Full Press Release Details
| Message from the CEO Welcome to the first issue of the Prima BioMed Investor Update for 2014. We have had a great start to 2014 here at Prima BioMed and are excited to share some news with you. | ||
| CEO Matthew Lehman |
Clinical Trial Update
As recently announced, we reached an important milestone in the development of CVac with the commencement of our amended phase 2 CAN-004 clinical trial in
Europe. Prima is now actively recruiting patients from 16 different sites across Europe, with further sites due to commence recruitment later this month. The amended phase 2 CAN-004 clinical trial will include a total of 210 epithelial ovarian
cancer patients in remission after second-line treatment. The primary endpoint is Overall Survival (OS), while the secondary endpoints include progression-free survival, and tolerability and quality of life assessment. We continue to explore the
CVac immune profile through specialised immune monitoring testing.
In September last year, based on the top-line data from the CAN-003 trial of CVac we
adjusted the focus of the ongoing CAN-004 clinical trial. These amendments received approval from a number of regulatory agencies in Europe which allowed for the amended CAN-004 trial to re-commence.
We have also advanced a 40 patient pilot trial of CVac for resected pancreatic cancer to assess signals in OS.
CAN-003 data to be presented at ASCO
We are pleased that the
final progression free-survival (PFS) data was accepted for oral presentation by Dr Heidi Gray at the 2014 American Society for Clinical Oncology (ASCO) Annual Conference on 31st May 2014 in Chicago. ASCO is among the world s largest
annual scientific events in the oncology community. We are excited about the opportunity at ASCO to update the medical community on our progress with CVac. Dr Gray will also provide an update on overall survival from CAN-003. Prima will make a
market announcement regarding the CAN-003 data on 14th May 2014 to coincide with the release of this data contained in the ASCO abstract. A further market announcement will also be made shortly after Dr Gray s presentation at ASCO.
In February, Prima entered into an exclusive Licence Agreement with Neopharm Group; the first commercial transaction for our CVac technology. The licence
permits Neopharm to seek registration approval for CVac as a cell-based immunotherapy for ovarian cancer and then exclusively market and supply CVac in Israel and Palestine.
This demonstrates a high level of confidence in our development program and CVac s commercial potential. Under the terms of the agreement, Neopharm will
reimburse Prima for commercial manufacturing costs of CVac and net profits from CVac sales will be shared equally between Prima and Neopharm. Prima BioMed retains the right to out-license CVac in the rest of the world and we regularly discuss
potential partnership opportunities with companies.
As reported in our Appendix 4C for the quarter ended 31 March 2014, we had A$26.74 million in cash and term deposits, which included an R&D tax refund
from the Australian Federal Government of approximately A$1.6 million received in March.
We have made good progress in reducing our cash outflows. This
has been partly achieved by consolidating the majority of our manufacturing into our German facility in collaboration with the Fraunhofer Institute, following grant funding from the Saxony Development Bank.
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New Board Appointments
In February, Pete Meyers joined the company as a Non- Executive Director. Pete brings to the Prima BioMed Board significant experience in U.S. capital markets
and in advising healthcare companies. He is currently the Chief Financial Officer of TetraLogic Pharmaceuticals Corporation, and prior to that was Co-Head of Global Healthcare Investment Banking at Deutsche Bank in New York, having also held various
senior investment banking positions at Dillon, Read & Co. and Credit Suisse First Boston. Also in February, we farewelled our retiring Non-Executive Director, Dr Richard Hammel and thanked him for his over eight years of service on
American Depository Receipt (ADR) Activity
Over the past year there has been a significant increase in the issuance of American Depository Receipts ( ADRs ) in Prima s NASDAQ listed ADR
program. As of March 2014, 3.7 million
ADRs have been issued and are outstanding, compared to only 109,711 ADRs outstanding in March 2013.
Our focus remains firmly on continuing to
develop the CVac program, with our highest priority being the phase 2 CAN-004 trial. With our dedicated team of highly experienced clinicians in the emerging field of cancer immunotherapy, we now have a clear, data-driven clinical development plan
for CVac in second-remission ovarian cancer. We are excited about the opportunity to deliver patients a product that has less toxicity than conventional cancer treatments and can extend their overall survival.
As always, I would like to thank you for your ongoing support of Prima BioMed and our development of CVac. We remain in a fundamentally strong position and I
look forward to reporting on further progress in the months ahead.
Matthew Lehman | Chief Executive Officer
Prima strengthens the Clinical Advisory
In March 2014, Prima BioMed appointed three new members to its Clinical Advisory Board (CAB). This follows the appointment of Dr Bradley J. Monk
as Chair of the CAB in February this year. Each new board member is a highly accomplished physician and preeminent leader in the field of gynaecological cancer. These three newly joined members will be working together with existing member of CAB:
Dr. Berek, Dr. Goh and Dr. Kuhn. Their summary biographies are included below.
The principal role of the CAB is to advise on the design
and implementation of Prima BioMed s clinical trials. The three new European appointments bring substantial relevant European experience to the CAB and coincide with the imminent start of the Company s amended phase 2 CAN-004 clinical
The Company engages with the CAB through frequent board meetings as well as ad hoc liaison with its Chief Technology Officer, Sharron
| Prof. Pujade-Lauranine, MD, PhD Prof. Pujade-Lauranine established the French GINECO Group, which is devoted to clinical research in gynecologic cancer. He is the head of the Women Cancers and Clinical research Department at H pitaux Universitaires Paris Center, site H tel-Dieu, AP-HP in Paris, France and Professor of Medical Oncology at University Paris Descartes. | ||
| Prof. Christian Marth, MD, PhD With 25 years of activity in clinical gynecologic oncology and translational research, Prof. Christian Marth is Head of the Department of Obstetrics and Gynecology at Innsbruck Medical University. He is also the president and founder of the Austrian Association for Gynecologic Oncology, and president elect of the European Network of Gynecological Trials Group (ENGOT). | ||
| Prof. Ignace Vergote, MD, PhD Prof. Ignace Vergote is Head of the Department of Obstetrics and Gynecology and Gynecologic Oncology at the Catholic University of Leuven, Belgium. He was Chairman of the European Organization for Research and Treatment of Cancer (EORTC) Gynecologic Cancer Group from 1997 to 2003, and is now the chairman of its Protocol committee. | ||
| Dr Bradley J. Monk, MD, FACS, FACOG Dr Monk is Professor in the Department of Obstetrics and Gynecology at the University of Arizona College of Medicine, Professor at the Creighton University School of Medicine, and Director of the Division of Gynecologic Oncology at St. Joseph s Hospital and Medical Centre in Phoenix. |
CVac target patient profile: maintenance after second line chemotherapy
Prima s CAN-003 protocol succeeded in helping to identify a potentially focussed, optimal Target Patient
Profile (TPP): maintenance (or consolidation) treatment of platinum- sensitive epithelial ovarian cancer in remission after recurrence. The clinical development objective of CVac is to extend the overall survival (OS) and progression-free survival
(PFS) of patients in this indication.
Twenty patients who attained complete remission after their second recurrence who participated in the CAN-003
trial, showed significant improvement in progression-free survival when treated with CVac. The next step in clinical development is the completion of a 210-patient randomised, standard-of- care controlled trial in this patient population to confirm
what we saw in the smaller number of patients from CAN-003. This CAN-004(2) protocol commenced enrolment in April.
CVac s place in ovarian cancer
Ovarian cancer is the seventh most common cancer in women worldwide in terms of new cases diagnosed (238,719 in
2012) and including previously diagnosed patients based on the 5 year prevalence data (586,624 in 2012), the sixth most common in women worldwide.(GLOBOCAN 2012 database http://globocan.iarc.fr/Pages/fact_sheets_ population.aspx).
Most patients with ovarian cancer achieve complete clinical remission after optimal debulking surgery and platinum- based chemotherapy. However, data from the
National Cancer Institute suggest around 80% will relapse despite high response rates to first-line treatment, and undergo
subsequent lines of chemotherapy. Generally, the progression free interval between treatments becomes shorter
with each relapse, and the patient eventually dies from the disease. The ability to increase the progression free intervals between remission windows would have a significant benefit to a patient s quality of life and would potentially lead to
longer overall survival.
CVac is intended as a maintenance therapy for ovarian cancer patients in complete second remission to increase quality of life
and extend overall survival and progression free intervals. There is a high unmet medical need for such treatments.
| Q&A with Dr Bradley J. Monk Dr Bradley J. Monk (MD, FACS, FACOG) is Chair of the Prima BioMed Clinical Advisory Board. He is one of the most recognised and experienced researchers in ovarian cancer today and shares some of his thoughts about immunotherapy and CVac. Q. What attracted you to join the Prima BioMed CAB? A: A considerable part of my career has been devoted to clinical research into gynaecological cancer. Maintenance therapy for ovarian cancer after second line treatment is a significant unmet medical need with an addressable market of more than 25,000 patients annually in major global markets. Prima BioMed is one of the leading companies in developing an immunocellular treatment with its CVac technology and it is great to be working alongside some of the most esteemed researchers and clinicians in our field. Q. What are the advantages of immunotherapy for ovarian cancer? A: The scientific community is confident that immunotherapy will play an important role in the future treatment of ovarian cancer. | Immunotherapy is a safer and potentially more effective treatment as it stimulates the patient s natural immune system to locate and kill malignant cancer cells. Ovarian cancer is one of the cancers where immunology would be most effective in treating patients and CVac is well tolerated with a very acceptable side effect profile, as demonstrated by Prima BioMed s early clinical trials. I am excited to be part of the CVac clinical trial program and help guide the product though development. Q. How significant is the development of CVac for the treatment of other cancers? A: The approval of CVac would potentially be a major break- through for the treatment of cancers related to the Mucin 1 protein, such as ovarian, pancreatic, breast and lung cancer. Prima BioMed will soon be initiating a 40 patient trial to assess the feasibility of CVac therapy for resected pancreatic cancer, the CAN-301 protocol. Available data strongly supports immunotherapeutic approaches to treating pancreatic cancer and with more than 80% of patients expected to have Mucin 1 overexpressing cancer cells, the target of CVac, the addressable market is estimated to be 17,000 patients annually. Therefore results of this trial could be very significant. | |||
| Lucy Turnbull meets Saxony s Minister of State in Leipzig, Germany | ||||
| In April, Prima BioMed Chairman, Lucy Turnbull and CFO Marc Voigt met with Saxony s Minister of State for Science and the Fine Arts, Prof. Sabine von Schorlemer at the Company s CVac manufacturing facility in Leipzig, Germany. In collaboration with the Fraunhofer Institute for Cell Therapy and Immunology ( Fraunhofer ), Prima BioMed will manufacture CVac for all European clinical trial sites from the Leipzig facility. The facility will also be the centre for administering all its European clinical trials for Ovarian and Pancreatic cancer. The Saxony Development Bank in Germany provided Prima BioMed and the Fraunhofer jointly with a grant of | nearly EUR 8 million to co-fund the development of CVac. Lucy Turnbull said: Based on funding by the Free State of Saxony we are able to advance the development of therapy candidate CVac in the amended phase 2 clinical trial on a Europe-wide scale. Sabine von Schorlemer commented: We are proud that we were able to attract internationally active companies such as Prima BioMed to BIO CITY LEIPZIG and to successfully support them. The positive development of Prima BioMed will also raise the international profile of Saxony as a high- technology location. | |||
| Picture of Lucy, Minister Prof. von Schorlemer, Dr Feist (Member of German Parliament), Marc Voigt, CFO | Lucy and Marc with the Prima team in Leipzig |