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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which
registered
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Item 8.01 |
Other Events.
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Item 9.01 |
Financial Statements and Exhibits.
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Exhibit
Number
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Description
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Press Release Dated May 9, 2024.
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL Document)
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PDS BIOTECHNOLOGY CORPORATION
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Date: May 9, 2024
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By:
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/s/ Frank Bedu-Addo, Ph.D.
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Name: Frank Bedu-Addo, Ph.D.
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Title: President and Chief Executive Officer
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• |
The VERSATILE-002 trial is evaluating Versamune® HPV + KEYTRUDA® (pembrolizumab) in patients with HPV16-positive
HNSCC.
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• |
Median overall survival (“mOS”) is 30 months (n=53) in first line recurrent metastatic HNSCC; Published results for immune checkpoint inhibitors are 7-18 months.
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• |
The immune checkpoint inhibitor (ICI) naïve cohort (n=53) met its primary endpoint of best overall response (BOR).
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o |
BOR by investigator assessment is 34% (Combined Positive Score (CPS) ≥1; n=18/53); 48% (CPS≥20; n=10/21); Published results for ICIs are <20% (CPS>1) and <25% (CPS≥20).
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o |
Progression free survival (“PFS”) is 6.3 months (CPS≥1); 14.1 months (CPS≥20); Published results for immune checkpoint inhibitors 2-3 months.
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o |
VERSATILE-002 data to date indicate a durable response in first line recurrent and / or metastatic HNSCC patients with CPS≥1.
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o |
The combination of Versamune® HPV + pembrolizumab was well tolerated.
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The Company announced an updated clinical strategy with a two-part registrational trial focused on the triple combination of Versamune® HPV + PDS01ADC + pembrolizumab as a
first line treatment in HPV16-positive recurrent/metastatic HNSCC.
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o |
PDS01ADC is the Company’s novel, investigational tumor-targeting IL-12-fused antibody-drug conjugate (ADC), which has shown promise in a clinical trial of Versamune® HPV +
PDS01ADC + an investigational ICI conducted by the National Cancer Institute.
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o |
Part one of the clinical trial will focus on dose optimization with a data readout based on safety and objective response rate.
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o |
The randomized second part of the trial will include an interim data readout with OS as its primary endpoint.
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Document and Entity Information |
May 09, 2024 |
---|---|
Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | May 09, 2024 |
Entity File Number | 001-37568 |
Entity Registrant Name | PDS BIOTECHNOLOGY CORPORATION |
Entity Central Index Key | 0001472091 |
Entity Incorporation, State or Country Code | DE |
Entity Tax Identification Number | 26-4231384 |
Entity Address, Address Line One | 303A College Road East |
Entity Address, City or Town | Princeton |
Entity Address, State or Province | NJ |
Entity Address, Postal Zip Code | 08540 |
City Area Code | 800 |
Local Phone Number | 208-3343 |
Title of 12(b) Security | Common Stock, par value $0.00033 per share |
Trading Symbol | PDSB |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | false |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
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