PDS Biotech Announces Colorectal Cancer Cohort of Phase 2 Clinical Trial with PDS01ADC Met Criteria for Expansion to Stage 2 Following Positive Stage 1 Results
PDS Biotechnology (NASDAQ:PDSB) announced successful completion of Stage 1 in their Phase 2 clinical trial for PDS01ADC in metastatic colorectal cancer patients. The trial, conducted in collaboration with the National Cancer Institute (NCI), met the pre-set RECIST v1.1 criteria for expansion into Stage 2, achieving at least 6 objective responses among 9 participants.
The study combines PDS01ADC with floxuridine (FUDR) administered via hepatic artery infusion pump. The trial includes three cohorts: metastatic colorectal cancer, cholangiocarcinoma, and adrenocortical cancer. Following this milestone, the colorectal cancer cohort will expand enrollment to 22 participants, with completion expected by Q4 2025.
PDS01ADC is a novel antibody drug conjugate targeting exposed DNA in tumor necrosis regions, designed to deliver IL-12 with minimal systemic exposure and reduced toxicity.
PDS Biotechnology (NASDAQ:PDSB) ha annunciato il completamento con successo della Fase 1 nel loro studio clinico di Fase 2 per PDS01ADC in pazienti con cancro colorettale metastatico. Lo studio, condotto in collaborazione con il National Cancer Institute (NCI), ha soddisfatto i criteri RECIST v1.1 predefiniti per l'espansione alla Fase 2, ottenendo almeno 6 risposte obiettive su 9 partecipanti.
Lo studio combina PDS01ADC con floxuridina (FUDR) somministrata tramite pompa di infusione nell'arteria epatica. La sperimentazione include tre coorti: cancro colorettale metastatico, colangiocarcinoma e cancro della corteccia surrenale. Dopo questo traguardo, la coorte del cancro colorettale amplierà l'arruolamento a 22 partecipanti, con completamento previsto entro il Q4 2025.
PDS01ADC è un nuovo coniugato anticorpo-farmaco che mira al DNA esposto nelle aree di necrosi tumorale, progettato per rilasciare IL-12 con minima esposizione sistemica e ridotta tossicità.
PDS Biotechnology (NASDAQ:PDSB) anunció la finalización exitosa de la Etapa 1 en su ensayo clínico de Fase 2 para PDS01ADC en pacientes con cáncer colorrectal metastásico. El estudio, realizado en colaboración con el National Cancer Institute (NCI), cumplió con los criterios RECIST v1.1 preestablecidos para expandirse a la Etapa 2, logrando al menos 6 respuestas objetivas entre 9 participantes.
El estudio combina PDS01ADC con floxuridina (FUDR) administrada mediante bomba de infusión en la arteria hepática. El ensayo incluye tres cohortes: cáncer colorrectal metastásico, colangiocarcinoma y cáncer de la corteza suprarrenal. Tras este hito, la cohorte de cáncer colorrectal ampliará la inscripción a 22 participantes, con finalización prevista para el Q4 2025.
PDS01ADC es un novedoso conjugado anticuerpo-fármaco que se dirige al ADN expuesto en las regiones de necrosis tumoral, diseñado para entregar IL-12 con mínima exposición sistémica y toxicidad reducida.
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� 연구� 간동� 주입 펌프� 통해 투여되는 플록시유리딘(FUDR)� PDS01ADC� 병용합니�. 시험에는 전이� 대장암, 담관�, 부신피질암� � � 코호트가 포함되어 있습니다. � 성과� 바탕으로 대장암 코호트는 참여� 수를 22명으� 확대� 예정이며, 완료� 2025� 4분기� 예상됩니�.
PDS01ADC� 종양 괴사 부위에 노출� DNA� 표적으로 하는 새로� 항체-약물 접합체로, 최소한의 전신 노출� 독성 감소� 목표� IL-12� 전달하도� 설계되었습니�.
PDS Biotechnology (NASDAQ:PDSB) a annoncé la réussite de l'étape 1 de son essai clinique de phase 2 pour PDS01ADC chez des patients atteints de cancer colorectal métastatique. L'essai, mené en collaboration avec le National Cancer Institute (NCI), a satisfait aux critères RECIST v1.1 prédéfinis pour passer à l'étape 2, avec au moins 6 réponses objectives parmi 9 participants.
Cette étude combine PDS01ADC avec de la floxuridine (FUDR) administrée via une pompe d'infusion dans l'artère hépatique. L'essai comprend trois cohortes : cancer colorectal métastatique, cholangiocarcinome et cancer corticosurrénalien. Après cette étape, la cohorte de cancer colorectal étendra son recrutement à 22 participants, avec une fin prévue pour le 4e trimestre 2025.
PDS01ADC est un nouveau conjugué anticorps-médicament ciblant l'ADN exposé dans les zones de nécrose tumorale, conçu pour délivrer de l'IL-12 avec une exposition systémique minimale et une toxicité réduite.
PDS Biotechnology (NASDAQ:PDSB) gab den erfolgreichen Abschluss von Phase 1 ihrer Phase-2-Studie zu PDS01ADC bei Patienten mit metastasiertem kolorektalem Krebs bekannt. Die Studie, die in Zusammenarbeit mit dem National Cancer Institute (NCI) durchgeführt wurde, erfüllte die vorgegebenen RECIST v1.1-Kriterien für die Erweiterung auf Phase 2 und erzielte mindestens 6 objektive Ansprechraten unter 9 Teilnehmern.
Die Studie kombiniert PDS01ADC mit Floxuridin (FUDR), das über eine Infusionspumpe in die Leberarterie verabreicht wird. Die Studie umfasst drei Kohorten: metastasierter kolorektaler Krebs, Cholangiokarzinom und Nebennierenrindenkrebs. Nach diesem Meilenstein wird die Kohorte für kolorektalen Krebs auf 22 Teilnehmer erweitert, mit Abschluss erwartet bis Q4 2025.
PDS01ADC ist ein neuartiges Antikörper-Wirkstoff-Konjugat, das auf freiliegende DNA in Tumornekrosebereichen abzielt und entwickelt wurde, um IL-12 mit minimaler systemischer Exposition und reduzierter Toxizität zu liefern.
- Met pre-set RECIST v1.1 criteria for Stage 2 expansion in colorectal cancer cohort
- Achieved at least 6 objective responses out of 9 participants in Stage 1
- Novel approach minimizes systemic IL-12 exposure while maintaining therapeutic benefits
- Trial addresses large market opportunity with 150,000+ new colorectal cancer cases annually in US
- Study still in early Phase 2 stage with limited patient data
- Two other cohorts (cholangiocarcinoma and adrenocortical cancer) still in Stage 1
- Complete enrollment not expected until Q4 2025
Insights
PDS Biotech's colorectal cancer trial advances to Stage 2 after meeting response criteria, showing promise for their novel IL-12 approach.
PDS Biotech has reached a significant clinical milestone with their PDS01ADC therapeutic for metastatic colorectal cancer. The Phase 2 trial, conducted under a Simon two-stage design, has successfully completed Stage 1 recruitment and met the predetermined efficacy threshold - achieving objective responses in at least 6 of 9 participants per RECIST criteria.
This is particularly notable because colorectal cancer represents a substantial unmet medical need, being the second leading cause of cancer deaths in the US with over 930,000 deaths worldwide in 2020. Approximately 20% of cases are metastatic at diagnosis, with another 25% eventually progressing to metastatic disease.
What makes PDS01ADC mechanistically interesting is its novel approach to IL-12 delivery. The molecule consists of IL-12 heterodimers fused to an antibody (NHS76) that targets exposed DNA in necrotic tumor regions. This design aims to concentrate IL-12 at tumor sites while minimizing systemic exposure, potentially avoiding the dose-limiting toxicities that have historically plagued cytokine therapies.
The trial combines PDS01ADC with floxuridine delivered via hepatic artery infusion pump - a specialized approach for liver metastases common in colorectal cancer. With Stage 2 now activated, the colorectal cohort will expand from 9 to 22 participants, with completion targeted for Q4 2025.
While this trial also includes cholangiocarcinoma and adrenocortical cancer cohorts (still in Stage 1), the colorectal indication represents the largest potential market. Meeting this milestone suggests the therapeutic approach may be viable, though larger studies will be needed to confirm efficacy and safety.
Metastatic Colorectal Cancer Cohort in NCI-Led Multi-Cohort Study Demonstrates Promising Response Rate, Triggering Enrollment Expansion Under Simon Two-Stage Design
PRINCETON, N.J., July 10, 2025 (GLOBE NEWSWIRE) -- 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, today announced patient recruitment has been completed in Stage 1 of a clinical trial of the Company’s PDS01ADC therapeutic administered systemically in combination with floxuridine (FUDR) administered by hepatic artery infusion pump (HAIP) for patients with metastatic colorectal cancer (), led by the National Cancer Institute (NCI), a component of the National Institutes of Health (NIH). The study met the pre-set RECIST v1.1 criteria for expansion into Stage 2 of the study.
The trial is an open label, single center, non-randomized Phase 2 study with three cohorts: metastatic colorectal cancer, cholangiocarcinoma, and adrenocortical cancer. It is led by Dr. Jonathan Hernandez, Chief of the Surgical Oncology Section, Surgical Oncology Program, Center for Cancer Research, at the NCI. A Simon two-stage trial design is being used for each cohort. For the colorectal cancer cohort, if at least 6 of 9 participants experienced an objective response by RECIST v1.1 criteria, the cohort would continue to enroll up to a total of 22 participants. This milestone has been achieved for the colorectal cancer cohort, and enrollment has progressed to Stage 2. The cholangiocarcinoma and adrenocortical cancer cohorts continue to enroll in Stage 1. The study is being performed under the Company’s collaborative research and development agreement with the NCI.
PDS01ADC is a fused antibody drug conjugate composed of two Interleukin-12 (IL-12) heterodimers, each fused to the NHS76 antibody, which binds to both single- and double-stranded DNA (dsDNA), and therefore targets regions of tumor necrosis where DNA has become exposed.
“Colorectal cancer is among the most deadly and difficult to treat cancers. In 2020, it was estimated that more than 930,000 deaths were due to colorectal cancer worldwide according to the World Health Organization, and more effective treatments are desperately needed,� said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “This novel investigational approach to the targeting and use of IL-12 results in little, or no systemic exposure to IL-12, and may allow patients to reap the benefits of cytokine therapy without the typical treatment-limiting toxicities. We are delighted that the NCI has achieved this milestone and anticipate completion of patient recruitment for the metastatic colorectal cancer cohort of the study by the fourth quarter of 2025.”�
Each year, more than 150,000 new cases of colorectal cancer are diagnosed in the U.S. Approximately
About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company has initiated a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. PDS01ADC is being evaluated in multiple phase 2 trials in various cancer indications in combination with standard of care.
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