Another Feather in Prescient’s Hat, Promising Efficacy Results from PTX-200 Phase 2a trial in HER2-Negative Breast Cancer

Of late, clinical stage oncology company, Prescient Therapeutics (ASX: PTX), focused on developing personalized medicines with an approach to address mutations causing cancer, has been under the spotlight for recent advancements in its clinical trials.

Prescient’s clinical trials are backed by a robust portfolio of products with its two lead drug candidates PTX-100 and PTX-200 that are known to switch off “master switches” that drives cancer. Prescient’s clinical trials are being conducted at world renowned cancer institutions in the U.S., with 4 open INDs granted by the US FDA.

In an announcement dated 23 December 2019, Prescient updated the market about the promising outcomes from Phase 2a trial of PTX-200 conducted in women with locally advanced, human epidermal growth factor receptor 2 or HER2 negative breast cancer revealing high overall response rate.

Post this encouraging news on 23 December 2019, PTX surged by 24% to make a day’s high of $0.098 amid heavy volumes, to finally close the day’s trade at $0.076.

Promising PTX-200 Phase 2a Efficacy Results

As per the GlobalData 2016, the treatment of triple negative and ER+/HER2 negative breast cancers is categorized by treatment with significant unmet clinical need.

Eleven women exhibited an overall response rate of 91%

· 10 of 11 patients were evaluable for the study.

· Primary efficacy endpoint of pathologic response in the breast is determined at the time of surgery.

· All 10 patients showed response to the treatment.

· Overall response rate (ORR) was 91% across all 11 patients.

· Pathologic complete response (pCR) meaning complete eradication of disease was observed in 2 patients.

· Pathological partial responses (PR) were observed in 8 patients.

· A clinical complete response was observed in another patient, though, this was unable to be confirmed surgically (cCR) due to passing away of the patient prior to the scheduled surgery from adverse event, which was believed to be associated with doxorubicin, a chemotherapy agent, and not related to PTX-200. As confirmed by the company, following treatment with PTX-200 and paclitaxel, this patient’s exceptionally large ER positive breast tumor was entirely exterminated however, during the subsequent treatment with Adriamycin and cyclophosphamide (AC), the patient passed away due to cardiac complications.

These results including 2 pCRs and an additional cCR reveals comparable proof of concept with regards to efficacy believes Prescient. Taken together, the 3 complete responses (27%) compares favorably against an anticipated pCR rate of 16% with current standard of care and improves the ORR to 100%.

Patients Exhibited Robust Durability of Response

It was further reported that the evaluation of duration of treatment response in patients is presently going on and patients continue to display strong durability of response.

· Progression-free survival with an average of 22 months so far, ranges from 6.7months to up to 40 months.

· Since 1 of the evaluable patients has passed away, so fare OS exhibits an average duration of 22.4 months.

· To date 9 of 10 patients remain progression free.

· These outcomes are tracking positively and favorably against the window of 24 months, during which many breast cancer patients typically relapse.

Prescient intends to commence a new trial with a specific focus on patients suffering from estrogen-receptor-positive (or ER positive) breast cancer, seemingly most responsive patient population.

Furthermore, strong durability of response augments the encouraging response rates witnessed in this study, contemplates Prescient.

PTX-200 in HER2-Negative Breast Cancer

HER2-negative Breast Cancer Phase 2a trial is being carried out at New York’s Montefiore Medical Center, Albert Einstein College of Medicine under the guidance of world-leading breast cancer specialist Professor Joseph Sparano, and at Florida’s H. Lee Moffitt Cancer Center, led by Dr Heather Han.

In this Phase 2a trial, a total of 11 patients diagnosed with locally advanced, HER2-negative breast cancer were registered. Of these 11 patients, 9 women were suffering from ER+ breast cancer, a type of cancer in which estrogen receptors are not found, and 2 patients were diagnosed with triple negative breast cancer, which is a kind of breast cancer that does not have any of the three receptors namely estrogen, progesterone and HER2 receptors that are otherwise commonly found on breast cancer cells.

Treatment regimen - Involves a dose of PTX-200 given to patients at a concentration of 35 mg/m² combined with paclitaxel at 80 mg/m²/week and standard doxorubicin-cyclophosphamide (AC therapy) and surgery afterwards.

Shedding light on the global market opportunity, the CEO mentioned that the global market demand for HER2-negative breast cancer therapies was predicted to grow to US$10.6 billion by 2025 with the major driving force for this growth anticipated to be the launch of new breast cancer drugs in the pre-operative setting; as is the strong demand for novel drugs for treating ER+ patients resistant to endocrine therapy.

Whilst a dearth of novel pipeline agents from pharmaceutical and biotechnology companies addressing this opportunity has been identified by the market watchers, Prescient’s PTX-200 is positioned well to address this poorly met need.

Prescient’s novel drug candidate PTX-200 has a unique mode of action

PTX-200 is a highly promising molecule which is being studied under three main areas including ovarian cancer, breast cancer and Acute Myeloid Leukemia (AML). PTX-200 has a unique mechanism of action as described below.

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