Immunotherapy - QIMR Berghofer’s T-cell therapies in clinical trials

---

Promising new immune therapies for cancer treatment have moved a step closer following major advances at the QIMR Berghofer Medical Research Institute. The therapy against virusassociated cancers has been developed in the laboratory of QIMR Berghofer’s renowned tumour immunologist, Professor Rajiv Khanna, who explains the relevance of this research.

---

The Brisbane-based Institute has obtained the first approval in Australia to produce clinical grade experimental T-cell therapies, opening the way for new clinical trials.
Our technique involves taking a patient’s T-cells from a blood sample, modifying and effectively training them to attack the virus, and then returning them to the patient’s body.
When the ‘killer’ T-cells destroy the virus, they also destroy the cancer.
Preliminary trials have shown the therapy is safe, has no major side effects and can be effective against tumours including the aggressive brain cancer, glioblastoma multiforme (GBM).
The Therapeutics Goods Administration (TGA) approval enables us to initiate new advanced clinical trials designed to assess the efficacy of T-cell therapies.
QIMR Berghofer’s clinical manufacturing facility, Q-Gen, will prepare novel immunotherapeutics including T-cell therapies for patients with cancers such as GBM and nasopharyngeal carcinoma (NPC).
QIMR Berghofer is focussed on producing research with outcomes beyond the laboratory, and this is an excellent example of our efforts to get laboratory discoveries through clinical trials and to the hospital bedside.
Q-Gen has a strong commercial track record and continues to work with industry in the manufacture of therapies to Good Manufacturing Practice (GMP) standards.
Immunotherapy is a rapidly emerging research area in the oncology divisions of major international pharmaceutical industries and academic centres of cancer medicine.
The QIMR Berghofer Centre for Immunotherapy and Vaccine Development includes more than 200 staff and students across 14 laboratories, focused on mobilising the immune system to fight cancer and autoimmune diseases.
Clinical trial for brain cancer patients
In Phase I clinical trial of the T-cell therapy in patients with recurrent GBM, most participants lived much longer than the six-month prognosis normally given, and some showed no signs of disease progression.
Survival rates for this aggressive cancer have barely changed in decades.
There is an urgent clinical need for new treatments and if this treatment can buy patients more time, then that is a big step forward.
GBM is the most common malignant brain cancer, diagnosed in about 800 Australians every year.
Despite surgery, radiotherapy and chemotherapy, less than 10 per cent of patients survive beyond five years.
The research team is now keen to begin the next phase of trials, involving patients at an earlier stage of the cancer’s development.
The Phase I trial was conducted in collaboration with Dr David Walker at Brisbane’s Wesley Hospital and built on previous research which found that many brain tumours carry cytomegalovirus (CMV).
Effective against NPC
We have also successfully used similar technology to target nasopharyngeal carcinoma (NPC) – an aggressive throat cancer prevalent in South East Asia. The common herpes virus, Epstein- Barr virus (EBV), is present in the NPC cells and provides the immunotherapy target.
In a Phase I clinical trial for NPC, overall survival rates for immunotherapy patients was 523 days, compared to only 220 days in patients who did not receive the treatment.
This Phase I clinical trial was conducted in collaboration with the Queen Mary Hospital in Hong Kong and the University of Hong Kong (UHK) Li Ka Shing Faculty of Medicine.
Patients who participated in the trial were in the late stages of the cancer and quite unwell, so it was important to ensure the treatment was non-invasive, non toxic and did not damage healthy cells.
By offering this treatment in the earlier stages of NPC, accompanied with chemotherapy and radiation, we are confident we can further enhance survival rates.
Phase II trials, involving the standard chemotherapy regimen combined with immunotherapy, are about to begin in Brisbane and Hong Kong.
NPC is common among people in China, Indonesia, Thailand, Philippines, Vietnam, Singapore and many other countries in the South-East Asia region.
NPC is common among people in China, Indonesia, Thailand, Philippines, Vietnam, Singapore and many other countries in the South-East Asia region.
Pioneering immunotherapy
QIMR Berghofer is also collaborating with various clinical centres in Australia to develop adoptive immunotherapy for Hodgkin’s lymphoma and other B-cell lymphomas which are associated with EBV.
QIMR Berghofer’s immunotherapy program is funded under a major Flagship Research Program on Cancer Immunotherapy which is supported through the Rio Tinto Ride to Conquer Cancer.
Under this program, the Institute’s researchers are also developing a special immunotherapy bank which will be able to provide off-the-shelf cellular therapies for cancer patients.
QIMR Berghofer is focussed on producing research with outcomes beyond the laboratory, and this is an excellent example of our efforts to get laboratory discoveries through clinical trials and to the hospital bedside.
The Institute is located in Brisbane’s key medical precinct at Herston.
QIMR Berghofer’s facilities for GMP manufacture of cell-based and molecular therapies are also available for hospitals, organisations and other external clients requiring a controlled environment for manufacture and research.
Co-located within the Institute is the commercial Phase I/II clinical trials facility, Q-Pharm Pty Ltd, allowing QIMR Berghofer scientists and external clients the extended and unique capability for taking research findings from the laboratory to hospitals and clinics.

---

“There is an urgent clinical need for new treatments and if this treatment can buy patients more time,then that is a big step forward.”

---

Professor Rajiv Khanna
Professor Rajiv Khanna is the Head of the Tumour Immunology Laboratory and the Coordinator of Centre for Immunotherapy and Vaccine Development at QIMR Berghofer Medical Research Institute. He is a Senior Principal Research Fellow with the National Health and Medical Research Council (NHMRC). Professor Khanna has authored many significant research publications, with a particular focus on exploiting viral infection as therapeutic target for disease and the development of vaccines. He completed his PhD in India in 1989 and is currently the Chief Investigator on two major NHMRC-funded projects.