The collaboration between Teva Pharma $TEVA and Oncogenex $OGXI for the development of custirsen (aka OGX-011, an antisense against clusterin, licensed from Isis Pharma $ISIS) was always envisioned to include three phase 3 trials, two in prostate cancer and one in non-small cell lung cancer. As I have been chronicling, there have been many false starts […]
Heat Shock Protein 90 (HSP90) inhibitors: Back in the spotlight – Part 1
Heat Shock Protein 90 (HSP90) was originally proposed as a cancer drug target in the 1990s, though no drug in this class have ever successfully completed a randomized clinical trial, let alone achieve regulatory approval. Despite repeated setbacks, HSP90 inhibitors are poised to find a significant niche in the evolving cancer treatment landscape. We will […]
CRIS – Updates from Curis 2011 year-end conference call
Curis (NASDAQ: CRIS) currently trades with an enterprise valuation slightly over $300m. The company’s best known asset is the Hedgehog inhibitor vismodegib (ERIVEDGE) which was recently approved for advanced basal cell carcinoma (BCC) and launched by Roche/Genentech ($5.5m in sales were booked in 1q-2012 representing about the first 6 weeks on the market). This article […]
MYRX – Myrexis update following earnings release
Myrexis $MYRX (spun off from Myriad Genetics $MYGN and formerly known as Myriad Phamaceuticals), announced fiscal second quarter 2012 earnings on February 9, 2012. A very brief webcast was held, though there was no question and answer session (it was not clear whether there was no one on the line to ask a question, or […]
Biotech catalysts at two upcoming medical conferences
We want to take a moment to highlight two upcoming oncology focused medical conferences that will showcase data that represent potential catalysts for several biotech companies we’re tracking. First up, we have the 2012 ASCO Gastrointestinal Cancers Symposium from January 19-21, 2012. This conference will be focused on developments in the treatment of cancers of […]
EXEL – Initiating Coverage on Exelixis
(Updated October 25th- MTC trial meets primary endpoint) Overview: Exelixis is a developmental stage oncology company with a single wholly owned compound XL184, or “cabozantinib” in Phase III trials for medullary thyroid carcinoma (MTC). This is a double blind placebo controlled trial with a final endpoint of progression free survival (PFS) initiated in 2008 after […]
YMI- Is It Investment Grade?
After taking a post-ASCO fall and sinking below $2.50, YM Biosciences is back near $3.00 with a couple assists from biotech columnist Adam Feuerstein, first naming it a top 10 pick for stocks under $300 million then in a separate article called it the best of the ten. Like many biotechs, YMI’s fortunes are tied […]
Exelixis- Why The Holdup?
Why so long to file an SPA (Special Protocol Assessment), investors wonder. An SPA in itself is not necessary, but sets up agreed upon protocols and endpoints of a pivotal trial that will be used to file for a new drug application (NDA). Having one in place may give the trial sponsor more confidence while […]
Dual-Targeted Kinase Inhibitors: The Next Wave In Cancer Treatments
Cancer drug developers have long waffled between the virtues of potent, highly specific inhibitors versus messier ones like Sutent; but there may be a middle ground. Today, multiple small molecules targeting receptor tyrosine kinases VEGF, EGFR, and HER2 have been approved along with a bunch of non-selective kinase inhibitors. The only successfully targeted non-receptor kinase […]
Exelixis May Have Competition For Its Prostate Cancer Drug
Bone metastases is a painful condition that occurs in about 90% of advanced prostate cancer patients and is associated with shorter overall survival. In the last few years, many advances have been made in the treatment of prostate cancer, with several new drugs approved and more on the horizon. Approved drugs include Provenge, Jevtana, Zytiga, […]
YM Biosciences Continues Post-ASCO Fall
YM Biosciences has taken it on the chin after its ASCO presentation failed to impress investors. Its stock is now down about 21% from a high of $3.78. The company has several projects but practically all its value is placed on lead JAK inhibitor CYT387, in development for the treatment of the blood cancer Myelofibrosis. […]
Oncogenex Jumps In Anticipation To ASCO
Oncogenex stock has been range-bound for over half a year but finally found some life today, jumping 18%. The company will be preventing three posters together with Teva June 4-6 at ASCO around its lead anti-cancer drug Custirsen. Custirsen has shown in Phase II trials the ability to extend survival and reduce pain in prostate […]
Micromet Leads In Bispecific Antibodies, Watch For DARTs
Bispecific antibodies are another front in the race to modify therapeutic antibodies for increased efficacy. Unlike normal antibodies, bispecifics are able to recognize and bind two or even three different antigens. The modified antibodies have new attributes allowing them to perform functions inconceivable for standard antibodies. The pursuit of bispecific antibodies began at least two […]
Incyte Or YM Biosciences, Which JAK To Choose?
Advances in treatment for myelofibrosis (MF) have come by leaps and bounds in the last few years since the discovery of the activating mutation JAK2V617F in myeloproliferative disorders including MF, polycythemia vera, and essential thrombocytopenia. Incyte’s JAK inhibitor, ruxolitinib (INCB018424), looks to be the first drug to reach approval for the disorder, but a slew […]
Celgene: Is It Time To Buy?
Celgene has been hit again with issues of secondary malignancies arising from prolonged treatment with its key drug, Revlimid. Shares have crumbled in the past month from $60/sh early this year to as low as $49 on February 4. It has now bounced back above $50. News of secondary malignancies has bedeviled the company since […]
Ardea Keeps On Rolling
Ardea’s stock has appreciated about 36% since mid-December, a couple weeks prior to its release of successful Phase IIb gout data. Gout hasn’t been the most exciting area of research. Until 2009, 40 years went by without a new approved treatment for the arthritic disorder. That year, febuxoxtat, marketed by Takeda in the US became […]
Oncogenex Has Novel Products and Financial Flexibility
Perhaps unprecedented in the realm of biotech companies, Oncogenex Pharmaceuticals has an astonishing four years of cash. It will end this year with approximately $83-85 million, enough to see it through the completion of three Phase III trials of lead candidate OGX-011 (custirsen) and two Phase II trials of the promising OGX-427. Oncogenex is a […]
Celgene Plunges on Revlimid Data
Celgene shares lost over 8% in regular trading to close at $55.64 Monday after the company released clinical data for its multiple myeloma drug, Revlimid, at the American Society of Hematology (ASH) over the weekend. The stock lost another 3% after hours. Revlimid is by far Celgene’s biggest selling product as well as major growth […]
