OvaCure Project Portfolio
Each of OvaCure’s projects is conducted by world-leading experts within the fields of immunotherapy, oncology and gynaecology and is guided by OvaCure’s Scientific and Clinical Advisory Board.
Only ground-breaking projects are selected
In collaboration with the Anticancer Fund and the OvaCure Scientific and the Clinical Advisory Board, OvaCure has generated a project portfolio of two Danish and three international projects. Each project developed through OvaCure has maximum potential for the development of curative treatments for ovarian cancer patients.
OvaCure Initiated Projects
T-cell infusion Project (DK)
Original title: “Immunotherapy by adoptive T-cell infusion in the event of advanced ovarian cancer (stage III and IV) and treatment trials for a total of 18 women”.
The project is conducted at the Center for Cancer Immune Therapy (CCIT), Copenhagen University Hospital Herlev, Copenhagen, Denmark. Principal investigator: Head of OvaCure Immunotherapy Dream Collaboration, Professor Inge Marie Svane, MD, PhD.
T-cell combination therapy Project (NL)
Original title: “Combined chemo and adoptive T-cell therapy (ACT) as treatment for recurrent epithelial ovarian carcinoma”.
This project is conducted at the Leiden University Medical Center, Leiden, the Netherlands. Principal investigator: Els M. E. Verdegaal, PhD.
Personal T-Cell Project(CH)
Original title: “Harnessing tumour diversity to develop personalised adoptive immunotherapy for ovarian cancer”.
This pre-clinical project is conducted at the Ludwig Center for Cancer Research, University of Lausanne, Switzerland. Principal investigator: Professor George Coukos, MD, PhD.
Therapeutic Personal Vaccine Project (CH)
Original title: “A Phase I/II study to test the feasibility, safety and immunogenicity of personalized mutanome peptide (PMP) vaccine vs. whole tumor oxidized lysate (OC-L) vaccine admixed with CpG adjuvant, in combination with low-dose cyclophosphamide in primary advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer.”
This project is conducted at the Ludwig Center for Cancer Research, University of Lausanne, Switzerland. Principal investigator: Professor George Coukos, MD, PhD.
Tumour-Match Project (DK)
Original title:”Molecular profiling of advanced gynaecological cancers in targeted therapies”.
This project will be conducted at Nordic Society of Gyneacological Oncology at Rigshospitalet, Denmark. Principal investigator: Mirza, Mansoor Raza, MD, Chief Oncologist.
OvaCure Immunotherapy Dream Collaboration
OvaCure’s flagship project (T-cell Infusion) is among the world’s first trials to treat ovarian cancer patients with adoptive T-cell therapy (ACT). The clinical phase I of this project is now almost complete. OvaCure’s 2nd project, T-cell Combination, will be conducted under the same clinical trial protocol and further the investigation by combining ACT with IFNα and chemotherapy. The subsequent projects based in Lausanne will further analyse individual ovarian tumour mutation-specific antigens as well as develop novel personalised vaccination programs.
The OvaCure Immunotherapy Dream Collaboration is planned to enrol approximately 46 women. All projects involved unique, interdependent, in-patient trials offering personalised immunotherapy to women with advanced ovarian cancer.
OvaCure plays an instrumental part in ensuring synergies between the projects and ensuring that the results are disseminated within the scientific community. Projects work in Dream Collaborations and are linked and share protocols and results. This creates a synergy that is not only unique but also acts to fast track the clinical trials process, thus brings treatments, from bench to bed - faster.
CAR T-cell therapy Project (US)
Original title: “CAR T-cell therapy for widespread application in recurrent Epithelial Ovarian Cancer”.
This project will be conducted at the Perelman School of Medicine, the University of Pennsylvania, PA, USA. Principal investigator: Carl June, MD, PhD.
The human immune system in short
The human immune system is the body’s defence mechanism against invasion of foreign elements. These elements are most often microorganisms that cause infectious diseases. The immune system consists of various different cells, antibodies, cell receptors and signalling molecules. The immune system is arranged and coordinated by a complex system of regulatory mechanisms that may accelerate or stop certain proceedings in order to achieve the desired immune response. Thus, there are several pathways in which the immune system can be stimulated in many different directions.
Recently, the role of the immune system in cancer diseases has been firmly investigated. There are now several different types of cancer treatments that involve manipulation of the immune system. Usually, these treatments are categorized as immunotherapy.
The treatment principle of immunotherapy is that it modulates the patient’s own immune system, which causes the body to eliminate the malignant cells. Several immunological treatments are currently being developed. Some of these are immunomodulation agents that may accelerate or block certain immunological pathways in order to produce the desired anti-cancer response. These will typically have a general effect on the immune system and can be produced and administered to many patients with the same type of cancer disease.
ADOPTIVE CELL TRANSFER IMMUNOTHERAPY IN BRIEF
Another type of immunotherapy treatment is based on infusions of very specifically and highly active immunological cells. These are tailor-made to target the genetic fingerprint of one specific tumour. The latter category includes Adoptive Cell Transfer Immunotherapy (ACT) with tumour-infiltrating lymphocytes (TILs). In brief, immunological “killer cells” (the tumour infiltrating lymphocytes) are harvested from the patients’ individual tumour and afterwards amplified in a laboratory under optimal conditions. Following, the cells are transfused back into the patient where the now abundant cells recognise and destroy tumour cells. Most often the treatment will be combined with immunomodulation agents in order to achieve a more effective immunological response. Each treatment is thereby made uniquely to the individual patients’ tumor.
Treatment with ACT has shown an effect in 40% of patients with melanoma, which is remarkable for this patient category. Pre-clinical data suggest that ovarian cancer tissue contains TILs that can be harvested. Consequently, treatment with ACT could be developed for ovarian cancer patients. A small trial from Japan examined the use of TILs as maintenance therapy in ovarian cancer and found that 100% of the patients treated with TILs were disease-free compared to 68% of the patients in the control group. These encouraging results indicate that treatment with TILs may potentially cure ovarian cancer.
THE MAIN DIFFERENCE BETWEEN IMMUNOTHERAPY AND TRADITIONAL ANTINEOPLASTIC TREATMENTS
Traditional chemotherapy and radiotherapy works by directly killing or inhibiting the growth of the malignant cells. However, both chemotherapy and radiotherapy affects not only the malignant cells but also the healthy normal-functioning cells. This leads to the well-known toxic side-effects such as nausea, vomiting, headaches, muscle pain, hair loss and fatigue, which can impact the fragile cancer patients quite severely. In contrast, immunotherapy targets only cancer cells. As a result, treatment with immunotherapy does not have the same harmful effects as chemo- and radiotherapy and is therefore much better tolerated by patients.
Immunotherapy has the Potential to Cure Cancer
The breakthrough results of treatment with immunotherapy has recently stirred great interest at some of the largest events such as the annual congresses of ASCO (American Society of Clinical Oncology):
”The field of immunotherapy has exploded in the last decade, and more and more patients are benefiting”
Steven O'Day, MD, ASCO expert, clinical associate professor of medicine University of Southern California, Keck School of Medicine
“The response rates are high, we can get some very large tumors to regress, and the responses can be very durable”’
Patrick Hwu, MD, University of Texas MD Anderson Cancer Center
“This field has spent several decades figuring out better ways to treat the cancer, and very important accomplishments have been made. We now have a way to treat the patient as well. With immunotherapy, you're treating the patient, and the patient is treating the cancer.”
Jedd Wolchok. MD, Ph.D. Memorial Sloan Kettering Cancer Center, New York
In 2013, the renowned scientific journal Science declared immunotherapy to be the breakthrough of the year. There are numerous indications that within a short time span, immunotherapy will considerably alter the treatment strategy for several types of cancer.
- Immunotherapy can be used across cancer types
- Immunotherapy has shown promising results in malignant melanoma
- Immunotherapy is a personalized treatment
- Immunotherapy is non-toxic
- Immunotherapy's enhanced effect may come from combination with other treatments
One of the most promising methods of immunotherapy is T-cell therapy, which has shown a 40% response rate in the treatment of melanoma. The data supports that the same treatment principles could apply to ovarian cancer.
What is a clinical trial?
Once researchers have completed a comprehensive screening and preclinical testing process, the investigational drug or treatment method is ready to be tested in human volunteers in a clinical trial. A clinical trial is a study that is carefully designed to test the benefits and risks of a specific medical treatment or intervention, such as a new drug, a treatment method (i.e. T-cell therapy) or a behavior change. The clinical part consists of 3 phases, phase 1 includes few healthy volunteers and phase 2 includes a limited group of patients.
The purposes of phase 1 and 2 studies are to investigate the safety and efficacy of the tested treatment in order to establish the correct treatment schedules and doses. Phase 3 includes a larger group of patients and the purpose is to investigate if the tested treatment has clinical benefits compared to the standard treatment. A principal investigator, who is usually a medical doctor, and a research team of nurses and others, leads every clinical trial. A multi-phase clinical trials process must be completed before determining whether a new treatment is safe and effective for a broader patient population.