The Need for Improved Efficacy & Safety Profile in NSCLC
NSCLC is the most common type of lung cancer, accounting for more than 75% of cases (Maghfoor & Perry, 2005).
With just 15% of NSCLC patients surviving beyond five years, effective agents that improve survival and life quality are needed. When compared to five-year survival rates of 93% for prostate cancer and 86% for breast cancer, it becomes clear that the prognosis for NSCLC remains extremely poor and the NSCLC patient population is underserved. Therefore, there is an obvious unmet need for an effective first-line treatment with minimal adverse effects.
Ora Bio took up the challenge and focuses its efforts on the development of a new first-line treatment. The ORA101, a second use drug, will provide a significantly less toxic, effective, and cost effective treatment for NSCLC. Moreover, the ORA101ís oral administration will save hospital visits usually associated with IV-administered anticancer therapy.
The Need for Comprehensive Treatment of AMD
AMD is the most common cause of irreversible blindness in the western world, currently affecting 25-30 million people worldwide. Wet AMD (exudative) is less common, but is more threatening to vision than dry AMD since it leads to rapid vision distortion and causes scar tissue to form. Wet AMD can be treated with laser surgery, photodynamic therapy, and injections into the eye. All three options may be associated with repeated treatments; however disease progression and vision loss may progress despite treatments.
Off-label use of intra-vitreal Avastin (bevacizumab) has become a widespread treatment for wet AMD, along with Genentechís new drug - Lucentis. Avastin and Lucentis are delivered by intra vascular (IV) direct multiple injections to the eye, making it a very invasive and discomfortable procedure to the patients. Furthermore, the drug is associated with many toxic side effects.
As life expectancy increases, advanced AMD is emerging as a major health and socio-economic problem, severely affecting the quality of life of millions of people throughout the world. There is a present need for employing combination therapy, in an attempt to inhibit different pathways that are involved in ocular neovascularization.
Ora Bioís ORA102 is positioned as a superior option to be orally administered either as a monotheraphy or together with Avastin or Lucentis injections. This will allow to simultaneously addressing a number of pathways involved in the progression of AMD, while potentially reducing the number of invasive eye-directed injections. Such treatment will not only provide significant clinical benefit to the patient, but also reduce the economic burden inflicted by AMD treatments on the health care system by reducing the number of doctor visits associated with the disease.
Discovering new uses for existing drugs is a growing trend among pharmaceutical companies, adopted by both established and early-stage drug developers. Ora Bio believes that a diversified pipeline of projects, based on second use drugs, indications, and different phases of development will mitigate the inherent risks associated with drug development, and increase the likelihood of commercial success. For that purpose, Ora Bio is working to in-license drug candidates from scientists, universities and pharmaceutical companies. Following the in-license agreements, Ora Bio continues to support the R&D process as necessary, based on the companyís R&D teamís extensive know-how. At the end of phase II of each product development, the company will aim to sign sub-licensing agreements with pharmaceutical and biotech companies.
Since the ORA101 and ORA102 offer significant advantages, including superior safety profile and oral administration, the company anticipates a substantial market penetration and commercial success in both indications.
The international team of management, board of directors and scientific advisory board include a seasoned group of experts with vast know-how in the development of therapeutic applications and management.
Ora Bioís key personal
Mr. Gary Jacobs - Chairman
Mr. Gary Jacobs is the managing director of Jacobs Investment Company LLC (JIC). Mr. Jacobs also serves as director in several biotech companies, in NGT technological incubator, as chair of the deanís advisory council for the social sciences at University of California, San Diego (UCSD) and as chairman of the board of trustees of the Gary and Jerri-Ann Jacobs High Tech High, a charter high school. Mr. Jacobs graduated in 1979 from the University of California at San Diego with a B.A. in Management Science.
Mr. Amichai Baron, M.Sc., CTO & CEO
Mr. Baron holds significant experience in the biotechnology sector, from both the R&D and the business development arenas. Mr. Baron served as a venture capital analyst where he initiated, assessed, and analyzed medical investment opportunities. Previously, Mr. Baron served as an associate director business development and the head of an R&D group in a biotechnology company. Mr. Baron graduated the M.Sc. program in life sciences at Weizmann Institute of Science and business administration (BBB program) at the faculty of managementís, Tel-Aviv University.
Dr. Mario Guralnik, Ph.D. Head of US clinical operation
Dr. Guralnik is the managing director of Medicina, a CRO company providing regulatory & drug development services. Previously, Dr. Guralnik worked in Amgen, Inc., as Manager of Clinical Affairs, Senior Director Clinical & Regulatory Affairs and Vice President of the R&D unit at Boulder Colorado. Dr. Guralnik received his PhD in cellular biophysics from the University of California, Los Angeles.
Ora Bioís Scientific Advisory Board
Prof. Tamar Peretz, MD,
Oncology clinical director
Prof. Peretz is the head, Sharett Institute of Oncology, Hadassah-Hebrew University Medical Center at Jerusalem, Israel
Prof. Anat Loewenstein , M.D.,
Director, Department of Ophthalmology Tel-Aviv Medical Center, Israel
Dr. Adiel Barak , M.D. ,
Senior Medical Ophthalmologist, Tel-Aviv Medical Center, Israel