Cancer fighter Prescient navigates challenging conditions for biotech, reports strong Q1 FY24

PTX-100 Phase 1b study nearing completion; data to be reported at major haematology conference in December
CellPryme pre-clinical data continues to surpass current cell therapy approaches
Business development meetings with international biotech companies continue 

Cancer fighter Prescient Therapeutics has made progress during Q1 FY24 with key clinical trials and says it is well-positioned to navigate challenging economic conditions for the biotech sector.  

Clinical stage oncology company Prescient Therapeutics (ASX:PTX) says spending during the quarter was in line with the budget. At the end of Q1 FY24, PTX held cash reserves of $18.7 million, down from the $21.8 million on June 30, 2023.

The net operating expenditure for the quarter remained on budget at $3.2 million with $2.4 million allocated to R&D and clinical development activities.

PTX-100 Phase 1b trial ongoing

PTX says Professor H Miles Prince AM and his clinical research team in Melbourne continue to report positive outcomes from the ongoing Phase 1b trial of PTX-100 in patients with relapsed and refractory T cell lymphomas (TCL).

The Phase 1b trial is nearing its conclusion, with data scheduled for release in December, coinciding with a presentation at a prestigious international hematology conference.

PTX is actively seeking input from key opinion leaders in TCL to prepare for a meeting with the US FDA in Q1 CY24, focusing on the design of the Phase 2 trial as a potential registration study for expedited approval and commercialisation.

Although the timeline is uncertain, the study could take 2-3 years if allowed as a registration study. If not, a conventional Phase 2 study will proceed. Simultaneously, PTX is manufacturing additional PTX-100 to support the Phase 2 study.

Prescient’s PTX-200 trial for acute myeloid leukemia (AML) is also nearing completion but has progressed slower than anticipated.

The company says the changing landscape of AML treatment, with many new available therapies in recent years, has created challenges for recruitment.

PTX seeks to recruit a final patient to complete a data package and evaluate any avenues for development of PTX-200 with the principal investigator, for example combinations with other new AML agents.

In the meantime, minimal resources are being spent on completion of the study.

CellPryme-M proves superior to existing cytokines

In August 2023, Dr Christina Scheffler PhD from the Peter MacCallum Cancer Centre presented the latest developments on CellPryme at the ISCT-ANZ Regional Scientific Meeting in Perth.

Scheffler showed the highly reproducible results of CellPryme-M and CellPryme-A using Her2 targeting CAR-T cells in immunocompetent syngeneic humanised Her2 mice,  which  are the workhorse in vivo model used by Professor Phil Darcy’s group.

Dr Scheffler was able to show that pre-treatment with CellPryme-M could improve the in vivo function of CAR-T cells expanded in IL2/7.

These outcomes were superior to those achieved by CAR-T cells expanded in IL7/15, which is the current industry standard for promoting enrichment of central memory T cells.

Thermo Fisher Scientific and Prescient collaboration 

In September, global biotech giant Thermo Fisher Scientific and PTX presented results of its collaboration using non-viral engineering of CAR-T cells for development of an enclosed,  GMP-compliant  manufacturing process.

In science speak, the collaboration objective was to introduce the SpyCatcher CAR construct into the TRAC locus, which effectively disrupts the gene expression of TRAC thereby enhancing T-cell persistence.

PTX says gene-editing was achieved through CRISPR/Cas9, with the introduction of CAR construct using a single-stranded DNA template combined with electroporation rather than viral infection of the human T cells.

The process yielded functional OmniCAR-T cells with high viability (>95%) where tumour killing ability was verified in vitro using breast cancer cells and Her2 binders.

PTX says it was demonstrated that the entire process is entirely scalable on Thermo Fisher’s closed automated systems for GMP manufacturing.

The company says the work is crucial in the development of processes to enable decentralised manufacturing by third-party manufacturers and will likely improve the cost of goods for its OmniCAR platform.

Navigating biotech challenges and adding value

Adverse economic conditions have put pressure on the global biotech sector, but PTX says it is well-positioned for ongoing challenges with a diverse portfolio, including mature clinical-stage assets like PTX-100, lower-risk profiles, and capital for progression.

The company says it remains alert to initiatives that can benefit shareholders. Emerging assets like CellPryme are moving towards clinical applications with a focus on regulatory integration and adjuvant treatments.

PTX’s OmniCAR platform is being optimised pre-clinically, enhancing value without heavy clinical investments.

Furthermore, PTX says engaging with the industry remains vital to showcase progress, build relationships and ensure a strong foundation for future partnerships when the sector improves.

This article was developed in collaboration with Prescient Therapeutics, a Stockhead advertiser at the time of publishing.  

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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