Ge Peoples
San Antonio Military Medical Center
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Human Vaccines & Immunotherapeutics | 2014
Erika J Schneble; Xianzhong Yu; Thomas Wagner; Ge Peoples
Dendritic cells (DCs) are professional antigen-presenting cells (APCs) that play an important role in stimulating an immune response of both CD4+ T helper cells and CD8+ cytotoxic T lymphocytes (CTLs). As such, DCs have been studied extensively in cancer immunotherapy for their capability to induce a specific anti-tumor response when loaded with tumor antigens. However, when the most relevant antigens of a tumor remain to be identified, alternative approaches are required. Formation of a dentritoma, a fused DC and tumor cells hybrid, is one strategy. Although initial studies of these hybrid cells are promising, several limitations interfere with its clinical and commercial application. Here we present early experience in clinical trials and an alternative approach to manufacturing this DC/tumor cell hybrid for use in the treatment of late stage and metastatic melanoma.
Cancer Research | 2012
Tj Vreeland; Gt Clifton; Diane F. Hale; Alan K. Sears; Ritesh Patil; Jarrod P. Holmes; Sathibalan Ponniah; Elizabeth A. Mittendorf; Ge Peoples
Background: We have completed phase I/II clinical trials vaccinating breast cancer patients (pts) with E75, a HLA-A2/A3-restricted HER2/neu (HER2) peptide vaccine. The vaccine was administered in the adjuvant setting to prevent recurrences in high risk patients rendered disease-free with standard of care therapy. We have previously reported preliminary results indicating that the vaccine (including booster inoculations) is safe and effective in stimulating an anti-tumor immune response. Here, we report the final 5 year results from these trials. Methods: The phase I/II trials were performed as dose-escalation/schedule-optimization trials enrolling node positive and high-risk, node negative breast cancer patients with tumors expressing any level of HER2. HLA-A2/A3+ pts were enrolled into the vaccine group (VG) while HLA-A2/A3- pts were followed prospectively as the untreated control group (CG). The VG pts were given 4–6 monthly intradermal inoculations of E75 with GM-CSF during the primary vaccine series (PVS). In addition, a voluntary booster program was initiated during the trial, with booster inoculations being offered every 6 months after completion of the PVS. Patients were monitored for local and systemic toxicity (graded by NCI Common Terminology Criteria for Adverse Events). In vivo immune response was assessed in the VG by delayed type hypersensitivity (DTH) reactions to both E75 and saline, pre- and post-PVS. VG and CG pts were followed for 60 months (mo) and recurrences were documented. Demographic differences were compared with the Fisher9s exact test and disease-free survival was determined using the Kaplan-Meier method and compared by log-rank test. Results: 195 pts were enrolled, 6 withdrew (2 from VG, 4 from CG), 1 was lost to follow-up prior to vaccination, and 1 was found to be ineligible, leaving 187 evaluable pts; 108 in the VG and 79 in the CG. 53 pts volunteered for the booster program and received at least one booster inoculation. The VG and CG were well-matched with the only statistically significant difference being ER−/PR- status (31.1% in VG vs 17.7% in CG, p = 0.04). Vaccination was well tolerated (maximum local toxicity: 73.1% Grade 1, 26.9% Grade 2, 0% Grade 3; maximum systemic toxicity: 72.2% Grade 1, 15.7% Grade 2, and 2.8% Grade 3). In the VG, pre- to post-PVS E75 DTH significantly increased (mean 3.8 ±1.0 vs 14.8±1.4, p Conclusions: The E75 breast cancer vaccine is safe and well–tolerated. It elicits strong immune responses in vaccinated patients. At the end of the 5 year follow-up period, the E75 vaccine shows a strong trend toward preventing breast cancer recurrence in vaccinated patients. To investigate this vaccine (now known as NeuVax) further, the PRESENT trial, a prospective, randomized, double-blind, placebo-controlled, multi-center phase III registration trial has been initiated and is actively enrolling. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P5-16-02.
Journal for ImmunoTherapy of Cancer | 2013
Erika J Schneble; John S. Berry; Alfred F. Trappey; Timothy J. Vreeland; Diane F. Hale; Alan K. Sears; Guy T. Clifton; Sathibalan Ponniah; Nathan M. Shumway; Elizabeth A. Mittendorf; Ge Peoples
Meeting abstracts HER2 is a commonly expressed tumor-associated antigen in breast (BrCa) and, therefore, an attractive target for immunotherapy. We have investigated HER2-derived peptides as vaccines mixed with GM-CSF to include GP2 (a HLA-A2 and HLA-A3 restricted, CD8+ eliciting epitope) and AE37
Cancer Research | 2011
Tj Vreeland; Gt Clifton; Alan K. Sears; Diane F. Hale; Ritesh Patil; Kevin S. Clive; Jarrod P. Holmes; Elizabeth A. Mittendorf; Sathibalan Ponniah; Ge Peoples
Background: We are conducting phase I/II clinical trials vaccinating breast cancer patients with E75, an HLA-A2/A3 restricted HER2/neu (HER2) peptide mixed with GM-CSF. The vaccine has been studied in the adjuvant setting to prevent recurrences in clinically disease-free patients after completion of standard therapy. We have previously reported that the vaccine is safe, effectively stimulates HER2−specific immunity, and appears to improve disease-free survival at 24 months. Here, we report long-term data at a median follow-up of 60 months. Methods: The phase I/II trials were performed as dose escalation/schedule optimization trials enrolling node positive and high-risk, node-negative patients with tumors expressing any level of HER2. Vaccinated patients were given 4–6 monthly inoculations of E75 with GM-CSF immunoadjuvant. Due to waning immunity, a voluntary booster program was initiated, with inoculations every 6 months after completion of the primary vaccine series (PVS). Patients were monitored for local and systemic toxicities, which were graded by the NCI9s Common Terminology Criteria for Adverse Events. Vaccinated patients and controls were followed for 60 months and recurrences were documented. Demographic differences were compared with the Fisher9s exact test and survival was analyzed by the log-rank test. Results: 187 patients were enrolled; 108 in the vaccine group (VG) and 79 in the unvaccinated control group (CG). The vaccine and control groups were well-matched with the only statistically significant difference being ER-/PR- status (31.1% in VG vs 17.7% in CG, p=0.04). Vaccination was well tolerated with primarily grade 1 and grade 2 toxicity in the PVS (Local Toxicity: 85% Grade 1, 15% Grade 2, 0% Grade 3; systemic toxicity: 71% Grade 1, 14% Grade 2, and 3% Grade 3). Fifty-three of the VG patients received at least one booster, with 34 receiving a second booster, 25 a third, 22 a fourth, 12 a fifth, and 9 receiving at least six boosters. Booster inoculations were well-tolerated with only grade 1 and 2 local and systemic toxicities. There were delayed urticarial reactions in 7/53(13%) of the boosted patients occurring at a median of 9 days (5-21 days) after inoculation; these were grade 2 reactions and well-tolerated. After a median follow-up of 60 months, there has been a nonsignificant decrease in recurrences observed in the VG compared to the CG (10.6% vs 20.3%, p=0.098). The hazard ratio is 0.52 in the VG. In patients with immunity maintained with voluntary boosters, there have been even fewer (3.8%) recurrences (p=0.03). Conclusions: The E75 breast cancer vaccine is safe and well-tolerated. With long-term follow-up at 60 months, the E75 vaccine continues to show a strong trend toward preventing breast cancer recurrence in vaccinated patients particularly in patients whose immunity is maintained with booster inoculations. To investigate this further, a phase III trial with prospective boosting is being initiated. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P1-13-02.
Cancer Research | 2012
Timothy J. Vreeland; Raetasha S. Dabney; Diane F. Hale; Alan K. Sears; Guy T. Clifton; Athina Zacharia; Yusuf Jama; Anna Chiplis; Mohamed Mursal; Nathan M. Shumway; Ritesh Patil; Jarrod P. Holmes; Elizabeth A. Mittendorf; Ge Peoples; Sathibalan Ponniah
Introduction: We are conducting a Phase II clinical trial of 2 HER2 peptide vaccines, GP2 (MHC Class I restricted) and AE37 (MHC Class II restricted), for the prevention of breast cancer (BCa) recurrence in disease-free, high risk patients (pts). We present analysis of T cell populations in trial patients at the time of enrollment and differences based on time since chemotherapy. We describe a “reconstitution” of the immune system after immunosuppressive chemotherapy. Methods: After completion of standard therapy, disease-free, BCa pts were enrolled. Demographic data was collected. Blood was collected prior to administration of their first vaccine. Peripheral blood mononuclear cells from 50 pts were isolated and evaluated for CD8+, CD4+CD8+, CD4-CD8- and CD4+ T cell populations. T cell proliferation responses were measured in patients of both arms of the trial; generically with FluM-specific CD8 cells (HLA-A2:Ig dimer assay) in the GP2 arm (n=58), and then with proliferation response to AE36 and AE37 in the AE37 arm (n=85). Linear regression analyses evaluated the relationship between time from chemotherapy and each T cell population. Immune responses of pts enrolled less than one year from chemotherapy ( 1yr group) using a t-test. Results: Chemotherapy regimens were determined by the treating oncologist and consisted primarily of anthracycline-based regimens with a taxane. Regression analysis revealed a significant correlation between time from chemotherapy and both CD4+ and CD8+ Tcell counts (R= .433, p=0.015 and R=.439, p=.014, respectively). Total T cell, CD4-CD8- and CD4+CD8+ populations, however, did not significantly correlate with increased time from chemotherapy (R=.28, p=0.128, R=.068, p=.715 and R=.058, p=.755, repectively). Comparison between the 1yr group in the GP2 arm (n=43 and n=15) for FluM-specific CD8 cells revealed a non-significant increase in immune response in the >1yr group (2.74 vs 3.57, p=0.15). A similar comparison in the AE37 arm (n=56 1yr) revealed increased proliferation in the >1yr group (AE36: 1110 vs 2167, p=0.034, AE37: 983 vs 2179, p=0.001). There were no significant differences between the >1yr and Citation Format: {Authors}. {Abstract title} [abstract]. In: Proceedings of the 103rd Annual Meeting of the American Association for Cancer Research; 2012 Mar 31-Apr 4; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2012;72(8 Suppl):Abstract nr LB-130. doi:1538-7445.AM2012-LB-130
Cancer Research | 2009
Jarrod P. Holmes; Linda C. Benavides; Jeremy D. Gates; Elizabeth A. Mittendorf; Sathibalan Ponniah; Ge Peoples
CTRC-AACR San Antonio Breast Cancer Symposium: 2008 Abstracts Abstract #3153 Background: Breast cancer prognosis is significantly impacted by expression levels of steroid hormone receptors for estrogen (ER) and progesterone (PR), as well as HER2/ neu, a member of the epidermal growth factor receptor family of tyrosine kinases. Recent advances in molecular typing of breast tumors have defined a poor risk subtype of tumor called basal cell. These basal cell breast tumors are “triple negative,” meaning ER and PR negative, and none to low HER2/ neu expression (immunohistochemistry [IHC] 0, 1+, or 2+ tumors). Basal cell tumors have a poorer prognosis and do not respond to conventional hormonal or targeted therapy aimed at HER2/ neu overexpressing tumors (IHC 3+). Our Cancer Vaccine Development Program (CVDP) has performed several phase I and II clinical trials using immunogenic peptides from the HER2 protein to include E75, GP2, and AE37. Here we present data analysis of ER, PR, and basal cell tumors in HLA-A2+ and A2- patients. Methods: Vaccine trials utilizing E75, GP2, and AE37 were performed separately with similar designs targeting patients with all levels of HER2 expression (IHC 1-3+). Upon completion of standard breast cancer therapy and prior to HLA-typing, disease-free patients were enrolled in the various vaccine trials. HLA-A2 status was determined via flow cytometry of peripheral blood mononuclear cells as E75 and GP2 are HLA-A2+ restricted whereas AE37 is a promiscuous HLA Class II binder. Standard demographic data (including ER, PR and HER2 /neu status) were collected, and patients vaccinated according to their respective trial protocol. Data from all trials were pooled for this analysis. Results: To date, of 254 patients enrolled in the trials 54.3% (n=138) were HLA-A2+. Age, tumor size and nodal status were similar between the A2+ and A2- patients. Significantly more A2+ patients had hormone receptor negative (ER-PR-) tumors (n=49) compared to A2- patients (n=27) (35.5% vs. 23.3%; p= 0.03). There was a trend towards increased basal cell tumors among A2+ patients compared to A2- (15.2% vs. 9.5%; p=0.17). Conclusions: Across these clinical trials conducted by the CVDP, HLA-A2+ patients have an increased incidence of ER-PR- tumors and trend toward increased basal cell tumors. ER-PR- and basal cell tumors have a worse prognosis and fewer treatment options than ER+PR+ tumors. As previously reorted, peptide vaccines targeting the HER2/ neu protein are safe and effective in eliciting an immune response in patients with tumors expressing various levels of HER2/ neu ,to include the low levels associated with basal cell tumors. Therefore, peptide cancer vaccines may provide an excellent adjunctive to current treatment for basal cell tumors. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 3153.
Cancer Research | 2015
Beth Mittendorf; Erika J Schneble; Nuhad K. Ibrahim; Julia M. Greene; John S. Berry; Alfred F. Trappey; Guy T. Clifton; Jarrod P. Holmes; Sathibalan Ponniah; Ge Peoples
Background: In an adjuvant phase II trial, the HER2-derived nelipepimut-S (E75) + GM-CSF vaccine (Neuvax) has been shown to reduce breast cancer recurrence. Preclinical testing of the combination of trastuzumab (Tz) and nelipepimut-S has shown synergistic cytolysis against HER2 expressing cancer cells. In pilot phase II data in HER2+ patients (pts), 55 pts dosed with CD8-eliciting HER2 derived peptide vaccines sequentially after treatment with Tz resulted in no recurrences at 36 months median follow-up compared with a 16% recurrence rate in 34 randomized controls treated with Tz without vaccine (p=.012). Based on these data, we have designed a trial to evaluate the ability of the combination of Tz and the E75 vaccine concurrently to prevent recurrence in pts with high-risk, HER2+ breast cancer. Trial Design: This study will be a multicenter, prospective, randomized, single-blinded, phase II trial evaluating adjuvant Tz + NeuVax (E75+GM-CSF) vs. Tz + GM-CSF alone in high-risk HER2+ (IHC 3+ and/or FISH >2.2) breast cancer pts. High-risk pts include: 1) those that did not achieve a pathologic complete response (pCR) after neoadjuvant chemotherapy and HER2- targeted therapy or 2) those treated with upfront surgery that are node positive (> 4+ LN or 1-3+ LN if hormone receptor negative). Pts must be HLA-A2 /A3+ to be eligible (E75 is HLA-A2/A3-restricted) with ECOG performance status 0-1. Pts will be enrolled after completing standard of care multi-modal therapy but prior to the 3rd dose of Tz maintenance therapy (monotherapy). Pts will be randomized 1:1 to receive either NeuVax or GM-CSF alone which will be administered as six monthly intradermal inoculations concurrently with Tz therapy. Pts will then receive four booster inoculations of either NeuVax or GM-CSF every 6 months. The primary efficacy endpoint is to compare disease-free survival (DFS) between treatment arms. Secondary objectives will include evaluation of local and systemic toxicity, distant recurrence free survival, and in vivo/in vitro immunologic responses. From previously published experience with Tz, we expect a recurrence rate of 20% in Tz (plus GM-CSF) treated pts and anticipate that the combination of Tz with E75+GM-CSF will reduce this recurrence rate to 5%. In order to show statistical difference between these recurrence rates, we plan to enroll 50 pts per treatment arm (100 total) with a type I error rate of 5% and 80% power to detect the primary endpoint. Trial accrual is anticipated to begin in September of 2014, with a two year period for trial enrollment followed by a three year follow-up period. Conclusion: We hypothesize that combination adjuvant immunotherapy with Tz and NeuVax will result in a greater reduction in breast cancer recurrence than Tz therapy alone. We have designed a prospective, randomized, single-blinded, phase II trial evaluating the efficacy of this immunotherapy combination in high-risk HER2+ breast cancer pts to test this hypothesis. Contact Information: This trial is funded by a DoD grant to EAM with matching funds from Galena Biopharma and is being conducted with the assistance of the academic CRO, Cancer InCITe, LLC. Citation Format: Beth A Mittendorf, Erika J Schneble, Nuhad K Ibrahim, Julia M Greene, John S Berry, Alfred F Trappey, Guy T Clifton, Jarrod P Holmes, Sathibalan Ponniah, George E Peoples. Combination immunotherapy with trastuzumab and the HER2 vaccine E75 (nelipepimut-S) in high-risk HER2+ breast cancer patients to prevent recurrence [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr OT3-1-09.
Cancer Research | 2014
Erika J Schneble; Alfred F. Trappey; Timothy J. Vreeland; John S. Berry; Diane F. Hale; Alan K. Sears; Guy T. Clifton; Sathibalan Ponniah; Elizabeth A. Mittendorf; Ge Peoples
Proceedings: AACR Annual Meeting 2014; April 5-9, 2014; San Diego, CA Introduction: Our group has been investigating HER2-derived peptide vaccines administered in the adjuvant setting to high risk breast cancer patients (pts) to prevent disease recurrence. Our group has previously shown that pts with HER2 low-expressing (LE) tumors are at higher risk of recurrence than over-expressing (OE) tumors in the trastuzumab era. Given peptide-based cancer vaccination require presentation by a specific HLA molecule, our group has also examined and found comparable disease recurrence rates between HLA-A2+ and HLA-A2- patients. Here, we report recurrence data based on HLA-A2 allele/HER2 expression sub-grouping in our unvaccinated, control pts. Methods: After completing standard of care therapy, high-risk, disease-free breast cancer pts with HER2 LE (IHC 1+, 2+) or OE (IHC 3+) tumors are eligible for enrollment in our phase II trial evaluating the HER2-derived peptide vaccines, AE37 (MHC Class II, HLA-non-restricted epitope) and GP2 (MHC Class I, HLA-A2+ restricted epitope). Patients are HLA-typed as A2+ or A2- then randomized to vaccine vs. adjuvant alone. Demographics between groups are compared using chi squared or fisher exact. Results: Thus far, 208 pts have been enrolled to the adjuvant alone control arms of the trial. Five pts were excluded from analysis (1 ineligible and 4 second malignancies) for a total of 203 evaluable pts: 88 HLA-A2+ (48 OE and 40 LE) and 115 HLA-A2- (48 OE and 67 LE). A2+ and A2- OE pts exhibited significant difference in respect to age (52 vs. 47, p=0.013) and tumor size (41.7% vs. 68.1% ≥ 2 cm, p=0.01) respectively. With median follow-up of 39 months, recurrence rates were again compared between A2+ vs. A2- pts (11.4% vs. 11.3%, p=0.50) as well as HER2 subgroups (OE, 6.25% vs. LE, 15.8%, p=0.02). The latter difference was particularly prominent among the A2- pts (A2-/OE, 4.2% vs. 16.4%, p=0.03) but less so in the A2+ pts (A2+/OE, 8.3% vs. A2+/LE, 15%, p=0.26). With no recurrence difference between LE A2 subgroups (LE/A2+, 15% vs. LE/A2-, 16.4%, p=0.54), the OE subgroup comparison was notable for 50% increased disease recurrence in A2+ pts (A2+/OE, 8.3% vs. A2-/OE, 4.2%, p=0.33). Conclusions: While there is no difference in recurrence between A2+ and A2- pts overall or among the HER2 LE subset, there does appear to be a difference in the HER2 OE subset. Compared to A2+/OE pts, the A2-/OE pts exhibit 50% decreased disease recurrence despite significantly younger age and larger tumor size. These findings need to be confirmed but are important given that many peptide vaccines target A2+ pts. Therefore, these results may impact future trial design. Citation Format: Erika J. Schneble, Alfred F. Trappey, Timothy J. Vreeland, John S. Berry, Diane F. Hale, Alan K. Sears, Guy T. Clifton, Sathibalan Ponniah, Elizabeth A. Mittendorf, George E. Peoples. HLA-A2 and HER2 expression levels as clinical prognostic factors in breast cancer patients: implications for peptide cancer vaccine trials. [abstract]. In: Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr 5-9; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2014;74(19 Suppl):Abstract nr 2558. doi:10.1158/1538-7445.AM2014-2558
Cancer Research | 2014
Erika J Schneble; John S. Berry; Alfred F. Trappey; Timothy J. Vreeland; Diane F. Hale; Alan K. Sears; Guy T. Clifton; Sathibalan Ponniah; Elizabeth A. Mittendorf; Ge Peoples
Background: We have conducted clinical trials of the HER2 peptide GP2 (MHC Class I restricted) vaccine in clinically disease-free breast cancer patients. Our Phase I/II trials showed the GP2+GM-CSF vaccine to be safe and effective in stimulating clonal expansion of GP2-specific cytotoxic CD8 + T-cells (GP2-CTLs) with anti-tumor activity. Here, we present data regarding the safety and immunologic response to boosters following completion of the primary vaccination series (PVS). Methods: Following completion of their PVS, patients enrolled on our phase II trial were administered booster inoculations every 6 months for 4 doses (500mcg GP2 peptide + 125mcg GM-CSF in the vaccine group (VG) or 125mcg GM-CSF alone in the control group (CG)). HLA A2- controls from the parallel study arm evaluating the HER2 peptide AE37 (MHC Class II restricted) vaccine were also eligible for evaluation as an extended CG (ECG). Patients were monitored for local and systemic toxicity, local reactions (LR) were measured, and GP2-CTLs were quantified using the HLA-A2:IgG dimer assay. Results: We have enrolled 294 patients (83 VG, 66 CG, and 145 ECG). Forty-six VG and 104 control (CG + ECG) have received booster doses. Boosters were well tolerated overall with toxicities comparable between VG and CG+ECG (Local: Gr 0: 2% vs 2%, Gr 1: 85% vs 93%, Gr 2: 13% vs 9%; Systemic: Gr 0: 52% vs 52%, Gr 1: 46% vs 45% , Gr 2: 0% vs 2%, Gr 3: 2% vs 1% ). Mean LR increased from booster 1 (B1) to booster 4 (B4) in the VG (B1: 63.8mm, B2: 66.0mm, B3: 85.2mm, B4: 72.6mm) and declined in the CG (B1: 47.8mm, B2: 43.8mm, B3: 40.2mm, B4: 37.8mm). Patients receiving B1 at 6 months after PVS in the VG group (n=46) were defined as early booster (EB, n=30), and those receiving B1 >6 months after PVS were defined as late booster (LB, n=16). GP2-CTLs prior to B1 were lower in LB patients (LB, 0.55±0.17 vs. EB, 1.00±0.16, p=0.07). Post-booster GP2-CTLs were compared between LB and EB at B1 (0.99±0.15 vs. 1.17±0.25, p=0.82), B2 (0.68±0.11 vs. 0.92±0.21, p=0.32), B3 (0.79±0.13 vs. 2.30±0.64, p=0.003), and B4 (1.08±0.43 vs. 3.37, p=na) respectively. EB post-booster GP2-CTLs levels were greater than LB at all time points although both groups sustained an increase in GP2-CTLs throughout the booster series. Conclusions: The GP2 peptide vaccine and boosters are safe with toxicities likely attributable to GM-CSF. The GP2 vaccine elicits a strong HER2-specific immune response that can be maintained with boosters. Based on these data, an optimal booster regimen is being devised. Citation Format: Erika Schneble, John S. Berry, Alfred F. Trappey, Timothy J. Vreeland, Diane F. Hale, Alan K. Sears, Guy T. Clifton, Sathibalan Ponniah, Elizabeth A. Mittendorf, George Peoples. Immunologic effects of a HER2 peptide (GP2) vaccine booster in previously vaccinated breast cancer patients. [abstract]. In: Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr 5-9; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2014;74(19 Suppl):Abstract nr 2899. doi:10.1158/1538-7445.AM2014-2899
Journal for ImmunoTherapy of Cancer | 2013
John S. Berry; Erika J Schneble; Alfred F. Trappey; Timothy J. Vreeland; Guy T. Clifton; Diane F. Hale; Alan K. Sears; Sathibalan Ponniah; Elizabeth A. Mittendorf; Ge Peoples
Background Folate Receptor Alpha (FRa) is an immunogenic protein that is over-expressed in breast, endometrial and ovarian cancer (OC). In fact, FRa expression in malignant cells is 20-fold higher compared to normal cells. We have begun a phase 1 clinical trial with E39, an HLA-A2 restricted, FRa peptide vaccine. The vaccine is administered in the adjuvant setting to prevent recurrences in high-risk, endometrial and OC patients (pts) rendered clinically diseasefree with standard-of-care therapy. Here, we summarize toxicity and in vivo immunologic responses after enrollment of three dose cohorts.