Full Press Release Details
Message from the CEO
Exciting times for cancer immunotherapy
of the Prima team attended the recent American Society for Clinical Oncology (ASCO) annual meeting in Chicago. This is one of the largest such meeting in the world every year and an important event to catch up on important developments in cancer
treatment and research. Immunotherapy was a major theme of the scientific presentations.
There is a strong feeling in the community that we are starting to obtain a better understanding of the immune
system, its role in cancer, and methods to utilize immunotherapies to control the disease. In simple terms, the best approach seems to be a combination of blocking the cancer s immune defenses and a stimulation of the body s own immune
Data from a number of clinical trials of targeted therapies or checkpoint
blockades presented promising data in melanoma, colorectal, and ovarian cancers, among other targets. These therapies such as CTLA-4 inhibitors (like ipilimumab), PD-1 inhibitors, and VEGF inhibitors (like pazopanib) are able to
block certain functions that otherwise allow cancer cells to thrive and escape detection from the body s immune system.
On the other side of immunotherapy is the need to stimulate the body s own cancer cell killing ability by actively engaging the killer T cells. This is where cytokine therapies (like
GM-CSF), adoptive T cell therapy, and cancer vaccines such as CVac play a role.
One very interesting
presentation at ASCO was a trial of ipilimumab combined with GM-CSF for treating metastatic melanoma. The combination treatment improved overall survival by 35% over treatment with ipilimumab alone. And very importantly the combination
actually decreased side effects!
Market outlook for cancer immunotherapy
It is not just the scientists that are excited about cancer immunotherapy. Industry investors are starting to take notice
of the space and the market potential for this class of therapy. Andrew Baum, an industry analyst from Citibank, predicts cancer immunotherapy will grow to be a US$ 35 billion market per annum by 2023. Mr Baum notes the durability of responses
with immunotherapy can last a decade, due to the induction of an ongoing immunological memory, targeting cancer cells for an indeterminate amount of time.
We at Prima are very excited about the future of cancer treatment. And we are very excited about CVac s potential place in the future treatment paradigm of ovarian cancer and other
cancer targets. We believe there is a very bright future for the patients and for investors in this field.
Advancing Prima s technology
To bring CVac s clinical potential to fruition, we are dedicated to leading on the technology and manufacturing side of our business.
Prima representatives caught up on the latest developments in the cell processing and manufacturing technology at the
recent ICST meeting in New Zealand.
I am pleased to report that Prima s presentations at the
international conferences detailed below were very well received and Prima is recognized as a leader among our colleagues in this technology space. Our investments in logistics, quality control, cell processing, and product characterization have put
us in a very strong position.
As most of our shareholders know, we have recently completed a share purchase plan and options entitlement offer. More
than 1000 shareholders contributed to raise approximately A$7.65 million dollars to help continue Prima s clinical and manufacturing development plans.
The funds raised allow us to move forward with our plans to test CVac in additional cancer targets. The German State of Saxony has awarded a EUR 3.8 million non-dilutive grant that will
co-fund these three pilot clinical trials, as well as a number of important additional manufacturing developments and laboratory tests.
On behalf of our patients, doctors, and everyone here at Prima, I thank our shareholders for their loyal and ongoing support of our important work. We also thank the German State of Saxony
for their continued support of our European R&D. Matthew Lehman | Chief Executive Officer
A patient s journey with CVac
In this issue we begin to introduce an in-depth journey of a patient in the clinical trials of CVac and an overview of the
trial process from a patient s perspective. In this edition, we will begin part one of this multi-part series discussing the cancer diagnosis and screening for eligibility featured on page 2.
The following topics will be covered in the patient journey series in upcoming newsletters:
Cell collection and logistics management
CVac Manufacturing and quality control process
Dosing and how CVac works in the body
Patient follow up and monitoring
Q & A with CAN-004 Investigator
Research and Development Update
Scientific Advisory Board
Meet the Prima team:
Chief Financial and Business Officer
A patient s journey with CVac
diagnosis and screening for eligibility
It is said that to truly understand you need to walk in
another s shoes . It is impossible to truly comprehend the experience of being told you have ovarian cancer, but in this piece we will try to overview the path walked by a patient who is enrolled into the CANVAS clinical trial and their
commitment to undergo the MNC blood collection process, the teams that are committed to the quality manufacturing of CVac, through the journey of chemotherapy and finally attaining clinical remission to start the injection schedule and treatment of
CVac. This is a patient s journey.
Commentary by Dr S. Gargosky and Dr J. Goh
My name is Sarah. I am 55 years of age and was generally in good health, but started feeling a little off color with
intermittent nausea, some abdominal discomfort and distention. Not knowing whether this was menopause or something else, I went to my general treating physician for a check-up. After having blood drawn for testing, being sent off for MRI/CT scans
and a full clinical evaluation, I was brought back into the office to be told that I have a probable diagnosis of stage 3-4 epithelial ovarian cancer. We started to discuss my treatment options with a gynecology surgeon-oncologist and I remember
thinking at the time, how is this possible? How did this occur without any hints of the severity of my condition? The web was a huge resource of information. I learned that if you are a woman over the age of 35 years you may be at risk for ovarian
cancer, although the median age is 63 years. There is no diagnostic for early detection. No biomarker or genetic testing. This meant that even in advanced stages like I was diagnosed for, having mild and nonspecific symptoms such as abdominal
discomfort or distension, I fitted into the majority (75%) that are diagnosed at advanced stages due to an asymptomatic course and the relative 5-year survival rate of 44% with disease recurrence in 12-18 months.
I also learned from my clinician (and the web) that the standard management of ovarian cancer is based on a multi-modality
approach, involving surgery and chemotherapy. This comes in two regimens. [1] chemo therapy (called neoadjuvant) then surgery and then more chemotherapy or [2] surgery and then chemotherapy. The first approach is to help shrink the tumor burden
before surgery. I am told by my physician that my tumor is immediately resectable or operable and that with optimal debulking I will have a better outcome. That was, the more removed the better as it meant the less cancer left behind to remove by
chemotherapy. Also, in some countries there is another product called Avastin [bevacizumab] that in combination with standard chemotherapy of platinum and paclitaxel has shown good outcome. It is another option for me. I decided to proceed to
debulking surgery which was performed successfully with no macroscopic residual tumour remaining.
told of the clinical trials that I could participate in to help research in this area of ovarian cancer. There are different trials on the web at www.clinicaltrials.gov in which some my doctor is part of and some my doctor is not. The doctor talked
to me of the trials he was involved with and I decided that for me, my options with optimal debulking surgery and chemotherapy are sufficient and that I might explore the new approach of individualized personal medicine for my remission phase. It
was a little hard to consider being part of a study now but getting the treatment 6-9 months from surgery when I am in remission seemed the better trial for me. When I agreed to listen and learn about the CANVAS clinical trial specifically, I looked
up CVac on www.clinicaltrials.gov to find out more details.
I then met again with the study coordinator Karen
who explained to me the study; my risks, benefits, the process and expectations. I was told that
chance of getting active treatment and a 50% chance of being on placebo. I was told of the risks associated with radiology and blood collection for safety testing, but I consider these part of my treatment and ongoing clinical surveillance. I was
told of the risk associated with the MNC collection to make the study drug; a process that takes 2-4 hrs and filters my blood to collect the right cells to make the immune therapy. I was told of the study visits, the frequency and the tests at each
time point. It s a commitment of time to be part of trial I have come to understand. But overarching this to me is the possibility of being part of making a difference to finding better or new treatments for this dreaded disease. It seemed
worthwhile to me. I took home the informed consent to read again and to consider my options.
surgery as I was recovering that I discussed with my family again whether I would or would not participate in the CANVAS clinical trial that will provide maintenance therapy and monitoring for the coming years. With their support of my decision, I
went back to the clinical center and signed the informed consent in the presence of a witness. This then allowed me to start the screening process to determine that I might be eligible for the study.
Step 1 for eligibility: Does my cancer tissue have the protein that this new therapy is targeting. These are tissue slides
that are sent to a specialty laboratory that tests for the mucin 1 target.
Step 2: Is my blood and am I
healthy enough to participate. This required blood draws and a physical exam and follow up. As we worked through the screening visit, as they are called, it took 2 weeks to learn that I had a mucin 1 positive cancer, the right type for
CVac and that my blood work was acceptable.
I was accepted for the trial. Karen entered all of my data into a
database and randomized me. Randomized means that a computer program assigns me to one of the two groups. I don t know if I am placebo or treatment and I won t know, but, I was ready for the next step the MNC collection
to make the study agent for my treatment. I feel that I am being pro-active in trying to prevent this cancer from returning and I know I will be monitored more closely, which is reassuring.
Q & A with CAN-004 Investigator
We are pleased to introduce Dr James Fiorica, a dedicated investigator from the USA who is participating in the CAN-004
trial. Dr Fiorica leads the Women s Cancer Care program at Sarasota Memorial Hospital in Florida and is a clinical professor in OB/GYN at Florida State University College of Medicine. His expertise is in the diagnosis and treatment of
reproductive cancers. In CAN-004, Dr Fiorica has cared for up to nine women who enrolled in the trial. We recently had an opportunity to discuss some of his experiences with CVac and the ongoing CAN-004 study.
Q: You were one of the first U.S. sites to start on the CAN-004 trial. Can we assume you are enthusiastic about the
A: Yes, our team is very excited to be a part of the CVac program! It has been over 20 years since a new drug has been approved for ovarian cancer treatment in the U.S. This treatment
could be really revolutionary and could lead the way for cellular therapies to meet the unmet medical need. With the interim CAN-003 data we are optimistic and hope that CVac may be able to help.
Q: What has been some of the feedback you receive from patients? Is the CVac process burdensome?
A: While it is not painful with minimal but acceptable risks, apheresis (or the cell collection) is inconvenient and it
does take a few hours of the patients time. The women on the trial had already undergone surgeries as well as several cycles of chemotherapy. It requires a lot of energy and resolve for these women to add an additional blood collection in
preparation to have CVac manufactured for them. However, CVac is really quite simple and quick to administer with small injections intradermally. Most patients felt that the potential benefit of participating on the study outweighed the upfront
inconvenience of the apheresis.
Q: Besides CVac, what else do you see on the horizon to potentially help
improve treatment for ovarian cancer?
A: I am an optimist by nature and believe that we will find some better
diagnostic methods and treatment options for ovarian cancer. The biggest challenge we currently have is that ovarian cancer is usually diagnosed so late there are few early symptoms and nao reliable early detection methods. There have been