Apr 21, 2016

Posted by in Biotech Stocks | 0 Comments

Stocks on Trader’s Radar: Medivation Inc (NASDAQ:MDVN), Galena Biopharma Inc (NASDAQ:GALE), Celgene Corporation (NASDAQ:CELG)

Stocks on Trader’s Radar: Medivation Inc (NASDAQ:MDVN), Galena Biopharma Inc (NASDAQ:GALE), Celgene Corporation (NASDAQ:CELG)

Medivation Inc (NASDAQ:MDVN) plunged -1.48% and ended at $51.38. The total traded volume was 2.82 million shares and market capitalization arrived at $8.25 billion. The stock has a 52-week high price of $66.90 and its 52-week low was recorded at $26.41, while during last trade its minimum price was $50.91 and it gained the highest price of $52.84.

Medivation Inc (NASDAQ:MDVN) on April 20, 2016 announced that data from an investigator-sponsored Phase II study of enzalutamide, an androgen receptor inhibitor, was presented at the American Association for Cancer Research (AACR) Annual Meeting 2016 in New Orleans. Preliminary data from a 12-patient subset demonstrated that treatment with enzalutamide alone resulted in potential immune-activating properties in patients with non-metastatic castration sensitive prostate cancer. The primary objective of the study was to evaluate the effect of a short-course of enzalutamide (three months) alone or in combination with a therapeutic cancer vaccine (PROSTVAC®) on prostate specific antigen kinetics four months after completing enzalutamide. Data from 12 patients treated with enzalutamide alone was presented by the study’s lead investigator Ravi Madan, M.D., Principal Investigator of the Study and Clinical Director, Genitourinary Malignancies Branch at the National Cancer Institute.

The effect of enzalutamide on peripheral immune cells was measured in 12 patients who were receiving enzalutamide alone (160 mg daily for 84 days, without androgen deprivation therapy). Measurements of CD4+ and CD8+ T cells, T-regulatory cells (Treg), B cells, conventional and plasmacytoid dendritic cells (cDC, pDC), natural killer cells (NK), natural killer T cells (NKT), and myeloid derived suppressor cells (MDSC), as well as 114 subsets related to immune cell maturation and function, were evaluated. Peripheral blood mononuclear cells were also assessed for T cell receptor excision circles (TREC) to identity recent thymic emigrants and to determine changes in global gene expression.

Results showed that treatment with enzalutamide induced several notable alterations in immune cells consistent with general immune activation. These changes occurred early following treatment, and included an increase in NK cells, decreased frequencies of MDSCs with a suppressive phenotype and decreased frequencies of both CD4+ and CD8+ T-lymphocytes expressing the immune inhibitory checkpoint molecule CTLA4. Additionally, treatment with enzalutamide increased TREC levels by more than 75% in 7 of 12 patients compared with pre-therapy levels (p=0.012). Gene expression analysis of PBMCs corroborated these findings, showing that enzalutamide increased activation of interferon-gamma signaling and related immune-activating pathways. These immune-activating activities for enzalutamide support evaluating the drug in combination with a number of immune-stimulating treatments including checkpoint inhibitors and vaccines.

Enzalutamide is being developed through a collaboration between Medivation and Astellas. Enzalutamide, which is known by the brand name XTANDI®, is currently approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).

Galena Biopharma Inc (NASDAQ:GALE) reported the decrease of -6.80% to close at $1.37 with the overall traded volume of 2.79 million shares. Its market capitalization on last close reached to $244.01 million. Its beta value stands at 1.63 times. The company has the total of 181.75 million outstanding shares. Its intraday-low price was $1.36 and its hit its day’s highest price at $1.46.

Galena Biopharma Inc (NASDAQ:GALE) on April 19, 2016 announced that data from the booster phase of the Company’s GALE-301/GALE-302 Phase 1/2a clinical trial was presented at the American Association for Cancer Research (AACR) Annual Meeting.

The poster, entitled, “Comparing an attenuated booster (E39’) vs. E39 booster to potentiate the clinical benefit of the folate binding protein (FBP)-derived vaccine (E39 + GM-CSF) in a phase I/IIa trial to prevent recurrence in endometrial (EC) and ovarian cancer (OC) patients,” was presented by Dr. Doreen Jackson from the San Antonio Military Medical Center.  In the Phase 2a portion of the trial, patients were randomized to two different boosters: E39 (GALE-301), versus E39’ (GALE-302). The purpose of the study was to evaluate the immune responses and determine which booster, if either, would provide a sustained immune response and potentially longer disease free survival (DFS) rates.

The use of the wildtype peptide (GALE-301/E39) demonstrated the same tolerable safety profile as the attenuated peptide (GALE-302/E39’) with only Grade 1 local reactions and minimal Grade 2 toxicities.  Importantly, the percentage of patients who received two booster inoculations and remained disease free was significantly better in the drug treatment arm, versus the control arm (p=0.02), regardless of which booster was used. At median follow up of 16 months, the boosters demonstrated equivalent efficacy after two booster inoculations with an estimated, two-year DFS rate of 66.7% (GALE-301 n=7, GALE-302 n=7) in each booster arm versus 36% (n=22) in the control arm.

Celgene Corporation (NASDAQ:CELG) moved up +0.19% to settle at $106.73. Its total traded volume during last trading session was 3.90 million shares. The overall market worth of this company is about $82.41 billion. The 52 week range of the stock remained $92.98 – $140.72, while its day’s lowest price was $105.86 and its hit its day’s highest price at $107.35. The beta of this stock currently stands at 1.19.

On April 11, 2016, Celgene Corporation (NASDAQ:CELG) and Juno Therapeutics, Inc. (JUNO) announced that Celgene exercised its option to develop and commercialize the Juno CD19 program outside North America and China. With the exercise of this option, Celgene will pay Juno a fee of $50 million and the companies will now share global development expenses for products in the CD19 program. Celgene has commercial rights outside of North America and China and will pay Juno a royalty at a percentage in the mid-teens on any future net sales of therapeutic products developed through the CD19 program in Celgene’s territories. Juno retains commercialization rights in North America and China.

Juno currently has three CD19-directed product candidates in clinical development, including JCAR015, JCAR017, and JCAR014. JCAR015 is in a Phase II trial for adults with relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL). JCAR017 is in two separate Phase I trials, one in pediatric patients with r/r ALL and another in patients with r/r non-Hodgkin lymphoma (NHL). JCAR014 is in a Phase I trial in three different indications, adult r/r/ ALL, r/r NHL, and r/r chronic lymphocytic leukemia (CLL), as well as a trial in combination with AstraZeneca’s investigational programmed death ligand 1 (PD-L1) immune checkpoint inhibitor, durvalumab.


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