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. (more…)
Dendreon’s (DNDN) recent meltdown already sent shockwaves throughout the entire biotech arena but one segment which could suffer the most is cancer vaccine companies. Dendreon’s Provenge, the first and only cancer vaccine approved by the FDA, made cancer immunotherapy very popular in the eyes of investors, who were looking for the next Dendreon among the tens of clinical stage cancer vaccine companies.
More melanoma breakthroughs
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. (more…)
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 month, Morphosys (MOR.DE) reported its 2010 earnings, which seems like a good point of revisiting the stock. Last time I wrote about Morphosys (see article) was almost two years ago. Since then, the company has made a lot of progress but still without reaching a real value creation event. Nevertheless, Morphosys’ value proposition is now greater than ever, as it still offers a rare opportunity to invest in the fastest growing segment of the pharma industry with limited downside.
Synta (SNTA) is recuperating nicely from last year’s meltdown following the failure of its melanoma drug, elesclomol. The company is gaining momentum thanks to its early stage Hsp90 (heat shock protein 90) inhibitor, STA-9090. STA-9090 seems to garner a lot of attention in the medical community following the presentation of encouraging phase I data at ASCO last June. Based on the preliminary results, STA-9090 could be what the industry has been waiting for: A broad and potent Hsp90 with an acceptable safety profile.
The past two weeks were anything but easy for Rigel’s (RIGL) shareholders, who saw their shares crash more than 50%. Rigel started 2008 on the right foot after a 200% jump in a single day last December, following impressive data for the company’s flagship product, R788, in Rheumatoid arthritis (RA) patients. Less than one year after, Rigel has given back all its gains, following the disclosure of additional data from the same trial.
R788 was perceived as such a promising drug because it represented a highly anticipated paradigm shift in the treatment of RA: An oral drug that may be as effective as the current standard of care biologic agents. RA is a severe auto-immune disease, where the patient’s immune system attacks the body’s tissues, leading to a gradual destruction of the joints, which results in severe pains and disabilities. The rate of disease progression varies from patient to patient, but in the vast majority of cases, the disease is incurable, progressing over the patient’s lifetime. Therefore, despite the relatively low incidence of the disease, it has a high prevalence, affecting 1.3 million patients in the
Synta Pharmaceuticals (SNTA) may look like the typical American biotech company: A promising phase III compound, which is, of course, partnered with a pharma giant, two agents in early clinical stages, a list of failed trials, and an alarming cash burn rate. Nonetheless, the story behind the company’s lead product, elesclomol, is shaping up as one of the most interesting events in oncology in recent years. Elesclomol is currently in a registrational phase III trial for metastatic melanoma, a major achievement by itself, however, if successful, this trial will mark two events on a historical scale.
Similarly to what happened in Europe, Ikanos was left out of the flagship VDSL project in
As we previously explained, the market for lymphomas, targeted by Rituxan is huge, and attracts many companies. There are, however, several lymphomas for which Rituxan is not effective since Rituxan’s target, the CD20 receptor, is not expressed by these cancers. These conditions, expected to be diagnosed in more than 15,000 Americans in 2007, can be divided into two groups: Hodgkin’s lymphoma [HL] and T-cell NHL [T-NHL]. Patients diagnosed with such conditions are treated with similar regimens that are used for NHL, however, Rituxan is omitted because it has no effect. Combining chemotherapy and radiotherapy with antibodies is a well validated concept, since antibodies can increase a regimen’s efficacy without substantial side effects. As there are currently no approved antibodies for the treatment of non CD-20 lymphomas, there is a great rational behind developing such antibodies that can be co administered with existing treatments. Although market opportunity for treatments for these “non Rituxan” lymphomas is substantially smaller than the Rituxan opportunity, it is still a viable niche which is poorly addressed by most players in the field. Seattle Genetics’ CD30 program is aimed specifically at that niche.
CD30 is a well known marker for Hodgkin’s Lymphoma [HL], expressed by certain malignant cells that are present in the patient’s lymph nodes. Interestingly, these cells (Reed-Sternberg cells), represent only a small portion of the tumor but are considered to be the driving force in the creation and development of the disease. In addition, CD30’s expression in normal tissues is very limited, making it ideal for antibody-based therapy. HL is one of the most curable cancers, as historical data shows that patients have a 75% chance of achieving complete remission with a combination of several chemo drugs. However, up to 40% of patients will relapse, some of which will develop chemo-resistant tumors. The most viable option for patients whose disease has relapsed is bone marrow transplant, an aggressive treatment that is associated with high incidence of mortality and low success rates in this type of patients. Interestingly, CD30 presence has been associated with aggressive disease, making anti-CD30 antibodies a very reasonable path for treating advanced stage patients. The market for HL will never become as gigantic as the NHL market, with “only” 8190 cases of HL and 1,070 HL-related deaths are expected in 2007 in the US.
CD30 is also expressed on 30% of T-NHL, most consistently on a subtype of T-cell lymphoma called anaplastic large cell lymphoma [ALCL]. Many T-NHL lymphomas, in contrast to HL, are characterized by very poor prognosis and new treatments are desperately needed. It is hard to estimate the market opportunity on this front, but it seems like it is in the scale of several thousand cases per year in the US. Seattle Genetics is currently evaluating 2 anti-CD30 platforms: SGN-30, which is a naked antibody and SGN-35 which is an antibody-drug conjugate [ADC].
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