NeoStem's PCT subsidiary signs manufacturing agreement with ImmunoCellular

NeoStem (AMEX:NBS) said Monday that its subsidiary Progenitor Cell Therapy (PCT) has inked a manufacturing deal with clinical-stage biotech company ImmunoCellular Therapeutics (OTCBB:IMUC).

Under the terms of the agreement, Progenitor's facility will serve as the second manufacturing site to produce ImmunoCellular's ICT-107, a stem cell vaccine which the Los-Angeles biotech company is developing to combat an aggressive type of brain cancer, for a phase two trial.

As part of the deal, Progenitor will transfer and qualify the cGMP manufacturing process for ICT-107 at its West Coast facility in Mountain View, California, for use in ImmunoCellular's US-based phase two trial, as well as future studies and development efforts.

"We are very excited to enter into this agreement with ImmunoCellular Therapeutics, whose promising products and technologies are designed to harness the power of the immune system to improve the treatment and diagnosis of cancer," said president and chief scientific office or Progenitor, Robert A. Preti, PhD.

"PCT will offer ImmunoCellular Therapeutics the same expertise and dedicated service it has offered past clients like Dendreon, for whom we were the primary manufacturer for Provenge for more than seven years during its clinical trials."

The ICT-107 vaccine uses cancer stem cells to target multiple tumour-associated antigens, which generate an antibody response from the body's own immune system.

In other words, white blood cells are primed in the lab to attach to markers present in brain tumours, and these cells are then injected back into the body, where they travel to the brain and attack tumour cells.

In a phase one trial, ImmunoCellular reported a two-year survival rate of 80.2% with the vaccine, compared to 26.5% with standard care alone. At three years, 55% of patients achieved overall survival, compared to 16% with standard care alone. After three years, 38% of patients continue to show no tumour recurrence, compared to 6% without the aid of ICT-107. After four years, 19% of patients remain disease-free.

The phase two trial is expected to enroll between 150 to 160 newly diagnosed patients to treat a total of 102 patients, with 36 subjects enrolled already.

President and CEO of ImmunoCellular, Dr. Manish Singh, added: "This agreement with PCT represents a major risk mitigation step in conducting our Phase II study of ICT-107 by having two manufacturing sites."

"PCT has significant experience in developing and manufacturing patient-specific products and capabilities for supporting this manufacturing into Phase III and commercialization.

"PCT's competencies in autologous cell therapies, cell manufacturing, cell processing and delivery make it ideally suited as a manufacturer for ImmunoCellular Therapeutics as we look forward to completing this Phase II trial and seek to secure a strategic partner in connection with a future potential Phase III trial for ICT-107 and its commercialization."

NeoStem acquired Progenitor Cell Therapy in January, expanding the company's cell processing capabilities in stem cell technologies, as well as providing a service business, with processing centres in southern California and northeastern USA.