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Biotech / Medical : Genitope GTOP

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To: tuck who wrote (2)12/3/2003 3:19:57 PM
From: tuck   of 37
 
OTOH couldn't find anything from LSBC at ASH. But Favrille was there. Genitope is, too:

>>[357] Recombinant Idiotype-KLH Vaccination (MyVax) Following CHOP Chemotherapy in Mantle Cell Lymphoma. Session Type: Oral Session

John P. Leonard, Julie Vose, John Timmerman, Ronald Levy, Morton Coleman, Susan King, Diane Ingolia, Dan Denney Center for Lymphoma and Myeloma, Weill Medical College of Cornell University and New York Presbyterian Hospital, New York, NY, USA; University of Nebraska Medical Center, Omaha, NE, USA; Stanford University, Stanford, CA, USA; Genitope Corporation, Redwood City, CA, USA

Mantle cell lymphoma (MCL) is typically associated with responsiveness to front-line combination chemotherapy, but a
relatively brief time to disease recurrence commonly within 1-2 years. In lymphoma patients in remission after chemotherapy, vaccination against the tumor-specific variable regions of the clonal immunoglobulin (idiotype or Id) expressed by the malignant B cell population can induce an anti-lymphoma immune response. This approach is in phase 3 evaluation in follicular lymphoma, and could also potentially improve time to disease progression following chemotherapy in aggressive lymphoma including MCL. In this phase 2 study, we evaluated vaccination with the personalized Id vaccine MyVax (Genitope Corporation, Redwood City CA), a recombinant Id protein conjugated to Keyhole Limpet Hemocyanin (KLH) co-administered with GM-CSF, for aggressive NHL patients in complete or partial response following CHOP chemotherapy. Subjects were required to have International Prognostic Index of 2, 3, or 4 at diagnosis (reflecting an adverse prognosis). Twenty-seven aggressive NHL patients received one of two immunization regimens. Schedule A (n=14 patients, including 5 with MCL) consisted of 5 immunizations administered over 24 weeks, starting 6 months after the completion of chemotherapy. The MCL patients progressed at a median of 254 days following the completion of chemotherapy (range 192-361 days), with three not completing vaccination due to rapidly progressive disease requiring other therapies. In an attempt to improve the clinical responses, an accelerated and extended administration regimen was subsequently developed. Schedule B was employed in 13 subjects (n=11 MCL), with vaccination beginning 13 weeks following completion of chemotherapy and continuing every 2 weeks for 7 doses (with an 8th dose at week 18 of vaccination). Median time to progression has not been reached in these MCL subjects at a median followup of 522 days following completion of chemotherapy (range 133 to 944 days). Anti-idiotype immune responses have been observed with both vaccination schedules, with no clear differences noted. Immunization-associated adverse events were generally grade 1-2, transient and manageable. These findings suggest that an accelerated and extended Id-KLH vaccination schedule can be safely administered, with resultant IRs and encouraging early clinical results in MCL. Further evaluation of this schedule, including correlations of immune response and disease status at vaccination with clinical outcomes, will further determine the potential benefit of this type of personalized active immunotherapy for the treatment of MCL.
Abstract #357 appears in Blood, Volume 102, issue 11, November 16, 2003v<<

Cheers, Tuck
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