HaemaLogiX and Peter MacCallum Cancer Centre Announce Myeloma CAR-T Phase I Clinical Trial Agreement

• HaemaLogiX and Peter MacCallum Cancer Centre have entered a collaboration agreement to develop and conduct the first Phase I human trial of HaemaLogiX's CAR-T cell therapy in patients with kappa-type myeloma
• The agreement is the culmination of previous preclinical research collaboration between the two teams, which demonstrated compelling proof of concept
• The Phase I trial aims to show the clinical safety and efficacy of KMA.CAR-T in a limited number of patients.

SYDNEY, July 25, 2023 /PRNewswire/ -- Clinical stage Australian biotech company HaemaLogiX Ltd is pleased to announce it has entered into a co-development agreement with the world leading Peter MacCallum Cancer Centre (Peter Mac) to conduct the first in human Phase I trial of HaemaLogiX's CAR-T immunotherapy, KMA.CAR-T, for kappa-type multiple myeloma.

KMA.CAR-T is a novel immunotherapy that targets a receptor called Kappa Myeloma Antigen (KMA) found only on the surface of myeloma cells in kappa-type multiple myeloma patients and not on normal immune cells, which means normal immune cells are not damaged by the treatment.

The agreement sees the HaemaLogiX and Peter Mac Centre of Excellence in Cellular Immunotherapy continue to co-develop KMA.CAR-T, following a collaborative preclinical research project that demonstrated compelling proof of concept. Preclinical data shows the anti-KMA CAR-T cells selectively killed KMA-expressing myeloma cell lines and demonstrated potent anti-myeloma activity in a xenograft mouse model.

Dr Rosanne Dunn, HaemaLogiX Director| Chief Scientific Officer and Founder, said: "CAR-T cell therapy is now a realistic option for myeloma patients who have failed standard of care treatments. We're excited to progress KMA.CAR-T to the clinic in collaboration with Peter Mac, a renowned Australian cancer hospital and research institute that has been involved in the development of many of the CAR-T therapies now approved as treatments."

Professor Simon Harrison, Director of the Peter Mac Centre of Excellence in Cellular Immunotherapy, said: "CAR-T cell therapy is a game-changer in the treatment of certain blood cancers, such as multiple myeloma. We are delighted to continue our project with HaemaLogiX to translate the preclinical potential of KMA.CAR-T into a novel first-in-human clinical trial therapy."

Under the agreement, HaemaLogiX brings its patented KappaMab technology to the collaboration with Peter Mac to develop the technology, method of manufacturing and conduct the trial.

The proof of concept trial will be conducted initially in six patients, with the possibility of expanding to twelve patients.

About HaemaLogiX Ltd - www.haemalogix.com^[1]:

Formed in 2014, HaemaLogiX is a public unlisted biotech company researching antibody therapies for multiple myeloma. Multiple myeloma is a haematological (blood) cancer of plasma cells (B cells) that can cause focused damage to a patient's bone marrow. Multiple myeloma is considered treatable but generally incurable. The HaemaLogiX team has a wide range and depth of experience in antibody research, nonclinical & clinical development, manufacturing and commercialisation. The Scientific Advisory Board (SAB) members are internationally recognised experts in monoclonal antibody therapies and haematology. Our current research and clinical trial partners are global leaders in Multiple Myeloma and AL Amyloidosis therapy. HaemaLogiX is located in Sydney, Australia

About Peter Mac - www.petermac.org^[2]

Located in Melbourne, Peter Mac is a world leading cancer research, education and treatment centre and Australia's only public health service solely dedicated to caring for people affected by cancer. We have over 3,900 staff, including more than 700 laboratory and clinical researchers, all focused on providing cutting-edge treatments, better care and potential cures for cancer. Worldwide, Peter Mac is one of the leading institutions in cancer immunotherapy research, with Peter Mac's researchers conducting Australia's first-ever CAR T-cell clinical trial. For more info or to arrange an interview contact the Peter Mac Communications team on 0417 123 048.

References

1. ^{^} www.haemalogix.com (www.haemalogix.com)
2. ^{^} www.petermac.org (www.petermac.org)