DC vaccine for prostate cancer / Medigene, Oslo University Hospital - LARVOL DELTA

WT1 and PRAME RNA-loaded dendritic cell vaccine as maintenance therapy in de novo AML after intensive induction chemotherapy. (PubMed, Leukemia) - "Oral azacytidine may be used as maintenance treatment in AML in first remission, but can be associated with substantial side effects, and less toxic strategies should be explored. OS at five years was 75% (95% CI: 50-89), with 70% of patients ≥60 years of age being long-term survivors. Maintenance therapy with this DC vaccine was well tolerated in AML patients in CR1 and was accompanied by encouraging 5-year long-term survival."

Journal • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation • PRAME

[VIRTUAL] Consistent high-quality dendritic cell vaccines produced post-chemotherapy in patients with acute myeloid leukemia for use in a Phase I/II trial (SITC 2020) - P1/2 | "DC vaccination was carried out in weeks 1, 2, 3, 4, 6 and monthly thereafter for 2 years. DC vaccines were remarkably consistent, although originating from patients differing in age, AML subtype and receiving varied amounts of standard chemotherapy regimens. Ethics Approval The study was approved by the responsible Norwegian ethics committee, approval number 2014/1677."

Clinical • IO Biomarker • P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • IL10 • IL12A • PRAME

Long-term first-in-man Phase I/II study of an adjuvant dendritic cell vaccine in patients with high-risk prostate cancer after radical prostatectomy. (PubMed, Prostate) - "Patients diagnosed with EPE and ISUP grade 5 PC were at particularly high risk of developing postsurgical BCR. In this subgroup, the vaccine response was related to a reduced BCR incidence. The vaccine was safe, without side effects. This adjuvant first-in-man Phase I/II DC vaccine study showed promising results. DC vaccines after curative surgery should be investigated further in a larger cohort of patients with high-risk PC."

Clinical • Journal • P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urology

Generation of clinical grade autologous TLR 7,8-polarized fast dendritic cell vaccines for active immunotherapy of patients with AML (AACR 2018) - P1/2; "Furthermore, high expression of the lymphocyte homing receptor CCR7 could be detected for all cell preparations. Taken together, these results clearly demonstrate the feasibility and robustness of our protocol for production of mature clinical grade TLR7/8-polarized fast DCs in high numbers from heavily pretreated post-remission AML patients allowing for long-term vaccination of trial subjects."

Clinical • IO Biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

[VIRTUAL] Consistent high-quality dendritic cell vaccines produced post-chemotherapy in patients with acute myeloid leukemia for use in a Phase I/II trial (SITC 2020) - P1/2 | "DC vaccination was carried out in weeks 1, 2, 3, 4, 6 and monthly thereafter for 2 years. DC vaccines were remarkably consistent, although originating from patients differing in age, AML subtype and receiving varied amounts of standard chemotherapy regimens. Ethics Approval The study was approved by the responsible Norwegian ethics committee, approval number 2014/1677."

Clinical • IO Biomarker • P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • IL10 • IL12A • PRAME

Immune Monitoring of Vaccine Quality and Persistence of Specific T Cell Responses in Five AML Patients Receiving Extended Dendritic Cell Vaccination Under Compassionate Use (ASH 2018) - P1/2; "To replace SCT in non-eligible patients, we designed an autologous dendritic cell (DC) vaccine approach that is given 4 times weekly at the beginning (immunization phase) followed by booster vaccines at week six and then monthly, with the intention to induce immune responses that delay or prevent relapse. The fifth patient was vaccinated for 24 months without signs of relapse but died due to unrelated heart disease. The ongoing clinical study using extended DC vaccination will provide more information whether persistent vaccination against these self-antigens contributes to immune responses that prevent disease relapse in AML patients."

Clinical • PD(L)-1 Biomarker • Acute Myelogenous Leukemia • Biosimilar • Cardiovascular • Heart Failure • Immune Modulation • Inflammation • Leukemia • Melanoma • Oncology • Renal Cell Carcinoma • Transplantation

INTERIM ANALYSIS OF A WT-1 AND PRAME ‘FAST-DC’ VACCINE SHOWS SAFETY AS ACTIVE IMMMUNOTHERAPY FOR THE PREVENTION OF AML RELAPSE (EHA 2019) - P1/2; "AML diagnoses were established with a median of 9.8 months before the first vaccination (range 4.5 to 17.5 months), and the last chemotherapy infusion was performed at a median of 6.9 months (range 2 to 14.8 months).Results The manufacture of the DC vaccine in these chemotherapy-pretreated subjects was feasible for all 20 patients and aliquots of 5 to 10 x 106 cells were used per vaccination. After a 12-months treatment period, the overall survival was 89% (18 of 20 patients, 95% confidence interval: 61 to 97%) and the progression free survival was 60% (12 of 20 patients, 95% confidence interval: 36 to 78%). Most relapses, 5 out of 8, occurred within the first 80 days after the start of the vaccination, out of which the 2 deaths were in patients with relapses on days 45 and 64, which could point to a starting relapse upon entering the study.Conclusion In summary, at a follow up time of 1 year, DC vaccination against WT-1 and PRAME appears to be safe and feasible for use..."

Clinical

DC Vaccination Induces Antigen Specific Immune Responses in AML Patients: A 1-Year Interim Assessment (ASH 2019) - "Based on expression profiles in AML and normal tissues, WT1 and PRAME were selected as target antigens for a DC vaccine, aiming to elicit adaptive and innate immune responses in AML patients. Stable or decreasing levels of WT1 and/or PRAME mRNA in bone marrow of most patients in remission is compatible with the hypothesis that a local response against AML antigens may be ongoing, despite a negative IFN-γ response in peripheral blood. Monitoring of the patients currently in remission may shed some light on the role of DC vaccination on the prevention of AML recurrence."

Clinical • IO Biomarker • IFNG • IL10 • IL12A

"Medigene $MDG1 Additional European patent granted for Medigene's DC vaccine platform https://t.co/yuEmvd5sSO" (@BiotechRadar)