Pharma Strategy Blog

We spend a lot of time researching biotechs in the oncology space and thus it occurred to me that many of them are located around the San Francisco bay area as a hub, in a landscape dominated by Genentech, now part of the Roche empire.  San Francisco has good logistic connections, a lot of roomy office space, active research in several universities and provides a pleasant haven for science, academia, research and industry to all flourish.

There are far to many to mention in one blog post, but here is a quick update on some of the companies we’ve been following over the last couple of years in the cancer market (in no particular order):

Sunesis ($SNSS): Got off to a rocky start with the early development of voreloxin, but have refocused the clinical trial designs with some interesting phase I and II results to date in AML.  The compound, a quinolone derivative that acts as DNA damaging agent, is also being developed in platinum resistant ovarian cancer.  I’d like to see some comparative data in AML at some point, or at least a study with just a standard chemo in it compared to the standard + voreloxin, otherwise it will be hard to see exactly what the agent actually adds.

Poniard ($PARD): Poniard are developing a new generation platinum agent, picoplatin, that seeks to offer equivalent efficacy as existing platinums, but with less neuropathy that is common to existing treatments such as oxaliplatin.  

Picoplatin got off to a good start with trials starting in small-call lung cancer (SCLC) and colorectal cancer (CRC).  Early results looked promising.  However, results from the pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial of in the second-line treatment of SCLC did not meet its primary endpoint of overall survival.  The analysis, based on 320 evaluable events (patient deaths), showed a hazard ratio of 0.82 with a p value of 0.089.  The company felt that the main reason for the discrepancy lay in pateints in the placebo arm receiving more chemotherapy than the picoplatin arm after relapse occurred.

A randomised, controlled Phase 2 trial of picoplatin in metastatic CRC patients is ongoing. The study recently met its primary objective.  Picoplatin, in combination with 5-fluorouracil and leucovorin (FOLPI regimen), was associated with a statistically significant reduction in neurotoxicity (p <0.004) compared to oxaliplatin given in combination with 5-fluorouracil and leucovorin (FOLFOX regimen).  The results also suggested that FOLPI had similar efficacy to FOLFOX.  More data is expected at ASCO in June.

Nodality: Is an interesting technology company that is developing next generation diagnostics by characterising cell signalling pathways.  The concept is based upon proprietary flow cytometry technology, originally developed in the laboratory of Professor Garry Nolan and licensed from Stanford University.

Flow cytometry has been widely used to characterise cell surface markers on hematologic cells. Nodality are now utilising advanced quantitative flow cytometry to define the signalling networks within individual cancer cells, in order to enable biologically-driven clinical decision making for cancer treatment.  Essentially, this technology can be used to determine changes before and after cancer treatment, eventually leading to the identification of appropriate biomarkers for treatments.

BiPar Sciences: Are developing BSI-201, a PARP inhibitor for the treatment of triple negative breast cancer and ovarian cancer.  They signed a deal with sanofi-aventis last year and are now a wholly owned subsidiary.  It looks to be a promising agent, albeit with a short patent life.  The race to market against KuDos/AstraZeneca will be an interesting one to watch over the next couple of years.  How will the two PARP inhibitors stack up?  Time will tell.  They also have a follow on PARP inhibitor (BSI-401) in development, and an anti-tubulin compound.

Exelixis ($EXEL): Have been in the news frequently over the last few years as they license out their in-house compounds to companies such as BMS, GSK, sanofi-aventis and Genentech.  Their stated goal is to develop first in class or best in class compounds through their own discovery and clinical programs.  The pipeline runs an interesting gamut of targeted agents to various pathways, including MET, VEGF, PI3-kinase, IGF-1R, MEK, RAF and others.

The most advanced agent (XL184) is in phase III development for metastatic medullary thyroid cancer (MTC) with BMS (aka BMS-907351).  This is a very slow growing cancer, so a rapid development is unlikely.  The compound is a multi-kinase inhibitor of VEGFR, MET and RET.  It is also being tested in phase I/II trials for recurrent glioblastoma (GBM), non-small cell lung cancer (NSCLC) in combination with erlotinib and a phase I trial in advanced malignancies is also ongoing.

BMS probably have the biggest investment in Exelixis, having licensed at least 5 of their compounds in cancer.  Time will tell if this proves to be a smart decision or not.

Plexxikon: Are a private Berkeley based company who focus on the discovery and development of small molecules in several therapeutic areas including cardio-renal disease, CNS, inflammation, metabolic disease and oncology.   They are most known for their BRAF inhibitor, PLX4032, which is being developed for the treatment of malignant melanoma. BRAF is thought to be mutated in approximately half of melanomas and may be one of the drivers of the disease.  

Plexxikon signed a deal to develop the agent with Genentech, now Roche, and phase III trials in melanoma were announced last month. This is definitely a promising agent to watch out for.

Facet Biotech ($FACT): have been in the news recently after Biogen Idec tried to purchase the company, but offers have been repeatedly rebuffed and dismissed as inadequate.  The company was launched as a spin-off from PDL BioPharma, Inc in December 2008.

Facet are developing several compounds in the multiple sclerosis and cancer markets, including volociximab (solid tumours) and elotuzumab (myeloma).  The MS agent in phase II, daclizumab, has received most attention but the oncologic agents are too immature to determine how effective they might be yet.  Definitely one to watch out for though, if a white knight in the form of a big pharma with cash descends in the near future.  The most obvious companies with cash and a declared growth by acquisition strategy are BMS and Celgene, but I’m not sure Facet would be a good fit for either.  On paper, Biogen Idec was probably a better option.

There are plenty of other interesting cancer companies in the Bay Area, but these are a few that I’ve been watching.  More will be covered in the next update of the cancer market in the area.  New data will no doubt be presented at the forthcoming American Society of Clinical Oncology (ASCO) meeting in June.