Prescient Therapeutics Limited · ASX:PTX
Prescient Therapeutics — Investor Presentation (September 2024)
39 slides from Prescient Therapeutics's investor presentation, Sep 5, 2024
Slide 1: For personal use only
For personal use only ASX: PTX
Slide 2: Disclaimer and Safe Harbor
DISCLAIMER AND SAFE HARBOR For personal use only 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 b
Slide 3: Key Messages
3 Key Messages For personal use only On the verge of a major inflection point 1 PTX-100 • Starting Ph2 potential registration trial in 2024 • Encouraging data in an area of unmet need Lower risk exposure to cell therapy sector 2 • Improves 3rd party cell therapies • Agnostic on cell type and targets
Slide 4: PTX is entering a major inflection point
PTX is entering a major inflection point For personal use only Typical Biotech Value Map PTX-100 Adapted from Future Healthcare Today , 2021 4
Slide 5: For personal use only
IST IN CLASS TARGETED THERAPY =) Yale University MOFFITT @®)
Slide 6: What we've been doing
What we’ve been doing For personal use only • Phase 1b trial ongoing, 25 enrolled with one patient still on therapy. Following safety, responses to treatment and duration of responses. • PK analysis provides insights into dose levels and dosing schedules • Presenting data and networking at specialis
Slide 7: PTX-100 strategy focussing on speed to market
PTX-100 strategy focussing on speed to market For personal use only • Prescient will focus its upcoming Phase 2 trial on relapsed and refractory CTCL • Faster, smaller trial than broader TCL trial • Addresses more urgent medical need with less competition • Subject to FDA feedback, aiming to commenc
Slide 8: Potential PTX-100 development plan
Potential PTX-100 development plan For personal use only 2024 2025 2026 2027 2028 r/r CTCL Mono Ph2 registration Optimal dose r/r PTCL Mono Ph1b expansion Mono Ph 2 registration NB: Does not take into account the additional opportunities of combining PTX-100 with existing therapies 8
Slide 9: Rationale of prioritising r/r CTCL for upcoming Ph2 trial
Rationale of prioritising r/r CTCL for upcoming Ph2 trial For personal use only CTCL PTCL • Higher confidence of PTX-100 in CTCL • PTCL is more prevalent than CTCL, but (more data; more responders) even though PTCL is still an unmet need, it has more existing and emerging competition • Greater need
Slide 10: What is Cutaneous T-cell Lymphomas (CTCL)?
What is Cutaneous T-cell Lymphomas (CTCL)? For personal use only • A rare type of cancer of white blood cells (T cells), normally involved in immune function. • These cancerous T cells travel to and live in the skin, where they grow and divide uncontrollably, attacking the skin. • CTCLs include grou
Slide 11: Relevant CTCL case study
Relevant CTCL case study For personal use only • Fusion protein of IL-2 and diphtheria toxin, developed by Lymphir Registration trial results: Citius and Dr Reddy’s • ORR: 36% • Purer version of Eisai’s Ontak (withdrawn from market in 2014 due to manufacturing issues) • Median duration of response:
Slide 12: Advantages of Orphan Drugs
Advantages of Orphan Drugs For personal use only Orphan 11.6% CAGR 7 7 years of guaranteed market exclusivity in US Non-orphan 7% CAGR Consistently higher sales growth Higher prices than non-orphan drugs Sales are more resilient Total orphan sales to cycles to reach $US300B by 2028 Evaluate Ltd, 202
Slide 13: PTX-100 Phase 1b study
For personal use only PTX-100 Phase 1b study 13
Slide 14: PTX-100: Ph1b Clinical Summary
PTX-100: Ph1b Clinical Summary For personal use only • Aims: Phase 1b to evaluate safety PK/PD • Design: Dose escalation in advanced malignancies; expansion cohort (n=25) in relapsed & refractory T cell lymphomas • Results: • Excellent safety Professor H. Miles Prince, AM • Target engagement at all
Slide 15: Drugs for relapsed/refractory TCL can be judged on criteria
Drugs for relapsed/refractory TCL can be judged on 3 criteria: For personal use only Expected SAFETY Serious Adverse Events >30% of the time RESPONSE ~30% patients respond RATES DURATION For those who respond: OF RESPONSE CTCL: 9-13 months PTCL: 3-4 months † Expected DoR 3-4 months for PTCL; 9-13 mo
Slide 16: PTX-100 is exhibiting an excellent safety profile
PTX-100 is exhibiting an excellent safety profile For personal use only Summary of Treatment-Related Serious Adverse Events (SAEs; Grade ≥ 3) PTX-100 PTX-100 PTX-100 Overall 500 mg/m2 1000 mg/m2 2000 mg/m2 (N=25) (N=3) (N=3) (N=19) Subjects with any 0 0 0 0 Treatment Related SAEs • No cases of Serio
Slide 17: PTX-100 Phase 1b responses: Strong response rates in evaluable patients
PTX-100 Phase 1b responses: Strong response rates in evaluable patients For personal use only Evaluable for Overall Response Rate Clinical Benefit Rate Response (n = 11) CR + PR CR + PR + SD >6 mths Benchmark1 30% 45% r/r PTCL (n=4) 50% (2/4) 50% (2/4) r/r CTCL (n=7) 43% (3/7) 71% (5/7) r/r TCL (n=1
Slide 18: PTX-100 Phase 1b study swimmer plot
PTX-100 Phase 1b study swimmer plot PTCL CTCL For personal use only Study ongoing; results as of 3 Sept 2024 *Patient 121-025 (complete response) is still active and on treatment. 18
Slide 19: Disease reduction in r/r CTCL patients
Disease reduction in r/r CTCL patients For personal use only * Significant reduction of mSWAT* score in 6 out 7 r/r CTCL patients (13-100% reduction) *mSWAT (Modified Severity-Weighted Assessment Tool) is a measure of disease in CTCL patients Study ongoing; results as of 3 September 2024, with one p
Slide 20: PTX-100 Phase 1b Study Summary
PTX-100 Phase 1b Study Summary For personal use only • PTX-100 showed GGT-1 sustained inhibition at all doses. • PTX-100 showed serum levels that exceeded the IC50 necessary for tumor inhibition. • PTX-100 was overall well tolerated at 2000 mg/m2 with no related serious adverse events • PTX–100 demo
Slide 21: PTX-100 stacks up favourably against all benchmark TCL criteria
PTX-100 stacks up favourably against all benchmark TCL criteria: For personal use only Expected PTX-100 Serious Adverse Events SAFETY >30% of the time ~30% RESPONSE RATES patients respond For those who respond: DURATION OF RESPONSE CTCL: 9-13 months PTCL: 3-4 months 21
Slide 22: Accelerated Approvals: Much faster & cheaper route to market
Accelerated Approvals: Much faster & cheaper route to market For personal use only Typical drug PHASE 3 approval PHASE 2 Accelerated approval PHASE 1 22
Slide 23: What does PTX-100's progress mean for PTX?
What does PTX-100’s progress mean for PTX? For personal use only • Biggest catalyst in company’s history, and the culmination of years of work • Potential Phase 2 registration study (i.e. the study required to get a drug into the market*) • Could accelerate clinical development • Greatly truncate th
Slide 24: Cell therapy platforms
i Prescient - ty = Therapeutics * ges \ tril THERAPY PLATFERMS
Slide 25: Platforms to overcome CAR-T's key challenges
Platforms to overcome CAR-T’s key challenges For personal use only Safety & Control - Targeting - Safer Escape - More Production efficiency - effective Exhaustion Accessible & Trafficking affordable Tumor penetrance Tumor microenvironment 25
Slide 26: Cell Therapy Enhancements
For personal use only CELL THERAPY ENHANCEMENTS 26
Slide 27: CellPryme: enhancing cell therapies in two ways
CellPryme: enhancing cell therapies in two ways For personal use only MANUFACTURING ENHANCEMENT ADJUVANT THERAPY Non-disruptive additive Administered to patient during cell manufacturing concurrent with cell therapy 27
Slide 28: Manufacturing Enhancement produces superior cells
For personal use only MANUFACTURING ENHANCEMENT PRODUCES SUPERIOR CELLS • 50% more “youthful” Tcm cells • Last longer; potent killing • Doubles helper Tcells • Doubles tumour control & survival 28
Slide 29: Adjuvant Therapy breaches the cancer's castle walls
For personal use only ADJUVANT THERAPY ↑9x expansion ↑4x tumour penetration BREACHES THE CANCER’S CASTLE WALLS Untreated CAR-T cells CAR T cells + CellPryme-A CellPryme-M CAR-T cells + CellPryme-A • 9X more CAR-T cells 60 • 4x penetration the cancer’s Tumour size (mm2) protective barriers 40 • Very
Slide 30: CellPryme progressing externally
CellPryme progressing externally For personal use only • PTX in advanced discussions with several potential partners for CellPryme-M that are progressing simultaneously. • Discussions have progressed from confidential due diligence to materials transfer agreements, so these parties can test CellPrym
Slide 31: Universal, Next-Gen cell therapies
For personal use only Universal, Next-Gen cell therapies 31
Slide 32: OmniCAR: modular "plug & play" cells
OmniCAR: modular “plug & play” cells For personal use only Conventional CAR-T • Static • Adaptable • Single target • Multi-target • Uncontrollable • Controllable 3 2
Slide 33: Any immune cell to any target
Any immune cell → to any target For personal use only OmniCAR can use any type of targeting ligand… …with any immune cell Adapted from Powell, DJ et al, JACS; 2020 33
Slide 34: OmniCAR redesign efforts progressing
OmniCAR redesign efforts progressing For personal use only • PTX team has been addressing cytotoxicity of unarmed OmniCAR cells. This is essential for clinical development. • A development effort to try to address the issue has been underway throughout 2024. Involves PTX team; Peter Mac & CSIRO acro
Slide 35: PTX strategically positioned in an evolving field
PTX strategically positioned in an evolving field For personal use only Current generation CAR-Ts Emerging immune cell types Manufacturing methods Emerging targets Can enhance existing and Other cancers emerging cell therapies Beyond oncology Other cell therapy companies are potential customers, not
Slide 36: Summary
For personal use only Summary 36
Slide 37: Key Messages
3 Key Messages For personal use only On the verge of a major inflection point 1 PTX-100 • Starting Ph2 potential registration trial in 2024 • Encouraging data in an area of unmet need Lower risk exposure to cell therapy sector 2 • Improves 3rd party cell therapies • Agnostic on cell type and targets
Slide 38: PTX is entering a major inflection point
PTX is entering a major inflection point For personal use only PTX-100 Adapted from Future Healthcare Today , 2021 38
Slide 39: For personal use only
For personal use only ASX: PTX
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