The treatment, which bears a striking resemblance to sorafenib (Nexavar), registered a successful response for gastrointestinal stromal tumors in Phase III, adding to the positive data already gathered on colorectal cancer.

Just a few months ago Bayer agreed to pay Onyx ($ONXX) $160 million and a hefty royalty slice on regorafenib to settle the biotech's claim that Bayer scientists had secretly created an analog closely matched to sorafenib, their blockbuster cancer medication. Now that that dispute has been replaced by a partnership, Bayer is eager to move ahead on a new drug program that promises to deliver more than a billion dollars a year in new revenue. Bayer has set its sights on applying for an approval on colorectal cancer with plans to expand its use for other cancers.

In this latest trial Dana-Farber's George Demetri studied regorafenib in advanced cancer patients who weren't responding to existing medications. Bayer says the treatment hit its primary endpoint on progression-free survival. The data will be detailed at an upcoming scientific meeting.

About 200 patients were enrolled in the study, with a 2-to-1 mix getting 160 mg of regorafenib daily, three weeks on and one week off. And patients in the control arm whose disease progressed were offered regorafenib.

"GIST is a difficult disease to treat. Patients treated with currently available therapies have a high likelihood that their disease will progress, and there are no remaining treatment options for those patients whose prior therapies have failed," said Ted W. Love, the EVP for R&D at Onyx. "These clinical data will show regorafenib's activity in patients with previously treated GIST."

- get the press release
- here's the story from Bloomberg

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