Slide 1: Phase I/II Trial of INKmune in Metastatic Castration-Resistant Prostate Cancer
HARNESSING THE POWER OF THE INNATE IMMUNE SYSTEM INMB Webinar Phase I/II Trial of INKmune ʳ in Metastatic Castration - Resistant Prostate Cancer
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS This presentation contains “forward - looking statements . ” Forward - looking statements reflect our current view about future events . When used in this presentation, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of
Slide 3: INKmune Primed mlNK cell Therapy (TpNK) for mCRPC: Participants and Agenda
INKmune Primed mlNK cell Therapy ( TpNK ) for mCRPC Participants • Matt Rettig MD - Professor of Medicine and Urology, Medical Director of the Prostate Cancer Program at the David Geffen School of Medicine at UCLA and member of the Jonsson Comprehensive Cancer at UCLA • Mark Lowdell, PhD – Chief Sci
Slide 4: Prostate Cancer Incidence and Mortality
Prostate Cancer 2018 2019 2020 2021 2022 Incidence 164,690 174,650 191,930 248,530 268,490 Mortality 29,430 31,620 33,330 34,130 34,500 0 50,000 100,000 150,000 200,000 250,000 300,000 350,000 2018 2019 2020 2021 2022 Incidence: Prostate vs. Breast Cancer Breast Cancer Prostate Cancer Prostate Cance
Slide 5: Timeline of Drug Development in mCRPC
2004: Docetaxel 2010: Cabazitaxel 2010: Sipuleucel - T 2011: Abiraterone (post - chemo) 2012: Enzalutamide (post - chemo) 2013: Abiraterone (pre - chemo) 2013: Radium 223 2014: Enzalutamide (post - chemo) Timeline of Drug Development in mCRPC 2004 2010 2012 2014 2016 2018 2020 2022 2020: PARPi ( ola
Slide 6: Monthly Median OS Benefit of Drugs Approved for mCRPC
Agent Sipuleucel - T Abiraterone Enzalutamide Docetaxel Cabazitaxel Radium - 223 PSMA RLT Olaparib Median OS benefit (months) 4.1 Post - doc: 4.6 Pre - doc: 4.4 Post - doc: 4.8 Pre - doc: 4.0 2.4 2.4 3.6 5.3 2.3 Monthly Median OS Benefit of Drugs Approved for mCRPC
Slide 7: Why NK Cells and Why INKmune?
WHY NK CELLS AND WHY INKmune? Why NK cells? ▪ NK cells are central to immune surveillance and innately kill cancer cells – people with low NK function have increased lifetime risk of all cancers – ▪ MEN WITH CaPros WITH LOW NK FUNCTION HAVE LOWER OS ▪ NKs help expand the immune response (interact wi
Slide 8: NK cell function in prostate cancer
NK cell function in prostate cancer Wu et al 2020 Pasero et al 2015 Peripheral Blood NK cell number Prostate cancer TME NK cell phenotype Reality : Lots of NK cells in TME of prostate cancer Problem: NK cells in TME are resting NK cells (rNK unable to lyse NK - resistant cancer cells) Reality: men w
Slide 9: INKmune primes NK to lyse NK-resistant DU145 cells
Lymphoma Myeloma Myeloma Prostate INKmune Ρ primes NK to lyse NK - resistant DU145 cells TpNK function in the hostile environment of the TME Problem: patient’s rNK cells do not kill NK resistant CaPros Solution: INKmune primed rNK cells become memory - like TpNK cells that kill NK resistant CaPros P
Slide 10: TpNK "fitter" than cytokine primed NK
TpNK “fitter” than cytokine primed NK Only INKmune induces changes which protect NK in TME rNK LAK - 15 CIML - NK INKMUNE - TpNK proteomics G A T B G A T C G F M 2 H A R S 1 H A R S 2 L A R S 2 M R P L 1 0 M R P L 1 6 M R P L 2 M R P L 2 3 M R P L 4 7 M R P L 5 1 M R P L 5 7 M R P S 1 1 M R P S 1 2
Slide 11: mCRPC Phase I/II protocol
mCRPC Phase I/II protocol • FDA “must haves” for trial design: • Understand short and long - term safety of product in target population • Justify dose to be used in pivotal trial • INmune Bio “must haves” for trial design: • Safety in target population • Evidence of Proof - of - Biology – evidence
Slide 12: mBOIN12 – a two step trial
mCPRC mBOIN12 – a two step trial • Step 1: 3X3 dose escalation “run - in” to demonstrate: • short - term safety (28 days) • short - term immunologic efficacy • Step 2: simultaneous testing of multiple doses to: • Demonstrate long - term safety (6 month) • Demonstrate proof - of - biology (PO = anti
Slide 13: mBOIN12 mCRPC trial criteria and design
mBION12 mCRPC • Inclusion criteria: mCRPC without contraindications or recent chemo or immunotherapy • Exclusions: chronic viral infection, short life expectancy • Definition of effective dose • Safe • Evidence of anti - tumor effects • Manufacturing efficiency low dose middle dose high dose 1 1 1 1
Slide 14: Thank you
14 Thank you Contact: mlowdell@inmunebio.com