Slide 1: VAL201 Prostate Cancer
Non-confidential VAL201 Prostate Cancer Q1 2021 ValiRx @valirxplc www.valirx.com info@valirx.com
Slide 2: Disclaimer
Disclaimer The information contained in these slides and any accompanying verbal presentation, any question and answer session and any document or material distributed at or in connection with the verbal presentation (together, the ‘Presentation’) have not been approved by an authorised person withi
Slide 3: VAL201
VAL201 Indication: • Prostate Cancer • Phase 1/2 clinical trial recently completed in 12 adult men, with incurable locally advanced or metastatic prostate cancer who have relapsed following radiotherapy treatment Mode of Action: • Inhibition of the interaction of the Androgen receptor with the SH3 d
Slide 4: VAL201 summary and timeline
VAL201 summary and timeline VAL201 is a decapeptide designed for the treatment of patients with prostate cancer. Administered once weekly as a sub-cutaneous injection, early clinical data supports further development of the project Phase 1/2 Clinical Trial Started 19th December 2014 End of Trial 27t
Slide 5: VAL201 mechanism
VAL201 mechanism H-Pro-Pro-Pro-His-Pro-His-Ala-Arg- Ile-Lys-OH Molecular Weight (free base) 1149.3481 Molecular Formula C55H84N18O11 Melting Point 186°C Solubility Freely soluble in water pH of a 1% solution in water 5.67 Salt Form acetate 5 Connected Innovation
Slide 6: Rationale for SRC inhibition
Rationale for SRC inhibition • SRC family kinases (SFK) are non-receptor protein Activation of SRC family kinases stimulates tyrosine kinases whose activity is increased in signalling pathways involved prostate cancer most solid tumours progression • In the active state, SRC interacts with downstrea
Slide 7: VAL201 Advantages
VAL201 Advantages • Inhibition of SRC kinase interaction with the Androgen receptor: - Inhibits androgen-induced proliferative activity of SRC kinase BUT - Without preventing kinase activity - Without impacting other activity of the androgen receptor • Due to close proximity to Estrogen Receptor bin
Slide 8: Phase 1/2 Clinical Trial Completed
VAL201 Phase 1/2 Clinical Trial Completed A Phase I/II, Dose Escalation Study to Assess the Safety and Tolerability of VAL201 in Patients with Locally Advanced or Metastatic Prostate Cancer and Other Advanced Solid Tumours 12 patients dosed between 0.5 mg/kg and 8 mg/kg (prostate cancer only) Adult
Slide 9: VAL201 Disease Impact Data
VAL201 Disease Impact Data • Disease Impact measures include PSA values measured at approx. 3 week intervals; and tumour measurements of primary prostate tumour, contributing to assessment under PCWG2 • Headline results revealed 6 out of 11 patients showed no disease progression by PCWG2 guidelines
Slide 10: Safety and Tolerability
VAL201 Safety and Tolerability • 1 SUSAR reported of severe hypertension Event Number of requiring overnight hospitalisation and Patients medication to control, the patient remained Severe hypertension on the trial at the same dose, with 1/12 (SUSAR) subsequent doses being preceded by Mild hypertens
Slide 11: Expected Future
VAL201 Expected Future • Additional data analysis being conducted by Physiomics - This will provide further insight into the clinical data collected, future positioning of VAL201 and design of future clinical trials • A partner or purchaser is sought to conduct and co-ordinate the next clinical tria
Slide 12: Contacts
Contacts • Valirx PLC (AIM:VAL) • Eliot Park Innovation Centre, 4 Barling Way, Nuneaton, CV10 7RH • Suzanne Dilly – Chief Executive Officer - Suzanne.dilly@valirx.com • Kevin Cox – Non-Executive Chairman - Kevin.cox@valirx.com • Mark Treharne – Corporate Development Manager - Mark.Treharne@valirx.co