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e15748 Background: Pancreatic cancer is one of the world’s deadliest malignancies with an average 5-year survival rate of only 9%. Fortunately, immunotherapy is providing encouraging results for treatment of this historically resistant malignancy. Kiromic Biopharma is performing a phase I/II dendritic cell vaccine trial for progressive solid malignancies. We present here a notable response to metastatic pancreatic cancer. Methods: The patient is a 73-year-old male with the history of a locally advanced pancreatic cancer treated initially with gemcitabine, concurrent 5FU and radiation therapy, and consolidation 5FU, followed by surgical resection in 2009 . Although the patient did well exceeding typical survival curves, the patient’s cancer became metastatic, requiring multiple lines of chemotherapy including FOLFIRINOX, gemzar and abraxane, and most recently Onivyde and leucovorin/5FU in February - August, 2017 for progressive liver and lung metastases. The patient was then enrolled onto Kiromic Biopharma’s DC vaccination trial in March, 2018. Results: He subsequently received 6 ID autologous dendritic cell vaccinations over 12 weeks, demonstrating a tumor antigen specific immunogenic response by IFN-gamma immunoassay. Total tumor burden (TTB) prior to clinical trial enrollment at the sites of metastatic disease was 2,221mm2, and after completion of the DC vaccination protocol in May, 2018, the TTB increased to 4,466mm2 in June, 2018 (not considered to be pseudo-progression due to a corresponding increase in tumor biomarkers). The patient then received a repeat course of Onivyde and leucovorin/5FU on 8-3-18, completing that course of therapy on 9-14-18, with subsequent TTB decreasing to 2,986 mm2. Conclusions: The sequential combination of dendritic cell vaccine and chemotherapy resulted in a substantial response with a recession in metastatic tumor burden. A CT scan was obtained just 6 days after the 5 week course of Onivyde was completed, and given the optimal immunotherapy window after the DC vaccination, and the repeat of the same chemotherapy regimen, it is unlikely that chemotherapy alone led to such a rapid decrease in the TTB. Metastatic sites were likely populated by chemo resistant clones that survived the August 2017 administration of the Onivyde regimen. Thus, chemo alone would be unlikely to act so quickly. We hypothesize that there was synergistic activity between the DC immunotherapy and the Onivyde/5FU regimen, accounting for the decrease in TTB between May and September, 2018. Clinical trial information: NCT02705703.

TPS3136Background: Despite advances in understanding the biology of hematologic malignancies (HM) and solid malignancies (SM), and the availability of new treatment options, many patients with HM a...

TPS216 Background: Despite advances in understanding the biology of hematologic malignancies (HM) and solid malignancies (SM), and the availability of new treatment options, many patients with HM and SM remain incurable. Since the majority of cancer patients display a defective immune response to tumor antigens, the ex-vivo activation of dendritic cells (DC), through their exposure to tumor associated antigens, is an attractive and active area of investigation. We and others have explored the potential immunotherapeutic targets included our DC vaccine, i.e., SP17, Ropporin, AKAP4, PTTG1, SpanxB, NY-ESO-1, MAGE-1, HM1.24, Her2/Neu. Notably, SP17-pulsed DC have been reported to induce a safe and clinically significant response in patients with multiple myeloma and ovarian cancer. Methods: We hypothesize that treatment of patients with HM or metastatic SM using autologous DC will result in antigen-specific CD4+ T-cell and/or CD8+ CTL responses without significant toxicities. We also hypothesize that the responses generated against specific antigens may translate into clinical anti-tumor activity. Primary Objective: Phase I (6 subjects). To determine safety of intradermal/subcutaneous DC vaccine therapy, low-dose cyclophosphamide and GM-CSF, in patients with metastatic SM or HM who demonstrate a response, or whose disease remains stable, after conventional first-line systemic therapy, or who have failed conventional systemic therapy. Secondary Objective: Phase II (up to 17 subjects). To determine immune responses associated with intradermal/subcutaneous DC vaccine therapy, low-dose cyclophosphamide and GM-CSF, in patients with metastatic SM or HM who demonstrate a response, or whose disease remains stable, after conventional first-line systemic therapy, or who have failed conventional systemic therapy. The study population is currently drawn from patients at various clinical institutions following contractual agreements. Clinical trial information: NCT02709993; NCT02705703; NCT02224599; NCT02223312.

e19581 Background: Multiple myeloma (MM) is a neoplastic plasma cell disorder which results in multiple organ failure. Anemia, hypercalcemia, renal failure and skeletal lesions are the most relevan...

e22005 Background: Ovarian cancer is the most deadly gynecologic malignancy worldwide. Since the pathogenesis of ovarian cancer is incompletely understood, and there are no available screening tech...

e22052 Background: Multiple myeloma (MM) is a cancer of plasma cells wherein aberrant cells accumulate in the bone marrow leading to bone damage and interference with normal blood cell production. Although MM remains incurable, it is treatable. As with most forms of cancer, early detection is the key to improving prognosis and avoiding permanent damage. Cancer Testis Antigens (CTAs) are a class of proteins that are expressed in male gametogenic tissue but generally not in the somatic tissue of healthy adults. However, a number of cancer types have been shown to produce these proteins, and their expression has been correlated with malignancy. Ropporin is a specific CTA shown to be associated with MM, and this protein represents a potential target for MM diagnosis as well as immunotherapy. In this study, we examine the impact of sex on the expression of Ropporin, in MM patients. Methods: The expression of this particular CTA in MM patients was analyzed using PCR, ELISA, and immunohistochemistry in a cohort of 59 MM patients (37 male and 22 female). Results: 61% of MM patients were positive for Ropporin expression. When the data were broken down by sex, it was revealed that Roporrin expression was 81.8% in females and 48.6% in males. Interestingly, 50% of female patients as well as 78% of males expressing Ropporin were deceased. In addition, 100% of the deceased subjects in the cohort were Ropporin positive. Conclusions: Our results provide indications that sex can shift the expression of CTA in multiple myeloma. Furthermore, the data indicate CTA expression may affect the prognosis in MM patients. Further studies in a large cohort of patients are warranted to validate the correlation of CTA/ropporin in MM patients and sex.

e21105 Background: Cancer testis antigens (CTA) are a class of tumor associated antigens, showing a restricted expression in cancer, a strong immunogenicity and weak expression or absence in normal tissues. CTA are a growing family of proteins involved in signal transduction control. Sp17/AKAP4/PTTG1 have been previously investigated, showing promising results as a target antigens. Our aim was to investigate the expression of Sp17/AKAP4/PTTG1 in lung cancer patients. Methods: We analyzed 2 lung cancer cell lines, one normal bronchus cell line, a panel of normal tissues and patient’s cells by RT-PCR, flow-cytometry, immunocytochemistry (ICC), and immunofluorescence (IF). CTA immunogenicity was investigated by measuring circulating specific antibodies in the sera of lung cancer patients. PCR was performed by 35 amplification cycles. RNA integrity in each sample was checked by amplification of ß-actin. We studied the pattern of expression in patients with NSCLC according to histology, gender, and age. Results: Specimens from 11 patients were examined.CTA, Sp17, AKAP-4 and PTTG-1 are aberrantly expressed in lung cancer cell lines and primary cells from patients by RT-PCR, immunocytochemistry, and flow cytometry. ELISA analyses show the presence of circulating CTA-specific antibodies in the sera of lung cancer patients, indicating the immunogenicity of Sp17, AKAP-4 and PTTG-1. The mean age of patients was 60 years(range 57-76). Fifty eight percent were males(N=7). Seventy two percent (n=8) had adenocarcinoma. Six patients were stage IV at diagnosis. There was no difference in the pattern of expression between gender, stage or histology. Conclusions: We showed that CTA, Sp17, AKAP-4 and PTTG-1 can be detected in both sera and tissue of patients with NSCLC. They are potential therapeutic targets for immunotherapies. These may me useful in determining response to treatment as well as asses possible recurrence.