New Data on MKC1106-MT and MKC1106-PP Presented at the International
Society for Biological Therapy of Cancer 2009 Annual Meeting
WASHINGTON--(BUSINESS WIRE)--Oct. 29, 2009--
Results of two phase 1 studies demonstrate that the novel,
investigational cancer vaccines MKC1106-MT and MKC1106-PP are
well-tolerated and show encouraging immune response rates and objective
tumor response in advanced melanoma, prostate cancer and other solid
malignancies, setting the stage for phase 2 studies. The data are being
presented at the International Society for Biological Therapy of Cancer
2009 Annual Meeting.
MKC1106-MT is an active immunotherapeutic product consisting of three
components, a DNA plasmid and two synthetic peptides, each of which is
administered separately by the unique route of intranodal injection and
together are designed to target two tumor-specific antigens that are
commonly expressed by melanoma tumor cells. MKC1106-PP is a similar
agent that is designed to target two specific tumor antigens commonly
expressed by various solid tumor cells.
“MKC1106-MT and MKC1106-PP met the primary end-points of both trials
and, in addition, showed early evidence of clinical benefit, which marks
an important step forward for MannKind’s oncology portfolio,” said Peter
Richardson, MRCP, Corporate Vice President and Chief Scientific Officer,
MannKind Corporation. “These encouraging results set the stage to move
into phase 2 trials with these innovative, targeted therapies, which
represent the cornerstone of our cancer immunotherapy program.”
MKC-1106 MT Study Design and Key Findings
In an ongoing, open-label, multicenter trial, 18 patients with advanced
melanoma were treated with MKC1106-MT and were evaluated after each
therapeutic cycle of six weeks. Patients demonstrating a clinical
response or no evidence of disease progression remained in the clinical
trial and received up to eight cycles of treatment over one year. In all
patients, repeat administration of the treatment was well tolerated with
limited adverse events.
Findings reveal an immune response rate of greater than 40 percent,
defined as the percentage of patients who showed elevated numbers of
antigen specific T cells in the blood upon immunization, and preliminary
evidence of clinical benefit. Of the 18 patients treated, 14 had
visceral metastases and the remaining four had metastases confined to
the lymphatic system. All four patients with lymphatic metastatic
disease achieved durable objective responses (partial response based on
tumor imaging [RECIST criteria]), an unexpected outcome for a phase 1
study in this type of setting. A subset analysis identified the presence
of melanoma-specific T cells at baseline in the patients with lymphatic
metastatic disease. Overall, these results identified patients that
could benefit most from this type of therapy and will be used to design
the phase 2 trial of MKC1106-MT in advanced melanoma.
“Cancer vaccines have been explored in the past with very limited
success to curb the disease progression of malignant melanoma,” said
Antoni Ribas, MD, Associate Professor, Division of Hematology-Oncology,
David Geffen School of Medicine at UCLA. “The promising preliminary
results of this ongoing study warrant further evaluation of MKC1106-MT
in advanced disease and as an adjuvant therapy.”
MKC1106-PP Study Design and Key Findings
In the second study, 26 patients with advanced cancer who had diverse
tumor types, metastatic disease and/or progressive, refractory disease
were treated with MKC1106-PP. Patients were evaluated after two
therapeutic cycles (12 weeks) and again at 24 weeks, as applicable.
Patients demonstrating a clinical response or no evidence of disease
progression remained in the clinical trial and received up to six cycles
of treatment over nine months. In all patients, repeat administration of
the treatment was well tolerated with limited adverse events.
As with the MKC1106-MT trial, an immune response rate and encouraging
preliminary evidence of clinical benefit were achieved. In this study,
an immune response rate of 60 percent was observed. Of the 26 patients
treated, seven patients achieved clinical responses defined as partial
response (RECIST), change in PSA doubling time or stable disease for at
least six months. Patients attaining an immune response against both
antigens, persisting throughout the first two cycles of therapy, were
more likely to show clinical benefit, setting the stage for further
evaluation in phase 2 studies.
“These findings lay the foundation for additional trials evaluating the
clinical benefit of MKC1106-PP in select indications,” said Nicholas J.
Vogelzang MD, Chair and Medical Director, Developmental Therapeutics and
Co-Chair, GU Committee, US Oncology Research, Comprehensive Cancer
Centers of Nevada. “Further study of this investigational agent’s
mechanism of action will also be important in assessing its promise in
biomarker-defined patient populations.”
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the discovery,
development and commercialization of therapeutic products for patients
with diseases such as diabetes and cancer. Its pipeline includes AFRESA®,
MKC253, MKC1106-PP, and MKC1106-MT. MannKind has submitted an NDA to the
FDA requesting approval of AFRESA for the treatment of adults with type
1 or type 2 diabetes for the control of hyperglycemia. Its other
programs are currently in Phase 1 clinical trials. MannKind maintains a
website at http://www.mannkindcorp.com
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Source: MannKind Corporation
MannKind Corporation
Peter Richardson
Chief Scientific Officer
201-983-5064
or
MannKind
Corporation
Matthew J. Pfeffer
Chief Financial Officer
661-775-5300
