Panvac-VF (falimarev/inalimarev) / Bavarian Nordic, National Cancer Institute - Bethesda - LARVOL DELTA

HCRN GI16-288: A Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Metastatic CRC (clinicaltrials.gov) - P2 | N=17 | Terminated | Sponsor: Patrick Boland | N=78 ➔ 17 | Active, not recruiting ➔ Terminated; Drugs Unavailable

Enrollment change • Trial termination • Colorectal Cancer • Oncology • Solid Tumor

Vaccine Therapy and Sargramostim in Treating Patients With Pancreas Cancer That Cannot Be Removed By Surgery (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Apr 2025 ➔ Apr 2026

Trial completion date • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Combination Immunotherapy in Biochemically Recurrent Prostate Cancer (clinicaltrials.gov) - P2 | N=40 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed | Trial completion date: Jan 2025 ➔ Jun 2024 | Trial primary completion date: Jan 2025 ➔ Jun 2024

Trial completion • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers (clinicaltrials.gov) - P2 | N=32 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Aug 2024

Metastases • Trial completion • Trial completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Small Intestinal Carcinoma • Solid Tumor • CD4 • CEACAM5

Combination Immunotherapy in Biochemically Recurrent Prostate Cancer (clinicaltrials.gov) - P2 | N=40 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | N=29 ➔ 40

Enrollment change • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT) (clinicaltrials.gov) - P1/2 | N=12 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed

Combination therapy • Metastases • Trial completion • Breast Cancer • Head and Neck Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • CD4 • ER • HER-2 • PD-L1 • PGR

HCRN GI16-288: A Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Metastatic CRC (clinicaltrials.gov) - P2 | N=78 | Active, not recruiting | Sponsor: Patrick Boland | Trial completion date: Jun 2023 ➔ Dec 2024 | Trial primary completion date: Jun 2023 ➔ Mar 2024

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Vaccine Therapy and Sargramostim in Treating Patients With Pancreas Cancer That Cannot Be Removed By Surgery (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Apr 2024 ➔ Apr 2025

Surgery • Trial completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Combination Immunotherapy in Biochemically Recurrent Prostate Cancer (clinicaltrials.gov) - P2 | N=29 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jan 2024 ➔ Jan 2025 | Trial primary completion date: Jan 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers (clinicaltrials.gov) - P2 | N=32 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Completed ➔ Active, not recruiting | N=23 ➔ 32 | Trial completion date: Feb 2023 ➔ Jan 2026

Enrollment change • Enrollment closed • Metastases • Trial completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Small Intestinal Carcinoma • Solid Tumor • CD4 • CEACAM5

Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=8 | Terminated | Sponsor: Georgetown University | Active, not recruiting ➔ Terminated; Study closed due to lack of enrollment.

Combination therapy • Metastases • Trial termination • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Combination Immunotherapy in Biochemically Recurrent Prostate Cancer (clinicaltrials.gov) - P2 | N=29 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Phase II evaluation of combination immunotherapy with CV301, N-803, bintrafusp alfa, and M9241 in patients with advanced small bowel and colorectal cancers. (ASCO-GI 2023) - P2 | "All patients had received prior 5-fluorouracil-based treatment, with 29/30 (96.7%) having received ≥ 2 lines of systemic therapy. Combination therapies with CV301, N-803, bintrafusp alfa, and M9241 had manageable safety profiles. Preliminary clinical activity was observed in patients with advanced MSS/pMMR small bowel or CRC. Median OS was promising as compared to historical median survivals of 6-7 months following receipt of multiple lines of therapy."

Clinical • Metastases • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • IL12A • MUC1 • TGFB1

Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT) (clinicaltrials.gov) - P1/2 | N=12 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial primary completion date: Oct 2021 ➔ Feb 2023

Trial primary completion date • Breast Cancer • Head and Neck Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • CD4 • ER • HER-2 • PD-L1 • PGR

Vaccine Therapy and Sargramostim in Treating Patients With Pancreas Cancer That Cannot Be Removed By Surgery (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Apr 2023 ➔ Apr 2024

Surgery • Trial completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers (clinicaltrials.gov) - P2 | N=23 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed | Trial completion date: Jul 2024 ➔ Feb 2023 | Trial primary completion date: Jul 2024 ➔ Oct 2022

Metastases • Trial completion • Trial completion date • Trial primary completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Small Intestinal Carcinoma • Solid Tumor • CD4 • IL12A • MUC1

Phase I trial of CV301 in combination with anti-PD-1 therapy in non-squamous NSCLC (ESMO 2019) - P1; "C1 included patients pre-treated with platinum-containing chemotherapy, who were considered eligible for nivolumab (N; 240 mg IV q2w). C2 included patients receiving frontline treatment with pembrolizumab (P; 200 mg IV q3w) after a minimum of 11 weeks of SD per RECIST... The treatment of NSCLC with CV301 + N or P is feasible and tolerated, with no observed increase in the frequency or severity of expected AEs or IRAEs for each component of the combination. Clinical trial identification: NCT02840994. Legal entity responsible for the study: Bavarian Nordic Inc."

Combination therapy • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Immunologic Response to a Therapeutic Cancer Vaccine (PANVAC): Initial Results from A Randomized Phase 2 Clinical Trial (AUA 2017) - "...25% of patients also had intravesical chemotherapy prior to enrollment (2 patient had Mitomycin C, 2 patients had Valrubicin)... BCG + PANVAC appears to induce an immunological response that is greater than BCG alone in many patients. The impact of this immunological response on patient outcomes will continue to be assessed as the trial matures."

Clinical • P2 data • Biosimilar • Bladder Cancer • Oncology • Urothelial Cancer

A phase II, multicenter, single-arm trial of CV301 plus atezolizumab (Atezo) in locally advanced (unresectable) or metastatic urothelial cancer (UC). (ASCO-GU 2019) - P2; " This is a Phase 2, single-arm, multi-institutional trial designed to study CV301 plus atezo as 1st-line treatment in pts with advanced UC ineligible for cisplatin-based chemotherapy regardless of PD-L1 (Cohort 1) and as salvage treatment in pts with UC progressing after platinum-based chemotherapy (Cohort 2). For Cohort 2, assuming H0 = 0.15, H1 = 0.33, then N1= 13, R1≥2, N = 35, R≥10. Accrual has begun; completion is expected within 1 year."

Clinical • IO Biomarker • P2 data • PD(L)-1 Biomarker

HCRN GI16-288: A phase II trial of perioperative CV301 vaccination in combination with nivolumab and systemic chemotherapy for resectable hepatic-limited metastatic colorectal cancer—Preliminary efficacy and correlative results. (ASCO-GI 2023) - P2 | "The addition of CV301 to perioperative nivolumab and mFOLFOX was safe, did not delay or prevent surgical resection, and gave a higher response (p=ns due to sample size). Changes in T cells suggest a vaccine response. Clinical trial information: NCT03547999."

Clinical • Combination therapy • Metastases • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD8 • CEACAM5 • MUC1

Durvalumab Plus CV301 With Maintenance Chemotherapy in Metastatic Colorectal or Pancreatic Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=8 | Active, not recruiting | Sponsor: Georgetown University | Trial completion date: Dec 2023 ➔ Aug 2023

Combination therapy • Metastases • Trial completion date • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

HCRN GI16-288: A Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Metastatic CRC (clinicaltrials.gov) - P2 | N=78 | Active, not recruiting | Sponsor: Patrick Boland | Trial primary completion date: Dec 2022 ➔ Jun 2023

Combination therapy • Metastases • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Rutgers Cancer Institute of New Jersey and RWJBarnabas Health to Present Data at the 2023 ASCO Gastrointestinal (GI) Cancers Symposium (Newswise) - "Rutgers Cancer Institute of New Jersey....together with RWJBarnabas Health, today announced that data from its Gastrointestinal Oncology Program will be presented at the 2023 Gastrointestinal (GI) Cancers Symposium, being held in person in San Francisco and online from January 19 to 21."

Clinical data • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers (clinicaltrials.gov) - P2 | N=23 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting | N=80 ➔ 23

Enrollment change • Enrollment closed • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Small Intestinal Carcinoma • Solid Tumor • CD4 • IL12A • MUC1

Clinical responses in pancreaticobiliary cancer patients who received bintrafusp alfa (BA) or BA plus CXCR1/2 inhibitor (SX-682) plus CEA/MUC1-targted vaccine (CV301) (ESMO-GI 2022) - P1, P1/2 | "With this triplet, grade 3 bleeding was observed at a substantially higher rate than expected (rate of grade ≥ 3 bleeding = 8.6% with BA alone). In PBC patients, investigation of an ICB that does not potentiate bleeding, combined with SX-682 + CV301 (or other vaccine against the MUC1 and CEA tumor antigens) is warranted."

Clinical • Biliary Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CXCR1 • MUC1 • TGFB1