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 →
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 →
Roche recently disclosed a decision to start phase III with GDC-0973 (formerly XL518), a MEK inhibitor licensed from Exelixis (EXEL) to Genentech 6 years ago. The trial is expected to start next month and will evaluate GDC-0973 in combination with Roche’s Zelboraf in patients with BRAF-mutated melanoma. This is an extremely positive catalyst for Exelixis, who now has a second drug in pivotal studies with a high likelihood of success and a substantial market opportunity.Continue reading →
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 →
This is the second part of an article I posted back in April. The final list includes only 9 candidates, as one of the candidates (Seattle Genetics’ SGN-75) was taken off the list after generating fairly disappointing results at ASCO. Enjoy.
Micromet (MITI), who is developing antibodies for cancer, definitely has a potential game changer in its hands. The company’s lead agent, blinatumomab (Bmab), belongs to a new class of antibodies called BiTE (Bispecific T cell Engagers). These antibodies can harness the patient’s immune system to attack tumors by redirecting T cells (the most potent immune cells in the body) against cancer cells. BiTE antibodies achieve this by simultaneously binding a cancer cell on one side and an immune cell on the other. This unleashes a potent anti-tumor immune response. Continue reading →
This year’s meeting will probably be remembered as a historical event with regards to melanoma. Last year, it was a phase III trial for BMS’ (BMY) Yervoy (ipilimumab), which was the first in history to show a survival benefit in advanced melanoma patients (discussed in my ASCO 2010 write up). This trial led to Yervoy’s historical approval 3 months ago.
This year, investigators will present studies evaluating Yervoy as well as Plexxikon/Roche’s vemurafenib in pretreated melanoma patients. Yervoy was evaluated in combination with chemotherapy while vemurafenib was compared with chemotherapy. According to BMS’ and Roche’s press releases, both studies were successful and each drug led to a survival benefit.The extent of this benefit is still unknown and will be revealed only at the conference. Continue reading →
In its earnings release last week, Seattle Genetics (SGEN) did not surprise anyone with the financial guidance and expected timelines for approval of its lead agent, SGN-35. However, on the business development front, the release did include an intriguing announcement that did not receive the attention it deserved. The company announced that Genentech recently advanced 3 new antibody drug conjugates (ADC) based on Seattle Genetics’ technology to phase I, this is inaddition to the CD22 ADC already in clinical testing.
The announcement has several important implications for Seattle Genetics. First, the number of clinical programs in its partnered pipeline instantly jumped 50% from 6 to 9. By definition, this provides Seattle Genetics with more shots on goal and increases chances of substantial milestones and royalties down the road. More importantly, it establishes Seattle Genetics’ technology as Genentech’s preferred ADC platform, an attractive position given Genentech’sdominance in oncology and ADCs in particular.Continue reading →
Last week, Sanofi-Aventis (SNY) announced disappointing results from a phase III trial evaluating iniparib in breast cancer. The drug failed to improve survival and progression-free survival (PFS) in breast cancer patients and although actual data were not published, approval is unlikely even for a subset of patients. Failed phase III trials are quite common in oncology, a field with one of the highest attrition rates in the pharmaceutical industry. Nevertheless, iniparib’s failure is particularly disturbing, as the phase III was supported by compelling results from a randomized controlled phase II trial as well as strong scientific rationale. Importantly, this trial could have broader implications as it raises questions regarding the role of randomized phase II trials as a go/no go decision point for pivotal trials.
As expected, earlier this month at the annual American Society of Hematology (ASH) meeting, Seattle Genetics (SGEN) reported positive results that will likely lead to the company’s first ever regulatory approval for Brentuximab vedotin (SGN-35). The data will transform Seattle Genetics into a commercial stage company, with an initial market opportunity of ~$250M in the US alone.In addition, the results further validate the company’s ADC (antibody drug conjugate) technology, which has broad utility and huge commercial potential. In particular, Seattle Genetics could become a market leader in hematology by next year’s meeting, with results for two additional ADCs.