NeoStem’s Subsidiary, Progenitor Cell Therapy, and ImmunoCellular Therapeutics Enter Into a Manufacturing Agreement
ImmunoCellular Therapeutics to Add PCT as a Second Manufacturing Site to Produce ICT-107 for Phase II Trial
ALLENDALE, N.J., LOS ANGELES and WOODLAND HILLS, Calif., Oct. 3, 2011 /PRNewswire/ — Progenitor Cell Therapy, LLC (“PCT”), an internationally recognized cell therapy services and development company and a wholly-owned subsidiary of NeoStem, Inc. (NYSE Amex: NBS), and ImmunoCellular Therapeutics, Ltd. (OTCBB:IMUC.ob – News) (“IMUC”), a clinical-stage biotechnology company that is focused on developing new immune-based products to treat and diagnose cancer, announced today that IMUC has retained the services of PCT to serve as the second manufacturing site to produce ICT-107, a dendritic cell-based vaccine targeting multiple tumor associated antigens for glioblastoma, for its Phase II clinical trial.
As part of this agreement, PCT will transfer and qualify the cGMP manufacturing process for ICT-107 at PCT’s West Coast facility in Mountain View, California for use in IMUC’s U.S. based Phase II clinical trial, as well as subsequent manufacturing to support future trials 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 Robert A. Preti, PhD, President and Chief Scientific Officer of PCT. “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.”
“This agreement with PCT represents a major risk mitigation step in conducting our Phase II study of ICT-107 by having two manufacturing sites,” said Manish Singh, PhD, President and Chief Executive Officer of IMUC. “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.”
“PCT’s unique expertise in manufacturing, regulatory, logistical transport and commercialization for therapeutics development, with its East and West Coast facilities, result in clients feeling great comfort entrusting their therapeutics to PCT. We foresee meaningful client base growth as therapeutic development companies come to understand the critical importance of the involvement of a skilled manufacturing partner and the cost-effectiveness of that partner possessing the ability to rapidly scale while providing excellent service,” said Dr. Robin L. Smith, Chairman and CEO of NeoStem.
About ImmunoCellular Therapeutics, Ltd.
IMUC is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. The Company recently commenced a Phase II trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor associated antigens for glioblastoma. To learn more about IMUC, please visit http://www.imuc.com.
About NeoStem, Inc.
NeoStem is a leader in the development and manufacturing of cell therapies. The Company’s strategic combination of revenues with manufacturing through its subsidiary, Progenitor Cell Therapy, and global reach has positioned the company for breakthroughs in the cell therapy space. The acquisition of Amorcyte, Inc. (which is expected to close in the fourth quarter subject to shareholder approval) will position NeoStem to achieve its mission of capturing the paradigm shift to cell therapy. NeoStem is also pursuing a T-cell therapeutic with potential in a range of auto-immune conditions and development of its VSEL™ Technology platform. For more information on NeoStem, please visit http://www.neostem.com.
NeoStem’s Subsidiary, Progenitor Cell Therapy, and ImmunoCellular Therapeutics Enter Into a Manufacturing Agreement
ImmunoCellular Therapeutics to Add PCT as a Second Manufacturing Site to Produce ICT-107 for Phase II Trial
ALLENDALE, N.J., LOS ANGELES and WOODLAND HILLS, Calif., Oct. 3, 2011 /PRNewswire/ — Progenitor Cell Therapy, LLC (“PCT”), an internationally recognized cell therapy services and development company and a wholly-owned subsidiary of NeoStem, Inc. (NYSE Amex: NBS), and ImmunoCellular Therapeutics, Ltd. (OTCBB:IMUC.ob – News) (“IMUC”), a clinical-stage biotechnology company that is focused on developing new immune-based products to treat and diagnose cancer, announced today that IMUC has retained the services of PCT to serve as the second manufacturing site to produce ICT-107, a dendritic cell-based vaccine targeting multiple tumor associated antigens for glioblastoma, for its Phase II clinical trial.
As part of this agreement, PCT will transfer and qualify the cGMP manufacturing process for ICT-107 at PCT’s West Coast facility in Mountain View, California for use in IMUC’s U.S. based Phase II clinical trial, as well as subsequent manufacturing to support future trials 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 Robert A. Preti, PhD, President and Chief Scientific Officer of PCT. “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.”
“This agreement with PCT represents a major risk mitigation step in conducting our Phase II study of ICT-107 by having two manufacturing sites,” said Manish Singh, PhD, President and Chief Executive Officer of IMUC. “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.”
“PCT’s unique expertise in manufacturing, regulatory, logistical transport and commercialization for therapeutics development, with its East and West Coast facilities, result in clients feeling great comfort entrusting their therapeutics to PCT. We foresee meaningful client base growth as therapeutic development companies come to understand the critical importance of the involvement of a skilled manufacturing partner and the cost-effectiveness of that partner possessing the ability to rapidly scale while providing excellent service,” said Dr. Robin L. Smith, Chairman and CEO of NeoStem.
About ImmunoCellular Therapeutics, Ltd.
IMUC is a Los Angeles-based clinical-stage company that is developing immune-based therapies for the treatment of brain and other cancers. The Company recently commenced a Phase II trial of its lead product candidate, ICT-107, a dendritic cell-based vaccine targeting multiple tumor associated antigens for glioblastoma. To learn more about IMUC, please visit http://www.imuc.com.
About NeoStem, Inc.
NeoStem is a leader in the development and manufacturing of cell therapies. The Company’s strategic combination of revenues with manufacturing through its subsidiary, Progenitor Cell Therapy, and global reach has positioned the company for breakthroughs in the cell therapy space. The acquisition of Amorcyte, Inc. (which is expected to close in the fourth quarter subject to shareholder approval) will position NeoStem to achieve its mission of capturing the paradigm shift to cell therapy. NeoStem is also pursuing a T-cell therapeutic with potential in a range of auto-immune conditions and development of its VSEL™ Technology platform. For more information on NeoStem, please visit http://www.neostem.com.