ASCO's Pre-Abstract Previews (ABII, ALTH, ARQL, CLDX, CTIC, CGRB, LLY, EXEL, GHDX, GSK, IMGN, MEDX, MDVN, OGXI, OSIP, PPHM, PFE, SNTA, ZIOP)
The first massive round of abstracts ahead of the huge American Society of Clinical Oncology, or ASCO meeting for 2009, is due out 6:00PM EST. This is thought of as the Holy Grail of cancer conferences and these abstracts are being picked apart all night by hundreds of investors, analysts, clinicians, doctors, and even by cancer patients. We have brief data here for the following biotech and drug companies, and you can bet there will be more than this: Abraxis BioScience, Inc. (NASDAQ:ABII), Allos Therapeutics, Inc. (NASDAQ: ALTH), Arqule Inc. (NASDAQ: ARQL), Celldex Therapeutics (NASDAQ: CLDX), Cell Therapeutics (NASDAQ: CTIC), Cougar Biotechnology, Inc. (NASDAQ: CGRB), Eli Lilly and Company (NYSE: LLY), Exelixis (NASDAQ: EXEL), Genomic Health, Inc. (NASDAQ: GHDX), GlaxoSmithKline (NYSE: GSK) , Immunogen (NASDAQ: IMGN), Medarex (NASDAQ: MEDX), Medivation, Inc. (NASDAQ: MDVN), OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI), OSI Pharmaceuticals (NASDAQ: OSIP), Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), Pfizer Inc. (NYSE: PFE), Synta Pharmaceuticals (NASDAQ: SNTA), and ZIOPHARM Oncology (NASDAQ: ZIOP).
Be advised that there may be new data from many of these companies between now and the May 29 to June 2, 2009 meeting in Orlando, Florida. We have already compiled a pre-ASCO cheat sheet to get in ahead of some of these abstracts, and the brief notes are as follows:
Abraxis BioScience, Inc. (NASDAQ:ABII) will present data on multiple clinical studies of the chemotherapy agent ABRAXANE® for Injectable Suspension. Clinical results will be shown from an ongoing study evaluating three dosing regimens of nab®-paclitaxel in combination with targeted agent bevacizumab for first-line treatment of metastatic breast cancer.
Allos Therapeutics, Inc. (NASDAQ: ALTH) is not seen yet, but it gave data demonstrating the anticancer activity of pralatrexate in colon, ovarian, lung, prostate, and head and neck cancer cell lines already at the at the 2009 American Association for Cancer Research (AACR) Annual Meeting in April. At almost $6.50, its market cap is $525 million and its 52-week trading range is $3.82 to $10.19.
Arqule Inc. (NASDAQ: ARQL) is still not definite, but may have interim data from a mid-stage trial of ARQ-197 against a group of cancers that tend to effect younger adults. At $3.87, its market cap is $172.8 million and its 52-week trading range is $1.75 to $4.91.
Celldex Therapeutics (NASDAQ: CLDX) will be presenting safety and immune activity data from its first antibody-based dendritic cell targeted vaccine, CDX-1307, in combination with multiple immune modulators. At $8.26 its market cap is $130 million and its 52-week trading range is $4.24 to $19.79.
Cell Therapeutics (NASDAQ: CTIC) is set to present its Pixantrone Phase III study results in June 1. At $1.13 its market cap is still listed around $500 million. That may have changed due to a tender, but its 52-week range is listed as $0.05 to $6.50. “Volatility is our middle name!”
Cougar Biotechnology, Inc. (NASDAQ: CGRB) is set to present mid-stage data on its Abiraterone in the possible treatment of prostate cancer. The company at the end of April announced that it had initiated its Phase 3 trial of CB7630 in chemotherapy-naïve castration-resistant prostate cancer patients. At $35.00-ish, it is at the top of its $16.35 to $40.00 trading range and its market cap is $about $730 million.
Eli Lilly and Company (NYSE: LLY) will unveil data from more than 50 studies continuing to support Lilly’s leadership in thoracic cancer research. The company will present the latest research findings on ALIMTA (pemetrexed for injection), as well as GEMZAR, and enzastaurin, an investigational, oral, targeted therapy.
Exelixis (NASDAQ: EXEL) is expected to show data in XL184 from early Phase 2 studies for the treatment of progressive or recurrent form of brain cancer (glioblastoma multiforme). Bristol-Myers Squibb Co. (BMY) has a co-development pact with EXEL on this one, signed in 2008. At $4.42, its 52-week range is $2.11 to $7.35 and its market cap is $470 million.
Genomic Health, Inc. (NASDAQ: GHDX) said that its QUASAR colon cancer validation study has been accepted for oral presentation at the ASCO annual meeting and full results will be highlighted as a noteworthy abstract in ASCO’s advance ‘presscast.’ With shares under $19.00, its market cap is $535 million and its 52-week trading range is $16.00 to $27.22.
GlaxoSmithKline (NYSE: GSK) will present data on nine oncology molecules. It will show data on kidney, gastric, breast, and leukemia. TYKERB, AVODART(R), elesclomol, eltrombopag, topotecan and GSK923925 will all have presentations.
Immunogen (NASDAQ: IMGN) is a Roche partner for T-DM1 in breast cancer, and there is expected to be some final data from the phase II study. Roche is already running pivotal phase III study of the drug, so the 2010 data will be newer than what is likely seen here as ASCO. At around $7.50, it is at the high-end of its $2.47 to $8.04 range.
Medarex (NASDAQ: MEDX) is supposed to have multiple candidates that are going to have abstracts out, from melanoma to prostate cancer to malignancies. At $6.40, its 52-week range is $3.40 to $10.12.
Medivation, Inc. (NASDAQ: MDVN) is set to report on its MDV3100, which it has received permission from the FDA to initiate a pivotal Phase 3 trial of MDV3100 in castration-resistant prostate cancer in men who were previously treated with docetaxel-based chemotherapy. It will have an abstract for oral presentation and the MDV3100 abstract was selected for the ‘Best of ASCO(R)’ program, an educational initiative covering highlights. At $20.00-ish, its 52-week trading range is $11.27 to $34.40.
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) will give an oral presentation showing final survival data from a randomized Phase 2 trial evaluating OGX-011 in combination with docetaxel versus docetaxel alone as first-line chemotherapy in patients with metastatic castration-resistant prostate cancer. This is a micro-cap with a $40 million market cap, and at $7.30 it is toward the top of its $2.00 to $9.38 trading range of the last 52-weeks.
OSI Pharmaceuticals (NASDAQ: OSIP) has not been a winner and is close to its 52-week lows. But this stock is one of the mid-cap biotechs ($2 billion market cap) that investors are looking at and hoping for positive data at ASCO. It will show data from two phase III studies looking at Tarceva as front-line maintenance therapy in patients with non-small cell lung cancer, but the drug is already a second-line drug. Investors have some hope that doctors may use it for maintenance.
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) has completed enrollment in its Phase II trial evaluating bavituximab in combination with docetaxel in advanced breast cancer patients; this data from a 46-patient study will be shown in an oral presentation there. This $0.45 stocjk is a small-cap with a $102 million market cap, and its 52-week trading range is $0.22 to $0.53.
Pfizer Inc. (NYSE: PFE) will present new data on its personalized approach to oncology clinical research. This will be over the evaluating PF-002341066 across a variety of solid tumor types and anaplastic lymphoma kinase (PHASE 1 data). It also will show a Phase 2 study of figitumumab (CP-751,871) in squamous cell lung cancer.
Synta Pharmaceuticals (NASDAQ: SNTA) is presenting results from a Phase 3 clinical trial of its drug elesclemol in melanoma patients. In late February there was very disappointing data that caused its stock to fall from over $6.00 to under $2.00. Its 52-week trading range is $1.20 to $10.30.
ZIOPHARM Oncology (NASDAQ: ZIOP) will present data for all three of its clinical-stage product candidates: darinaparsin (ZinaparTM or ZIO-101), palifosfamide (ZymafosTM or ZIO-201) and indibulin (ZybulinTM or ZIO-301). ZIOPHARM is a micro-cap stock with a market cap of under $20 million. With shares around $0.75, its 52-week trading range is $0.50 to $2.73.
As a reminder, this data will be updated likely more than once per company between now and the actual ASCO conference.
JON C. OGG