Pyxis Oncology, Inc. · NASDAQ:PYXS
Pyxis Oncology — Technical Presentation (December 2020)
10 slides from Pyxis Oncology's technical presentation, December 2020
Slide 1: PBTC-051: First in pediatrics phase 1 study of APX005M
PBTC-051: First in pediatrics phase 1 study of CD40 agonistic monoclonal antibody APX005M in pediatric subjects with recurrent/refractory brain tumors Holly Lindsay MD, MS, Arzu Onar-Thomas PhD, Mehmet Kocak PhD, Tina Young Poussaint MD, Girish Dhall MD, Alberto Broniscer MD, Anna Vinitsky MD, Tobey
Slide 2: COI Declaration
ISPNO 2020 COI Declaration The following presenters have no conflict of interest relating to this presentation with any corporate organizations : Alberto Broniscer Tobey MacDonald Girish Dhall Arzu Onar-Thomas Jason Fangusaro Anna Vinitsky Mehmet Kocak Tina Young Poussaint Holly Lindsay 2
Slide 3: COI Declaration
ISPNO 2020 COI Declaration The presenter below has potential conflict of interest related to this presentation with the corporate organizations below: Ira Dunkel Consultant, Apexigen Inc. Ovid Trifan CMO and senior vice president, Apexigen Inc. 3
Slide 4: APX005M Mechanism of Action
APX005M Mechanism of Action APX005M: CD40 agonist IgG1 humanized monoclonal antibody (Apexigen, Inc.) CD40: co-stimulatory molecule expressed on antigen presenting cells (APCs) CD40 functions to: • suppression Reverse systemic cancer-induced immune • Activate immunity APCs → activates innate a
Slide 5: PBTC-051 Study Overview
PBTC-051 Study Overview First-in-pediatrics evaluation of APX005M by the Pediatric Brain Tumor Consortium APX005 administered IV over 1 hour every 3 weeks for maximum 36 cycles Stratum 1: Patients 1-21 years old with recurrent, refractory, or progressive primary malignant CNS tumors • Patients wi
Slide 6: Study Objectives
Study Objectives Primary study objectives: • Evaluate safety of APX005M administered IV q3 week to children with CNS tumors • Determine maximum tolerated dose and/or recommended phase 2 dose • Determine APX005M pharmacokinetics Exploratory study objectives • Assess incidence of anti-drug antibodie
Slide 7: Stratum 1 Enrollment
Stratum 1 Enrollment 21 total patients enrolled on study • 19 patients off treatment for progressive disease • 1 patient off treatment for side effects • 1 patient ineligible Youngest enrolled patient: 2 yo, oldest: 21 yo Most common diagnoses: ependymoma (7 patients) and glioblastoma (5 patient
Slide 8: Stratum 1 APX005M Adverse Events
Stratum 1 APX005M Adverse Events Most common adverse events: neutropenia (max grade 3) and leukopenia and lymphopenia (max grade 4) 2 dose-limiting toxicities: both grade 3 infusion-related reactions • Both at highest dose level (dose level 3) 1 death on study and 1 death within 1 month off-study
Slide 9: Stratum 1 Results
Stratum 1 Results Highest dose level (dose level 3 = 0.6 mg/kg) is stratum 1 pediatric recommended phase 2 doses Total 12 evaluable patients enrolled at dose level 3 in dose escalation and expansion cohorts • For reference, the adult R2PD is DL2=0.3 mg/kg 2 patients received >15 cycles of therap
Slide 10: Acknowledgements
Acknowledgements NCI/NIH grant UM1 CA081457 supporting the Pediatric Brain Tumor Consortium The American Lebanese Syrian Associated Charities for partial support of the PBTC Operations, Biostatistics and Data Management Core Our patients and their families 11
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