As if sentiment around Smid-cap biotechs wasn’t bad enough, Q1 provided a painful reminder of the high failure rate in biotech. The slew of disappointing results at ASH in December 2015 (which I discussed here) was followed by numerous clinical failures and regulatory setbacks. Most notable blowups came from Celldex (CLDX), Incyte (INCY), Alkermes (ALKS), Oncomed (OMED), Chimerix (CMRX), Atara (ATRA), PTC (PTCT) and Portola (PTLA). Continue reading
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
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
There was a lot of activity in my coverage universe in the last two weeks, including positive data readouts for three companies and an acquisition announcement. However, of the four cases, only two resulted in share appreciation.
Ambit – To keep or not to keep (the CVR)
Two weeks ago, Ambit (AMBI) agreed to be acquired by Daiichi Sankyo in a deal that included a $15 upfront payment and $4.5 in Contingent Value Right (CVR) per share. The CVR represents a milestone-like mechanism in which Ambit’s shareholders may eventually get additional payments equal to 30% of the initial purchase price. Continue reading
Below is my ASCO 2014 preview (better late than never…). I tried to make this recap as comprehensive as possible but it is practically impossible to cover all the interesting stuff (let me know if I missed anything dramatic). Unlike last year, I decided to group interesting abstracts based on mechanism of action rather than companies in order to provide a more holistic perspective. On top of attending the conference itself, I will try to attend as many analyst events as possible (this year I have Clovis, Roche, BMS and Incyte on my list) and include them in my post-ASCO write-up. Continue reading
A lot has been written about the immuno-oncology (cancer immunotherapy) field and how it is expected to revolutionize cancer treatment. In 2013, excitement around immuno-oncology and PD-1 antibodies in particular reached record high levels. In 2014, the trend is expected to continue on several fronts. These include potential approvals, new combination regimens, new indications and new targets.
Below is a review of key catalysts and drivers for immuno- oncology in 2014. Continue reading
Seattle Genetics (+65% in 2013)
In 2013, Seattle Genetics’ (SGEN) Adcetris reached market saturation in its approved labeling (relapsed/refractory HL), shifting market attention to label expansion. These include DLBCL, where Adcetris showed impressive efficacy in highly refractory patients (42% response rate, PFS of 5 months) and CTCL (73% response rate). Adcetris is in phase III for earlier stages of HL as well as CTCL, which are viewed as the next opportunity to grow sales. The company will outline its registration strategy for DLBCL in early 2014. Continue reading
Earlier this week, Genmab (GEN.CO) announced the first J&J (JNJ) – initiated study for daratumumab, an anti-CD38 antibody that already demonstrated phenomenal clinical activity in multiple myeloma. The announcement comes after a drought of more than a year without any new clinical trials or meaningful clinical data. From this point onwards, investors should expect J&J to accelerate daratumumab’s development with a broad and aggressive program, just like it did with ibrutinib. Continue reading
Array Biopharma – Following Puma’s footsteps
Last month Array Biopharma (ARRY) announced a licensing deal with Oncothyreon (ONTY) for ARRY-380, a selective HER2 kinase inhibitor for the treatment of HER2+ breast cancer. ARRY-380 is regarded as an insignificant program, evidenced by the modest deal size ($10M upfront) and the lack of market reaction, but this could change once investors make the connection between ARRY-380 and Puma Biotechnology’s (PBYI) neratinib (EGFR/HER2 inhibitor). Although neratinib is more advanced, backed by more clinical data and probably has broader potential, ARRY-380’s selectivity profile could differentiate it in certain clinical settings. As the market is clearly excited with neratinib (Puma has a market cap of ~$1.6B), some of the excitement could eventually be tunneled toward Array as well. Continue reading
Below is a recap of interesting data expected to be presented at the Annual meeting of The American Society of Clinical Oncology (ASCO). This year’s meeting will have a strong focus on immunotherapy (PD-1 antibodies in particular) as well as novel oral agents for hematology. Companies for which important data are expected are reviewed as well.
PD-1 takes center stage
PD-1 antibodies are by far the hottest and most active field in cancer drug development. Although technically, all data to date were from phase I studies, there is wall to wall consensus that inhibitors of the PD-1 pathway will become a cornerstone in several cancer types and a $5-$10B franchise.