Oncology

Pipeline Table:

Project / Compound	Potential Indication	Clinical Phase
TV-1011 (OGX-011)	Solid Tumors	Phase III
StemEx® (partner - Gamida Cell Ltd.)	Hematological malignancies	Phase III
CT-011 (partner - Curetech Ltd.)	Solid tumors and Hematologic malignancies	Phase II

TV-1011 (OGX-011)

Teva and OncoGenex have entered in December 2009, into a global license and collaboration agreement to develop and commercialize TV-1011/OGX-011. TV-1011 is an antisense drug developed by Isis Pharmaceuticals Inc. and licensed to OncoGenex and designed to inhibit the production of clusterin, a protein that is associated with cancer treatment resistance. TV-1011 has completed Phase II clinical trials in prostate, lung and breast cancer and received Fast Track designation from the FDA for the treatment of progressive metastatic prostate cancer in combination with docetaxel.

Clusterin is a protein that is over-produced in several types of cancer and in response to many cancer treatments, including hormone ablation therapy, chemotherapy and radiation therapy. TV-1011 was developed to increase the efficacy of chemotherapeutic drugs and may have broad market potential to treat many cancer indications and disease stages.

Teva and Oncogenex intend to initiate during 2010, two phase III studies in first and second line hormone resistance prostate cancer patients in combination with docetaxel.

Gamida Cell's Phase III Product: StemEx® for Leukemia and Lymphoma

Gamida Cell's phase III product, StemEx, offers a novel solution for patients with various critical hematological diseases such as leukemia and lymphoma, who cannot find a matched bone marrow donor and are in need of a transplant. StemEx is composed of ex vivo expanded cord blood stem/progenitor cells which are transplanted with non-expanded cells from the same unit. StemEx production utilizes modification of the level of free copper in the cells to allow large-scale, ex vivo self-renewal of stem/progenitor cells, with limited differentiation. The StemEx product and its underlying technology are covered by two broad US patents: No. 6,887,704 and No. 09/463,320, and numerous other related patents granted worldwide.

Partnership with Teva Pharmaceuticals

StemEx is being developed by the Gamida-Cell-Teva Joint Venture which owns the commercialization and marketing rights for the product. The JV is now enrolling for the ExCell trial - a multi-center, multi-national, historical cohort-controlled pivotal phase III study to evaluate efficacy and safety of transplantation of StemEx in subjects with hematologic malignancies following myeloablative therapy (http://stemexstudy.com/). The clinical protocol received a Special Protocol Assessment with the FDA, in October 2006. The same agency granted StemEx orphan drug designation in March 2005.

Curetech's Phase II Study in Patients with Diffuse Large B cell Lymphoma

CureTech is a privately held biotechnology company which focuses on the research, development and commercialization of novel, broad-spectrum, immune modulating products for the treatment and control of cancer.

CureTech's lead drug, CT-011 is a humanized monoclonal antibody (mAb) that modulates the immune response and inhibits tumor growth and the spread of metastases. CT-011 interacts with PD-1 (Programmed Death-1), an inhibitory receptor belonging to the B7-receptor family that is expressed on lymphocytes and myeloid cells. Mechanistically, CT-011 blocks the function of PD-1, resulting in the attenuation of apoptotic processes in lymphocytes, primarily effector/memory T cells. CT-011 also augments anti-tumor activities of natural killer (NK) cells. The enhanced activities of T and NK cells are translated into the intensification of anti-tumor immune response and the generation of tumor-specific memory cells. Teva is currently investing in the study.

Phase II Study in Patients with Diffuse Large B cell Lymphoma

This is an open-label, non-randomized, multicenter, Phase II safety and efficacy study of the monoclonal antibody CT-011 administered to patients with diffuse large B cell lymphoma (DLBCL), transformed follicular lymphoma, diffuse mixed cell lymphoma or primary mediastinal large cell lymphoma, following autologous peripheral stem cell transplantation (PBSCT). Eligibility criteria require that the lymphoma was determined to be chemosensitive and has not progressed up to 30-90 days following autologous PBSCT. The study, aimed at treating 68 patients, is taking place in in selected medical centers across the US, India, Latin America and Israel.

Administration of CT-011 in this clinical study will be between 2 to 5 months following autologous PBSCT, which corresponds to the time where natural killer (NK) cells have reached optimal activity and reconstitution of T cells has been initiated. Accordingly, it is anticipated that administration of CT-011 during this period will induce immunological response by circulating NK and T cells and lead to enhancement of tumor-specific immune response and induction of tumor-specific memory cells in the study patient population.

Further details on the study and participating centers can be obtained at http://clinicaltrials.gov/ct2/show/NCT00532259