Major trends in cancer drug development – Notes from TAT 2013

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

Name Change

I decided to change the name of the blog to Open Reading Frame (ORF). In biology, the term ORF refers to a sequence that can serve as a template for a protein. In other words, ORFs enable reading the human genome in the right context, just as investors in biotech are trying to do with the data we receive.

http://ghr.nlm.nih.gov/glossary=openreadingframe

Everything else stays the same. Thanks for your continued support.

Ohad

 

AVEO Pharmaceuticals– Attractive following recent de-risking events

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

Seattle Genetics – Positive read-through from Roche’s investor day

Roche’s investor day, held last week, gave Seattle Genetics’ (SGEN) investors reasons for optimism. Roche has 9 antibody drug conjugates (ADC) in clinical testing: T-DM1, powered by Immunogen’s (IMGN) technology and 8 additional ADCs (in phase I) that are based on Seattle-Genetics’ technology. These ADC programs are expected to have data readouts in the coming year, making them Seattle Genetics’ major near-term growth opportunity. Following last week’s event, it is now clear that at least 5 of the 8 ADCs are active in cancer patients.

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Synta- The Signal Looks Real

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.

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Drugs to watch at ASCO 2012

Below is a list of drugs and companies which will have meaningful data at this year’s annual meeting of American Society of Clinical Oncology (ASCO). As I will be attending this year’s conference, I will try to write updates on a regular basis. Feel free to send me questions or post them as comments to this post. Continue reading

Threshold Scores Big With Pancreatic Cancer Data

Last month, Threshold Pharmaceuticals (THLD) surprised the market with positive data for its lead program (TH-302) in pancreatic cancer. Although actual results were not published and despite several issues with the trial design, TH-302 generated what is possibly the best pancreatic cancer data set in over a decade. Continue reading

5 Winners of ASH 2011

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. Continue reading

Celldex’s Vaccine Gets a Boost

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.

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Drugs to Watch at ASCO 2011

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. Continue reading