Primary-source record

Decision-gradeTopline results

PDSB reports 71.4% ORR and ~80% 24-mo OS for PDS0301 + chemo in mCRC liver mets

NCI-led Phase 2 trial of PDS0301 plus hepatic artery infusion chemotherapy showed 71.4% objective response rate at 6 months and approximately 80% survival at 24 months versus 35% ORR for chemotherapy alone in sequentially-treated MSS/pMMR mCRC patients with liver metastases. A registrational Phase 3 protocol is now in design.

Key facts

Filed
Sep 21, 2026, 08:05 PM
Event
Topline results
Direction
Positive
Asset
PDS0301
Source
SEC 8-K
Confidence
Sourced
ORR
71.4% at 6 months
OS 24m
~80%
median OS
NE (>34 months)
median PFS
>13.1 months (hepatic 12.7 months)

Source excerpt

EX-99.1 2 ef20082538_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Overview of PDS Biotech Drug Development Programs (Oncology) NASDAQ: PDSB September 2026 Forward-Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to

SEC 8-K

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PDSB reports 71.4% ORR and ~80% 24-mo OS for PDS0301 + chemo in mCRC liver mets | SimianX AI