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PTX-100 Phase 1b study nearing completion; data to be reported at major haematology conference in December<\/strong> \u00a0<\/em><\/strong><\/p>\n 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. <\/strong>\u00a0<\/strong><\/p>\n Clinical stage oncology company Prescient Therapeutics (ASX:PTX)<\/strong><\/a>\u00a0says 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.<\/p>\n 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.<\/p>\n \u00a0<\/p>\n 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).<\/p>\n 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.<\/p>\n 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.<\/p>\n 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.<\/p>\n Prescient\u2019s PTX-200 trial for acute myeloid leukemia (AML) is also nearing completion but has progressed slower than anticipated.<\/p>\n The company says the changing landscape of AML treatment, with many new available therapies in recent years, has created challenges for recruitment.<\/p>\n 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.<\/p>\n In the meantime, minimal resources are being spent on completion of the study.<\/p>\n \u00a0<\/p>\n 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.<\/p>\n Scheffler showed the highly reproducible results of CellPryme-M and CellPryme-A using Her2 targeting CAR-T cells in immunocompetent syngeneic humanised Her2 mice,\u00a0 which\u00a0 are the workhorse in vivo model used by Professor Phil Darcy\u2019s group.<\/p>\n 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.<\/p>\n 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.<\/p>\n \u00a0<\/p>\n 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,\u00a0 GMP-compliant\u00a0 manufacturing process.<\/p>\n 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.<\/p>\n 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.<\/p>\n 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.<\/p>\n PTX says it was demonstrated that the entire process is entirely scalable on Thermo Fisher\u2019s closed automated systems for GMP manufacturing.<\/p>\n 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.<\/p>\n \u00a0<\/p>\n 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.<\/p>\n 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.<\/p>\n PTX\u2019s OmniCAR platform is being optimised pre-clinically, enhancing value without heavy clinical investments.<\/p>\n 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.<\/p>\n \u00a0<\/p>\n This article was developed in collaboration with Prescient Therapeutics, a Stockhead advertiser at the time of publishing. <\/em>\u00a0<\/em><\/p>\n This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.<\/em><\/p>\n <\/span><\/p>\n The post Cancer fighter Prescient navigates challenging conditions for biotech, reports strong Q1 FY24<\/a> appeared first on Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"
\nCellPryme pre-clinical data continues to surpass current cell therapy approaches<\/strong>
\nBusiness development meetings with international biotech companies continue<\/strong>\u00a0<\/em><\/strong><\/p>\nPTX-100 Phase 1b trial ongoing<\/strong><\/h2>\n
CellPryme-M proves superior to existing cytokines<\/strong><\/h2>\n
Thermo Fisher Scientific and Prescient collaboration\u00a0 <\/strong><\/h2>\n
Navigating biotech challenges and adding value<\/strong><\/h2>\n