Clinical stage oncology company Prescient Therapeutics Ltd (ASX:PTX, OTC:PSTTF) had a cash and term deposit balance of $14.5 million on June 30, 2024, with spending in line with budget and has been actively engaged in the Phase 2 trial of PTX-100 in the past quarter, focusing on refining the trial design based on feedback from T-Cell Lymphoma experts, regulatory bodies, manufacturing and commercial advisors.
A further highlight for the quarter was the last patient enrolled in the Phase 1b study achieved a complete response, defined as the complete eradication of the disease.
This patient, a 51-year-old woman with cutaneous T-cell lymphoma (CTCL), had previously failed three therapies. This result further strengthens the encouraging data from the study, addressing a patient population characterised by unmet needs and poor outcomes.
Refining trial design
During the quarter, Prescient was focused on activities related to the Phase 2 trial of PTX-100.
The company has been reviewing and refining the trial design, incorporating feedback from experts in T-Cell Lymphoma (TCL), regulatory bodies, manufacturing and commercial sectors. This guidance aims to optimise the trial’s success, address unmet medical needs and minimise the time and resources required.
As a result, Prescient has deferred its planned meeting with the US Food and Drug Administration (FDA). The company believes this additional planning and advice will be beneficial.
Prescient plans to meet with the FDA with the revised trial strategy in the coming months and aims to start the Phase 2 trial before the end of the year. The company looks forward to sharing the trial design soon.
By refining the trial design, Prescient aims for greater success in the long term. This approach is expected to optimise the clinical path for PTX-100, leading to more effective therapies and better patient outcomes, which is the company’s main goal.
Substantial Chemistry, Manufacturing and Control (CMC) activities are ongoing to support PTX-100’s development plans. CMC requirements for registration studies are more detailed and stringent compared to earlier-stage clinical studies.
Phase 1b data well received at TCLF24
In June, Prescient Therapeutics presented the Phase 1b results of PTX-100 at the 15th Annual T-Cell Lymphoma Forum (TCLF) in California. The forum, which focuses on the latest developments in T-cell lymphomas (TCLs), gathers clinicians, scientists and industry participants to discuss cutting-edge research, novel agents and innovative treatments.
Professor H. Miles Prince, a globally renowned expert in TCLs and principal investigator of the PTX-100 study, delivered the plenary presentation. The data from the study, which involved patients with relapsed and refractory T-cell lymphomas (r/r TCLs), received overwhelmingly positive feedback. Attendees particularly praised PTX-100’s safety profile and the duration of response observed in patients.
Discussions at the forum were highly productive, covering trial design and garnering interest from leading international clinicians to participate in the upcoming Phase 2 study. Additionally, Prescient engaged in several in-depth conversations with commercial companies active in the TCL field, highlighting the broader interest and potential impact of PTX-100 in T-cell lymphoma treatment.
CellPryme and OmniCAR advances
Prescient, in collaboration with the Peter MacCallum Cancer Centre (PMCC), is advancing studies to further understand the impact of CellPryme on the tumour microenvironment (TME).
The TME is a complex ecosystem surrounding tumours, significantly influencing cancer progression and often hindering the effectiveness of therapies, including cell-based treatments. These studies aim to elucidate how CellPryme can mitigate TME resistance, potentially enhancing the efficacy of cell therapies.
Prescient is actively engaged in discussions with several prospective partners to evaluate CellPryme-M. Although these discussions require thorough evaluation, Prescient is pleased to report that multiple discussions are progressing concurrently.
In preparation for clinical applications, Prescient is manufacturing additional clinical-grade CellPryme-A for upcoming first-in-human studies. These studies will assess the combination of CellPryme-A with CAR-T therapies. Despite the challenges faced by cell therapies, Prescient remains committed to exploring third-party opportunities to clinically evaluate CellPryme-A's potential to enhance these treatments.
Regarding OmniCAR, Prescient is collaborating with PMCC and the Commonwealth Scientific and Industrial Research Organisation (CSIRO) to address challenges in its development. This collaboration integrates expertise in cell biology, protein engineering, and bioinformatics. Several OmniCAR variants have been designed and are currently undergoing testing.
On the financial front
Prescient ended the quarter with cash reserves of A$14.5 million, down from A$15.8 million on March 31, 2024, with A$4 million held in term deposits with maturities greater than three months.
Net operating expenditure for the quarter was A$1.4 million, aligning with the budget. The company invested A$1.1 million in research and development and clinical development activities.
With a current cash runway of 10.7 quarters based on net cash used during the quarter, Prescient anticipates increased expenditure later this year due to escalated clinical trial activities.
Poised for growth with Phase 2 PTX-100 study
Prescient is on the cusp of a significant value inflection with the commencement of the Phase 2 study of PTX-100, building on years of dedicated effort. The data from the Phase 1b study has garnered praise from international lymphoma experts, highlighting the industry's focus on addressing this critical unmet need.
Moreover, Prescient is strategically positioned to capitalise on a recovery in the cell therapy sector. The company boasts two platform technologies, CellPryme and OmniCAR, which are designed to enhance third-party cell therapy programs.