San Diego Conference info 9:30 Synthetic Therapeutic Cancer Vaccines: What are Useful and
Meaningful Endpoints?
Biomira Inc. has now tested four synthetic vaccines in clinical trials
in a program that commenced in 1990. THERATOPE® Vaccine, our lead
product candidate, induces an antibody response and a T cell response
to STn, a cancer associated carbohydrate epitope. Based on apparent
survival improvements in a phase II trial, THERATOPE® Vaccine is now
in a large phase III trial in 11 countries in 120 sites. The primary
endpoints are survival and TDP. As we develop vaccines and
immunotherapeutics, consideration needs to be given to primary
endpoints, particularly at interim analyses that enable evaluation of
efficacy of vaccines, in addition to studying immune response induced
by vaccines. An important consideration is the minimal toxicity
associated with the use of these vaccines as they are developed in the
management of systemic cancer. The following is discussed:
Biomira's vaccine program began in 1990. Four vaccines are being
tested to date
THERATOPE® Vaccine, which incorporates synthetic STn, a cancer
associated carbohydrate, appeared to have an effect on survival in
patients with metastatic breast cancer and is now in a large Phase III
trial
Another of the four vaccines, BLP25, uses a lipopeptide formulation
incorporating a synthetic version of the MUC1 tandem repeat and this
is currently being tested in lung cancer
Because of the minimal toxicity, and to assist in development of
vaccines and exploration of the position of their use, there needs to
be careful consideration of alternative endpoints that enable interim
analyses to be meaningful
Grant MacLean, MB, ChB, FRACP, is Vice President of Clinical and
Regulatory Affairs at Biomira Inc., Edmonton, Canada. Previously Dr.
MacLean was Professor of Oncology at the University of Alberta and
Senior Specialist in Medical Oncology at the Cross Cancer Institute,
Edmonton, Alberta. Originally from Auckland, New Zealand, Dr. MacLean
was active as a clinical oncologist, teacher and researcher. Working
closely with Biomira?s scientists since the 1980?s, Dr. MacLean
initiated Biomira?s synthetic cancer vaccine clinical trial program in
1990, and was the principal investigator for the cancer vaccine
program until he joined Biomira in 1996.
https://www.iir-ny.com/agenda.cfm?EventID=p0641&EventType=w&Day=1&NavbarID=10085&
9:15 Active Specific Immunotherapy Development to MUC1 in Breast
and Lung Cancer
Active specific immunotherapy is the administration of an immunogenic
substance to actively stimulate the immune system to respond to a
specific antigen. Biomira Inc. has developed synthetic
tumor-associated antigens into vaccine-like formulations targeting the
STn dissacharide and the apoprotein core of the mucinous glycopeptide
MUC1 that has broad distribution in many normal and malignant tissues.
This talk presents an overview of the development of the anti-STn
therapeutic vaccine THERATOPE® currently in a phase III clinical trial
in breast cancer and the development of an anti-MUC1 liposomal BLP25
vaccine currently in a phase IIB clinical trial in metastatic
non-small cell lung cancer. The clinical and immunological experience
from these developmental programs is discussed including the following:
Clinical trial accrual challenges and solutions
Clinically meaningful endpoints
Assessing immunological responses
Safety data
Martin Palmer, MD
Medical Oncologist
CROSS CANCER INSTITUTE/BIOMIRA
https://www.iir-ny.com/agenda.cfm?EventID=p0641&EventType=a&Day=2&NavbarID=10087&
10:45 Addressing Regulatory Issues Surrounding Fast Track Approval of
Cancer Vaccines
Cancer vaccines are unlike conventional vaccines that are given to
prevent diseases. Because cancer vaccines are used to fight a disease
that is already found within the body, there is a dire need for
companies to be knowledgeable about ways to work productively with the
FDA to meet regulatory standards and receive fast track approval.
Seize this opportunity to hear from the FDA and some of the companies
whose vaccine trials are furthest along in the regulatory process and
voice your perspective and questions among these distinguished
panelists and other session attendees.
PANELISTS:
Denis R. Burger, PhD
CEO
AVI BIOPHARMA, INC.
Grant MacLean, MD
Vice President, Clinical and Regulatory Affairs
BIOMIRA, INC.
Christopher S. Henney, MD
Chairman and CEO
DENDREON CORPORATION
Philip Livingston, MD
Head, Laboratory of Experimental Vaccinology
MEMORIAL SLOAN KETTERING
Jeffrey Webber, MD, PhD
Associate Professor, Medicine & Molecular Microbiology/Immunology
UNIVERSITY OF SOUTHERN CALIFORNIA/NORRIS CANCER CENTER