Buying AVEO ahead of FDA panel

AVEO’s (AVEO) controversial drug, tivozanib, will face an FDA’s advisory committee (Oncologic Drugs Advisory Committee or ODAC) on May 2nd. Despite the negative sentiment around AVEO, I still view tivozanib as an approvable drug with a compelling risk/benefit profile and expect an overwhelmingly positive ODAC recommendation. The FDA does not always follow the ODAC’s recommendations, but in tivozanib’s case it should be regarded as an important risk mitigation event. Continue reading

ArQule’s Akt inhibitor – A fast-follower call option

Following the failure of ArQule’s (ARQL) tivantinib in lung cancer, market attention shifted to the ongoing phase III in liver cancer. With a $173 market cap and $130M in cash, the market ascribes little value to tivantinib. In addition, the market completely ignores 2 additional clinical programs (both in phase I):  ARQ092 is an Akt inhibitor that was developed with Daiichi Sankyo (Daiichi recently returned rights to ArQule) and ARQ087 is an FGFR inhibitor. Continue reading

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

Incyte’s Jakafi is likely a $1B drug

Predicting future sales for a given drug is always challenging, let alone in a case like Incyte’s (INCY) Jakafi (Marketed in Europe under the name Jakavi by Novartis), which is the first drug in history to receive approval for myelofibrosis (MF). With no precedents to serve as a benchmark, it is still unclear how big Jakafi can be. However, based on Incyte’s recent 2013 guidance and remarks from the head of Novartis’ (NVS) oncology business unit, it has a high likelihood to reach $1B already in 2016.
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Onyx – A “must own” biotech for 2013

After a great 2012, Onyx (ONXX) is well positioned as one of the few remaining commercial stage biotech companies with a diverse oncology pipeline. The company has 4 assets: Nexavar (co marketing agreement with Bayer), Kyprolis (wholly owned in US +EU), Stivarga (20% royalties from Bayer), PD-0332991 (~7.5% royalties from Pfizer).

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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

 

Biotech portfolio update – 2012 summary and 2013 outlook

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

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

Top picks for ASH 2012

The American Society of Hematology’s (ASH) annual meeting is the most important event in the field of hematology. Although blood cancers represent the minority of cancer cases, the field is garnering a lot of attention thanks to great advancements over the past decade which translated to huge commercial success stories. This year’s meeting, scheduled for next month, will include important data for the following companies.

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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

Winners of ESMO 2012

Synta

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.

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