Disappointing cancer data triggers sharp drop in Peregrine shares

Posted under Blog, Cancer Drugs, Companies, Diagnostics, Funding, lung cancer, Medical Devices, Medical Supply, Peregrine, Pharmaceuticals, Startups, Universities, Videos by John Carroll

On Friday morning you would have had to dig deep into Peregrine Pharmaceuticals' release on its data for its lung cancer drug bavituximab, but once in you would have found that the progression-free survival rate for patients was dangerously close to a chemo-only control arm. To be precise, the drug arm demonstrated a PFS rate of 6.7 months compared with 6.4 months for the current standard treatment. Most investors managed to make it through the details, as Peregrine's shares ($PPHM) dropped by close to a third. "The unexpected long progression-free estimate for the control arm based on central reads confounds our ability to fully interpret this secondary efficacy endpoint," the company noted. Story

Oncothyreon shares routed as Stimuvax PhIII trial soldiers on

Posted under Blog, Companies, Diagnostics, Funding, lung cancer, Medical Devices, Medical Supply, Merck KgAA, Oncothyreon, Pharmaceuticals, Startups, Stimuvax, Universities, Videos by John Carroll

Merck KGaA told analysts today that after assessing its late-stage study for the lung cancer vaccine Stimuvax in a second interim analysis, investigators were told to push on to an ultimate read-out in 2013, dashing hopes that the treatment could find a shortcut to market approval and raising fears of failure. A few minutes later, shares of Oncothyreon--which out-licensed the cancer therapy--began to slide and the slide quickly turned into a rout. By mid-morning its stock ($ONTY) had plummeted 43% as investors fretted over the implications.

Cowen's Simos Simeonidis didn't find it hard to understand the rationale for the plunge. Many investors had been praying that the company would stop the trial at this stage--which occurred after 75% of the projected patient "events" tracked in the study had occurred--and tell the world they had the efficacy data needed for an approval of the blockbuster hopeful. Continuing to the trial's projected conclusion point had to spell trouble. But he wasn't buying the argument.

"We were never believers of the argument that 'the longer the trial goes on, the better the chances of success,' given a number of high-profile failures in oncology, where trials ran much longer than expected, with the trial ending up being a failure," Simeonidis dashed off in a quick note to investors. "On the other hand, given that the p-value that this trial would have to hit in order to be stopped for efficacy at this second interim look was, in theory, less than 0.025, we are not surprised that the trial was not stopped for efficacy at this point. We definitely hear the argument that 'we are close to the completion of the trial, and the fact that the trial wasn't stopped for efficacy at 75% of the events, decreases the chances that the trial will ultimately work.'" But he went on to note that the "chances of a successful START outcomes are still intact."

The fretting and speculation can now continue until 2013.

- here's the AP report

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Lee Hood startup grabs $10M to advance class of protein-capture agents

Posted under Blog, Companies, Diagnostics, Funding, lung cancer, Medical Devices, Medical Supply, Pharmaceuticals, startup, Startups, Universities, VC, Videos by Ryan McBride

Biotech visionary Lee Hood's startup Integrated Diagnostics has reeled in fresh capital to roll into commercial mode with its novel protein-catalyzed capture (PCC) agents. The molecules are in development as diagnostic and therapeutic agents, with the bold goal of being able to simultaneously detect myriad markers in a patient's blood to detect diseases such as lung cancer and Alzheimer's.

The Seattle-based company's $10 million tranche announced today wraps up its $30 million Series A round first revealed in 2009. With the company initially seeking to bring to market blood-based diagnostics, CEO Al Luderer told Xconomy that he expects the company's first commercial product to be available in a little more than a year. To bolster its commercial aspirations, the company has named Jim Garner its chief business officer and Guy Seaton as its CFO.

"As InDi moves swiftly towards commercialization, the third tranche demonstrates the progress we've made in validating our in vitro diagnostic programs as well as our novel class of diagnostic and therapeutic molecules," Luderer said in a statement. "In two short years, we have met our two main objectives: define a new in vitro proteomic diagnostic platform capable of answering previously unanswerable diagnostic questions and; demonstrate the feasibility of a new in vivo molecular diagnostic and therapeutic molecular class: PCCs."

The company's platform is based on work from Hood's lab at The Institute for Systems Biology and it has licensed tech from Caltech as well. Its lineup of venture backers includes InterWest Partners, The Wellcome Trust and the Grand Duchy of Luxembourg.

- here's the release

- get more in Xconomy's article

Avila pockets payment in $209M lung cancer drug deal

Posted under Avila Therapeutics, Blog, Clovis Oncology, Companies, Diagnostics, Funding, lung cancer, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by Ryan McBride

Avila Therapeutics (a 2010 Fierce 15 company) has banked $4 million from partner Clovis Oncology ($CLVS). The payment was made as part of Avila's $209 million alliance with Clovis (a 2009 Fierce 15 company) struck in 2010 to develop Avila's covalent inhibitor of epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer. Avila said the payment was triggered after the FDA allowed Clovis' investigational new drug (IND) application for early trials of the compound, dubbed CO-1686, expected to kick off in the second quarter. Release