Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Corporate Update (June 2022)
15 slides from Pds Biotechnology's corporate update, Jun 7, 2022
Slide 1: Precision Designed Science For Immunotherapy Post-ASCO Presentation
Precision Designed Science For Immunotherapy Post-ASCO Presentation NASDAQ: PDSB | June 7, 2022
Slide 2: Forward-looking statements
2 Certain information in this presentation may include forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corpo
Slide 3: PDS0101: Lead Asset Designed to Treat HPV16-Associated Cancers
More than 46,0002 patients were estimated to have been diagnosed last year with HPV-associated cancers in the US1,2 HPV vaccination is not expected to impact the rate of HPV-related cancer incidence for decades3 Existing immunotherapies cost $150,000+ annually per patient1 US HPV-associated cancer i
Slide 4: Phase 1 Trial: PDS0101 Monotherapy
Lesion regression in 8/10 CIN patients within 3 months of treatment (retrospective analysis) No recurrence within 2-year evaluation period suggests durable immune responses Phase 1 Trial: PDS0101 Monotherapy CD8+ T cell induction with memory T cell response demonstrated 4 PDS0101 T cell induction on
Slide 5: Phase 2: PDS0101 in Combination with KEYTRUDA
Phase 2: PDS0101 in Combination with KEYTRUDA® Company-sponsored trial for the treatment of HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002) Status Fast Track designation Q2 2022 Efficacy and safety data presented on first 19 patients at ASCO Q2 2022 Safety data presented at
Slide 6: Phase 2: PDS0101 + KEYTRUDA (VERSATILE-002) Response Data
Phase 2: PDS0101 + KEYTRUDA® Company-sponsored trial for the treatment of HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002) 6 Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) N=17 Subjects w/Imaging Data OR (2 CR + 5PR) 7 (41.2%) SD (re
Slide 7: Phase 2: PDS0101 + KEYTRUDA Safety and Survival
Phase 2: PDS0101 + KEYTRUDA® Company-sponsored trial for the treatment of HPV16-positive metastatic/recurrent head and neck cancer (VERSATILE-002) 7 Treatment Emergent Adverse Events (TEAEs) Safety Population (N=19) CPI Naïve Subjects (N=19) N (%) : Events Subjects with any TEAEs Grade 1 Grade 2 Gra
Slide 8: Phase 2: PDS0101 + Bintrafusp alfa + M9241 (Triple Combination)
Phase 2: PDS0101 + Bintrafusp alfa + M9241 (Triple Combination) NCI-led trial for the treatment of HPV16-positive anal, cervical, head and neck, penile, vaginal, vulvar cancers Status Updated efficacy and safety data released at ASCO Q2 2022 Preliminary efficacy and safety data released at ASCO Q2 2
Slide 9: PDS0101 Designed to Promote Efficacy in HPV16 Cancers
PDS0101 Designed to Promote Efficacy in HPV16 Cancers Studies show key contributions of PDS0101, M9241 & Bintrafusp alfa* to clinical response to date 9 *Bintrafusp alfa monotherapy showed 30% ORR in CPI naïve and 10% ORR in CPI refractory HPV-positive cancers (Strauss et al, 2020, Dec 8(2) **All HP
Slide 10: Best Overall Response Active Against Diverse HPV16 Cancers
Best Overall Response Active Against Diverse HPV16 Cancers PDS0101: Triple Combination Active Against HPV16 Cancer Responses to date across tumor types and higher NHS-IL12 dose show the potential to result in greater clinical efficacy 10 *HNSCC – head and neck squamous cell carcinomas Higher M9241 D
Slide 11: Phase 2: Triple Combination May Extend Patient Survival
Phase 2: Triple Combination May Extend Patient Survival High dose M9241 may provide improved synergy with PDS0101 11 CPI Naïve Subjects CPI Refractory Subjects Objective Response Rate (ORR) > 30% tumor shrinkage High Dose M9241 - 83% Low Dose M9241 (2/2) - 100% Overall - 88% High Dose M9241 - 63% Lo
Slide 12: Versamune + M9241 May Overcome CPI-Independent Tumor T Cell Evading Mechanisms
Versamune® + M9241 May Overcome CPI-Independent Tumor T Cell Evading Mechanisms Potential to advance cancer immunotherapy 12 Tumors blocking T cell attack using immune checkpoints Tumors blocking T cell attack using alternative immune suppressive mechanisms KEYTRUDA® unlocks checkpoint-dependent imm
Slide 13: Next Steps
Next Steps 13 Align with FDA on regulatory pathway, timing and trial design for pivotal trials VERSATILE-002: PDS0101 + KEYTRUDA® Fast track designation successfully granted by FDA on 06/01/2022 Triple combination: PDS0101 + high dose M9241 + Bintrafusp alfa Anticipate discussions with the FDA in Q3
Slide 14: Conclusions
Conclusions 14 We believe Versamune® proof-of-concept data has been successfully demonstrated In vivo CD8+ T cell induction may promote synergy with CPI and enhanced clinical efficacy Lack of severe adverse events to date may represent an advantage for PDS0101 combination therapy Versamune® and M924
Slide 15: Q&A Session
Precision Designed Science For Immunotherapy Q&A Session NASDAQ: PDSB | June 7, 2022