Sydys Corp. Announces Publication of Phase 2b CVac™ Data Against Ovarian Cancer in Journal for ImmunoTherapy of Cancer
Data Demonstrate Significant Overall and Progression Free Survival Improvements in Second Remission Ovarian Cancer Patients
17 May 2016 – SEATTLE, WASHINGTON - Sydys Corporation (OTCQB:SYYC), a clinical stage biotechnology company focused on the development of immunotherapies, today announced the publication of findings from a study demonstrating the potential of CVac™ in ovarian cancer in the Journal for ImmunoTherapy of Cancer.
The study entitled “Progression-free and overall survival in ovarian cancer patients treated with CVac™, a mucin 1 dendritic cell therapy in a randomized Phase 2b trial was led by Dr Heidi Gray at the University of Washington Medical Center, WA, USA with Dr Jeffrey C Goh of Greenslopes Private Hospital, Queensland Australia and included several universities and institutions in the United States and Australia (NCT01068509), including:
- Scripps Cancer Center, San Diego CA
- Peter MacCallum Cancer Centre, East Melbourne Vic, Australia
- Cleveland Clinic Foundation, Cleveland OH
- Duke Cancer Institute, Duke University Health System, Durham NC
- University of California, San Francisco & Sutter Health Research Institute, San Francisco, CA
- Stanford University Cancer Institute, Stanford, CA
The publication outlines results obtained from a Phase 2b clinical trial evaluating the safety, efficacy and immune outcomes of CVac™ in patients with advanced epithelial ovarian cancer. (Read More)
• Sydys Licenses Clinical-Stage Immuno-oncology Assets in ‘spin out’ transaction
• Potential for over A$400M in milestones and royalties
• Prima to receive 9.9% equity in Sydys
12 May 2016 – SYDNEY, AUSTRALIA and SEATTLE, WASHINGTON - Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) (“Prima”) and U.S.-based Sydys Corporation, Inc. (OTC: SYYC) (“Sydys”), today announced an agreement through which Sydys will license Prima’s CVac™ immuno-oncology program and oversee its future development.
In this spin out transaction Prima will receive a 9.9% equity stake in Sydys at the time of closing as consideration for the assets being transferred. Given the significant capital requirements for conducting clinical trials, no upfront payment will be received however should CVac be successfully commercialized, Prima could receive over A$400 million (US$293 million) in development, regulatory and commercial milestone payments payable for achievement of set commercial sales targets, in addition to low single digit royalties on sales.
Marc Voigt, Prima’s CEO, commented:
“Following extensive discussions with a number of third parties, we have reached what we consider to be an entrepreneurial solution which we believe best positions CVac for clinical success and, hopefully, commercialization. Importantly, this partnership continues the CVac program development without further resource commitment from Prima, while providing the potential for considerable future milestone and royalty payments over time. The ongoing development will be contingent on further successful capital raising for subsequent trials but we are confident that the Sydys team has the ability and connections in the US to undertake this program.”
Experienced biotech entrepreneur Joseph Hernandez, the newly appointed Executive Chairman of Sydys Corporation, added: “We believe that the CVac program has tremendous potential, supported by encouraging Phase I and II data in ovarian cancer patients. Studies conducted to date have reinforced CVac’s strong safety profile and demonstrated meaningful improvements in both overall survival and progression-free survival compared to standard-of- care. We look forward to further evaluating the efficacy of CVac with the goal of bringing the treatment to this underserved patient population.”
CVac therapy is a personalized immunocellular therapeutic that has been investigated for the treatment of epithelial cancers. CVac stimulates the patient’s own immune system to target and destroy tumours. It has been investigated in multiple Phase I and Phase II studies with positive results.
Development highlights for CVac include:
- Completion of a randomized Phase II trial that identified epithelial ovarian cancer patients in second remission (CR2) as the target CVac patient population
- CR2 patients receiving CVac have experienced a clinically meaningful improvement in overall survival (OS), as indicated by final data analysis. These data demonstrated median OS of standard of care patients of 25.53 months, while the CVac arm had not reached a median at 42 months (HR=0.17)
- CR2 patients receiving CVac experienced a clinically significant improvement in progression free survival (PFS) of greater than 12.91 months, compared with a PFS of 4.94 months (HR=0.32) for the standard-of-care
- CR2 for ovarian cancer is a high unmet medical need; CVac has obtained Orphan Designation for the treatment of ovarian cancer by both the FDA and EMA and Fast Track Designation with the FDA.
About Prima BioMed
Prima BioMed is a globally active biotechnology company that is striving to become a leader in the development of immunotherapeutic products for the treatment of cancer. Prima BioMed is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximise value to shareholders.
Prima’s current lead product is IMP321, based on the LAG-3 immune control mechanism which plays a vital role in the regulation of the T cell immune response. IMP321, which is a soluble LAG-3Ig fusion protein, is an APC activator boosting T cell responses. IMP321 is currently in a Phase II clinical trial as a chemoimmunotherapy for metastatic breast cancer termed AIPAC (clinicaltrials.gov identifier NCT 02614833) and in a Phase I combination therapy trial in metastatic melanoma termed TACTI-mel (clinicaltrials.gov identifier NCT 02676869). A number of additional LAG-3 products including antibodies for immune response modulation in autoimmunity and cancer are being developed by large pharmaceutical partners.
Prima BioMed is listed on the Australian Securities Exchange and on the NASDAQ in the US. For further information please visit www.primabiomed.com.au
About Sydys Corporation
Post completion of the transaction, Sydys Corp will be a globally active, publicly traded biotechnology company developing immuno-oncology products including an autologous dendritic cell immunotherapy that recently completed Phase II trials for ovarian cancer. That trial generated clinically meaningful progression free survival (PFS) and overall survival (OS) data. More information is available at www.sydyscorp.com.
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