Revolutionary Cancer Treatment Could Transform Lives by 2027

A groundbreaking cancer treatment developed in Wellington has the potential to change the lives of patients facing terminal diagnoses. This innovative therapy, known as CAR T-cell therapy, could be accessible to the public health system in New Zealand by 2027, provided health officials approve the necessary support.

BioOra Limited, a biotechnology firm partially owned by the Malaghan Institute of Medical Research, is preparing to scale up production of this treatment following the completion of a clinical trial. The company aims to manufacture CAR T-cell therapy, which has shown promise in inducing long-term remission in patients who previously had limited options. Currently, many such patients are seeking treatment overseas, incurring significant expenses.

Manufacturing Ambitions and Hurdles Ahead

BioOra is establishing a state-of-the-art manufacturing facility in Christchurch, designed to produce this therapy using advanced automated processes that minimize contamination risks. The company’s managing director, John Robson, expressed concerns regarding the speed of public health system responses, stating, “We’re kind of on this knife edge of, will they go fast enough for us?” He emphasized that timely action is crucial, as delays could lead to patients receiving treatment through private providers instead.

CAR T-cell therapy works by harvesting a patient’s immune cells, genetically modifying them to target cancer cells, and reintroducing them into the bloodstream. This approach has become a standard treatment for certain blood cancers in countries like Australia, yet it remains unavailable in New Zealand’s public or private healthcare systems.

The Malaghan Institute is leading efforts to change this landscape. Its custom CAR T therapy, currently undergoing phase 1 clinical trials, has demonstrated remarkable success, with over half of participants suffering from lymphoma achieving cancer clearance within months. Additionally, patients experienced significantly fewer severe side effects compared to commercial therapies available abroad.

Phase 2 of the trial is set to enroll its final patient with large B-cell lymphoma by October 2023, with results anticipated shortly thereafter for Medsafe approval.

Funding and Future Prospects

BioOra emerged from the Malaghan Institute to advance CAR T-cell therapy beyond the experimental phase. While the company is currently producing the therapy in Wellington, it is seeking to raise tens of millions of dollars from private investors to complete its new facility in Christchurch. Construction is underway, and Robson expects the site to be certified and operational by the end of 2026.

The new facility will create approximately 45 to 50 jobs and aims to manufacture enough therapy for 160 patients in its first year, increasing to over 300 in the second year. Robson noted the importance of synchronizing production capabilities with patient demand, especially as BioOra is half-owned by private investment firm Bridgewest Ventures and formed in 2021 with government support.

To facilitate public access, BioOra requires special funding from the government, which could provide initial access while a more permanent arrangement through Health NZ is established. Robson indicated that the per-patient cost would be significantly lower than the approximately $1 million charged for similar treatments in Australia and the United States, and would not be “massively different” from the $200,000 typically charged in other international markets, like China.

Robson emphasized that the therapy’s effectiveness outweighs cost considerations, stating, “The global story for us is that this is a safer immunotherapy than anything else that’s currently approved.”

BioOra plans to reinvest a substantial portion of its profits back into the Malaghan Institute to fund research for additional CAR T therapies and immunotherapies, aiming to address a range of conditions including childhood acute lymphoblastic leukaemia, other blood cancers, and autoimmune diseases.

As BioOra seeks to establish itself as a leader in immunotherapy, the potential for medical tourism is also on the horizon. Robson noted, “The more doses you make, the cheaper your average dose will be,” suggesting that offering competitive pricing could attract international patients seeking treatment.

The Malaghan Institute is actively fundraising to support the phase 2 trial, which is expected to cost over $17 million. This effort is separate from BioOra’s funding initiatives, which include a recent capital funding round that raised $15 million, with plans for an additional round aiming for $30 to $45 million.

As discussions continue regarding the necessary funding for public access, Robson highlighted the potential long-term savings for New Zealand’s healthcare system, noting that a single treatment could prevent years of costly interventions. The urgency to secure funding is underscored by the need for timely access to potentially life-saving treatments.

The regulatory landscape is evolving, with the Cancer Control Agency, Te Aho o Te Kahu, leading the official response to CAR T-cell therapy alongside various health ministries. New legislation, the Medical Products Bill, is set to introduce more flexible approval pathways for treatments like CAR T-cell therapy, which could be implemented by late 2030.

Despite the challenges ahead, the developments surrounding CAR T-cell therapy in New Zealand represent a significant step forward in cancer treatment options, with the promise of improved patient outcomes on the horizon.