Aktis Oncology Reports First-in-Human Clinical Imaging…

This past year has held some pleasant surprises for me. I was particularly intrigued by the Plexxikon buyout for $935 million, the bulk of it upfront. In a sane world, Plexxikon--which developed the remarkable new skin cancer drug Zelboraf (vemurafenib)--would have gone public. But as far as the IPO market for biotech companies is concerned, this isn't a sane world.

Plexxikon helped illustrate the potential biotechs have to distinguish themselves with great science and a sharp development focus. That kind of expertise is clearly worth a considerable sum; a maxim other companies like Pharmasset have clearly learned how to profit by. Plexxikon's experience also demonstrated the limitations developers face in a world where investors will typically turn a cold shoulder to all the risks involved in drug development.

I'm wrapping this year's run of FierceBiotech reports with a look back, and forward. The key trends of 2011--with a wide array of venture capitalists complaining loudly, the R&D revolution still at the midway point, deal-making more important than ever, and regulators feeling the heat from a disgruntled industry--will all play into 2012.

Fundamental changes can't occur quickly in biotech. It took years to get where we are today. Years more are required to see if new strategies can work or new biotechs can navigate the hazards of clinical development. Now that we've passed the 10th anniversary of FierceBiotech, we can say we've reached the second generation of the publication. And we're planning to take our coverage of the industry up a notch or two in 2012. Call it FierceBiotech 2.0.

We'll be taking our traditional holiday break next week, returning the Tuesday after New Year's Day. It's a chance for us to retool some aspects of our coverage and come back stronger than ever. We hope you enjoy your own break and will see you in the new year.

- John Carroll

Study Meets Co-Primary Endpoints: Overall Survival and Progression-Free Survival Benefit

Plexxikon's U.S. Patent for PLX4032 Issues

Berkeley, CA — January 18, 2011 - Plexxikon Inc. today announced positive data from an interim analysis of the BRIM3 trial, a large multi‐ center Phase 3 clinical study of PLX4032 (RG7204) in patients with previously untreated metastatic melanoma with the BRAF mutation. Patients treated with PLX4032 had an improved overall survival (OS) compared to patients treated with dacarbazine, the current standard of care. In addition, these patientslived longer on average without their disease getting worse, as measured by progression‐free survival (PFS). PLX4032 is an oral, novel kinase inhibitor that targets the oncogenic BRAF mutation.

 
September 15, 2010

With pharma focused on new frontline therapies, developers are relying on new technology to advance a fresh series of best-in-class therapies--anything that looks like a me-too approach won't get pushed. And Plexxikon hit paydirt when it collected a $60 million upfront from Roche in early 2009 pact covering its PLX-5568, an experimental therapy for a rare genetic kidney disease as well as additional undisclosed programs. Altogether the developer has rounded up a whopping $185 million in non-dilutive partnership funding, a stellar record in an industry that thrives on that kind of cash.

 
BERKELEY, Calif., September 3, 2008--(Business Wire)--Plexxikon Inc. today announced that it has initiated a Phase 1 human clinical trial for PLX5568, a novel kinase inhibitor targeted for the treatment of at least two major indications with unmet medical needs: pain as well as polycystic kidney disease (PKD). PLX5568 has demonstrated robust preclinical efficacy in multiple pain models, including neuropathic pain as well as acute and inflammatory pain. In addition, PLX5568 has demonstrated compelling efficacy in multiple preclinical models of PKD.