Exhibit 99.2
IMMUNOCERV Phase II Trial Combining the HPV-specific T Cell Immunotherapy PDS0101 with Chemoradiation for Treatment of Locally Advanced Cervical Cancer Adam J Grippin1, Kyoko Yoshida-Court1, Madison O’Hara1, Olsi Gjyshi2, Geena Mathew1, Maliah Domingo1, Lilie Lin1, Anuja Jhingran1, Melissa Joyner1, Tatiana Cisneros Napravnik1, Kathleen Schmeler1, Michael Hernandez1, Erica Lynn1, Aaron Seo1, Sage Copling1, Lauren Colbert1, Jagannadha K Sastry1 and Ann Klopp1 1The University of Texas MD Anderson Cancer Center, 2Department of Radiation Oncology, Saint Elizabeth Cancer Center, Edgewood, KY
Disclosure Employed by The University of Texas MD Anderson Cancer Center. Inventor on a patent application related to cancer vaccines This presentation discusses investigational use of PDS0101 in a clinical trial sponsored by PDS Biotechnology.
Rationale Although they express virus-associated antigens, there are currently no HPV-targeted therapies to treat HPV-related cancers.1 PDS0101 is a novel, subcutaneously administered Type I interferon and CD8 T-cell activating immunotherapy containing peptide pools encoding HPV antigens E6/E7.2 The IMMUNOCERV trial was designed to test the hypothesis that PDS0101 would be safe and effective in combination with standard of care chemoradiation for locally advanced HPV-related cervical cancer. 1Schwartz, JNCI, 1998; Gillison, JNCI, 2000; Burd, Clin Micro Rev, 2003 2Price, ASCO, 2023
Trial Design Primary Endpoint: Clinically significant grade ≥3 acute toxicities from first vaccine injection up to 30 days following completion of chemoradiation (Day -10 to day 80) Prespecified secondary endpoints: Complete metabolic response (CMR) on Day 170 PET CT (± 14 days) ≥90% gross tumor volume reduction (GTVR) on Day 35 MRI (± 5 days) Progression-free survival (PFS) Overall survival (OS) at 12 and 18 months
Patient Enrollment and Demographics n (%) Age, median (range), years Age, median (range), years 40 (26-79) Ethnicity Native Hawaiian or Other Pacific Islander 1 (5.8) White or Caucasian 11 (64) Other 1 (5.8) Patient Refused 1 (5.8) Black or African American 2 (11) Clinical Stage IB3 1 (5.8) IIB 4 (23.5) IIIC1 9 (52.9) IIIC2 1 (5.8) IVA 2 (11.7) HPV Serotype 16 9 (52.9) 18 4 (23.5) 59 1 (5.8) 45 2 (11.7) Negative 1 (5.8) *Trial was closed early due to a change in the standard of care. Median follow up at time of analysis was 575 days. n (%) Highest Positive Clinical Node Internal Iliac 3 (18) External Iliac 9 (53) Common Iliac 2 (12) Para-aortic 2 (12) Inguinal 1 (6) Tumor Diameter (cm), median (Range) 6 (2.2-9.8) Tumor Size (cm3), median (Range) 56.5 (4.5-251)
PDS0101 was well-tolerated Acute grade 3+ adverse events occurred in eight patients (47%), approximating the expected rate of Grade 3+ adverse events among patients receiving chemoradiation and brachytherapy boost of 46% (Rose, NEJM 1999; Rose, JCO 2007; Keys, NEJM 1999; Morris, JCO 1999; Eifel, JCO 2004). Adverse events likely related to PDS0101 injection included injection site reaction (n=12, 71%), Grade 3 urticarial allergic reaction (n=1, 5.8%) and Grade 2 pain (n=1, 5.8%). Grade 3+ Adverse Event Frequency, n (%) Nausea 2 (12%) Vomiting 2 (12%) Hydronephrosis 2 (12%) Urinary tract infection 1 (6%) Diarrhea 1 (6%) Thromboembolic event 1 (6%) Vaginal hemorrhage 1 (6%) Renal insufficiency 1 (6%) Hematuria 1 (6%) Urticaria 1 (6%)
Complete metabolic response* at 4 months** GTV Reduction at Day 35 MRI Radiographic Response *Maximum SUV<4 on PET. ** CMR ultimately achieved in 15/17 (88%) patients
Patients in this high-risk cohort demonstrated promising survival outcomes 36 month OS = 84.4% 36 month PFS = 74.9% *Both deaths occurred in patients with Stage IVA disease. One death was related to disease and the other was caused by cardiac arrest in a disease-free patient.
Receipt of all five planned doses of PDS0101 was associated with improved PFS
>75% volume reduction at Day 35 MRI was associated with improved PFS
Conclusions In this final report of the IMMUNOCERV clinical trial, PDS0101 was safe and well-tolerated, and receipt of all prescribed doses of PDS0101 was associated with improved PFS. Further investigation of PDS0101 in cervical cancer in combination with pembrolizumab is warranted.
Acknowledgements MD Anderson Department of Radiation Oncology Kyoko Yoshida-Court, PhD Kathleen Schmeler Geena Mathew Erica Lynn Maliah Domingo Aaron Seo, MD, PhD Lilie Lin, MD, PhD Sage Copling Anuja Jhingran, MD Lauren Colbert, MD Melissa Joyner, MD Ann Klopp, MD Tatiana Cisneros Napravnik Saint Elizabeth Cancer Center Department of Radiation Oncology Olsi Gjyshi, MD, PhD MD Anderson Department of Immunology Madison O’Hara, PhD Jagannadha K Sastry, PhD MD Anderson Department of Biostatistics Michael Hernandez, PhD MD Anderson/RICE University T32 in Cancer Nanotechnology Gang Bao PhD Konstantin Sokolov PhD This work was supported in whole or in part by: PDS Biotechnologies MD Anderson/RICE University T32 in Cancer Nanotechnology Radiological Society of North America Resident Research Award