November 3, 2008
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Hightlights

  • CBLI is a biopharma company developing drugs for two major sides of the $50 billion cancer market.
  • “Curaxins” are anti-cancer agents that could act either alone, or in combination with other existing drugs, representing a market opportunity of approximately $30 billion. “Protectans” protect healthy tissues from acute stresses such as radiation and chemotherapy – which represent a $20 billion market in supportive care of cancer treatment toxicities.
  • CBLI was originally spun-out of the Cleveland Clinic, one of the top three clinics in the United States.
  • CBLI is now also partnered with Roswell Park Cancer Institute in Buffalo, NY, one of the first cancer centers in the United States.
  • The key to CBLI’s science is a proprietary understanding that healthy tissues and cancer cells die thru two different mechanisms, which enables one to treat them separately.
  • CBLI’s long-term strategy is to pursue huge unmet medical needs for its compounds. CBLI will, however, receive additional benefit and a near-term revenue stream by capitalizing on ready biodefense opportunities for its lead drug, Protectan, CBLB502 within next two years.
  • CBLI‘s lead compounds and target markets include:
      • Protectan CBLB502: Reduction of radiation and chemotherapy side effects in cancer treatment
        • Approximately $20 billion market, since about 40% of cancer market is supportive care for side effects of cancer therapies
        • First medical indications are reduction of mucositis in head and neck cancer and bone marrow transplantation for acute leukemia
        • Plan to start Phase I/II head and neck cancer trial late 2008/early 2009
      • Protectan CBLB502: Defense market for acute radiation syndrome
        • $500 million market or more annually, within the first 2-3 years based on published requirements by initial potential buyers:
          • US Department of Defense (DoD) to protect military forces
          • US Department of Health and Human Services (HHS) to protect civilian population
          • Israeli Ministry of Defense to protect both military and civilian populations
        • Won $8.9 million development contract from Department of Defense in April 2008
        • $13.5 million potential development contract from Department of Health and Human Services/BARDA pending
        • Expedited approval pathway through FDA’s two animal rule (for vaccines and other drugs where it is unethical to test efficacy in humans), when efficacy is demonstrated in two animal species and only safety is demonstrated in humans with biomarkers
        • Animal efficacy has been conducted with spectacular results. Examples include a study where 70-80% of non-human primates were saved from a killing dose of radiation (similar to Chernobyl), with one administration of CBLB502 up to 48 hours after exposure
        • Human safety studies are anticipated to begin in 2008. This will encompass two trials with healthy human volunteers: 
          • A dose escalation study involving approximately 42 patients with a 30-day follow up period, which will take approximately six months. 
          • A single dose extended trial with 600 healthy volunteers, expected to last approximately 12 months.
        • CBLI believes it has opportunities for pre-selling to DoD, HHS and Israel after initial human safety trial
      • Protectan CBLB612: Stem cell induction – blood recovery during chemotherapy
        • Potential to compete with or complement G-CSF or Neupogen, a $4 billion market drug from Amgen
        • CBLI animal studies show effects 8-10 times greater than G-CSF, even in combination therapy.
        • Currently in manufacturing and pre-clinical safety
        • Plan to start Phase I in humans in 2009
        • Potential licensing after Phase I, as study will be predictor for Phase III efficacy outcomes
      • Curaxins: Anti-cancer drugs with potential activity in broad range of cancer types
        • $30 billion + growing market 
        • Phase II data for lead compound CBLC102 in advanced hormone refractory prostate cancer trial due 4Q2008
        • Further development may include trials looking at dose escalation, other cancer types, or synergistic therapies
        • Next generation Curaxins may be up to 50x more efficacious, with same mechanism
        • Next generation Curaxins currently in manufacturing and pre-clinical safety
        • Plan to start Phase I in humans 2009
        • Potential licensing after Phase I, since have proof of concept from CBLC102, plus new chemical entities

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