Top member reports
Company Report
Last edited 2 hours ago
PerformanceCommunity EngagementCommunity Endorsement
ranked
#5
Performance (43m)
-5.5% pa
Followed by
27
Straws
Sort by:
Recent
Content is delayed by one month. Upgrade your membership to unlock all content. Click for membership options.
#Appendix 4d and Half year repo
stale
Added 10 months ago

bottom line is that a highly speculative microcap in the oncology research basket. Better capital managers than others and right now you can take a share of a business with some near term possibilities of commercialisation and a market cap of 39 mil with 21 mil in cash on the balance sheet. Hold IRL and buyer at 4.5 cents

#Media
stale
Added one year ago


nice little nod to the possibility of commercialisation in the next 2 - 3 years for PTX. They’ve been pretty gentle in capital but I suppose it will cost a bit to run the phase 2 trial of PTX-100 in T cell lymphoma… but probably a lot less than a phase 3 trial


https://smallcaps.com.au/prescient-therapeutics-pivotal-year-ptx-100-development-treat-t-cell-lymphomas/

#ASX Announcements
stale
Added 2 years ago

 encouraging results… the glamour has been all about prescient’s CAR-T platform but PTX-100 is looking like it might be in patients in the shorter term…





Continued promising results in PTX-100 T Cell Lymphoma Phase 1b Cohort

Key Points:

 Positive response rates, with two new complete responses in patients with relapsed and refractory PTCL since last update

 7 of 10 evaluable patients had durations of response exceeding standard of care

 Excellent safety profile maintained

 Will modestly increase number of patients to create robust regulatory package

for FDA meeting, following recent Orphan Drug Designation from FDA

MELBOURNE Australia, 16 March 2023: Prescient Therapeutics Limited (ASX: PTX), a clinical stage oncology company developing personalised therapies to treat cancer, is pleased to provide an update on the PTX-100 Phase 1b expansion cohort in relapsed and refractory T cell lymphomas (TCL). PTX-100 continues to show encouraging clinical activity in this difficult-to-treat patient population, with several clinical responses that include two patients with relapsed and refractory peripheral TCL (PTCL) that have had complete responses (complete eradication of cancer) since the prior update in November 2022, which is not generally expected in this disease. PTX-100 also continues to exhibit an excellent safety profile at the highest dose of 2000 mg/m2. The study is being led by globally renowned haematologist, Professor H. Miles Prince at Epworth Hospital in Melbourne, Australia.

Phase 1b Enrolment

A total of 13 TCL patients have been dosed with PTX-100: 8 patients with PTCL and 5 patients with cutaneous TCL (CTCL). Patients had received a median of 3 prior lines of therapy and up to 5 systemic prior lines of therapy. PTX-100 was administered at doses up to 2,000 mg/m2. The expansion cohort has met its minimum enrolment schedule, and the study is ongoing as patients are responding for longer than expected (see Clinical Activity, below).

Four patients currently remain on therapy and additional patients are being recruited.

              

 Safety

PTX-100 continues to exhibit an excellent safety profile on the study, with very few serious adverse events. Grade 3 (severe) adverse events observed as being possibly related to PTX-100 include cases of neutropenia, thrombocytopenia and anaemia. Several of these cases were observed in the same patient and the patients recovered/resolved these events. Prescient believes that such side effects are not uncommon in treating this patient population and are likely manageable.

Clinical activity

Although the primary goal of the study is to evaluate safety, PTX-100 continues to exhibit encouraging clinical activity in the difficult-to-treat patient population, especially when considered against responses expected from current standards of care. This is summarised in Table 1.

Table 1: Summary of TCL patients’ responses so far in PTX-100 Phase 1b study

Target1 Actual2 Target1 Actual2

1. Considered a target benchmark for a Phase 2 or registration study. S.M. Horowitz et al; Blood Dec 2021 2. Study ongoing; based on evaluable patients. Results as at 6 March 2023

Comments of note for this update:

 All 13 TCL patients were assessable for safety; 10 patients were assessable for

efficacy. 5 patients had r/r PTCL and 5 patients had r/r CTCL.

 Targeted progression free survival (PFS) is median, however with small patient

numbers in this study PTX is reporting mean PFS. In this update, PFS is impacted by newer patients on the study, whose treatments are in the earlier stages but remain ongoing. This results in a lowering of the overall PFS figures. PFS for r/r PTCL was 9.2 months and for r/r CTCL was 8.2 months.

 In CTCL, an additional measure of clinical utility is Clinical Benefit Rate (CBR), which includes those patients with complete and partial responses and those with durable

  Overall Response Rate

  Progression Free Survival (months)

   r/r TCL

(n=10)

 >30%

  40%

  5-6

  8.7

           

 stable disease. Typically, CTCL therapies have a CBR of 50%1, so far on this study the observed CBR is 60%.

Individual patient responses are summarised in the swimmer plot in Figure1.

 Figure 1: Swimmer plot of individual TCL patient responses and duration

Results as at 6 March 2023

SoC: duration of response (months) from current Standard of Care treatments

Target: Duration of response (months) that is considered a target benchmark for a Phase 2 or registration study (S.M. Horowitz et al; Blood; Dec 2021)

Next steps

Based on encouraging data so far, regulatory advisors have recommended enrolling seven additional patients in order to support a more robust data package for a meeting with the US FDA.

Prescient is planning a subsequent Phase 2 trial in TCL, which will be conducted subject to satisfactory Phase 1b outcomes. Prescient will seek to apply for this Phase 2 trial to be an Accelerated Approval trial with the FDA in an Orphan Indication. If this is granted, Accelerated Approval could pave the way for the Phase 2 trial to be the study enabling

1 H.M. Prince; et al; J Clin Oncol; 2010

           

 expedited regulatory approval of PTX-100. If Accelerated Approval is not granted, the Phase 2 trial will proceed as per conventional drug development pathways, with a subsequent study likely required for approval.

Prescient will also be seeking clarification on the dose optimisation and dose schedule considerations for the Phase 2 study pursuant to the FDA’s Project Optimus, which seeks to maximizes not only the efficacy of a drug but also its the safety and tolerability.

Prescient will be applying for a meeting the FDA later this year. A favourable outcome would see the registrational Phase 2 study open within 12 months, subject to satisfactory results from the Phase 1b trial. A possible scenario may involve regulatory interactions taking place and/or a subsequent Phase 2 trial initiated before the current Phase 1b officially concludes, due to the long duration of responses being observed in this Phase 1b study.

To facilitate further studies, Prescient will conduct another manufacturing campaign of PTX- 100, planning for this has already commenced. Manufacturing will be conducted and documented at higher levels of rigour required to support later stage trials and regulatory submissions.

Prescient’s Chief Medical Officer, Dr Terrence Chew, said, “We are very pleased to see these promising efficacy and safety results in this difficult to treat patient population. With confirmation of these preliminary results, we expect to proceed expeditiously to a registration trial and to be able to provide PTX100 to these patients who desperately need more effective therapies.”

Prescient’s CEO and Managing Director, Steven Yatomi-Clarke, said, “It is very exciting to see this clinical data for PTX-100 continue to unfold so favourably, especially in these relapsed and refractory T cell lymphomas, which are particularly difficult to treat and where other therapies have failed. Unlike other TCL therapies, PTX-100 continues to exhibit an excellent safety profile, and the patient responses we are observing are very promising for a Phase 1b study.

Whilst Phase 1 trials necessarily focus on safety, we have a valuable opportunity to bolster our trial with a small number of additional patients to enable Prescient to have a more meaningful and productive dialogue with the FDA. This follows last week’s decision by the FDA to grant PTX-100 Orphan Drug Designation for all TCLs, and presents an exciting and unique opportunity for Prescient and for TCL patients awaiting more effective therapies.”

          

 – Ends –

About Prescient Therapeutics Limited (Prescient)

Prescient Therapeutics is a clinical stage oncology company developing personalised medicine approaches to cancer, including targeted and cellular therapies.

Targeted Therapies

PTX-100 is a first in class compound with the ability to block an important cancer growth enzyme known as geranylgeranyl transferase-1 (GGT-1). It disrupts oncogenic Ras pathways by inhibiting the activation of Rho, Rac and Ral circuits in cancer cells, leading to apoptosis (death) of cancer cells. PTX- 100 is believed to be the only GGT-1 inhibitor in the world in clinical development. PTX-100 demonstrated safety and early clinical activity in a previous Phase 1 study and recent PK/PD basket study of hematological and solid malignancies. PTX-100 is now in a Phase 1b expansion cohort study in T cell lymphomas, where it is showing encouraging efficacy and safety. The US FDA has granted PTX-100 Orphan Drug Designation for all T cell lymphomas.

PTX-200 is a novel PH domain inhibitor that inhibits an important tumour survival pathway known as Akt, which plays a key role in the development of many cancers, including breast and ovarian cancer, as well as leukemia. Unlike other drug candidates that target Akt inhibition, PTX-200 has a novel mechanism of action that specifically inhibits Akt without non-specific kinase inhibition effects. This highly promising compound is currently in a Phase 1b/2 trial in relapsed and refractory AML, where it has resulted in 4 complete remissions so far. PTX-200 previously generated encouraging Phase 2a data in HER2-negative breast cancer and Phase 1b in recurrent or persistent platinum resistant ovarian cancer.

Cell Therapies

OmniCAR: is a universal immune receptor platform enabling controllable T-cell activity and multi- antigen targeting with a single cell product. OmniCAR’s modular CAR system decouples antigen recognition from the T-cell signalling domain. It is the first universal immune receptor allowing post- translational covalent loading of binders to T-cells. OmniCAR is based on technology licensed from Penn; the SpyTag/SpyCatcher binding system licensed from Oxford University; and other assets.

The targeting ligand can be administered separately to CAR-T cells, creating on-demand T-cell activity post infusion and enables the CAR-T to be directed to an array of different tumour antigens. OmniCAR provides a method for single-vector, single cell product targeting of multiple antigens simultaneous or sequentially, whilst allowing continual re-arming to generate, regulate and diversify a sustained T-cell response over time.

Prescient is developing OmniCAR programs for next-generation CAR-T therapies for Acute Myeloid Leukemia (AML); Her2+ solid tumours, including breast, ovarian and gastric cancers; and glioblastoma multiforme (GBM).

CellPryme-M: Prescient's novel, ready-for-the-clinic, CellPryme-M technology enhances adoptive cell therapy performance by shifting T and NK cells towards a central memory phenotype, improving persistence, and increasing the ability to find and penetrate tumours. CellPryme-M is a 24-hour, non- disruptive process during cell manufacturing. Cell therapies that could benefit from additional

 To stay updated with the latest company news and announcements, please update your details on our investor centre.

           

 productivity in manufacturing or increased potency and durability in-vivo, would be good candidates for CellPryme-M.

CellPryme-A: CellPryme-A is an adjuvant therapy designed to be administered to patients alongside cellular immunotherapy to help them overcome a suppressive tumour microenvironment. CellPryme-A significantly decreases suppressive regulatory T cells; increases expansion of CAR-T cells in vivo; increases tumour penetration of CAR-T cells. CellPryme-A improves tumour killing and host survival of CAR-T cell therapies, and these benefits are even greater when used in conjunction with CellPryme-M pre-treated CAR-T cells.

The Board of Prescient Therapeutics Limited has approved the release of this announcement.

Find out more at www.ptxtherapeutics.com or connect with us via Twitter @PTX_AUS and LinkedIn.

  Steven Yatomi-Clarke

CEO & Managing Director

Prescient Therapeutics

[email protected] [email protected]

Media enquiries:

Andrew Geddes – CityPR

+61 2 9267 4511 [email protected]

Investor enquiries:

Sophie Bradley – Reach Markets +61 450 423 331

            

 Disclaimer and Safe Harbor Statement

Certain statements made in this document are forward-looking statements within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements are not historical facts but rather are based on the current expectations of Prescient Therapeutics Limited (“Prescient” or the “Company”), their estimates, assumptions, and projections about the industry in which Prescient operates. Material referred to in this document that use the words ‘estimate’, ‘project’, ‘intend’, ‘expect’, ‘plan’, ‘believe’, ‘guidance’, and similar expressions are intended to identify forward-looking statements and should be considered an at-risk statement. These forward-looking statements are not a guarantee of future performance and involve known and unknown risks and uncertainties, some of which are beyond the control of Prescient or which are difficult to predict, which could cause the actual results, performance, or achievements of Prescient to be materially different from those which may be expressed or implied by these statements. These statements are based on our management’s current expectations and are subject to a number of uncertainties and risks that could change the results described in the forward-looking statements. Risks and uncertainties include, but are not limited to, general industry conditions and competition, general economic factors, global pandemics and related disruptions, the impact of pharmaceutical industry development and health care legislation in the United States and internationally, and challenges inherent in new product development. In particular, there are substantial risks in drug development including risks that studies fail to achieve an acceptable level of safety and/or efficacy. Investors should be aware that there are no assurances that results will not differ from those projected and Prescient cautions shareholders and prospective shareholders not to place undue reliance on these forward- looking statements, which reflect the view of Prescient only as of the date of this announcement. Prescient is not under a duty to update any forward-looking statement as a result of new information, future events or otherwise, except as required by law or by any appropriate regulatory authority.

Certain statements contained in this document, including, without limitation, statements containing the words “believes,” “plans,” “expects,” “anticipates,” and words of similar import, constitute “forward- looking statements.” Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of Prescient to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, the following: the risk that our clinical trials will be delayed and not completed on a timely basis; the risk that the results from the clinical trials are not as favourable as we anticipate; the risk that our clinical trials will be more costly than anticipated; and the risk that applicable regulatory authorities may ask for additional data, information or studies to be completed or provided prior to their approval of our products. Given these uncertainties, undue reliance should not be placed on such forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the results of any revisions to any of the forward-looking statements contained herein to reflect future events or developments except as required by law.

This document may not contain all the details and information necessary for you to make a decision or evaluation. Neither this document nor any of its contents may be used for any other purpose without the prior written consent of the Company.

Supplemental COVID-19 Risk Factors

Please see our website : Supplemental COVID-19 Risk Factors

           

#ASX Announcements
stale
Added 2 years ago

 

easy to forget with the sexiness of OMNICAR and CAR-T that PTX has a couple of promising ‘targeted’ therapy drugs in trials.


bullish


PTX-100 Expansion Cohort Continues to Exhibit Safety & Encouraging Clinical Activity

Key Points:

 Ongoing safety profile very favourable

 PTX-100 continues to exhibit encouraging clinical activity

 Additional CTCL patients to be added to trial

MELBOURNE Australia 25 October 2022: Prescient Therapeutics Limited (ASX: PTX), a clinical stage oncology company developing personalised therapies to treat cancer, is pleased to provide an update on the PTX-100 Phase 1b expansion cohort in relapsed and refractory T cell lymphomas (TCL). The study is being led by globally renowned haematologist, Professor H. Miles Prince at Epworth Hospital in Melbourne, Australia. PTX- 100 continues to exhibit an excellent safety profile at the highest dose of 2000 mg/m2. Moreover, PTX-100 continues to show encouraging clinical activity in a difficult to treat patient population, including a striking response in a patient with refractory cutaneous TCL (CTCL).

Phase 1b Enrolment

The expansion cohort has targeted 8-12 patients. A total of 8 patients have been screened and 7 patients have been dosed with PTX-100 in the expansion cohort so far: 4 with peripheral TCL (PTCL) and 3 with CTCL. Patients had received a median of 4 prior lines of therapy and up to 6 prior lines of therapy. PTX-100 was administered at 2,000 mg/m2. Four patients remain on therapy and additional patients are being recruited.

Safety

PTX-100 continues to exhibit an excellent safety profile on the study. There have been very few adverse events in the expansion cohort so far, and no serious adverse events related to PTX-100.

2 PTCL patients that had commenced therapy withdrew from the study for reasons unrelated to the trial. Another PTCL patient passed away due to reasons not associated with the study, as frequently occurs in studies of advanced malignancies. In each of these cases, subjects were not on the study long enough to observe responses, however, relevant pharmacokinetic and safety data were still collected, which are to the primary objectives of the study.

             

 Clinical activity

Although the primary goal of the expansion cohort is to evaluate safety, PTX-100 continues to exhibit encouraging clinical activity in the difficult-to-treat patient population. An update of observed responses is summarised below:

 Patient 121-003 (previously reported in dose escalation component of the study) with aggressive PTCL that had failed five prior treatments, had a partial response that endured for over 32 months before the disease progressed.

 Patient 121-010 with CTCL that had failed 4 prior lines of therapy experienced a very good partial response (VGPR), which is almost a complete response, that has endured for 6 months so far. This patient remains on therapy. Please refer to the case study photos below.

 Another 2 patients with CTCL that failed three prior therapies have experienced stable disease that have endured for 3-4 months so far and remain on therapy.

Case study: Patient 121-010

CTCL patient that had failed 4 prior therapies. Patient had VGPR on PTX-100 and is still on treatment.

           

             

 Next steps

In light of these encouraging responses in CTCL in particular, Prescient has amended the study protocol to accommodate the recruitment of additional CTCL patients. Recruitment remains on schedule, notwithstanding the new objective of recruiting additional CTCL patients, which may commensurately extend the study period. The study will remain open while patients continue to derive clinical benefit from PTX-100. Prescient looks forward to providing further details on the expansion cohort study in the coming quarter.

Principle Investigator of the study, Professor H. Miles Prince, said, “We continue to see impressive responses in both systemic and cutaneous T cell lymphomas on this study. Furthermore, PTX-100 continues to be extremely well tolerated by patients. We look forward to continue accruing patients to the trial who otherwise have limited treatment options.”

Prescient’s CEO and Managing Director, Steven Yatomi-Clarke said, “It is very exciting to see PTX-100 show clinical activity in a patient population that is notoriously difficult to treat, and where these patients have failed several lines of prior therapies. Furthermore, PTX-100 continues to exhibit an excellent safety profile, which is uncharacteristic of available TCL therapies. It is exciting to see encouraging responses in CTCL patients, alongside PTCL patients, and we will aim to recruit more CTCL patients to the study. We look forward to sharing these updates with the market.”

– Ends –

About Prescient Therapeutics Limited (Prescient)

Prescient Therapeutics is a clinical stage oncology company developing personalised medicine approaches to cancer, including targeted and cellular therapies.

Cell Therapies

OmniCAR: is a universal immune receptor platform enabling controllable T-cell activity and multi- antigen targeting with a single cell product. OmniCAR’s modular CAR system decouples antigen recognition from the T-cell signalling domain. It is the first universal immune receptor allowing post- translational covalent loading of binders to T-cells. OmniCAR is based on technology licensed from Penn; the SpyTag/SpyCatcher binding system licensed from Oxford University; and other assets.

The targeting ligand can be administered separately to CAR-T cells, creating on-demand T-cell activity post infusion and enables the CAR-T to be directed to an array of different tumour antigens. OmniCAR provides a method for single-vector, single cell product targeting of multiple antigens simultaneous or

 To stay updated with the latest company news and announcements, please update your details on

 our investor centre.

          

 sequentially, whilst allowing continual re-arming to generate, regulate and diversify a sustained T-cell response over time.

Prescient is developing OmniCAR programs for next-generation CAR-T therapies for Acute Myeloid Leukemia (AML); Her2+ solid tumours, including breast, ovarian and gastric cancers; and glioblastoma multiforme (GBM).

CellPryme-M: Prescient's novel, ready-for-the-clinic, CellPryme-M technology enhances adoptive cell therapy performance by shifting T and NK cells towards a central memory phenotype, improving persistence, and increasing the ability to find and penetrate tumours. CellPryme-M is a 24-hour, non- disruptive process during cell manufacturing. Cell therapies that could benefit from additional productivity in manufacturing or increased potency and durability in-vivo, would be good candidates for CellPryme-M.

CellPryme-A: CellPryme-A is an adjuvant therapy designed to be administered to patients alongside cellular immunotherapy to help them overcome a suppressive tumour microenvironment. CellPryme-A significantly decreases suppressive regulatory T cells; increases expansion of CAR-T cells in vivo; increases tumour penetration of CAR-T cells. CellPryme-A improves tumour killing and host survival of CAR-T cell therapies, and these benefits are even greater when used in conjunction with CellPryme-M pre-treated CAR-T cells.

Targeted Therapies

PTX-100 is a first in class compound with the ability to block an important cancer growth enzyme known as geranylgeranyl transferase-1 (GGT-1). It disrupts oncogenic Ras pathways by inhibiting the activation of Rho, Rac and Ral circuits in cancer cells, leading to apoptosis (death) of cancer cells. PTX- 100 is believed to be the only GGT-1 inhibitor in the world in clinical development. PTX-100 demonstrated safety and early clinical activity in a previous Phase 1 study and recent PK/PD basket study of hematological and solid malignancies. PTX-100 is now in a Phase 1b expansion cohort study in T cell lymphomas, where it has shown encouraging efficacy signals and safety.

PTX-200 is a novel PH domain inhibitor that inhibits an important tumour survival pathway known as Akt, which plays a key role in the development of many cancers, including breast and ovarian cancer, as well as leukemia. Unlike other drug candidates that target Akt inhibition, PTX-200 has a novel mechanism of action that specifically inhibits Akt without non-specific kinase inhibition effects. This highly promising compound is currently in a Phase 1b/2 trial in relapsed and refractory AML, where it has resulted in 4 complete remissions so far. PTX-200 previously generated encouraging Phase 2a data in HER2-negative breast cancer and Phase 1b in recurrent or persistent platinum resistant ovarian cancer.

The Board of Prescient Therapeutics Limited has approved the release of this announcement.

Find out more at www.ptxtherapeutics.com or connect with us via Twitter @PTX_AUS and LinkedIn

  Steven Yatomi-Clarke

CEO & Managing Director

Prescient Therapeutics

[email protected] [email protected]

Media enquiries:

Andrew Geddes – CityPR

+61 2 9267 4511 [email protected]

Investor enquiries:

Sophie Bradley – Reach Markets +61 450 423 331

            

 Disclaimer and Safe Harbor Statement

Certain statements made in this document are forward-looking statements within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements are not historical facts but rather are based on the current expectations of Prescient Therapeutics Limited (“Prescient” or the “Company”), their estimates, assumptions, and projections about the industry in which Prescient operates. Material referred to in this document that use the words ‘estimate’, ‘project’, ‘intend’, ‘expect’, ‘plan’, ‘believe’, ‘guidance’, and similar expressions are intended to identify forward-looking statements and should be considered an at-risk statement. These forward-looking statements are not a guarantee of future performance and involve known and unknown risks and uncertainties, some of which are beyond the control of Prescient or which are difficult to predict, which could cause the actual results, performance, or achievements of Prescient to be materially different from those which may be expressed or implied by these statements. These statements are based on our management’s current expectations and are subject to a number of uncertainties and risks that could change the results described in the forward-looking statements. Risks and uncertainties include, but are not limited to, general industry conditions and competition, general economic factors, global pandemics and related disruptions, the impact of pharmaceutical industry development and health care legislation in the United States and internationally, and challenges inherent in new product development. In particular, there are substantial risks in drug development including risks that studies fail to achieve an acceptable level of safety and/or efficacy. Investors should be aware that there are no assurances that results will not differ from those projected and Prescient cautions shareholders and prospective shareholders not to place undue reliance on these forward- looking statements, which reflect the view of Prescient only as of the date of this announcement. Prescient is not under a duty to update any forward-looking statement as a result of new information, future events or otherwise, except as required by law or by any appropriate regulatory authority.

Certain statements contained in this document, including, without limitation, statements containing the words “believes,” “plans,” “expects,” “anticipates,” and words of similar import, constitute “forward- looking statements.” Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of Prescient to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, the following: the risk that our clinical trials will be delayed and not completed on a timely basis; the risk that the results from the clinical trials are not as favourable as we anticipate; the risk that our clinical trials will be more costly than anticipated; and the risk that applicable regulatory authorities may ask for additional data, information or studies to be completed or provided prior to their approval of our products. Given these uncertainties, undue reliance should not be placed on such forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the results of any revisions to any of the forward-looking statements contained herein to reflect future events or developments except as required by law.

This document may not contain all the details and information necessary for you to make a decision or evaluation. Neither this document nor any of its contents may be used for any other purpose without the prior written consent of the Company.

Supplemental COVID-19 Risk Factors

Please see our website : Supplemental COVID-19 Risk Factors

           

#Management
stale
Added 2 years ago

I always enjoy listening to Steve Yatomi-Clarke discuss PTX's progress and plans when I tune in. However, as a long term shareholder (IRL) I'm developing a touch of scepticism based on the regularity of presentations and IR exercises...


Steve presents weekly sometimes more than once in a week and whilst I understand they're a pre-revenue biotech and therefore communication and IR relations are pretty important. BUT... Does anyone worry that this is just a way to string the market along and continue to milk the market for cap raises? I don't feel this way with PTX, I feel they've been decent stewards of shareholder capital but I have some doubts just based on the extreme number of presentations...


Does anyone else have a view on this for PTX or more generally?

#ASX Announcements
stale
Added 2 years ago

And there it is… the cap raise:


  Prescient Therapeutics Launches Share Purchase Plan

 to raise $8.0 million

 Key highlights:

 Prescient Therapeutics targeting to raise $8.0 million via a Share Purchase Plan at $0.175 per share (14.6% discount to 5 day VWAP).

 Funds raised will be used to progress the Company’s deep pipeline of innovative cancer therapies, namely the ongoing clinical development of its targeted therapies PTX-100 and PTX-200, and progressing its innovative cell therapies towards and into first-in-human clinical studies.

 Join CEO and MD Steven Yatomi-Clarke for a live shareholder briefing on Tuesday 30th August at 12pm (AEST). Register here.

MELBOURNE Australia, 24 August 2022 – Prescient Therapeutics (ASX: PTX), a clinical stage oncology company developing personalised therapies to treat cancer, is pleased to announce a Share Purchase Plan (SPP) targeting to raise $8.0 million. Funds raised will be used to progress Prescient’s deep pipeline of innovative cancer therapies, namely the ongoing clinical development of its targeted therapies PTX-100 and PTX-200, and progressing its innovative cell therapies towards and into first-in- human clinical studies. Funds will also go towards general working capital and costs of the offer.

        Under the SPP new fully paid ordinary shares will be issued at $0.175 per share, equivalent to a 14.6% discount to the volume weighted average price (VWAP) over the five trading days before the date the

 SPP was announced, and a 16.7% discount to the close price on 23 August 2022.

The Company will offer Eligible Shareholders who were registered shareholders as at 5:00pm (AEST) on Tuesday 23rd August 2022 (Record Date) the opportunity to apply for up to A$30,000 of new fully paid

 ordinary shares (New Shares) in the Company under the SPP. Full details of the SPP will be set out in the SPP Offer Booklet which is expected to be released to the ASX and despatched to eligible shareholders within five business days.

Prescient CEO & Managing Director, Steven Yatomi-Clarke commented: “The last couple of years in

 particular have been a period of incredible growth and progress for Prescient, and the Company is seeking to maintain this momentum and its position at the forefront of oncology innovation. The Prescient Board acknowledges, values and thanks shareholders for their continued support of the Company. We are pleased to provide our shareholders with the opportunity to participate in this SPP by purchasing

 

 additional shares at a modestly discounted price without incurring brokerage or transaction costs. Funds raised will assist the Company to progress its clinical and pre-clinical programs along with providing general working capital.

Prescient continues to build out a diverse and innovative pipeline of personalised therapies for cancer.”

 Participate in the Share Purchase Plan

Shareholders can request an electronic copy of their personalised Share Purchase Plan application form be emailed to them as soon as available from the below link: https://prescienttherapeutics.investorportal.com.au/request-SPP/

Reach Corporate are the advisers managing the Share Purchase Plan Offer and can be contacted by calling 1300 805 795 or via [email protected]

Share Purchase Plan Timetable

An indicative timetable of key dates is detailed below. This timetable may change at the discretion of the Company, subject to the requirements of the ASX Listing Rules.

       Event

Indicative Date

  Record Date

  Announcement of SPP Offer

SPP Opens & Despatch of SPP Offer Booklet

SPP Closes

SPP results announced to the ASX

Issue of Shares under SPP

Trading of all SPP Shares (subject to ASX Listing Rules)

23 August 2022

24 August 2022

24 August 2022

5pm AEST, Wednesday, 28 September 2022

3 October 2022 5 October 2022 6 October 2022

13 October 2022

         Despatch of holding statements to Eligible Shareholders participating in

 the SPP

  In accordance with the instructions in the SPP booklet the only action required is to transfer the funds for the amount you would like to invest in this Offer, using your Unique Reference Number, via BPAY or Electronic Funds Transfer (EFT). The action of paying the funds via either of these methods will constitute acceptance of the Offer. Acceptances and payment must be received by the Company’s registry, Automic, before 5pm (AEST) on Wednesday 28 September 2022.

   

 Join a shareholder briefing

Join CEO and MD of Prescient Therapeutics, Steven Yatomi-Clarke, for a live and interactive shareholder briefing on Tuesday 30th August at 12pm (AEST) where he will discuss the Share Purchase Plan, use of funds and how to participate. Register here.

- Ends -

About Prescient Therapeutics Limited (Prescient)

Prescient Therapeutics is a clinical stage oncology company developing personalised medicine approaches to cancer, including targeted and cellular therapies.

Cell Therapies

OmniCAR: is a universal immune receptor platform enabling controllable T-cell activity and multi- antigen targeting with a single cell product. OmniCAR’s modular CAR system decouples antigen recognition from the T-cell signalling domain. It is the first universal immune receptor allowing post- translational covalent loading of binders to T-cells. OmniCAR is based on technology licensed from Penn; the SpyTag/SpyCatcher binding system licensed from Oxford University; and other assets.

The targeting ligand can be administered separately to CAR-T cells, creating on-demand T-cell activity post infusion and enables the CAR-T to be directed to an array of different tumour antigens. OmniCAR provides a method for single-vector, single cell product targeting of multiple antigens simultaneous or sequentially, whilst allowing continual re-arming to generate, regulate and diversify a sustained T-cell response over time.

Prescient is developing OmniCAR programs for next-generation CAR-T therapies for Acute Myeloid Leukemia (AML); Her2+ solid tumours, including breast, ovarian and gastric cancers; and glioblastoma multiforme (GBM).

CellPryme-M: Prescient's novel, ready-for-the-clinic, CellPryme-M technology enhances adoptive cell therapy performance by shifting T and NK cells towards a central memory phenotype, improving persistence, and increasing the ability to find and penetrate tumours. CellPryme-M is a 24-hour, non-disruptive process during cell manufacturing. Cell therapies that could benefit from additional productivity in manufacturing or increased potency and durability in-vivo, would be good candidates for CellPryme-M.

Targeted Therapies

PTX-100 is a first in class compound with the ability to block an important cancer growth enzyme known as geranylgeranyl transferase-1 (GGT-1). It disrupts oncogenic Ras pathways by inhibiting the activation of Rho, Rac and Ral circuits in cancer cells, leading to apoptosis (death) of cancer cells. PTX- 100 is believed to be the only GGT-1 inhibitor in the world in clinical development. PTX-100 demonstrated safety and early clinical activity in a previous Phase 1 study and recent PK/PD basket study of hematological and solid malignancies. PTX-100 is now in a Phase 1b expansion cohort study in T cell lymphomas, where it has shown encouraging efficacy signals and safety.

   To stay updated with the latest company news and announcements, please update your details on our

 investor centre.

 

 PTX-200 is a novel PH domain inhibitor that inhibits an important tumour survival pathway known as Akt, which plays a key role in the development of many cancers, including breast and ovarian cancer, as well as leukemia. Unlike other drug candidates that target Akt inhibition, PTX-200 has a novel mechanism of action that specifically inhibits Akt without non-specific kinase inhibition effects. This highly promising compound is currently in a Phase 1b/2 trial in relapsed and refractory AML, where it has resulted in 4 complete remissions so far. PTX-200 previously generated encouraging Phase 2a data in HER2-negative breast cancer and Phase 1b in recurrent or persistent platinum resistant ovarian cancer.

Find out more at www.ptxtherapeutics.com or connect with us via Twitter @PTX_AUS and LinkedIn.

The Board of Prescient Therapeutics Limited has approved the release of this announcement.

  For more information please contact:

Company enquiries

Steven Yatomi-Clarke

CEO & Managing Director Prescient Therapeutics [email protected]

Investor enquiries

Sophie Bradley

Reach Markets

+61 450 423 331 [email protected]

Media enquiries

Andrew Geddes

CityPR

+61 2 9267 4511 [email protected]

  Disclaimer and Safe Harbor Statement

Certain statements made in this document are forward-looking statements within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements are not historical facts but rather are based on the current expectations of Prescient Therapeutics Limited (“Prescient” or the “Company”), their estimates, assumptions, and projections about the industry in which Prescient operates. Material referred to in this document that use the words ‘estimate’, ‘project’, ‘intend’, ‘expect’, ‘plan’, ‘believe’, ‘guidance’, and similar expressions are intended to identify forward-looking statements and should be considered an at-risk statement. These forward-looking statements are not a guarantee of future performance and involve known and unknown risks and uncertainties, some of which are beyond the control of Prescient or which are difficult to predict, which could cause the actual results, performance, or achievements of Prescient to be materially different from those which may be expressed or implied by these statements. These statements are based on our management’s current expectations and are subject to a number of uncertainties and risks that could change the results described in the forward-looking statements. Risks and uncertainties include, but are not limited to, general industry conditions and competition, general economic factors, global pandemics and related disruptions, the impact of pharmaceutical industry development and health care legislation in the United States and internationally, and challenges inherent in new product development. In particular, there are substantial risks in drug development including risks that studies fail to achieve an acceptable level of safety and/or efficacy. Investors should be aware that there are no assurances that results will not differ from those projected and Prescient cautions shareholders and prospective shareholders not to place undue reliance on these forward- looking statements, which reflect the view of Prescient only as of the date of this announcement. Prescient is not under a duty to update any forward- looking statement as a result of new information, future events or otherwise, except as required by law or by any appropriate regulatory authority.

Certain statements contained in this document, including, without limitation, statements containing the words “believes,” “plans,” “expects,” “anticipates,” and words of similar import, constitute “forward- looking statements.” Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of Prescient to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, the following: the risk that our clinical trials will be delayed and not completed on a timely basis; the risk that the results from the clinical trials are not as favourable as

 

 we anticipate; the risk that our clinical trials will be more costly than anticipated; and the risk that applicable regulatory authorities may ask for additional data, information or studies to be completed or provided prior to their approval of our products. Given these uncertainties, undue reliance should not be placed on such forward- looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the results of any revisions to any of the forward-looking statements contained herein to reflect future events or developments except as required by law.

This document may not contain all the details and information necessary for you to make a decision or evaluation. Neither this document nor any of its contents may be used for any other purpose without the prior written consent of the Company.

Supplemental COVID-19 Risk Factors

Please see our website: Supplemental COVID-19 Risk Factors

  

#ASX Announcements
stale
Added 2 years ago

A 20% gain in SP today on this news. I hold and can't see that it's changed the value of the company by that degree but I guess it's all sentiment in a pre revenue business...


Summary of announcement is just that PTX-100 has gained orphan drug designation from the FDA. If (big if) PTX-100 demonstrates safety and efficacy for peripheral T Cell Lymphoma it will enjoy some commercial and development benefits...


It's a rare cancer and very early days. For me it's a yawn. Happy to be wrong (Held!)


US FDA Grants Orphan Drug Designation

to PTX-100 for PTCL

Key points

• US FDA grants PTX-100 Orphan Drug Designation

• Confers several developmental benefits and 7 years of market exclusivity

• PTCL is a blood cancer with high unmet clinical need

• Expansion cohort in TCL on track to fully recruit this year under the leadership of

globally-renowned lymphoma expert, Professor H. Miles Prince, AM.

MELBOURNE Australia, 15 July 2022 – Prescient Therapeutics (“Prescient”; ASX: PTX), a clinical stage

oncology company developing personalised therapies to treat cancer, is pleased to announce that the

Office of Orphan Products Development at the US Food and Drug Administration (FDA) has granted

Orphan Drug Designation for PTX-100 for the treatment of peripheral T-cell lymphomas (PTCL).

The Orphan Drug Designation program provides orphan status to drugs which are defined as those

intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer

than 200,000 people in the US. It is designed to provide benefits to incentivize drug development in less

common diseases.

The benefits of an Orphan Drug Designation are considerable and include guaranteed market exclusivity

of seven years from granting of regulatory approval; and a waiver of Prescription Drug User Fee Act

(PDUFA) fees for orphan drugs, which has a value of over US$3.1 million in 20221.

Orphan Drug Designation will allow Prescient to benefit from incentives that can assist the development

of PTX-100, a first-in-class prenylation inhibitor that disrupts oncogenic Ras pathways in cancer cells.

PTX-100 showed an encouraging efficacy signal in PTCL in the dose escalation of a Phase 1b basket

study, and is now in an expansion cohort of 12 patients with relapsed and refractory T cell lymphomas

(TCL), including PTCL, under the leadership of globally-renowned lymphoma expert, Professor H. Miles

Prince, AM. The expansion cohort is due to fully recruit this year.

PTCL is a disease of serious unmet need. Survival following relapse is poor and has not significantly

improved in the last 20 years2,3 . Whilst PTCL is not a common malignancy, the nature of disease and

the paucity of effective treatment options for refractory patients creates a potentially shorter regulatory

path for PTX-100 in this setting, and the fastest route to market in a high value area of unmet clinical

need.

Currently available therapies for PTCL are typically characterised by high occurrence of serious toxicities;

low response rates (<30%) and short duration of responses (3-4 months)4. So far, PTX-100 is exhibiting

a favourable safety profile with encouraging efficacy signals, including one PTCL patient with a durable

response that is still on therapy after 28 months.

1 www.fda.gov; updated May 2022

2 Mak V, et al.; J Clin Oncol 2013; 31:1970-6.

3 Chihara D, et al.; Br J Haematol 2017; 176:750-8.

4 Saleh et al.; J Exp Pharmacol; 2021:13 577–591






Prescient Managing Director and CEO Steven Yatomi-Clarke said “The granting of Orphan Drug

Designation by the FDA is significant for Prescient’s development of PTX-100. Orphan drugs often enjoy

shorter and cheaper development pathways. Additionally, the Company now has the certainty of 7 years

of market exclusivity in the event of regulatory approval of PTX-100 for PTCL.

PTCL is a disease of unmet need, where safer and more effective therapies will be welcomed by patients

and clinicians. As our expansion cohort unfolds, ultimately it will be supporting clinical data and Orphan

Drug Designation that will combine to help bring PTX-100 to patients with this challenging disease.”

- Ends -

To stay updated with the latest company news and announcements, please update your details on our

investor centre.

About Prescient Therapeutics Limited (Prescient)

Prescient Therapeutics is a clinical stage oncology company developing personalised medicine approaches

to cancer, including targeted and cellular therapies.

Cell Therapies

OmniCAR: is a universal immune receptor platform enabling controllable T -cell activity and multi- antigen

targeting with a single cell product. OmniCAR’s modular CAR system decouples antigen recognition from the

T-cell signalling domain. It is the first universal immune receptor allowing post- translational covalent loading

of binders to T-cells. OmniCAR is based on technology licensed from Penn; the SpyTag/SpyCatcher binding

system licensed from Oxford University; and other assets.

The targeting ligand can be administered separately to CAR-T cells, creating on-demand T-cell activity post

infusion and enables the CAR-T to be directed to an array of different tumour antigens. OmniCAR provides a

method for single-vector, single cell product targeting of multiple antigens simultaneous or sequentially, whilst

allowing continual re-arming to generate, regulate and diversify a sustained T-cell response over time.

Prescient is developing OmniCAR programs for next-generation CAR-T therapies for Acute Myeloid Leukemia

(AML); Her2+ solid tumours, including breast, ovarian and gastric cancers; and glioblastoma multiforme

(GBM).

CellPryme-M: Prescient's novel, ready-for-the-clinic, CellPryme-M technology enhances adoptive cell therapy

performance by shifting T and NK cells towards a central memory phenotype, improving persistence, and

increasing the ability to find and penetrate tumours. CellPryme-M is a 24-hour, non-disruptive process during

cell manufacturing. Cell therapies that could benefit from additional productivity in manufacturing or increased

potency and durability in-vivo, would be good candidates for CellPryme-M.

Targeted Therapies

PTX-100 is a first in class compound with the ability to block an important cancer growth enzyme known as

geranylgeranyl transferase-1 (GGT-1). It disrupts oncogenic Ras pathways by inhibiting the activation of Rho,

Rac and Ral circuits in cancer cells, leading to apoptosis (death) of cancer cells. PTX- 100 is believed to be

the only GGT-1 inhibitor in the world in clinical development. PTX-100 demonstrated safety and early clinical

activity in a previous Phase 1 study and recent PK/PD basket study of hematological and solid malignancies.

PTX-100 is now in a Phase 1b expansion cohort study in T cell lymphomas, where it has shown encouraging

efficacy signals and safety.



PTX-200 is a novel PH domain inhibitor that inhibits an important tumour survival pathway known as Akt, which

plays a key role in the development of many cancers, including breast and ovarian cancer, as well as leukemia.

Unlike other drug candidates that target Akt inhibition, PTX-200 has a novel mechanism of action that

specifically inhibits Akt without non-specific kinase inhibition effects. This highly promising compound is

currently in a Phase 1b/2 trial in relapsed and refractory AML, where it has resulted in 4 complete remissions

so far. PTX-200 previously generated encouraging Phase 2a data in HER2-negative breast cancer and Phase

1b in recurrent or persistent platinum resistant ovarian cancer

The Board of Prescient Therapeutics Limited has approved the release of this announcement.

Find out more at www.ptxtherapeutics.com or connect with us via Twitter @PTX_AUS and LinkedIn.

Steven Yatomi-Clarke

CEO & Managing Director

Prescient Therapeutics

[email protected]

Investor enquiries:

Sophie Bradley – Reach Markets

+61 450 423 331

[email protected]

Media enquiries:

Andrew Geddes – CityPR

+61 2 9267 4511

[email protected]

Disclaimer and Safe Harbor Statement

Certain statements made in this document are forward-looking statements within the meaning of the safe

harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These forward-looking

statements are not historical facts but rather are based on the current expectations of Prescient Therapeutics

Limited (“Prescient” or the “Company”), their estimates, assumptions, and projections about the industry in

which Prescient operates. Material referred to in this document that use the words ‘estimate’, ‘project’, ‘intend’,

‘expect’, ‘plan’, ‘believe’, ‘guidance’, and similar expressions are intended to identify forward-looking

statements and should be considered an at-risk statement. These forward-looking statements are not a

guarantee of future performance and involve known and unknown risks and uncertainties, some of which are

beyond the control of Prescient or which are difficult to predict, which could cause the actual results,

performance, or achievements of Prescient to be materially different from those which may be expressed or

implied by these statements. These statements are based on our management’s current expectations and are

subject to a number of uncertainties and risks that could change the results described in the forward-looking

statements. Risks and uncertainties include, but are not limited to, general industry conditions and competition,

general economic factors, global pandemics and related disruptions, the impact of pharmaceutical industry

development and health care legislation in the United States and internationally, and challenges inherent in

new product development. In particular, there are substantial risks in drug development including risks that

studies fail to achieve an acceptable level of safety and/or efficacy. Investors should be aware that there are

no assurances that results will not differ from those projected and Prescient cautions shareholders and

prospective shareholders not to place undue reliance on these forward- looking statements, which reflect the

view of Prescient only as of the date of this announcement. Prescient is not under a duty to update any forward-

looking statement as a result of new information, future events or otherwise, except as required by law or by

any appropriate regulatory authority.

Certain statements contained in this document, including, without limitation, statements containing the words

“believes,” “plans,” “expects,” “anticipates,” and words of similar import, constitute “forward- looking

statements.” Such forward-looking statements involve known and unknown risks, uncertainties and other

factors that may cause the actual results, performance or achievements of Prescient to be materially different

from any future results, performance or achievements expressed or implied by such forward-looking

statements. Such factors include, among others, the following: the risk that our clinical trials will be delayed

and not completed on a timely basis; the risk that the results from the clinical trials are not as favourable as

we anticipate; the risk that our clinical trials will be more costly than anticipated; and the risk that applicable

regulatory authorities may ask for additional data, information or studies to be completed or provided prior to

their approval of our products. Given these uncertainties, undue reliance should not be placed on such forward-

looking statements. The Company disclaims any obligation to update any such factors or to publicly announce








the results of any revisions to any of the forward-looking statements contained herein to reflect future events

or developments except as required by law.

This document may not contain all the details and information necessary for you to make a decision or

evaluation. Neither this document nor any of its contents may be used for any other purpose without the prior

written consent of the Company.

Supplemental COVID-19 Risk Factors

Please see our website : Supplemental COVID-19 Risk Factors

#ASX Announcements
stale
Added 2 years ago

important tech to patent but business as usual I would think




Key OmniCAR US Patent Granted

 Key US patent granted in the OmniCAR portfolio

 Unique covalent binding system is advantageous in modular cell therapy approach

 Protection out to at least 2039

MELBOURNE Australia, 5 July 2022 – Prescient Therapeutics (“Prescient”; ASX: PTX), a clinical stage oncology company developing personalised therapies to treat cancer, is pleased to announce the

Universal Immune Receptor For T Cells”. The patent provides protection in the world’s largest healthcare market out to at least 2039.

OmniCAR is a universal immune receptor (UIR) platform that creates next-generation modular cell therapies that are controllable, flexible and adaptable. The key component of the system enabling modularity is a two-part covalent binding system called SpyTag and SpyCatcher that were developed by and licensed from Oxford University. The University of Pennsylvania applied this unique binding system to cell therapy, which is described in the patent which has been exclusively licensed to Prescient. The patent provides protection for molecules currently being developed by Prescient for use in the OmniCAR system.

Prescient believes that OmniCAR is the only known UIR system employing covalent binding, a very strong chemical bond. OmniCAR’s covalent binding of UIRs confers several important advantages over other approaches that rely on weaker, temporary binding, including greater efficacy, control and the ability to pre-arm T cells.

Prescient Managing Director and CEO Steven Yatomi-Clarke said, "This patent is a key plank in the protection of the OmniCAR platform, especially in the US, which is the world’s largest healthcare market. Prescient continues to bolster the protection of this innovative platform through the development of new intellectual property as we progress our three exciting OmniCAR programs through pre-clinical development and towards the clinic.”

- Ends -

Join an investor briefing

Join Prescient MD and CEO Steven Yatomi-Clarke for an investor 

#ASX Announcements
stale
Added 3 years ago

PTX announced a refinement to their CAR-T program today and have dropped by 13%.


CellPryme-M: Prescient’s newest family member

  PLATFORM TO ENHANCE CELL THERAPIES

• Current gen and next gen

• Complementary to OmniCAR

DEVELOPMENT OPPORTUNTIES

• Internal PTX programs

• External collaboration & sales

to 3rd parties

• Use with any existing CAR-T manufacturing process with no loss of time

PRODUCES SUPERIOR CELLS • Doubles tumour control & survival

• Longer lasting

• Tumour trafficking & penetration

   READY FOR CLINICAL TESTING

IP FULLY OWNED BY PTX

Developed by PTX in collaboration with Peter Mac



haven’t looked in detail but are people just extrapolating higher expenditure? Not sure what’s to dislike…

#ASX Announcements
stale
Added 3 years ago

Prescient expands PTX-200 AML Cohort Following Additional

 Key points

Complete Remission

 Patient achieved CRi at 45mg/m2 PTX-200 + cytarabine

 4th complete remission on relapsed & refractory AML study

 No dose limiting toxicities reported at 45mg/m2

 Expanding cohort to three additional patients at same dose level

MELBOURNE Australia, 9 May 2022: Prescient Therapeutics Limited (ASX: PTX) (“Prescient”), a clinical stage oncology company developing personalised medicine approaches to cancer, today announced that its Phase 1b clinical study of PTX-200 and cytarabine in patients with relapsed and refractory acute myeloid leukemia (AML) will expand the cohort at 45 mg/m2 PTX-200 following another complete remission and no dose limiting toxicities at this dose level.

Three patients were treated at 45 mg/m2 PTX-200 together with cytarabine, with no dose limiting toxicities reported. One patient in the cohort achieved a CRi, meaning complete remission of disease, with neutrophils and/or platelets yet recover to normal levels. CR (complete remission) and CRi are typically ascribed the same predictive value of successful treatment outcome1 This latest patient brings the total of complete remissions on this study to four patients.

Additionally, one patient in the prior cohort at 35mg/m2 PTX-200 has been determined to have had a partial response (reduction in cancer burden).

Approximately 158,000 patients globally suffer from AML2, a cancer of the bone marrow that prevents formation of normal blood cells. AML progresses quickly and has poor survival rates. After initial chemotherapy, most patients relapse, leading to an ongoing unmet medical need.

The Principal Investigator of the AML study is world-renowned leukemia expert Professor Jeffrey Lancet at the H. Lee Moffitt Cancer Center (Moffitt) in Florida, US, where he is Chair of the Department of Malignant Hematology.

This latest data, together with data from the previous Phase 1 monotherapy study of PTX-200 in acute leukemias, has guided Prescient and Professor Lancet to expand enrolment at this dose level to another three patients, in order to further explore safety and efficacy at this dose level.

1 Innes et al., Blood, 2018

2 Research and Markets, 2020

  

 The study’s Principal Investigator, Professor Lancet, said, “It is encouraging to see a CRi at this dose level, which brings a total of four complete remissions on the study so far. It was also pleasing to see that this dose level was well tolerated by patients, with no reported dose-limiting toxicities. It is believed that 45mg/m2 may be a biologically effective dose of PTX-200, therefore we will recruit an additional three patients at this dose level to further investigate safety and efficacy in this fragile patient population.”

Prescient CEO and Managing Director, Steven Yatomi-Clarke, said, “It is very satisfying to see another patient with remission in a disease that is so aggressive and fatal. Despite recent advancements, AML remains a disease of unmet medical need, and we look forward to advancing this study with the aim of benefiting more AML patients.”