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 →
The American Society of Hematology’s (ASH) annual meeting is the most important event in the field of hematology. Although blood cancers represent the minority of cancer cases, the field is garnering a lot of attention thanks to great advancements over the past decade which translated to huge commercial success stories. This year’s meeting, scheduled for next month, will include important data for the following companies.
Roche’s investor day, held last week, gave Seattle Genetics’ (SGEN) investors reasons for optimism. Roche has 9 antibody drug conjugates (ADC) in clinical testing: T-DM1, powered by Immunogen’s (IMGN) technology and 8 additional ADCs (in phase I) that are based on Seattle-Genetics’ technology. These ADC programs are expected to have data readouts in the coming year, making them Seattle Genetics’ major near-term growth opportunity. Following last week’s event, it is now clear that at least 5 of the 8 ADCs are active in cancer patients.
Exelixis (EXEL) and Immunogen (IMGN) will have important phase III readouts in 2014. For Exelixis, the readout is from 2 phase III trials in prostate cancer and for Immunogen, a phase III trial in 1st line breast cancer. This raises the question – why should investors hold the stocks throughout 2012-2013?
It is important to identify near term catalysts for biotech companies, but biotech stocks tend to be volatile and their movement is not always catalyzed by fundamental events. A good example for that is the recent surge in Pharmacyclics (PCYC) despite limited news flow. Unfortunately, we sold Pharmacyclics 6 months ago for a 413% profit, under the assumption that the company had no meaningful catalysts until 2014. Since then the stock is up more than 150%…
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 →
Below is a list of drugs and companies which will have meaningful data at this year’s annual meeting of American Society of Clinical Oncology (ASCO). As I will be attending this year’s conference, I will try to write updates on a regular basis. Feel free to send me questions or post them as comments to this post. Continue reading →
Exelixis (EXEL) is starting to recuperate after last year’s clash with the FDA regarding a registration trial for its lead agent, cabozantinib (cabo), in prostate cancer. The company, which still sticks to its original plan of conducting a phase III trial using pain as a primary endpoint, is expected to announce it has enrolled the first patient in the study in the coming weeks. The trial will enroll 250 patients with bone metastases who are suffering from cancer associated pain and will evaluate cabo’s effect on bone scans and pain. Continue reading →
The annual meeting of the American Society of Hematology (ASH) was concluded last week and provided investors a peek into the future of blood cancer treatment. Below are 5 companies that presented promising data that could change the therapeutic landscape in the coming years.Continue reading →
Developing oncology drugs is getting harder and harder. The rising regulatory hurdles, the constant flow of new agents and competition for trial participants all make getting a drug to market a formidable challenge. This is particularly true in drugs for blood cancers, a field that saw tremendous progress in the past decade and is becoming very crowded. As a result, even highly effective drugs require long and expensive studies with active regimens in the control arm and survival as an endpoint. Continue reading →