AVEO’s (AVEO) controversial drug, tivozanib, will face an FDA’s advisory committee (Oncologic Drugs Advisory Committee or ODAC) on May 2nd. Despite the negative sentiment around AVEO, I still view tivozanib as an approvable drug with a compelling risk/benefit profile and expect an overwhelmingly positive ODAC recommendation. The FDA does not always follow the ODAC’s recommendations, but in tivozanib’s case it should be regarded as an important risk mitigation event. Continue reading
Earlier this month, I attended the TAT (Targeted anticancer therapies) congress in Paris. This conference focuses exclusively on targeted therapies for cancer, one of the most active areas in drug development. As a small conference (~500 participants), it does not generate a lot of high profile clinical data, still, it is a great opportunity to “feel the pulse” of oncology drug development. Speakers include clinical oncologists, basic scientists and industry researchers, which provide a fairly broad spectrum with respect to existing and upcoming trends.
Here, I focus on three major themes from the meeting: PD-1 inhibitors, antibody drug conjugates (ADCs) and cancer metabolism. Continue reading
In the last post of the year, I will try to provide a status update as well as key 2013 milestones for the stocks in our portfolio. I would like to use this opportunity to wish everybody happy holidays and a happy New Year.
Seattle Genetics’ (SGEN) main task is expanding Adcetris’ use outside of approved niche indications (Hodgkin’s Lymphoma and ALCL). As an anti-CD30 antibody-drug conjugate (ADC), Adcetris has potential utility wherever CD30 is expressed by tumors. Continue reading
AVEO (AVEO) is down 45% in less than 3 months due to uncertainties around its lead program, tivozanib. Tivozanib was recently submitted for FDA approval in renal cancer based on positive phase III data showing superiority over the approved drug, Nexavar. Although tivozanib led to superior progression-free survival (PFS) and was substantially safer than Nexavar, investors are concerned about Regulatory and market positioning risks. Continue reading
BMS’ PD-1 antibody – As good as it gets
The biggest news at this year’s ASCO came from BMS’ (BMY) PD-1 antibody, BMS-936558. This antibody belongs to a new class of antibodies that stimulate patients’ immune system to attack cancer. This approach has been recently validated with another BMS antibody, Yervoy, which was approved last year for melanoma.
Based on results presented at the meeting, BMS-936558 is superior to Yervoy by any measure. In fact, it is probably one of the most promising oncology drugs ever to be tested in humans. It induces tumor shrinkage in a substantial portion of patients, creates an immune response that keeps the disease under control for long periods and it does so with limited side effects. To make things even better, there might be a way to pre-select patients who are more likely to respond to this agent. Continue reading
The ESMO meeting is the most important oncology conference in Europe. This year in particular, it included very interesting data that affected the sentiment towards many biotech companies. Here, I intend to focus on what I view as three clear winners from the conference: Seattle Genetics (SGEN), Arqule (ARQL) and Dendreon (DNDN).
Seattle Genetics is about to conclude the best year in its history, since it was incorporated 13 years ago. The company’s lead agent, SGN-35 (aka Brentuximab Vedotin), generated astonishing results in two types of blood cancers earlier this year. Based on the results in Hodkin’s Lymphoma, SGN-35′s approval seems inevitable, even though results are not from large randomized studies. Unlike T-DM1′s case, Seattle Genetics negotiated a special protocol assessment (SPA) with the FDA, implying that the trial design and endpoints are acceptable by the FDA.
Earlier this week, Immunogen (IMGN) got closer than ever to having a commercial product in the market. During its quarterly call, Roche removed the regulatory overhang on T-DM1’s near term fate after it disclosed plans to file for T-DM1’s approval already this year. The submission will be based on results from a recently announced phase II trial where T-DM1 demonstrated overwhelming activity in late stage breast cancer patients. Until now, it was unclear whether the FDA would be willing to consider approval based on a single arm phase II trial. Roche’s decision implies the FDA gave its unofficial and non-binding blessing for the accelerated approval.