Prescient Therapeutics (ASX: PTX) reported encouraging results in several key targeted and cell therapies in its September quarter activities report. 

The clinical-stage oncology company report they have a strong cash position, with a cash balance of $18.7 million. In the current prolonged downturn of the biotechnology sector, Prescient believe they are in a strong financial position, relatively speaking. The company’s diversified portfolio comprises more mature clinical-stage assets with a lower risk profile and a shorter potential path to market, with the capital to progress these assets.

Join Prescient CEO and MD Steven Yatomi-Clarke for a fireside discussion next Wednesday 8th November at 12pm (AEDT) where he will field questions and outline advancements through the quarter and what’s next. Click here to register or request the replay.

PTX-100 trial nearing completion

The ongoing Phase 1b trial of PTX-100 continues to see encouraging results in patients with relapsed and refractory T-cell lymphomas.

In this difficult-to-treat patient population, the durability of these responses to date is robust, with seven of ten evaluable patients having durable responses exceeding typical standard care treatments of 3-4 months.

Additional TCL patients have been enrolled in the ongoing Phase 1b trial to inform subsequent clinical development. The Phase 1b trial is nearing its conclusion, with Prescient planning to report the final data in December.

Prescient will be presenting data at a prestigious haematology conference in December, attended by international pharmaceutical and biotech companies and leading oncologists.

The completion of the PTX-100 Phase 1b study and reporting of this data is planned to be followed by a meeting with the US FDA early next year, to focus on the design of the Phase 2 trial and potential to use this as a registration study. 

If a registration study is allowed by the FDA, this could mean a much shorter and faster pathway to approval and commercialisation, in the event of clinical success. 

If the trial is not permitted as a registrational study, it would be conducted in line with non-accelerated clinical development. Manufacturing of additional PTX-100 drug products to support the Phase 2 study has been initiated.

CellPryme-M releases positive data 

Presenting the latest developments on CellPryme, Prescient’s high-performance cell therapy enhancement platform, Dr Christina Scheffler PhD showed highly reproducible results of CellPryme-M and CellPryme-A in immunocompetent syngeneic humanised Her 2 mice, used as the workhorse in vivo model.

The results showed that pre-treatment with CellPryme-M could improve the in vivo function of CAR-T cells expanded in IL2/7, which were superior to those achieved by CAR-T cells expanded in IL7/15, currently the industry standard.

Additionally, by combining CellPryme-M and CellPryme-A, Dr Scheffler was able to demonstrate the most effective outcomes, confirming previous Prescient study results.

As a result, CellPryme now has a compelling body of evidence to move towards the clinic.

Thermo Fisher collaboration yields encouraging results

In September, Prescient presented encouraging results in collaboration with Thermo Fisher, using non-viral engineering of CAR-T cells for the development of an enclosed, GMP-compliant manufacturing process.

The process yielded functional OmniCAR-T cells with over 95% viability where the ability to kill a tumour was verified in vitro using breast cancer cells and Her2 binders.

OmniCar is a universal immune receptor platform enabling controllable T-cell activity and multi-antigen targeting with a single-cell product.

In further positive news, the whole process is entirely scalable on Thermo Fisher’s closed automated systems for GMP manufacturing.

The company noted that this work was “crucial in the development of processes to enable decentralised manufacturing by third party manufacturers” and said it would likely improve the cost of goods for OmniCAR.

While many companies have shown enthusiasm for this potentially revolutionary approach, there is a paucity of resources to adopt it in the current risk-averse environment. Prescient is continuing to optimise the OmniCAR platform pre-clinically, adding value to the platform with minimal investment. 

Join Prescient CEO and MD Steven Yatomi-Clarke for a fireside discussion next Wednesday 8th November at 12pm (AEDT) where he will field questions and outline advancements through the quarter and what’s next. Register here.

Reach Corporate provides Corporate Advisory Services, including managing investor communications on behalf of Prescient Therapeutics Limited and may receive fees for its services.

Past performance is not a reliable indicator of future performance.