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 →
Synta (SNTA) reported updated results for its Hsp90 inhibitor, ganetespib, in non-small cell lung cancer (NSCLC). Synta is evaluating ganetespib in a randomized phase II trial (the GALAXY trial) where ganetespib is given in combination with standard chemotherapy. This update comes 3 months after the previous read-out, which I discussed here.
So what does the market really think about Synta’s (SNTA) lung cancer data?2 weeks ago, the stock lost 33% in 1 trading session following interim results from the phase II trial for the company’s lead agent, ganetespib. Since then, Synta regained most of the fall, as the market digested the data with the help of supporting analysts from Jefferies and Roth Capital.
Looking at the clinical results, it is easy to understand the market’s bi-polar reaction. One the one hand, there are multiple promising efficacy signals and a good safety profile. On the other, the data set was less mature than what investors had expected.
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 →
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 →
Immunogen (IMGN) concluded the week with a market cap of ~$1B, up 200% in less than a year. This valuation is quite unusual for a company that ascribes the vast majority of its value from a 3-5% royalty stake in a single drug – Roche’s T-DM1. T-DM1, which utilizes Immunogen’s antibody-drug conjugate (ADC) technology, comprises of Herceptin conjugated to a drug payload. It is in two phase III trials and multiple phase II studies in breast cancer. If proven effective, many believe T-DM1 will eventually replace Herceptin, at least in certain treatment lines.
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 →
2011 is shaping up as a transformational year for Synta (SNTA), who is making progress on multiple fronts with its lead agent ganetespib (formerly known as STA-9090). Ganetespib is an Hsp90 inhibitor, a protein with a well recognized role in cancer. The concept of inhibiting Hsp90 to fight cancer goes back two decades, but all attempts have been beset by failures so far. As Synta’s ganetespib appears to be the first active and safe Hsp90 inhibitor, it is poised to make a big dent in the multibillion dollar oncology market. I discussed the history of Hsp90 inhibitors and Synta’s unique positioning in a previous write up.)
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.