Revolutionary Cancer Treatment Set for Public Access by 2027

A promising cancer treatment developed in Wellington, New Zealand, could soon be available to patients through the public healthcare system by 2027. This innovative therapy, known as CAR T-cell therapy, has shown remarkable results, putting patients with limited life expectancy into long-term remission. BioOra Limited, a biotech company associated with the Malaghan Institute of Medical Research, is preparing to manufacture this treatment for both public and private healthcare systems as soon as clinical trials conclude.

Currently, patients desperate for this life-saving therapy are seeking treatment abroad, often at significant financial costs. The company has ambitious plans to emulate the success of Rocket Lab in the field of immunotherapy, establishing a state-of-the-art manufacturing facility in Christchurch to produce CAR T-cell therapy at scale. This facility aims to eliminate contamination risks through advanced automation.

John Robson, managing director of BioOra, expressed concerns about the speed of the public system’s response. He emphasized the urgency, stating, “We’re kind of on this knife edge of, will they go fast enough for us? Quarter 1 of 2027 is a distinct possibility for public access, but it has to dovetail with a funding stream.” Without timely approval and support, the treatment may only be available privately, with discussions already underway with interested providers.

Understanding CAR T-cell Therapy

CAR T-cell therapy involves modifying a patient’s immune cells to recognize and attack cancer cells. The process includes collecting immune cells, genetically altering them, multiplying them, and infusing them back into the patient. This approach has become a standard treatment for certain blood cancers in countries like Australia, but it is not yet available in New Zealand.

The Malaghan Institute’s phase 1 clinical trial of its CAR T-cell treatment yielded impressive results; over half of the lymphoma patients, who had exhausted other treatment options, experienced cancer remission within months. Notably, the trial demonstrated lower rates of severe side effects compared to existing commercial CAR T therapies. This suggests that the New Zealand-developed CAR T therapy could be administered as an outpatient treatment, significantly reducing overall costs.

The phase 2 trial is expected to enroll its final patient by October 2024, with results submitted to Medsafe for approval shortly thereafter. BioOra is currently manufacturing the CAR T cells in Wellington while securing substantial private investment to facilitate the construction of its new facility in Christchurch.

Challenges and Future Prospects

The timeline for public access to CAR T-cell therapy hinges on the synchronization of demand and production scaling. BioOra, partly owned by the private investment firm Bridgewest Ventures, formed in 2021, has already raised tens of millions of dollars to support its growth. With the goal to manufacture enough therapy for 160 patients in the first year of operations and over 300 in the second, the company is preparing for significant expansion.

Robson refrained from commenting on the exact cost per patient but indicated it would be significantly lower than the approximately $1 million charged for similar treatments in the United States and Australia, and not dramatically different from the $200,000 typically charged in markets like China. He emphasized the importance of patient safety, stating, “The global story for us is that this is a safer immunotherapy than anything else that’s currently approved.”

Profits generated by BioOra are expected to be reinvested into the Malaghan Institute to further research and develop additional CAR T therapies and other immunotherapeutic options. Future treatments could target a range of conditions, including acute lymphoblastic leukaemia and various solid tumor cancers.

Robson articulated a vision for BioOra to become a leader in global immunotherapy, potentially attracting international patients for treatment. He noted, “The more doses you make, the cheaper your average dose will be. So you would underwrite your country’s sovereign cost through medical tourism.”

As BioOra explores avenues to tap into the Australian market, it faces logistical challenges. Current protocols necessitate transporting patient cells to laboratories in the United States or Europe, a process that can delay treatment for critically ill patients. To alleviate this, BioOra is considering establishing a manufacturing facility in Australia.

Meanwhile, the Malaghan Institute has initiated a fundraising campaign to cover the costs of the phase 2 trial, projected to exceed $17 million. This funding is separate from the capital raised by BioOra, which includes $15 million raised in a funding round last year, with plans for an additional $30-45 million in the next round.

Robson highlighted the potential economic benefits of timely public access to CAR T-cell therapy, arguing that the upfront costs would be offset by long-term health and productivity savings. He noted, “If you have a 20 or 30-year-old that’s treated and they effectively go down this curative pathway, then their benefit and their input to New Zealand is huge.”

The Cancer Control Agency, known as Te Aho o Te Kahu, which is part of the Ministry of Health, is overseeing the regulatory process for CAR T-cell therapy. Acting Chief Executive Nicola Hill stated, “This work will enable a streamlined approach for the agencies to identify the regulatory, health technology assessment and operational implications of technologies such as CAR-T cells.”

In response to the growing need for innovative treatments, new legislation will be introduced this year, allowing flexible approval pathways for therapies like CAR T-cell. However, the implementation of this legislation is not expected until late 2030. As BioOra moves forward, the company remains committed to bringing this transformative therapy to patients in New Zealand and beyond.