Aktis Oncology, Inc. · NASDAQ:AKTS

Aktis Oncology — EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics 2024

16 slides from Aktis Oncology's conference presentation, October 2024

  1. Slide 1: AKY-1189, a novel, first-in-class miniprotein radiopharmaceutical designed to deliver Actinium-225

    AKY-1189, a novel, first-in-class miniprotein radiopharmaceutical designed to deliver Actinium-225 (225Ac) to Nectin-4 expressing tumors with broad therapeutic applications in metastatic urothelial carcinoma (mUC) and other Nectin-4 expressing tumors Authors: Mike Sathekge, Honest Ndlovu , Joseph Ka

  2. Slide 2: Disclosures

    Disclosures Mike Sathekge • Advisory Board: Novartis • Board of Directors: Adcock, AHRI, NuMeRI • Corporate-sponsored Research: Novartis, ABX, NTP, POINT Biopharma Global, Inc. Khaled Nasr • Employee of Aktis Oncology and holds stock options in the company Tom Morley • Employee of Aktis Oncology and

  3. Slide 3: Miniprotein radiopharmaceuticals engineered to deliver actinium-225 to tumor targets

    Miniprotein radiopharmaceuticals engineered to deliver actinium-225 to tumor targets [111In]Ac-AKY-1189 [225Ac]Ac-AKY-1189 2000 Tumor Volume (mm3) 1500 1000 500 Trx 0 0 3 6 9 12 15 18 21 24 27 30 Day Vehicle [225Ac]Ac-AKY-1189 (1μCi) DISCOVERY: Yeast surface OPTIMIZATION: Solid-phase PRE-CLINICAL Po

  4. Slide 4: Nectin-4 target is clinically validated in urothelial cancer and expressed at high levels in multiple additional tumor types

    Nectin-4 target is clinically validated in urothelial cancer and expressed at high levels in multiple additional tumor types Nectin-4 Imaging or Therapeutic – Targeting Nectin-4 has been proven to extend Isotope survival in metastatic urothelial cancer (mUC) – Nectin-4 is overexpressed in urothelial

  5. Slide 5: Imaging assessment of AKY-1189 in patients with solid tumors

    Imaging assessment of AKY-1189 in patients with solid tumors Regulatory Pathway Section 21 SAPHRA Named Patient Supply Manufacturing Aktis: AKY-1189 Precursor NuMeRI: Labeling with [68Ga]Ga or [177Lu]Lu Image acquisition [68Ga]Ga-AKY-1189 PET/CT [177Lu]Lu-AKY-1189 SPECT/CT for Dosimetry [low adminis

  6. Slide 6: Patient demographics and diagnoses

    Patient demographics and diagnoses Demographics ECOG and Tumor Site [68Ga]Ga-AKY-1189 [177Lu]Lu-AKY-1189 [68Ga]Ga-AKY-1189 [177Lu]Lu-AKY-1189 Characteristic (n = 20) (n=9) Characteristic (n = 20) (n=9) Age (years), 58 57 ECOG PS, n (%) Median (Min, Max) (28, 76) (28, 72) 0 16 (80.0) 7 (77.8) Gender,

  7. Slide 7: Patient disposition

    Patient disposition [68Ga]Ga-AKY-1189 imaging Evaluable Uptake positive [177Lu]Lu-AKY-1189 dosimetry (N=20) (n=15) (n=15) (n=8) Tumor type Tumor type Tumor type Tumor type Bladder n=9 Cervical n=3 Bladder n=9 Cervical n=2 Bladder n=9 Cervical n=2 Bladder n=4 Cervical n=1 Breast n=3 Lung n=3 Breast n

  8. Slide 8: Safety assessment

    Safety assessment SAFETY ASSESSMENT NO ADVERSE EVENT FINDINGS • Prompt reporting (within 24 hours) of any severe • No injection site or infusion-related reactions or serious adverse events (AEs) • No AEs attributable to • All AEs at the time of submission to the South – [68Ga]Ga-AKY-1189 (n=20) Afri

  9. Slide 9: Biodistribution of [68Ga]Ga-AKY-1189 in a patient with metastatic urothelial cancer

    Biodistribution of [68Ga]Ga-AKY-1189 in a patient with metastatic urothelial cancer Robust tumor uptake with kidney as potentially dose-limiting normal tissue Brain Metastases Bone Metastasis 1 hr 3 hr Lacrimal gland Salivary glands Tumors Lung Metastases Liver Metastases Kidney • Maximum intensity

  10. Slide 10: Biodistribution of [68Ga]Ga-AKY-1189 in a patient with metastatic urothelial cancer

    Biodistribution of [68Ga]Ga-AKY-1189 in a patient with metastatic urothelial cancer Robust tumor uptake with kidney as potentially dose-limiting normal tissue Paraaortic Lymph Node Metastases Sacral Metastasis Lacrimal gland Salivary glands Tumors Bladder Recurrence and Bone Metastasis Kidney • Maxi

  11. Slide 11: No accumulation of [177Lu]Lu-AKY-1189 in healthy tissues, with progressive washout in the kidney observed over 48h

    No accumulation of [177Lu]Lu-AKY-1189 in healthy tissues, with progressive washout in the kidney observed over 48h Retention in tumor through at least 48 hours 3 hours 24 hours 48 hours [177Lu]Lu-AKY-1189 SPECT/CT* * ~5.55 GBq (150mCi) administered activity 11

  12. Slide 12: Kidney and bone marrow dosimetry in eight patients with [177Lu]Lu-AKY-1189 suggests promising therapeutic index

    Kidney and bone marrow dosimetry in eight patients with [177Lu]Lu-AKY-1189 suggests promising therapeutic index ABSORBED DOSE PREDICTIONS Results with AKY-1189 vs organ benchmarks Kidneys Kidney median absorbed dose :  0.30 Gy/GBq < ~1Gy/GBq* benchmark Bone Marrow median absorbed dose:  0.01 Gy/GB

  13. Slide 13: [68Ga]Ga-AKY-1189 tumor uptake suggests actionable therapeutic range across tumor types

    [68Ga]Ga-AKY-1189 tumor uptake suggests actionable therapeutic range across tumor types AKY-1189 Patient # by tumor type • In each evaluable patient, multiple regions of Bladder n=9 Cervical n=2 Breast n=2 Lung n=1 interest were identified for evaluation of SUVs CRC n=1 with AKY-1189 – Assessment ca

  14. Slide 14: Visual comparison of [18F]F-FDG-PET and [68Ga]Ga-AKY-1189 suggests that AKY-1189 reliably identifies malignancy

    Visual comparison of [18F]F-FDG-PET and [68Ga]Ga-AKY-1189 suggests that AKY-1189 reliably identifies malignancy [18F]F-FDG PET/CT Triple Negative Breast Primary Hepatic Metastases Skeletal Metastases Breast Cancer [68Ga]Ga-AKY-1189 PET/CT 14

  15. Slide 15: Visual comparison of [18F]F-FDG-PET and [68Ga]Ga-AKY-1189 suggests that AKY-1189 reliably identifies malignancy

    Visual comparison of [18F]F-FDG-PET and [68Ga]Ga-AKY-1189 suggests that AKY-1189 reliably identifies malignancy [18F]F-FDG PET/CT Hormone Receptor + Breast primary, regional Skeletal Breast and mediastinal nodes metastases Cancer [68Ga]Ga-AKY-1189 PET/CT 15

  16. Slide 16: Summary and Conclusions

    Summary and Conclusions • AKY-1189 is a promising first-in-class radiopharmaceutical for the treatment of patients with Nectin-4 expressing tumors. • AKY-1189 was safe and well-tolerated when conjugated to 68Ga or 177Lu. • Dosimetry analyses of kidneys and bone marrow suggests a wide therapeutic ind

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