ASCO 2015 preview

As in previous years, the upcoming ASCO meeting will be dominated by immuno-oncology with a particular focus on PD-1 antibodies. The market’s primary focus is expected to be on non-small cell lung cancer (NSCLC) with data from three large randomized trials from BMS (BMY) and Roche. Beyond lung cancer, investors will look for additional indications where PD-1 agents may have clinical utility as monotherapy or in combination with other agents.

Overall, PD-1 programs continue to generate positive data across many indications but to date clinical experience has been sobering. PD-1 antibodies may lead to durable responses in some cases but the vast majority of patients derive limited benefit or don’t respond at all. This is true in most indications with the exception of melanoma where PD-1 antibodies have a dramatic impact and combination with Yervoy appears to lead to further improvement. Below is a recap of some of the data which will be presented over the weekend. Abstract numbers and links are also provided. Continue reading

Biomarin – testing the boundaries of evidence-based medicine

As an outside observer to the rare disease community, I find the recent acquisition of Prosensa (RNA) by Biomarin (BMRN) puzzling. To me, Prosensa’s drisapersen was just another case where promising phase II results were not corroborated in phase III. This happens frequently with oncology drugs (metmab, iniparib, tivantinib, palifosfamide etc.) and typically leads to termination of the program. Judging by Biomarin’s optimism, drisapersen’s fate may be different, which raises questions regarding approval of drugs despite negative P3 outcome. Continue reading

Roche acquires majority stake in Foundation Medicine

Last night, Roche and Foundation Medicine (FMI) announced a strategic collaboration under which Roche will become the majority owner in Foundation Medicine. Roche will become Foundation’s marketing partner and intends to use the company’s tests for its drug development projects.

Roche is paying $1.03B for 56.3% of the company, representing a price per share of $50 (109% premium over Friday’s close). For investors, the deal validates the bull thesis  for Foundation (which I discussed here) as the undisputed leader of NGS-based tumor profiling. Turns out that being first matters also in the diagnostics business! Continue reading

Biotech portfolio update – 2014 summary and 2015 preview

Below is my traditional end of the year summary and a recap of catalysts for 2015. As always, I did my best to cover the most important events, let me know if I missed anything… I would like to use this opportunity and wish the readers of this blog a happy and prosperous new year.

Ohad Continue reading

Clovis Oncology – The more you ignore me, the closer I get

Earlier this week at the EORTC meeting, Clovis provided an update on rociletinib (CO-1686) and rucaparib. Not only do the data prove that both drugs are highly efficacious in the relevant patient populations, they also provide key distinguishing factors (safety profile and patient selection) relatively to competing programs. The negative market reaction exemplifies the discrepancy between the progress Clovis is making and its stock behavior. Continue reading

The AML pipeline – New approaches starting to bear fruit

AML (Acute myeloid leukemia) remains one of the few blood cancers in which no progress has been made for decades. This is in contrast to other blood cancers where novel treatments have turned fatal conditions into chronic diseases with long term remissions. Prominent examples are CML, which today has a low mortality rate and multiple myeloma where median survival is approaching 8 years and counting. The recent launch of Imbruvica and Gazyva followed by the anticipated approval of ABT-199 is expected to have a similar impact on CLL as well as on certain subtypes of B cell lymphoma. Continue reading

Clovis Oncology – still a long term core holding

Clovis (CLVS) was one of ASCO’s clear losers following safety issues for its lead program, CO-1686. Despite demonstrating robust efficacy in T790M+ lung cancer, hyperglycemia associated with the drug raised concerns about its ultimate market positioning vs. its close competitor, AstraZeneca’s (AZN) AZD9291. Continue reading

2 prominent themes at ASCO 2014

As expected, the major theme this year was (again) Immuno-oncology with a focus on PD-1 antibodies. Another theme that is gaining momentum is segmentation of tumor types to small niches based on high resolution genomic profiling. This approach can be used to identify a drug’s target population already in phase I, as exemplified by multiple presentations I will discuss below. In most cases, these drugs are ineffective in the general population but highly effective in rare subsets of cancer patients. Continue reading