PDS Biotechnology Corporation · NASDAQ:PDSB
PDS Biotechnology — Corporate Update (June 2021)
22 slides from PDS Biotechnology's corporate update, Jun 8, 2021
Slide 1: Post-ASCO Conference Call Interim Data Review
Post-ASCO Conference Call Interim Data Review JUNE 8, 2021 A new generation of multi-functional cancer immunotherapies and infectious disease vaccines
Slide 2: Forward-Looking Statements
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 activi
Slide 3: Versamune-based immunotherapies promote CD8+ killer T-cell response
PDS Biotech’s Versamune®-based A significant barrier to immunotherapies are designed to effective immunotherapy promote a powerful in vivo tumor-specific CD8+ killer T-cell response has been the inability to promote adequate CD8+ Versamune®-based therapies also show promising potential to: killer T-
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 Checkpoint inhibitor naïve Checkpoint inhibitor refractory Patients have failed Patients have failed Description chemotherapy and radiation chemotherapy, radiation
Slide 5: PDS0101 induces polyfunctional CD8+ killer T-cells in vivo
PDS0101 is designed to efficiently induce polyfunctional (potent) CD8+ killer T-cells in-vivo that recognize cancers caused by HPV Type 16 PDS0101 is developed to treat cancers caused by Human papillomavirus (HPV)16 infection • Combines the Versamune® technology with proprietary modified proteins fr
Slide 6: Preclinical study: triple combination demonstrated higher targeted T-cell response
Preclinical study: Triple combination of PDS0101, Bintrafusp alfa (M7824) and M9241 (NHS-IL12) demonstrated higher targeted T-cell response Combination of PDS0101 with Bintrafusp alfa or M9241 generated superior targeted T-cell response; triple combination demonstrated superior efficacy Bintrafusp a
Slide 7: PDS0101 used in combination resulting in a multifunctional therapy
PDS0101 is used in combination with other immunotherapies resulting in a multifunctional therapy TUMOR BINTRAFUSP PDS0101 DESTROYED ALFA M9241 Activated CD4+ helper T-cell Activated CD8+ killer T-cell The PDS0101 Bintrafusp triple combination induces alfa exposes a powerful, workstheintumor HPV16-ta
Slide 8: Phase 2 Trial Interim Clinical Data
PHASE 2 TRIAL OF PDS0101 + BINTRAFUSP ALFA + NHS-IL12 INTERIM CLINICAL DATA (L. V. Wood)
Slide 9: Phase 2 NCI-led trial of PDS0101, Bintrafusp alfa and M9241
Phase 2 NCI-led clinical trial evaluating the triple combination of PDS0101, Bintrafusp alfa and M9241 in advanced HPV-associated cancer Indication Patients with advanced HPV-associated cancer who have failed prior treatment Bintrafusp alfa: Bifunctional “trap” fusion protein Clinical Agents M9241:
Slide 10: HPV-associated cancers represented in interim data from Phase 2 trial
Most HPV-associated cancers are represented in interim data from NCI-led Phase 2 trial - >95% of all US cases Percentages of HPV-related cancers (anal, cervical, head and neck, vaginal and vulvar cancers) included in the study population Vaginal/ Vulvar 3 (12%) Head & Neck Cervical 6 (24%) 10 (40%)
Slide 11: Study enrolled a challenging patient population
Study enrolled a challenging patient population: 96% had failed both chemotherapy and radiation treatment; 56% had also failed checkpoint inhibitor therapy All patients • As of March 1, 2021, 25 patients had N=25* received the triple combination of Age, median (range), years 50 (37-80%) PDS0101, M92
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 Percentage of CPI Naïve Patients Who Experienced Objective Response with Treatment PDS0101 + 83% (5/6) Bintafusp alfa + M9241 Historical standard of care 12 –
Slide 13: Promising durability in HPV16-positive CPI naïve patients
Triple combination shows promising durability in HPV16-positive checkpoint inhibitor naïve patients, suggesting potential efficacy PDS0101 + Bintrafusp alfa + M9241 Standard of Care HPV16-positive (Checkpoint Inhibitors) Number of subjects 6 80% (4/5) Ongoing responses at median of 8 months 1 patien
Slide 14: 58% tumor reduction among HPV16 CPI refractory patients
Triple combination achieved 58% tumor reduction among 12 HPV16 checkpoint inhibitor refractory patients • 50% (2/4) recently added patients already have ongoing tumor reduction but have not yet attained ORR – Tumor reduction is consistent with first 8 patients showing tumor reduction in 5/8 Percenta
Slide 15: Promising durability in HPV16-positive CPI refractory patients
Triple combination shows promising durability in HPV16-positive checkpoint refractory patients PDS0101 + Bintrafusp alfa + M9241 Standard of Care (Checkpoint HPV16 positive Inhibitors) Number of patients 12 Number of patients with ongoing tumor 86% (6/7) reduction at a median of 8 months Number of p
Slide 16: HPV16-negative patients suggest critical role of PDS0101 T-cells in tumor reduction
Results in seven (7) HPV16-negative patients suggests critical role of PDS0101-induced HPV16-specific CD8+ T-cells in promoting tumor reduction Percentage of HPV16-Positive and HPV16-Negative Patients Who Experienced Tumor Reduction at Median 8 Months HPV16-Positive 67% (12/18) (n=18) HPV16-Negative
Slide 17: HPV16-negative patients suggest critical 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 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 combina
Slide 18: No new or elevated toxicities from adding PDS0101
No new or elevated toxicities observed from the addition of PDS0101 to the combination; PDS0101 only caused transient injection site reactions All patients Adverse Event Summary N=25* • PDS0101 does not appear to compound Grade ≥2 toxicities to the triple combination therapy Treatment-related advers
Slide 19: Review of Key Findings and Implications for PDS Biotech
REVIEW OF KEY FINDINGS AND IMPLICATIONS FOR PDS BIOTECH (F. Bedu-Addo)
Slide 20: Implications for efficacy in ongoing Phase 2 trials
Evidence of PDS0101 in vivo HPV16-specific CD8+ T-cell induction has direct implications for potential efficacy in ongoing Phase 2 trials • PDS0101 + KEYTRUDA® (VERSATILE-002): First line treatment of recurrent/metastatic HPV16- positive head and neck cancer • PDS0101 highly active in promoting HPV1
Slide 21: Combination therapy demonstrates notable clinical activity in HPV16-positive cancer
Combination therapy with PDS0101 demonstrates evidence of notable clinical activity for patients with advanced treatment refractory HPV16-postitive cancer • Tumor reduction occurred in 67% (12/18) of all patients including both CPI naïve and CPI refractory patients who had HPV16-positive cancer • CP
Slide 22: A new generation of multi-functional cancer immunotherapies
A new generation of multi-functional cancer immunotherapies