MedImmune, Inc.
(Nasdaq: MEDI) announced today that results from three programs within the
company’s expanding oncology pipeline will be presented at the American
Society of Hematology (ASH) 48th Annual Meeting, held December 9-12, 2006
in Orlando, FL. Clinical program updates include interim data for potential
cancer therapies targeting multiple myeloma and certain leukemias and
lymphomas.
“MedImmune continues to affirm its commitment to oncology as a vital
therapeutic area by advancing and expanding its pipeline of product
candidates targeting various cancers, signified by ASH’s acceptance of
seven scientific presentations by MedImmune and its partners,” commented
Dirk Reitsma, M.D., MedImmune’s vice president, clinical development,
oncology.
Data to be presented at ASH include:
— “Update on Phase 1 Clinical Trial of IPI-504, a Novel, Water-Soluble
Hsp90 Inhibitor, in Patients with Relapsed/Refractory Multiple Myeloma”
(Abstract 3579, presented in a poster session, “Myeloma: Novel Agents
and Toxicities,” on Monday, Dec. 11 at 10:30 a.m.)
— “A Phase 1 Open Label Dose Escalation Study To Evaluate MEDI-507 in
Patients with CD2-Positive T-Cell Lymphoma/Leukemia” (Abstract 2727,
presented in a poster session, “Novel and Targeted Therapy of NHL,” on
Sunday, Dec. 10 at 9 a.m.)
— “The Bi-Specific T-Cell Enhancer (BiTE) MT103 (MEDI-538) Induces
Clinical Responses in Heavily Pre-Treated NHL Patients: Update from the
Ongoing Phase 1 Study MT103-104” (Abstract 693, presented in an oral
session, “Targeted Therapy of NHL,” on Monday, Dec. 11 at 4 p.m.)
— “Hsp90 Inhibition Decreases Survival of BCR-ABL T315I Leukemic Stem
Cells in Mice” (Abstract 2184, presented in a poster session, “Chronic
Myeloid Leukemia: New Drugs,” on Sunday, Dec. 10 at 9 a.m.)
— “IPI-504, a Novel, Orally Active Hsp90 Inhibitor, Prolongs Survival of
Mice with BCR-ABL T315I CML and B-ALL” (Abstract 2183, presented in a
poster session, “Chronic Myeloid Leukemia: New Drugs,” on Sunday, Dec.
10 at 9 a.m.)
— “T Cell Responses During Long-Term Continuous Infusion of MT-103 (MEDI-
538; Anti-CD19 BiTE) In Patients with Relapsed B-NHL: Data from Dose-
Escalation Study MT103-104” (Abstract 2725, presented in a poster
session, “Novel and Targeted Therapy of NHL,” on Sunday, Dec. 10 at 9
a.m.)
— “Mechanistic Evaluation of Siplizumab (MEDI-507) Activity On Normal and
Malignant T-Lymphocytes” (Abstract 2504, presented in a poster session,
“Lymphoma: Pre-Clinical — Chemotherapy and Biologic Agents,” on Sunday,
Dec. 10 at 9 a.m.)
All abstracts presented at the ASH meeting were published in Blood,
Volume 108, Issue 11 on November 16, 2006.
About Hsp90 and IPI-504
IPI-504 is a proprietary small molecule therapeutic drug candidate
currently being evaluated as part of a drug development and worldwide
commercialization agreement between MedImmune and Infinity Pharmaceuticals,
Inc. In preclinical studies, IPI-504 has potently and selectively inhibited
Hsp90, thereby killing cancer cells. Hsp90 is an emerging therapeutic
target of interest for the treatment of cancer. Proteins are the mainstay
of structural and signaling elements of all cells. Hsp90 functions to
stabilize and maintain the activity of proteins in the cancer cell, thereby
allowing a cancer cell to survive despite an abundance of misfolded and
unstable proteins. Inhibition of Hsp90 may have broad therapeutic potential
for the treatment of patients with solid tumors and blood-related cancers,
including cancers that are resistant to other drugs.
IPI-504 preferentially targets and accumulates in tumor tissues,
sparing healthy tissues. In preclinical studies it has demonstrated a broad
potential to treat certain cancers as both a single agent as well as in
combination with existing anti-cancer drugs. The water-based formulation of
IPI-504 is convenient to deliver as an intravenous infusion. Infinity is
currently conducting two Phase 1 clinical trials with intravenous
formulations of IPI- 504. In July 2005, Infinity initiated the first of
these Phase 1 clinical trials in refractory multiple myeloma. In December
2005, Infinity initiated the second Phase 1 clinical trials with IPI-504 in
refractory gastrointestinal stromal tumors (GIST). Infinity has also begun
developing an oral formulation of IPI-504, which if successful, could be a
more convenient route of administration for cancer therapy.
About Siplizumab (MEDI-507)
Siplizumab is a humanized, monoclonal antibody (MAb) that binds to the
CD2 receptor found on the surface of T-cells and natural killer (NK) cells.
In July 2003, the U.S. Food and Drug Administration (FDA) approved an
orphan drug designation for MEDI-507 for the treatment of T-cell lymphoma.
In both preclinical and clinical studies, siplizumab has been shown to
cause depletion of T-cells. Siplizumab is therefore considered to be an
immunomodulator in clinical settings where the depletion of T-cells may
have clinical benefits, such as certain autoimmune diseases and T-cell
cancers. MedImmune has previously conducted clinical development programs
with siplizumab in patients with other conditions, including psoriasis,
graft-versus-host disease and renal transplantation. In addition,
preclinical studies have also suggested that siplizumab, by binding to the
CD2 receptor, may selectively produce cell death and reduce cancerous
cells.
About MT103 (MEDI-538)
MT103 is a Bi-Specific T cell Engager (BiTE(R)) molecule being
developed by MedImmune and Micromet, Inc. with the intent to treat certain
types of B- cell lymphomas. In February 2006, the U.S. Food and Drug
Administration (FDA) approved an orphan drug designation for MEDI-538 for
the treatment of indolent B-cell lymphoma, excluding chronic lymphocytic
leukemia and non-hodgkins lymphoma with central nervous system involvement.
BiTE molecules are part of a novel class of antibody derivatives that may
have the potential to selectively direct and activate an individual’s own
immune system to act against cancer cells. This action is believed to occur
as a result of the molecule’s stimulation of T cells (a very potent type of
white blood cell) to target and destroy cancer cells that over-express a
specific antigen. MEDI-538 specifically targets the CD19 antigen, which is
present on cancerous B cells but not on other types of blood cells or
healthy tissues.
About MedImmune, Inc.
MedImmune strives to provide better medicines to patients, new medical
options for physicians, rewarding careers to employees, and increased value
to shareholders. Dedicated to advancing science and medicine to help people
live better lives, the company is focused on the areas of infectious
diseases, cancer and inflammatory diseases. With more than 2,500 employees
worldwide, MedImmune is headquartered in Maryland. For more information,
visit the company’s website at medimmune/.
This announcement contains, in addition to historical information,
certain “forward-looking statements” regarding the development of product
candidates by MedImmune, Inc. Such forward-looking statements are based on
current expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change current expectations
and could cause actual outcomes and results to differ materially from
current expectations. In addition to risks and uncertainties disclosed in
MedImmune’s filings with the U.S. Securities and Exchange Commission,
MedImmune can provide no assurance that these products will be commercially
successful. In addition, no assurance exists that development efforts for
these products will succeed, that these products will receive required
regulatory approval or that, even if regulatory approval is received, they
will be commercially successful. MedImmune undertakes no obligation to
update any forward-looking statement, whether as a result of new
information, future events or otherwise except as may be required by
applicable law or regulation.
MedImmune, Inc.
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