Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Post-ASCO Conference Call (June 2021)
38 slides from Pds Biotechnology's conference presentation, Jun 8, 2021
Slide 1: Post-ASCO Conference Call Interim Data Review
Post-ASCO Conference CallInterim Data Review JUNE 8, 2021
Slide 2: Forward-Looking Statements
2 Forward-Looking Statements This presentation contains forward-looking statements about PDS Biotechnology Corporation (“PDSB”), and its businesses, business prospects, strategies and plans, including but not limited to statements regarding anticipated pre-clinical and clinical drug development acti
Slide 3: Versamune-based immunotherapies promote CD8+ killer T-cell response
3 PDS Biotech’s Versamune®-based immunotherapies are designed to promote a powerful in vivo tumor-specific CD8+ killer T-cell response Generate the right type and quantity of effective CD8+ killer T-cells Generate potency without systemic side effects Generate memory T-cells, to enhance durability o
Slide 4: PDS0101 triple combination evaluated in CPI naïve and CPI refractory patients
The PDS0101 triple combination is being evaluated in advanced HPV-positive checkpoint inhibitor (CPI) naïve and CPI refractory patients 4 Checkpoint inhibitor naïve Checkpoint inhibitor refractory Description Patients have failed chemotherapy and radiation treatment Patients have failed chemotherapy
Slide 5: PDS0101 is developed to treat HPV16-caused cancers
PDS0101 is developed to treat cancers caused by Human papillomavirus (HPV)16 infectionCombines the Versamune® technology with proprietary modified proteins from the HPV16 viral protein that is expressed by or contained in the HPV16-positive cancersThe interim data suggest that PDS0101 may be effecti
Slide 6: Preclinical triple combination demonstrated higher targeted T-cell response
6 Bintrafusp alfa (bi-functional checkpoint inhibitor) Tumor Regression: 0/16 (0%)T-cell Clones: 22 PDS0101 + Bintrafusp alfa + M9241 Tumor Regression: 13/17 (76%)T-cell Clones: 3 *Reference: Smalley Rumfield C, Pellom ST, Morillon II YM, et al; Journal for ImmunoTherapy of Cancer 2020; 8:e000612. d
Slide 7: PDS0101 used in combination with other immunotherapies
PDS0101 is used in combination with other immunotherapies resulting in a multifunctional therapy 7 Bintrafusp alfa exposes the tumor to attack and M9241 issues a signal calling T-cells to the tumor Reference: Smalley Rumfield C, Pellom ST, Morillon II YM, et al; Journal for ImmunoTherapy of Cancer 2
Slide 8: Phase 2 Trial of PDS0101 + Bintrafusp alfa + NHS-IL12 Interim Clinical Data
PHASE 2 TRIAL OF PDS0101 + BINTRAFUSP ALFA + NHS-IL12 INTERIM CLINICAL DATA(L. V. Wood)
Slide 9: NCI-led clinical trial of triple combination in advanced HPV-associated cancer
Phase 2 NCI-led clinical trial evaluating the triple combination of PDS0101, Bintrafusp alfa and M9241 in advanced HPV-associated cancer 9 Indication Patients with advanced HPV-associated cancer who have failed prior treatment Clinical Agents Bintrafusp alfa: Bifunctional “trap” fusion proteinM9241:
Slide 10: HPV-related cancers included in the study population
Percentages of HPV-related cancers (anal, cervical, head and neck, vaginal and vulvar cancers) included in the study population Most HPV-associated cancers are represented in interim data from NCI-led Phase 2 trial - >95% of all US cases 10 Cervical10 (40%) Anal6 (24%) Vaginal/Vulvar3 (12%) Head & N
Slide 11: Patient baseline characteristics as of March 1, 2021
As of March 1, 2021, 25 patients had received the triple combination of PDS0101, M9241 and Bintrafusp alfa The median follow-up has been 8 months Study enrolled a challenging patient population: 96% had failed both chemotherapy and radiation treatment; 56% had also failed checkpoint inhibitor therap
Slide 12: 83% objective response among HPV16-positive CPI naive patients
Triple combination achieved 83% objective response among 6 HPV16-positive checkpoint inhibitor naive patients, suggesting potential efficacy 12 Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and Bintrafusp alfa in patients with HPV 16 positive malignanc
Slide 13: Durability in HPV16-positive CPI naïve patients
13 Triple combination shows promising durability in HPV16-positive checkpoint inhibitor naïve patients, suggesting potential efficacy PDS0101 + Bintrafusp alfa + M9241 Standard of Care(Checkpoint Inhibitors) HPV16-positive Number of subjects 6 Ongoing responses at median of 8 months 80% (4/5)1 patie
Slide 14: 58% tumor reduction among HPV16 CPI refractory patients
Triple combination achieved 58% tumor reduction among 12 HPV16 checkpoint inhibitor refractory patients 14 Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and Bintrafusp alfa in patients with HPV 16 positive malignancies. Presented at: American Society o
Slide 15: Durability in HPV16-positive checkpoint refractory patients
15 Triple combination shows promising durability in HPV16-positive checkpoint refractory patients PDS0101 + Bintrafusp alfa + M9241HPV16 positive Standard of Care(Checkpoint Inhibitors) Number of patients 12 Number of patients with ongoing tumor reduction at a median of 8 months 86% (6/7) Number of
Slide 16: Results in HPV16-negative patients suggest role of HPV16-specific CD8+ T-cells
Results in seven (7) HPV16-negative patients suggests critical role of PDS0101-induced HPV16-specific CD8+ T-cells in promoting tumor reduction 16 Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and Bintrafusp alfa in patients with HPV 16 positive malign
Slide 17: HPV16-negative results suggest role of CD8+ T-cells in survival
Results in seven (7) HPV16-negative patients suggests critical role of PDS0101-induced CD8+ T-cells in promoting survival 17 Observation of survival in patients with HPV16-positive cancer relative to those patients with HPV16-negative cancer highlights the critical role of PDS0101 in the triple comb
Slide 18: Adverse Event Summary
Adverse Event Summary All patientsN=25* Grade ≥2 Treatment-related adverse events (TRAEs) 23 (92%) TRAEs leading to discontinuation of ≥ 1 drug(s) 5 (20%) Treatment-related serious AEs 7 (28%) TRAEs in ≥5% of patients Anemia 12 (48%) Lymphocyte decrease 7 (28%) Flu like symptoms 6 (24%) Injection si
Slide 19: Review of Key Findings and Implications for PDS Biotech
REVIEW OF KEY FINDINGS ANDIMPLICATIONS FOR PDS BIOTECH(F. Bedu-Addo)
Slide 20: Implications for ongoing Phase 2 trials VERSATILE-002 and IMMUNOCERV
PDS0101 + KEYTRUDA® (VERSATILE-002): First line treatment of recurrent/metastatic HPV16-positive head and neck cancerPDS0101 highly active in promoting HPV16-specific T-cells even in advanced cancer patientsPatients treated earlier in disease recurrence may be “relatively healthier” with even higher
Slide 21: Tumor reduction in 67% of HPV16-positive patients
Tumor reduction occurred in 67% (12/18) of all patients including both CPI naïve and CPI refractory patients who had HPV16-positive cancerCPI naïve diseaseTumor reduction in 83% (5/6) of patientsObjective response (ORR) in 83% (5/6) of patients with 1 achieving a complete response100% (6/6) alive at
Slide 22: PDS Biotechnology: a new generation of multi-functional cancer immunotherapies
®) PDS Biotechnology A new generation of multi-functional cancer immunotherapies
Slide 23: Appendix: 2021 ASCO Presentation
APPENDIX: 2021 ASCO Presentation
Slide 24: Phase II evaluation of the triple combination in HPV 16 positive malignancies
Phase II evaluation of the triple combination of PDS0101, M9241, and Bintrafusp alfa in patients with HPV 16 positive malignancies Julius Strauss1, Charalampos S. Floudas2, Houssein Abdul Sater2, Michell Manu3, Elizabeth Lamping2, Deneise C Francis2, Lisa M Cordes2, Jenn Marte2, Renee N Donahue1, Ca
Slide 25: Introduction
25 J. Strauss Introduction >630,000 new cases of HPV-related cancer (e.g. cervical, oropharyngeal, anal) reported worldwide annually1PD-1 inhibitors have been evaluated in these tumor types and ORRs have ranged from 13–24%2-8Nivolumab & pembrolizumab are FDA approved for HNSCC; pembrolizumab is appr
Slide 26: Bintrafusp alfa: a TGF-β and PD-L1 Inhibitor
J. Strauss Bintrafusp alfa: a TGF-β and PD-L1 Inhibitor Bintrafusp alfa is an innovativefirst-in-class bifunctional fusion protein composed of the extracellular domain of the TGF-βRII receptor (a TGF-β “trap”) fused to a human IgG1 mAb blocking PD-L1In a phase 1 study, Bintrafusp alfa was well toler
Slide 27: Bintrafusp alfa in HPV-Related Cancers
J. Strauss Bintrafusp alfa in HPV-Related Cancers 1.Strauss J, et al. J Immunother Cancer. 2020 Dec;8(2):e001395. . 2020 Dec;8(2):e001395 . 2020 Dec;8(2):e001395 . 2020 Dec;8(2):e001395. 79 patients with advanced HPV-associated cancers (59 checkpoint naïve and 20 checkpoint refractory) received Bint
Slide 28: PDS0101: Versamune-based HPV cancer vaccine
J. Strauss PDS0101: Versamune®-based HPV 16 cancer vaccine Micellar multi-peptide based therapeutic vaccine targeting HPV 16 E6/ E7 (HPV 16 is the genotype responsible for majority of HPV-related cancers worldwide)Versamune® nanoparticles contain the cationic lipid R-DOTAP which upregulates type I I
Slide 29: M9241 (NHSIL12) Tumor targeting IL12 immunocytokine
J. Strauss M9241 (NHSIL12) Tumor targeting IL12 immunocytokineComposed of two IL12 heterodimers fused to NHS76 antibody which binds to histones on free DNA fragments found in areas of tumor necrosisIn phase 1 trial in patients with advanced solid tumors the most frequently observed AEs included flu
Slide 30: Preclinical Studies with PDS0101 + NHSIL12 + M7824
Preclinical Studies with PDS0101 + NHSIL12 + M7824 30 Preclinical Combo of PDS0101, M9241 & Bintrafusp alfa Single, double and triple combinations were evaluated in a TC-1 HPV16+ tumor modelTriple combination generated the maximum HPV-specific immune response, T cell infiltration in the TME and tumo
Slide 31: Study Design
J. Strauss Study Design Patients with advanced HPV-related cancers received the combination of Bintrafusp alfa at 1200 mg flat dose i.v. q 2wks, M9241 at 16.8 mcg/kg s.c. q 4 wks and PDS0101 given as two separate 0.5 ml s.c. injections q 4 wks [NCT04287868]Dose reductions of M9241 to 8 mcg/kg were a
Slide 32: Key baseline patient and disease characteristics
J. Strauss Results Key baseline patient and disease characteristicsAs of 01 MAR 2021, 25 patients had received the triple combination of PDS0101, M9241 & Bintrafusp alfa The median follow-up is 8 months All patientsN=25 Age, median (range), years 50 (37-80) Female, n (%) 17 (68) Tumor type, n (%) Ce
Slide 33: Safety summary
J. Strauss Results Safety summaryGrade 3 TRAEs occurred in 10 (40%) patientsanemia due to hematuria (n=4), AST/ALT elevation (n=2); flu like symptoms (n=1), nausea/ vomiting (n=1), leukopenia (n=1), lymphopenia (n=2), HLH1 (n=1)All four patients with grade 3 hematuria had cervical ca with prior pelv
Slide 34: Results: best overall response and survival
J. Strauss Results All patientsN=25 HPV 16+N=18 HPV 16+ CPI Naïve N=6 HPV 16+ CPI RefractoryN=12 BOR, n (%) Complete response (CR) Partial response (PR) 2 (8)8 (32) 2 (11.1)8 (44.4) 1 (16.7)4 (66.7) 1 (8.3)4 (33.3) ORR (CR+PR), n (%) 10 (40) 10 (55.6) 5 (83.3) 5 (41.7) Disease Reduction, n (%) 13 (5
Slide 35: Responses in HPV 16+ disease irrespective of tumor type
J. Strauss Results Responses in HPV 16+ disease occurred irrespective of tumor type 35
Slide 36: Majority of HPV 16+ CPI naive patients had a response
J. Strauss Results Overwhelming majority of HPV 16+ CPI naive pts had a responseMajority of HPV 16+ CPI refractory pts had tumor shrinkage Primary Refractory: Prior PD or SD < 6 months Secondary Refractory: Prior PR or SD > 6 months 36
Slide 37: Conclusions
J. Strauss Conclusions Triple combination of PDS0101, M9241 and Bintrafusp alfa appears to have a manageable safety profile along with early evidence of notable clinical activity for pts with advanced HPV 16+ malignanciesClinical activity noted irrespective of tumor type or CPI statusORR was 55.6% (
Slide 38: Acknowledgments
J. Strauss Acknowledgments The authors would like to thank the patients and their familiesFunding for the trial was provided by the Center for Cancer Research, National Cancer Institute, and National Institutes of Health Clinical CenterM9241 and Bintrafusp alfa were provided by Merck KGaA, Darmstadt
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