Healthcare Economy

An Early Look at 2012 ASCO Biotech Cancer Stocks (DNDN, LLY, AMGN, ARIA, ARQL, ARRY, AVEO, BVTI, ABPI, BMY, CLDX, CYTR, CYCC, GALE, EXEL, GNBT, GHDX, IMGN, MYGN, NKTR, NLNK, ONXX, OPTR, PCYC, SGEN, SNSS, SNTA)

We are now just about two weeks away from the king of biotech and pharma events in cancer treatments.  The 2012 annual meeting of the American Society of Clinical Oncology (ASCO) is set to take place from June 1 to June 5 in Chicago.  This has been a make or break event for many cancer treatment and identification efforts.  Some of the exhibitors being featured by ASCO are Dendreon, Eli Lilly & Co. (NYSE: LLY), Genentech, Helsinn, Eisai, and Montefiore/Einstein.

24/7 Wall St. has compiled a log of companies which have already signaled in press releases that they will be presenting data or that data will be presented on their behalf at the 2012 ASCO Annual Meeting.  We have previewed more than 25 companies so far and that is not even including Big Pharma names.  As of May 18, the total abstracts submitted were 5,264 and of those there have been 2,744 which have been accepted for presentation at ASCO.  Of those accepted for presentation, some 1,859 are going to be ‘ePublication only’ for viewers.  The breakdown for the Abstracts shows that the oral presentation is currently 257 presentations and 2,487 are listed as poster presentation only.

The most presentations accepted (203) so far are focused on Genitourinary Cancer, which covers urinary tract and male genital tract as follows: Prostate cancer; Bladder cancer; Kidney cancer; Testicular cancer; Penile cancer; Nonmalignant tumors of the urinary tract and male reproductive system; and Von Hippel Lindau disease.  As of today, the fewest accepted presentations (93) cover Pediatric oncology.

Amgen Inc. (NASDAQ: AMGN), the largest independent biotech that there is, recently showed updated results from a Phase 2 study showing that treatment with blinatumomab helped achieve a high-rate of complete response in 72% of adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia treated in the study. This blinatumomab is the first of a new class of agents called bi-specific T cell engagers antibodies, which are designed to harness the body’s cell-destroying T cells to kill cancer cells.  Blinatumomab targets cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas, such as ALL. Full results of the study will be presented during an oral abstract session on June 4 at the ASCO Annual Meeting.

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) recently sold off but will will have updated clinical data from the pivotal PACE trial of ponatinib, its investigational pan-BCR-ABL inhibitor in patients with chronic myeloid leukemia (CML) on June 4.  The company said that the data will form the basis of its regulatory filings for marketing approval of Ponatinib for patients with chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblasatic leukemia.

ArQule, Inc. (NASDAQ: ARQL) and Daiichi Sankyo, Co., Ltd. (Japan) will have an oral presentation at the ASCO Annual Meeting featuring Phase 2 trial data with tivantinib as a single agent investigational second-line treatment in hepatocellular carcinoma. ArQule announced that this randomized, double-blind study met its primary endpoint in January and will now present the full results from this trial, including positive data in the pre-defined c-MET high population. Additional clinical data with tivantinib will be featured in two poster discussions and two general poster sessions.

Array BioPharma Inc. (NASDAQ: ARRY) has recently risen on its lung cancer and melanoma results.  The company has three oral presentations at the annual meeting after having already presented Phase 1 data on MEK162 in 28 patients with biliary tract cancer at the ASCO Gastrointestinal Cancers Symposium in January 2012 showing that it was well tolerated and showed evidence of clinical efficacy in this patient population, including a complete response and a partial response. Stable disease was observed in 12 patients. The company has licensed selumetinib to AstraZeneca (NYSE: AZN) and licensed MEK162 to Novartis (NYSE: NVS).

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) will present via its AVEO Oncology unit and with Astellas on June 2 in an oral session by the principal investigator at the 2012 Annual ASCO Meeting its TIVO-1 study as the first superiority pivotal study in first-line advanced renal cell carcinoma (kidney) where the investigational agent called tivozanib demonstrated statistically significant and clinically meaningful progression-free survival superiority versus an approved targeted agent (sorafenib) in advanced kidney cancer.

Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI) announced in early May that the new data from the BiovaxID® Phase II mantle cell lymphoma clinical trial conducted by the U.S. National Cancer Institute will be presented by the NCI at the 2012 American Society of Clinical Oncology Annual Meeting.

Bristol-Myers Squibb Company (NYSE: BMY) will have ten oral presentations on various approved and investigational oncology compounds.  Some will focus on YERVOY, and there will be a long-term follow-up data presentation on SPRYCEL.

Celldex Therapeutics, Inc. (NASDAQ: CLDX) previously noted that interim, topline results of the Phase 2b EMERGE study of CDX-011 in patients with advanced breast cancer will be presented in a webcast on May 23, 2012 but it is not going to get in at ASCO as it noted, “Celldex anticipated presenting these topline results at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting. Due to a clerical error in which the incorrect submission category was inadvertently selected in the on-line ASCO submission form, the abstract for the EMERGE study was not considered for acceptance. Celldex attempted to rectify this clerical error but was informed that no exceptions are made to the submission policy.”  Call this the “ASCO-less ASCO presentation.”

Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC) recently announced that its lead candidate will have new clinical data for oral sapacitabine capsules which will be presented as posters during the 2012 ASCO Annual Meeting.  The first is doe Phase II sapacitabine in MDS refractory to hypomethylating agents on Friday June 1; the second is a Phase I study of sequential sapacitabine and seliciclib in patients with advanced solid tumors on Monday June 4.

CytRx Corporation (NASDAQ: CYTR) will present data from its Phase 1b/2 clinical trial in patients with advanced solid tumors, primarily soft tissue sarcomas.

Dendreon Corporation (NASDAQ: DNDN) has been in trouble of late with soft sales and with a possible investigation, but it will be presenting positive new data on PROVENGE showing higher survival rates in different groups of PSA measurement.

Eli Lilly and Company (NYSE: LLY) recently confirmed that it will present data from several molecules that make up its clinical oncology pipeline during ASCO Annual Meeting.  The company claims to have over 30 molecules in early-stage and late-stage development to treat various types of cancer.  It will show two first-in-human Phase I studies, one on its oral NOTCH inhibitor LY900009 and the other for its oral p38 MAPK inhibitor LY2228820 dimesylate. Another oral presentation will highlight LY2780301 as a first-in-human Phase I study of patients with refractory solid tumors.

Exelixis, Inc. (NASDAQ: EXEL) recently announced that cabozantinib will be the subject of nine presentations at the upcoming Annual Meeting… The company noted that cabozantinib encompasses phase 3 pivotal trials in medullary thyroid cancer (MTC) and metastatic castration-resistant prostate cancer (CRPC). The most recent press release showed that there will now be four poster discussion presentations and one general poster presentation: oral presentations for medullary thyroid cancer, castration-resistant prostate cancer, renal cell carcinoma, and hepatocellular carcinoma.

Galena Biopharma (NASDAQ: GALE) will present “Safety and Long-Term Maintenance of Anti-HER2 Immunity Following Booster Inoculations of the E75 Breast Cancer Vaccine” and it will host a panel called “HER2 Targeted Cancer Therapies” which includes NeuVax update from the Phase 2 and current Phase 3 PRESENT trials.

Generex Biotechnology Corporation (OTCBB: GNBT) will be presenting data on its breast cancer treatment ambitions.

Genomic Health, Inc. (NASDAQ: GHDX) recently announced that 18 abstracts were accepted for presentation at ASCO which will be highlighting Breast, Colon and Prostate progress.

ImmunoGen, Inc. (NASDAQ: IMGN) recently noted that the findings in the trastuzumab emtansine EMILIA Phase III trial will be featured in an ASCO plenary session on June 3, and findings with SAR3419 administered with its Phase II dosing schedule will be reported in a poster presentation on June 4, 2012. Trastuzumab emtansine and SAR3419 are in development by Roche and Sanofi, respectively.

Myriad Genetics, Inc. (NASDAQ: MYGN) recently confirmed the presentation of a study at the ASCO Annual Meeting which will include the complete results from a study titled, “Use of a proliferation-based mRNA signature to predict outcome in early-stage non-small cell lung adenocarcinoma.”

Nektar Therapeutics (NASDAQ: NKTR) has two abstracts: one covering a Phase 3 study of NKTR-102 versus Treatment of Physician’s Choice in patients with locally recurrent or metastatic breast cancer previously treated with an anthracycline, a taxane and capecitabine; a second will be NKTR-102 in patients with platinum-resistant ovarian cancer.

NewLink Genetics Corporation (NASDAQ: NLNK) announced in April that data from its HyperAcute(R) Pancreas immunotherapy and its HyperAcute(R) Lung immunotherapy as well as its D-1MT IDO pathway inhibitor will be presented at the annual meeting.

Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) recently announced that the upcoming presentations of data highlighting Nexavar tablets, Kyprolis™ (proposed trademark for carfilzomib) and regorafenib, a Bayer-owned compound for which Onyx will receive a royalty on global net sales. On Monday, June 4, 2012 there will be an oral presentation showing the randomized Phase III trial of regorafenib in patients with metastatic and/or unresectable gastrointestinal stromal tumor progressing; on Sunday June 3 will be an oral presentation of its Phase III CORRECT trial of regorafenib in metastatic colorectal cancer.

Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) recently announced the results of a retrospective subpopulation analysis of 183 patients with cancer from its two large Phase 3 trials, which showed the cancer patients with Clostridium difficile-associated diarrhea who were treated with DIFICID® (fidaxomicin) tablets experienced resolution of their diarrheal symptoms approximately two days faster than those treated with oral vancomycin. The results are to be presented on June 2nd at the 2012 ASCO Annual Meeting.

Pharmacyclics, Inc. (NASDAQ: PCYC) will have two oral presentations and one poster discussion session: oral presentations will highlight the first reporting on data from the ibrutinib (formerly PCI-32765) Phase II CLL single agent trial in treatment naïve patients and the ibrutinib Phase Ib/II CLL combination trial with ofatumumab in relapsed or refractory patients; the poster discussion session will highlight data from the ibrutinib Phase Ib CLL combination trial with bendamustine and rituximab in relapsed or refractory patients.  The company noted that the Bruton’s tyrosine kinase inhibitor PCI-32765 abstract was selected to be presented at the “Best of ASCO Meetings.”

Seattle Genetics, Inc. (NASDAQ: SGEN) will show updated information on ADCETRIS for patients with relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). The company listed what appears to be four different abstracts.

Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) recently said along with its financial results that its VALOR design poster presentation was accepted for ASCO 2012. Sunesis will present the poster titled “VALOR, an adaptive design, pivotal phase III trial of vosaroxin or placebo combined with cytarabine in first relapsed or refractory acute myeloid leukemia” at the 2012 ASCO Annual Meeting.

Synta Pharmaceuticals Corp. (NASDAQ: SNTA) recently announced that four different presentations will be made at the ASCO Annual Meeting: “The GALAXY Trial™ (NCT01348126): A Randomized 2b/3 Study of Ganetespib (STA-9090) in Combination with Docetaxel versus Docetaxel Alone in Subjects with Stage IIIB or IV NSCLC.”; also updated Phase 1 results of Ganetespib/docetaxel combination in solid tumors; also Ganetespib activity in ALK- and ROS-driven cancer models; and Ocular toxicity profiles of Hsp90 inhibitors.

Here are some third-party reads worth looking at for more detailed ASCO presentations:

ASCO Preview: Eight Cancer Drugs to Watch at the Big Show from Xconomy.

ASCO ’12 Abstract Dump: Cancer Stocks in Focus by Adam Feuerstein at TheStreet.com.

Here was a recent list of other stocks to watch covered by an analyst in the Denver Post.

JON C. OGG

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