HCD122 Mab

HCD122 is a fully human anti-CD40 antibody intended as a treatment for B-cell mediated diseases, including malignancies and autoimmune diseases.  The antibody has a dual mechanism of action that involves blocking tumor cell growth and survival signals while recruiting immune effector cells to kill tumor cells through a process known as antibody-dependent cellular cytotoxicity (ADCC).

HCD122 is the first product candidate selected under the multi-product antibody development and commercialization agreement for the treatment of cancer announced by Chiron and us, and initiated in March of 2004.

HCD122 is an investigational drug candidate and has not been approved by the U.S. Food and Drug Administration.

Indications

  • Lymphoma
  • Multiple Myeloma

Development Status

The first Investigational New Drug (IND) application submission took place in December of 2004. In April of 2005, XOMA and Chiron announced the initiation of Phase 1 clinical testing of HCD122 in patients with advanced chronic lymphocytic leukemia. The clinical program was extended to a Phase 1 trial in patients with multiple myeloma in October 2005 and to a Phase 1/Phase 2 trial in patients with lymphoma in May 2008. The leukemia study was ended in May 2008 after an evaluation of patient availability and enrollment patterns.

Collaboration Background

In 2004, XOMA and Chiron entered into a worldwide, multi-product, cost and profit sharing collaborative agreement for the development and commercialization of antibody products for the treatment of cancer. In April of 2006, Novartis acquired Chiron and the corresponding collaborative agreement.  HCD122 (formerly known as CHIR-12.12) is the first lead product candidate to come out of the collaboration.  In addition to HCD122, multiple undisclosed preclinical stage programs are included in our collaboration with Novartis.

Publications and Presentations

  • "In Vitro Activity of a Novel Fully Human Anti-CD40 Antibody CHIR-12.12 in Chronic Lymphocytic Leukemia: Blockade of CD40 Activation and Induction of ADCC" (PDF), Xia Tong, et. al, American Society of Hematology Meeting, 2004.
  • "Safety Evaluation of a Fully Antagonist Anti-CD40 Antibody, CHIR-12.12, in a Dose Range-Finding Study in Cynomulgus Monkeys" (PDF), Ursula Jeffry, et. al, American Society of Hematology Meeting, 2004.
  • "Antagonist Anti-CD40 Monoclonal Activity, CHIR-12.12, Inhibits Growth of a Rituximab-resistant NHL Xenograft Model and Archives Synergistic Activity when Combined with Ineffective Rituximab" (PDF), Li Long, Ph.D., et. al. American Society of Hematology Meeting, 2004.
  • "Human Anti-CD40 Antagonist Activity Triggers Significant Antitumor Activity Against Human Multiple Myelomas" (PDF), Yu-Tzu-Tai, et. al, American Society of Hematology Meeting, 2004.
  • "A Fully Human Anti-CD40 Antagonist Antibody, CHIR-12.12, Inhibits the Proliferation of Human B Cell in Non-Hodgkin's Lymphoma" (PDF), Wen-Kai Weng, et. al, American Society of Hematology Meeting, 2004.