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Here it is in full. tremendous report.The ProActive...

  1. 58 Posts.
    Here it is in full. tremendous report.
    The ProActive Network
    Social Media Release
    New Client - Prima BioMed, Ltd. (ASX-PRR)
    Cancer Drug Gem in Small Package
    04.18.2011? The field of cancer immunotherapy is littered with products that have showed early efficacy only to fall short in Phase III trials or to tank in the final stages of FDA approval. Prima Biomed, Ltd ($PRR-AX) of Australia is developing Cvac? as the world?s first vaccine therapy for ovarian cancer ---- one of the more lethal malignancies for which the standard of care (surgery and chemo) has not changed in decades.
    Prima BioMed appears to have a solid position in this technology:
    ? Depth and experience in management for drug approval --- as well as an scientific advisory team including Prof Ian Frazer, co-inventor of Merck/CSL?s ($MRK) cervical cancer vaccine, Gardasil?
    ? Targeted cancer therapies are a hotbed of licensing and M&A activity (See Healthcare Megatrends --- Targeted Cancer Drugs) so the future progress of Prima BioMedical is likely to attract a lot of Big Pharma scrutiny and interest.
    ? Only 20-30% of patients with cervical cancer with late diagnosis survive for 5 years, so a treatment so that a safe and effective treatment would seem to have a tactical advantage in the FDA approval process. The global market size for ovarian cancer approximates $3.6B.
    ? Cvac? has been granted "orphan status" by the FDA, which allows it seven years of exclusivity from commercial launch. It also receives priority review by the FDA, which waives its fees for orphan drugs.
    ? CVac? is based on the same cellular technology as Provenge from Dendreon Corp. ($DNDN). The recent approval of Provenge for asymptomatic or minimally symptomatic metastatic hormone-refractory prostate cancer would seem to validate the underlying concept. Like Provenge, CVac? utilizes activates dendritic cells to stimulate a cellular immune response, rather than just an antibody response.
    ? Prima has completed Phase IIa clinical trials with CVac? in Australia in 28 patients with advanced disease, and the company has filed with the FDA for an "investigational new drug" application to start a Phase IIB clinical trial in the U.S.
    ? CVac? has broad potential because it is directed toward the mucin-1 antigen and thus may be effective against other cancers that overexpress mucin-1 such such as ovarian, breast, lung, colon and pancreatic cancer.
    ? Phase IIa trial results showed that 21% of patients responded to therapy in patients with incurable ovarian cancer (life expectancy at least 6 months). This is not dissimilar to the response times of some of the most successful cancer therapies when they were at this stage of development incuding Avastin? (Roche $ROG.VX), Aromasin? (Pfizer $PFE), Iressa? (AstraZeneca $AZN), and Provenge? (Dendreon $DNDN).
    ? Prima is hedging its bets with respect to the FDA approval process by pursuing fast-track commercialization in other jurisdictions with a registration study planned for Europe, with patient recruitment commencing by Q3 2011.
    ? Prima is currently well funded; $40M committed for current work.
    Stock. Prima BioMed is applying for NASDAQ listing but will continue to trade on the Australian Securities Exchange. The current market cap of roughly $200 million is large enough to attract broad institutional investor interest in the stock.
 
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