PDS Biotech Announces Presentation of Preliminary Results from Phase 2 Study of IL-12 Tumor Targeted Immunocytokine (PDS01ADC) in 3rd Line Metastatic Castration Resistant Prostate Cancer by the NCI

On January 28, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported that results of a National Cancer Institute ("NCI")-led study of the Company’s investigational Interleukin-12 (IL-12) tumor targeted immunocytokine, PDS01ADC, were presented at the American Association of Cancer Research ("AACR") special conference on prostate cancer research, held in Boston, MA on January 20-22, 2026.

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!

The study, titled Docetaxel and the Tumor-Targeting Interleukin-12 ("IL-12") PDS01ADC in Patients with Metastatic Castration-Resistant Prostate Cancer ("mCRPC"), was presented by Melissa Abel, MD., Assistant Research Physician, Genitourinary Malignancies Branch, Center for Cancer Research, at the NCI, part of the National Institutes of Health ("NIH"). The clinical study is being done to evaluate the ability of PDS01ADC to enhance responses to docetaxel in advanced prostate cancer, based on the potential synergy of PDS01ADC with the necrosis inducing chemotherapeutic agent. The study was performed in advanced cancer patients, the majority of whom had failed 2nd line treatment with androgen deprivation therapy and an androgen pathway inhibitor (ARPI), and therefore had few remaining treatment options (3rd line). Results showed median progression-free survival ("PFS") of 9.6 months (range: 4.3–32.2 months) for the combination therapy in mCRPC patients. Additionally, a promising median PSA decline of 40% was observed, with 6 of 16 patients achieving greater than 50% decline. Patients interested in enrolling in this study may contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or visit the web site: View Source and/or email [email protected].

"These findings reinforce the potential of our tumor-targeting IL-12 immunocytokine to enhance the efficacy of existing therapies across multiple solid tumor types," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We are encouraged by the progression-free survival and PSA declines observed in this difficult-to-treat population and remain focused on advancing PDS01ADC as a key component of our immuno-oncology pipeline."

PDS01ADC is a fused IL-12 antibody drug conjugate designed using an antibody that binds to necrotic DNA found within tumors. This enables targeted delivery of IL-12 into the tumor microenvironment, suppressing the tumor’s ability to evade the immune response while promoting T cell and Natural Killer (NK) cell infiltration and activation within the tumor.

(Press release, PDS Biotechnology, JAN 28, 2026, View Source [SID1234662328])