On May 26, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines, reported an upcoming poster presentation of preliminary data from its ongoing Phase 2 VERSATILE-002 clinical trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7, 2022 in Chicago and online (Press release, PDS Biotechnology, MAY 26, 2022, View Source [SID1234615162]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
VERSATILE-002 is a single-arm Phase 2 study evaluating the safety and efficacy of PDS0101, an HPV16-targeted investigational T cell-activating immunotherapy that leverages PDS Biotech’s proprietary Versamune technology, in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab). The combination is being evaluated in checkpoint inhibitor (CPI) -naïve and CPI-refractory patients with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). The data being presented at ASCO (Free ASCO Whitepaper) will detail preliminary safety and efficacy data for CPI-naïve patients at a prespecified interim analysis point.
In the VERSATILE-002 clinical trial, patients are being treated with KEYTRUDA 200 mg by IV infusion every three weeks, plus subcutaneous injection of PDS0101 for the first 4 treatment cycles (Cycles 1-4) and again on Cycle 12; KEYTRUDA treatment continues for up to 35 cycles, or until disease progression or demonstrated intolerance to therapy.
Highlights of the abstract from 19 patients (safety) with available imaging data for 17 of the 19 (efficacy) in the VERSATILE-002 clinical trial include:
Response rates thus far** (tumor shrinkage greater than 30%) seen in 7/17 (41.2%) patients in comparison to the published results of approximately 19% for approved checkpoint inhibitors used as monotherapy for recurrent or metastatic head and neck cancer, with 2 of the 7 having complete responses (CR)*
Stable disease (SD) was reported in 6/17 (35.3%) patients, with 4 of the 6 (67%) experiencing tumor shrinkage of less than 30%
Clinical efficacy (ORR** + SD) was seen in 13/17 (76.5%) patients
Progressive/ongoing disease was reported in 4/17 (23.5%) patients
Patients had received a median of 4/5 doses of PDS0101 (range 1-5) and 9/35 doses of KEYTRUDA (range 1-18)
There were no treatment-related adverse events greater than or equal to Grade 3 (N=19)
No patients required dose interruption or reduction on the combination treatment
No patients discontinued the combination treatment
At 9 months of follow up (median not yet achieved):
Progression free survival (PFS) rate was 55.2%
Overall survival (OS) rate was 87.2%
"While preliminary, we are excited to see the enhanced clinical responses and tolerability of PDS0101 in combination with KEYTRUDA in the CPI-naive arm of the VERSATILE-002 trial," said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "We believe PDS0101’s ability to generate tumor-attacking killer T-cells without increasing toxicity based on these preliminary results speaks to the specificity of the Versamune-based immunotherapies and the potential of these drug candidates to work in combination with a broad range of anti-cancer therapies. These data continue to strengthen our confidence that PDS0101 in combination with KEYTRUDA could potentially improve patient outcomes."
"The clinical activity seen with PDS0101 in combination with KEYTRUDA thus far, in addition to the favorable safety profile continues to show promise in this difficult-to-treat patient population," stated Dr. Jared Weiss, MD, Lead Principal Investigator at the University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center. "While the patient pool is small, the responses we are seeing in these patients based on the preliminary results are significant, leading to shrinking of tumors, and extending overall survival."
The abstract for this poster is now available online on the ASCO (Free ASCO Whitepaper) conference website: View Source; data in this press release have been updated since the abstract submission.
Abstract/Poster Number: 6041
Poster Title: PDS0101 a novel type 1 interferon and CD8+ T-cell activating immunotherapy in combination with pembrolizumab in subjects with recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC).
Presenting Author: Jared Weiss, M.D., Section Chief of Thoracic and Head and Neck Oncology at the University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, who serves as the Lead Principal Investigator for VERSATILE-002
Session Title: Head and Neck Cancer
Date: Monday, June 6, 2022
Time: 1:15 PM-4:15 PM CDT
PDS Biotech is presenting a second abstract #2518 which presents clinical results for a PDS0101-based novel triple combination. The press release describing these data can be seen on the company website here.
The company is hosting a conference call on Tuesday, June 7 at 8:00 AM EDT to discuss the data from the two trials presented at ASCO (Free ASCO Whitepaper). To participate on the live call, please dial 877-407-3088 (US) or +1 201-389-0927 (International) and provide the conference ID "13729901" five to ten minutes before the start of the call. A live webcast of the event will be available online in the investor relations section of the company’s website at View Source
KEYTRUDA is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
*No control or comparative studies have been conducted between checkpoint inhibitors and PDS0101; Ferris R.L., Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck; N Engl J Med 2016; 375:1856-1867; Burtness B et al., Pembrplizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (keynote 048): a randomized, open label phase 3 study; Lancet 2019;394(10212):1915-1928
View Source
View Source
**The study is on-going and includes confirmed and unconfirmed responses.