Pyxis Oncology, Inc. · NASDAQ:PYXS

Pyxis Oncology — SITC 32nd Annual Meeting 2017

19 slides from Pyxis Oncology's conference presentation, November 2017

  1. Slide 1: SITC Annual Meeting, National Harbor, Maryland

    ea vember 8-12 * NATIONAL HARBOR MARYLAND + Gaylord National Hotel & Convention Center * Csitc> Society for Immunotherapy of Cancer

  2. Slide 2: First in Human Study with the CD40 Agonistic Monoclonal Antibody APX005M

    First in Human Study with the CD40 Agonistic Monoclonal Antibody APX005M in Subjects with Solid Tumors Melissa Johnson1, Marwan G. Fakih2, Johanna C. Bendell1, David L. Bajor3, Mihaela C. Cristea2, Thomas M. Tremblay4, Ovid C. Trifan4, Robert H. Vonderheide3 1 Sarah Cannon Research Institute/Tenness

  3. Slide 3: Presenter Disclosure Information

    Presenter Disclosure Information Robert H. Vonderheide The following relationships exist related to this presentation: -Investigator in the APX005M-001 study 3

  4. Slide 4: CD40 as a Target for Cancer Treatment

    CD40 as a Target for Cancer Treatment Antigen CD8 T cell Tumor APC CD86 CD28 CD40 Cytokines Agonist anti-CD40 mAb Vonderheide and Glennie, Clin Can Res, 2013 4

  5. Slide 5: CD40 Activation Has Anti-tumor Effect in a Variety of Tumor Models

    CD40 Activation Has Anti-tumor Effect in a Variety of Tumor Models MB49 Bladder Carcinoma AT3 Mammary Adenocarcinoma Days Sandin et al. Cancer Immunol Res 2014 Ngiow et al. Cancer Res 2016 MC38 Colon Carcinoma Pancreatic Ductal Adenocarcinoma Zippelius et al. Cancer Immunol Res 2015 Winograd et al 2

  6. Slide 6: APX005M Profile

    APX005M Profile  Humanized IgG1κ mAb against human CD40  Binds with high affinity (Kd = 1.2 x 10-10M) to CD40 ligand binding domain on CD40  Fc mutation increases binding affinity to FcγRIIb and decreases binding affinity to FcγRIIIa resulting in:  20 fold increase in CD40 agonistic potency vs.

  7. Slide 7: APX005M-001 Phase 1 Study Design

    APX005M-001 Phase 1 Study Design APX005M-001  Patients with solid tumors and no available treatment options  (IV infusion, 60-90 minutes) 3-week treatment cycle  8 dose levels from 0.0001 to 1 mg/kg Treatment until disease progression or unacceptable toxicity Study Objectives:  Primary: Establis

  8. Slide 8: APX005M-001 Study Population and Treatment

    APX005M-001 Study Population and Treatment Patients Treatment Patient Demographics 30 patients:  60-90 minute IV infusion  Median age 65 years (range 37-79)  All patients receiving APX005M at doses ≥ 0.3mg/kg  90% Caucasian were pre-medicated with oral H1 antagonist, NSAID, acetaminophen, option

  9. Slide 9: Overall Safety

    Overall Safety Adverse Events % AEs of Special Interest  On-target infusion reaction/cytokine release ≤ Grade 2 88% syndrome (CRS) Grade ≥ 2 has been observed 406/462 at highest dose levels Grade 3 or 4 12%  Transient elevation in LFTs (≤ Grade 3) observed 54/462 in some patients with liver metast

  10. Slide 10: APX005M Activates Dendritic Cells and Monocytes in Cancer Patients

    APX005M Activates Dendritic Cells and Monocytes in Cancer Patients 100 * * 2 .0 24 hours/baseline N =8 (C D 5 4 M F I o n m D C ) % m DC CD 54+ Dose range: 0.3 to 1mg/kg F o ld In c r e a s e * T-test vs. baseline p<0.05 1 .5 50 1 .0 0 0 4 24 48 168 0 .0 0 0 1 0 .0 0 1 0 .0 1 0 .0 3 0 .1 0 .3 0 .6 1

  11. Slide 11: APX005M Activates B Cells in Cancer Patients

    APX005M Activates B Cells in Cancer Patients 24 hours/baseline N =8 CD83 Dose range: 0.3 to 1mg/kg * T-test vs. baseline p<0.05 CD86 CD54 APX005M (mg/kg) Time (hours) 11

  12. Slide 12: APX005M Activates B Cells in Cancer Patients

    APX005M Activates B Cells in Cancer Patients 24 hours/baseline CD80 HLA-DR APX005M (mg/kg) APX005M (mg/kg) 12

  13. Slide 13: APX005M Activates T Cells in Cancer Patients

    APX005M Activates T Cells in Cancer Patients N =7 Ki67 Dose range: 0.03 to 1mg/kg * T-test vs. baseline p<0.05 24 hours/baseline HLA-DR APX005M (mg/kg) Time (hours) 13

  14. Slide 14: APX005M Stimulates Cytokine Production in Cancer Patients

    APX005M Stimulates Cytokine Production in Cancer Patients Average value for all patients treated at ≥ 0.1mg/kg (N=14) 14

  15. Slide 15: Model of Pharmacodynamic Changes Following Therapy with APX005M

    Model of Pharmacodynamic Changes Following Therapy with APX005M 15

  16. Slide 16: Best Tumor Response

    Best Tumor Response Response Evaluable Patients (n=21) 16

  17. Slide 17: Recommended Phase 2 Dose

    Recommended Phase 2 Dose Recommended Phase 2 Dose of APX005M is the dose with maximum pharmacodynamic effect and toxicity ≤ Grade 2 APX005M (mg/kg) APX005M (mg/kg) CTCAE 17

  18. Slide 18: Ongoing Clinical Trials with APX005M (N~290)

    Ongoing Clinical Trials with APX005M (N~290) Apexigen IND • NCT02482168: Single agent APX005M in patients with selected solid tumors (P252) • NCT03123783: APX005M in combination with nivolumab in immunotherapy naïve NSCLC and PD-1/PD-L1 failing metastatic melanoma (P251) Other INDs • NCT02706353: In

  19. Slide 19: Conclusions

    Conclusions • APX005M has demonstrated single agent robust immune pharmacodynamic effects in cancer patients • APX005M exhibits a good overall safety profile with expected on- target toxicities • APX005M is currently investigated in combination with immunotherapy and other cancer treatment modalitie

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