Memgen, LLC announced the presentation of clinical and preclinical results for its lead product, ISF35, during the 52nd Annual Meeting of the American Society of Haematology (ASH) in Orlando, Florida. The research and clinical development of ISF35 announced today was led by Januario Castro, MD, and Thomas Kipps, MD, PhD, both at the University of California, San Diego (UCSD).

A poster presentation (Abstract 1472), entitled Ad-ISF35-Transduced Autologous Cells Promote In Vitro and In Vivo Chemo-sensitization to FCR and Durable Complete Responses In Patients with Del(17p) / P53 Defective Chronic Lymphocytic Leukaemia, described results from a phase I b clinical trial co-sponsored by the Leukaemia & Lymphoma Society. The clinical study is evaluating the safety and efficacy of ISF35 in combination with chemotherapy in patients with fludarabine-refractory and/or 17p-deleted CLL.

Patients in this study received their own tumour cells modified to express ISF35. Following ISF35 cell therapy, subjects received monthly courses of FCR, a standard chemotherapy regimen. Dr. Castro's data show three of four patients in the study responded, including two durable complete responses which continue to date with a median follow-up of 18 months.

A second poster presentation (Abstract 1476), entitled Immune Gene Therapy for Patients with CLL Using Repeat Dose Intra-nodal Injection of Ad-ISF35, a Replication Incompetent Vector Expressing a Membrane-Stable CD40 Binding Protein, highlighted results from an ongoing Phase II clinical trial evaluating multiple direct intra-nodal injections of Ad-ISF35 in patients with high-risk, progressive CLL.

Most patients experienced reductions of 50 per cent or greater in three response parameters: leukaemia cell counts, swollen lymph nodes, and enlarged spleen. The findings suggest that multiple direct injections of ISF35 are feasible, have a favourable safety profile consisting mostly of flu-like symptoms, and induce systemic biological responses and apoptosis in cancer cells.

A third poster presentation (Abstract 1470), entitled Ad-ISF35 Intra-tumoural Administration Induces a Bystander Effect and Immune-Mediated Tumour Rejection with a Safe Vector Bio-distribution and Toxicology Profile In a NHL Mouse Model, described results from a preclinical study showing that Ad-ISF35 injected directly into the tumours of mice bearing subcutaneous NHL breaks tumour tolerance and induced complete tumour regression and immunity to tumour re-challenge.

“This clinical and preclinical research lays the groundwork for expanded studies evaluating ISF35 in combination with chemotherapy,” said Mark Cantwell, PhD, Memgen's VP of Research & Development and co-inventor of ISF35. “Not only does this approach show promise in refractory CLL, which has an urgent medical need, but the results of direct injection of ISF35 for CLL suggest a broad applicability of ISF35 for many haematologic and solid tumour indications.”

Memgen is a clinical-stage biotechnology company developing immunotherapies to improve survival and quality of life of patients with cancer, autoimmune conditions and infectious diseases. Memgen’s patent-protected re-engineered molecules, which are based on the Tumour Necrosis Factor (TNF) super family of molecules, target specific receptors expressed on disease cells such as tumours, eliminating the disease cells.