On-shore commercial manufacture and wider subsidy for CAR T Cell therapy

Cell Therapies Pty Ltd, a company situated at Peter Mac, has signed an agreement with Novartis to manufacture Kymriah (tisagenlecleucel) in Melbourne. This is the first and only Australian site approved to make Novartis’ CAR T-Cell therapy product.

Currently, Australians who receive this immunotherapy have their blood collected and sent overseas to undergo a manufacturing process, before their reprogramed cells are flown back to be reinfused.

“Being able to complete this whole process within Australia – and, in fact, entirely within Peter Mac – is a real game changer for Australian patients who need this treatment and their clinicians,” says Associate Professor Dominic Wall, who is the Executive Director at Peter Mac responsible for cellular immunotherapy.

“On-shore manufacture removes a major bottle-neck of international transport while patients benefit from substantially less time needed from blood collection to reinfusion.”

“CAR T-Cell treatments like Kymriah can be life-changing for patients who have exhausted all other options and I, along with all of our clinicians at Peter Mac, could not be more delighted by today’s developments.”

The Federal Government also announced today it will move to expand subsidised access to CAR T-Cell therapy to patients with relapsed or refractory Diffuse Large B Cell Lymphoma (DLBCL), and also Transformed Follicular Lymphoma and Primary Mediastinal B Cell Lymphoma.

This accounts for about 250 patients in Australia every year.

Currently, only young people (up to 25 years) with relapsed or refractory Acute Lymphoblastic Leukaemia (ALL) have subsidised access to CAR T-Cell therapy. There are about 20 to 30 of these patients each year, and many of these are treated at Peter Mac.

“DLBCL is the most common lymphoma in adults and is curable in most cases with standard treatments such as chemotherapy,” says Dr Michael Dickinson, a haematologist and Peter Mac’s Disease Group Lead for Aggressive Lymphoma.

“There are very few options for patients where conventional therapies no longer work and Kymriah is the first CAR T-Cell therapy to be funded in Australia.

“The news that it will be available soon for patients with these types of relapsed and refractory lymphomas is welcome as it offers eligible patients a chance of durable remission,” Dr Dickinson says.

CAR T-Cell therapy is a once-off, individualised treatment that uses the patient’s own reprogrammed T-Cells to fight their cancer. It is primarily used to treat blood cancers however clinical trials are underway to also apply CAR T-Cell therapies to solid tumours.

In March 2019, the Commonwealth Government also announced an $80 million investment (with $25 million coming from Peter Mac and the Peter MacCallum Cancer Foundation) to established the COE in Cellular Immunotherapy at Peter Mac. This includes a new 14 bed / chair dedicated clinical unit.

For latest information on CAR T-Cell therapy at Peter Mac, and to see a video of how it works, go online to www.petermac.org/car-t

Click here to read the original media release.

Additional resources

• Read Minister Hunt’s statement “Expanded access to cutting edge CAR T-cell therapy”
• Read Novartis’ announcement
  “Novartis announces landmark steps for Kymriah® (tisagenlecleucel): reimbursement for adult DLBCL eligible patients and agreement to manufacture in Australia”

Contacts:

For more information contact the Peter Mac Communications team on 0417 123 048.

About Cell Therapies Pty Ltd (CTPL)

CTPL is a leading provider of cGMP contract manufacturing and deployment services for cell and gene therapy products in the Asia Pacific. CTPL is dedicated to enabling patient access to, and furthering the development of, these ground-breaking therapies on behalf of clients from around the world. Building on more than 15 years’ experience and strategic partnerships with our owner, Peter MacCallum Cancer Centre in Melbourne Australia, we provide a complete process development and GMP product supply service from translational studies through to commercial supply and can serve as a single access point for regional deployment of cellular therapies for our clients. We have TGA licences that allow us to safely manufacture and supply these CAR-T therapies to patients in Australia.

About Peter Mac

Peter MacCallum Cancer Centre is one of the world’s leading cancer research, education and treatment centres globally and is Australia’s only public hospital solely dedicated to caring for people affected by cancer. We have over 2,500 staff, including more than 580 laboratory and clinical researchers, all focused on providing better treatments, better care and potential cures for cancer.