Known for developing breakthrough personalised medicines using an approach to address specific mutations that drive cancer, thereby providing resistance to front line chemotherapy, Prescient Therapeutics Limited (ASX: PTX) has been gaining industry’s attention for the recent advancements in its clinical trials, backed by a robust targeted therapy portfolio of product with its two lead drug candidates, PTX-100 and PTX 200.
Remarkable Clinical Development of Prescient’s PTX-200
PTX-200 is an effective small molecule that is positioned as a novel PH domain inhibitor incorporating a novel mechanism of action that explicitly inhibits a vital survival pathway known as Akt.
Akt is a growth switch found in cancer cells, that plays a crucial role in the progression of several solid tumours including breast and ovarian cancer as well as hematologic tumours including leukemia, while also conferring resistance to many frontline therapies.
Source: Company Presentation
PTX-200 is being investigated under three ongoing clinical trials including ovarian cancer, breast cancer and Acute Myeloid Leukemia (AML).
PTX-200 in Recurrent or Persistent Platinum Resistant Ovarian Cancer
With a very poor clinical outcome, ovarian cancer is considered one of the most commonly occurring cancers in women. The patients often regarded as platinum resistant, since the majority of patients relapse & become resistant to the front-line platinum-based chemotherapy, such as carboplatin. In addition, abnormally high Akt further contributes to this resistance. Given these facts, the study has been designed to inhibit Akt to re-sensitise platinum resistant patients towards platinum therapies, in turn, effectively reversing and overcoming tumour resistance to chemotherapy.
Promising Interim Data from PTX-200 Phase 1b Clinical Trial
Of 15 patients’ women with recurrent or persistent platinum resistant ovarian cancer dosed with 15- 25 mg/m2 PTX-200 in combination to carboplatin, 11 patients exhibited signs of stable disease and 1 patient displayed a partial response, i.e., 80% displayed disease control (overall, 12 out of 15 patients).
PTX-200 in HER2- Negative Breast Cancer
Triple negative and ER+/HER2 negative breast cancer treatment is classified by treatment with significant unmet clinical need, as per the GlobalData 2016.
HER2- negative is the most locally advanced breast cancer and remains underserved by new drugs, thereby drawing a huge opportunity in the market which is expected to reach a significant $10.6 billion by 2025.
Source: Company Presentation
Encouraging data from the Phase 2a trial of PTX-200
Phase 2a trial of PTX-200 conducted in 11 women with HER2- negative breast cancer wherein 10 of 11 patients were evaluable for the study. The primary efficacy endpoint of pathologic response in the breast was determined at the time of surgery, with all ten patients showing response to the treatment, revealing an overall 91% response rate across all 11 patients. Complete eradication of disease or Pathologic complete response (pCR) was observed in 2 patients while pathological partial responses (PR) were observed in 8 patients.
PTX-200 in Acute Myeloid Leukemia
PTX-200 act as a targeted therapy under this study focusing on the “phenotype, not the genotype” in Acute Myeloid Leukemia (AML) mutations, synergising with cytarabine in AML cells complementing a “backbone” of traditional chemotherapy.
Phase 1 trial conducted under the guidance of Jeffrey E Lancet, MD, at Moffitt Cancer Center has previously been completed successfully wherein PTX-200 was used as a monotherapy in advanced hematologic malignancies, mainly AML that revealed promising data.
Promising results in PTX-200 Phase 1b trial
Given the promising results observed in PTX-200 Phase 1b trial in patients with relapsed and refractory (AML) with 3 of 15 subjects revealing total eradication of the disease in this difficult to treat patient population, Prescient recently announced an expansion of the study with an aim to identify the optimal PTX-200 dosing schedule with chemotherapy, and minimising the side effects based on these findings.
To summarise, Prescient with its robust pipeline of clinical programs leads the key developments being made in precision oncology globally and pledge to transform cancer treatment.
PTX was trading at $0.054 up by 8% on 19 February 2020 (AEDT: 1:55PM).
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