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Amplia reshapes board for next phase of cancer drug push

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Source : THE AGE NEWS

Amplia Therapeutics has refreshed its board, handing the chairman’s role to experienced life sciences director Jane Bell AM as the Melbourne-based drug developer looks to convert encouraging clinical momentum into regulatory and commercial success.

The company has framed the transition as part of a planned board renewal and succession process, timed to align with a genuine inflection point for its lead drug candidate, narmafotinib.

Amplia Therapeutics incoming chairman Ms Jane Bell AM

The move follows strong pancreatic cancer trial results, growing scientific validation for its Focal Adhesion Kinase (FAK) inhibitor portfolio and preparations for the next stage of United States regulatory engagement.

At the core of Amplia’s game plan is its push to develop FAK inhibitors that strip away the defensive armour protecting some of the toughest solid tumours such as pancreatic cancer.

‘It is an appropriate time to initiate changes in the Board and to prepare for new and exciting opportunities.’

Amplia Therapeutics outgoing chairman Dr Warwick Tong

These tumours often produce high levels of FAK protein, helping them grow, survive and fight off treatment. They also build a dense, scar-like fibrotic shield that can block chemotherapy from getting in and doing its job.

By weakening that shield, Amplia believes its drugs can make conventional cancer therapies hit harder. For patients, that could be critical. If tumours cannot be shrunk enough, surgeons often cannot perform successful debulking surgery, a key step in improving long-term recovery and survival.

Recent studies, including a pivotal paper in the journal Nature Medicine, have confirmed FAK signalling as a critical driver of fibrosis and immunosuppression in pancreatic cancer, validating the scientific rationale behind Amplia’s approach.

That strategy is already building a compelling clinical case.

The company’s phase 1b/2a ACCENT trial, evaluating narmafotinib alongside standard chemotherapy, delivered a seriously impressive 36 per cent objective response rate and a median survival of 11.1 months in patients with first-line advanced pancreatic cancer. The company says the survival figure is more than two months better than the historical benchmark for chemotherapy alone, without adding significant toxicity.

Amplia Therapeutics outgoing chairman Dr Warwick Tong said: “With the success of our recent clinical trials and increasing interest in the therapeutic potential of the portfolio, it is an appropriate time to initiate changes in the board and to prepare for new and exciting opportunities.”

Under the planned transition, Dr Tong has retired as chairman after steering the board since 2018, but will remain as a non-executive director. Ms Jane Bell AM, who joined Amplia’s board in April 2021 and chairs its Audit and Risk Committee, was unanimously appointed as the company’s new chairman.

Management says Bell’s two decades of board experience in the medical and life sciences sectors, backed by banking and finance legal expertise, equip her to guide Amplia through its next stage of development.

That strategy appears to be coming into focus.

Chief executive officer Dr Christopher Burns described 2026 as a “watershed year”, with several pieces now falling into place. The company has moved manufacturing to commercial-scale Good Manufacturing Practice (GMP) production, recently completing a 13-kilogram batch of the active pharmaceutical ingredient for narmafotinib.

It is also advancing discussions with the United States Food and Drug Administration (FDA) on registration-enabling studies, with formal engagement targeted around the middle of the year. Narmafotinib already holds FDA fast-track designation for advanced pancreatic cancer, in addition to orphan drug designations for both pancreatic cancer and idiopathic pulmonary fibrosis.

While pancreatic cancer is the lead act, the pipeline has significant optionality. Narmafotinib is advancing into ovarian cancer studies and has additional potential in idiopathic pulmonary fibrosis.

Waiting in the wings is another opportunity in fast-moving oncology research, where Amplia is positioning narmafotinib as a potential companion therapy for a new class of drugs known as KRAS inhibitors.

A landmark phase 3 trial has thrust KRAS inhibition into the spotlight after daraxonrasib dramatically improved survival in patients with advanced pancreatic cancer. The breakthrough validates decades of research aimed at shutting down mutant KRAS – the genetic driver behind roughly 90 per cent of pancreatic cancers – and signals a potential new standard of care for one of the world’s deadliest tumours.

Amplia is doing more than changing chairs. Rather than changing course, it is changing drivers for the next leg of the journey. With mature clinical data, commercial-scale manufacturing and a clearer FDA pathway, the refreshed board must steer the company from proving the science to delivering on its market potential.

Is your ASX-listed company doing something interesting? Contact: mattbirney@bullsnbears.com.au