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OncBioMune Presentation Phase 1 Prostate Cancer Trial

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Poster Presentation Title: A Phase 1 clinical trial of a therapeutic prostate cancer vaccine containing PSA/IL-2/GM-CSF in PSA defined biochemical recurrent prostate cancer patients

Meeting: CRI-CIMT-EATI-AACR: Inaugural International Cancer Immunotherapy Conference: Translating Science Into Survival

Immunotherapy for cancer has had two main approaches that have lead to clinical applications. The first is stimulating immune responses to tumor cells with cytokines or cellular immunotherapy and the second is blocking tumor immune evasion and the associated inhibition of T-cell activation with antibodies to the CTLA-4 receptor, PD-1 receptor or PD-L1. At OncBioMune, we have taken a different approach and have developed therapeutic cancer vaccines that are a combination of tumor antigens (whole cells or proteins) with biological adjuvants (the cytokines IL-2 and GM-CSF). This study is a Phase 1a/1b clinical trial of a PSA/IL-2/GM-CSF vaccine in recurrent prostate cancer in hormone-naïve and hormone-independent patients. Major inclusion criteria include adenocarcinoma of the prostate, rising serum PSA and no measurable disease. Phase 1a examines the rate of dose limiting adverse events (DLAEs) in an initial course of 6 vaccinations (“induction vaccination”). The Phase 1b examines the rate of DLAEs with a continued coarse of an additional 6 vaccinations (“maintenance vaccine”). All patients will receive intradermal injections of the PSA/IL-2/GM-CSF vaccine at weeks 1, 2, 3, 7, 11, and 15. In an additional 28 patients the six maintenance vaccines will alternate IL-2 and the complete vaccine (PSA/IL-2/GM-CSF) at weeks 23, 27, 31, 35, 39 and 43. To date, twelve of twenty patients in the Phase 1a portion of the trial have received at least one vaccine injection and ten patients have received all 6 vaccines. Seven of the ten patients that have received 3 vaccines had increased responses to PSA in a lymphocyte blastogenesis assay and five of the nine patients had an increase in their response after 6 vaccines. None of the patients vaccinated in the Phase 1a portion have had a DLAE and enrollment continues in the Phase 1a.

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OncBioMune Presentation Phase 1 Prostate Cancer Trial

  1. 1. Phase 1 clinical trial of a therapeutic prostate cancer vaccine containing PSA/IL-2/GM-CSF in PSA defined biochemical recurrent prostate cancer patients Jonathan F. Head, Gregory A. Daniels, Michelle McKinney, Weg Ongkeko, Jessica Wang- Rodriguez, Kyoko Sakamoto, Robert L. Elliott VA San Diego Healthcare System, San Diego, CA; VA Medical Center, San Diego, CA; Oncbiomune, Baton Rouge, LA OncBioMune
  2. 2. Navy Cancer Vaccine Program (NCVP) with OncBioMune Naval Health Research Center (NHRC), San Diego, CA Veterans Administration Medical Center (VAMC), La Jolla, CA UCSD Medical School, La Jolla, CA OncBioMune, LLC, Baton Rouge, LA OncBioMune
  3. 3. PSA Vaccine Components Antigens  PSA 50 micrograms “Biological” Adjuvants  IL-2 2 x 104 IU  GM-CSF 16.7 micrograms OncBioMune
  4. 4. NCVP Patient Group Prostate Cancer Patients at Relapse (defined by rising PSA) after initial treatment (surgery, radiation or seeds) OncBioMune
  5. 5. NCVP Phase 1a Clinical Trial Vaccinate 20 patients to confirm minimal toxicity of the PSA vaccine OncBioMune NCVP Phase 1b Clinical Trial Enroll 28 additional patients Add Boosters, #7-12, every month, alternating IL-2 (11 million units) and PSA vaccine
  6. 6. INDICATIONS TO BE STUDIED Men with PSA-only recurrent prostate cancer will be enrolled equally between hormone naïve patients (Cohort 1), and hormone-independent patients (Cohort 2). SAFETY ANALYSIS The safety of PSA/IL-2/GM-CSF vaccine will be assessed by the Investigator and the Sponsor using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 to grade adverse events and laboratory abnormalities. Conventional clinical parameters will be assessed in all patients. OncBioMune
  7. 7. Table 1 (Updated 4/15/15) PATIENT # WEEK 1 LBA WEEK 7 LBA AFTER 3 VACCINES WEEK 19 LBA AFTER 6 VACCINES 1 ------ ------ ------ 2 1.56 1.72 0.91 3 0.76 1.12 1.21 4 2.08 1.41 1.52 5 1.60 1.75 1.64 6 3.27 3.57 1.46 7 1.10 ------ ------ 8 1.16 1.31 1.93 9 1.43 40.16 1.72 10 0.82 1.19 1.00 11 1.24 0.89 1.05 12 1.49 0.90 ------ OncBioMune
  8. 8. TRIAL DESIGN Phase 1A. All patients will receive the 6 induction vaccinations at a single dose. Enrollment will be suspended after 20 patients accrue and an interim safety analysis will occur 30 days after the 20th patient receives the last vaccine. If 3 or more DLAEs have occurred among the first 20 patients, the study will terminate. Otherwise, the study will proceed to Phase 1B. Phase 1B. Should the safety analysis of Phase 1A demonstrate the safety of the vaccine according to the above-mentioned criterion, 28 additional patients will be recruited to the Phase 1B and receive induction vaccination (same as in Phase 1A). Patients who tolerate therapy and have an increase in PSADT of greater than 50% will proceed to receive maintenance vaccination. If at any time 3 or more DLAEs have occurred among these 28 patients, the study will terminate. OncBioMune
  9. 9. KEY INCLUSION CRITERIA Adenocarcinoma of the prostate. Rising serum PSA levels documented by 3 values over the last 6 months prior to study enrollment. Each value must be > 2 weeks from the previous value. Patients with rising PSA must have had either 1) prior definitive therapy including surgery or radiation therapy (hormone-naïve, defined as hormone-naïve patients and patients who received hormone therapy in the past who currently have total testosterone > 50 ng/dL), OR 2) hormone suppressive therapy as documented by surgical castration or a serum testosterone value < 50 ng/dL (hormone-independent). Patients must have completed these therapies for at least 6 months but no longer than 20 years prior to enrollment. PSA value within 4 weeks of starting therapy < 20 ng/mL for hormone- naïve (defined as hormone-naïve patients and patients who received hormone therapy in the past who currently have total testosterone > 50 ng/dL) patients or < 60 ng/mL for hormone-independent patients. NO radiographically measurable disease. OncBioMune
  10. 10. PRIMARY OBJECTIVE To evaluate the safety and tolerability of the induction vaccination (Phase 1A), and if acceptable, the maintenance vaccination (Phase 1B). SECONDARY ANALYSIS Secondary endpoints will be analyzed by cohort, i.e., hormone-naïve patients and hormone independent patients. Prostate-specific antigen doubling time (PSADT) will be analyzed descriptively using a repeated measures longitudinal model. The percentage of change from baseline will be given at each time point. An increase from baseline in PSADT > 50% will be considered clinically significant. The percent of subjects who achieve a clinically significant change will be calculated and compared to historical controls at our institution. Time to measurable disease, time to subsequent therapy, disease- specific survival, and overall survival will be calculated and compared with historical controls at our institution using Kaplan-Meier curves and log-rank tests. vaccine-induced immune response. OncBioMune
  11. 11. Progress Recombinant PSA has been manufactured cGMP Engaged Theradex as our CRO for putting together our IND submission and as Medical Monitor FDA IND approved UCSD Medical School IRB approved Fully funded Phase 1 Clinical Trial initiated 1st quarter 2013 OncBioMune
  12. 12. Patient Number PSA Doubling Time Before Vaccine (Days) PSA Doubling Time After Vaccine (Days) Improvement in Doubling Time Increase in Immunity to PSA After Vaccine 1p 121 54 NO --- 2 478 302 NO YES 3 522 1235 YES YES 4 324 429 YES NO 5pr 259 807 YES YES 6 659 672 YES YES 7* --- --- --- --- 8 314 511 YES YES 9 76 70 NO YES 10 463 657 YES YES 11 579 167 NO YES 12** --- --- --- --- 6/10 8/9 *Patient Withdrew **No Data Yet OncBioMune
  13. 13. Twelve of twenty patients in the Phase 1a portion of the trial have received at least one vaccine injection and 10 patients have received all 6 vaccines. None of the 12 patients who have had at least one vaccine have had a DLAE. None of the 10 patients who have received all 6 vaccines in the Phase 1a have had a DLAE. Seven of the 10 patients who have received 3 vaccines have had increased immune responses to PSA as determined with a Lymphocyte Blastogenesis Assay. Five of the 9 patients who have received 6 vaccines have had increased immune responses to PSA as determined with a Lymphocyte Blastogenesis Assay. Eight of 9 patients at 31 weeks post first vaccine have had an increased immune response to PSA as determined with a Lymphocyte Blastogenesis Assay. RESULTS OncBioMune
  14. 14. Trial at University of California San Diego Moore's Cancer Center and the Veterans’ Hospital, La Jolla, CA Trial in patients with recurrent disease 11 biochemically progressing patients enrolled, 3 dropped out of study for progression (2 PSA,1 radiological) and 8 remain on study OBM plans to ask the FDA to allow us to initiate a Phase 2 Trial due to lack of toxicity of the PSA therapeutic vaccine OncBioMune Phase 1 Highlights
  15. 15. OncBioMune Phase 2 Patient Number will be 120 (80 vaccinated prostate cancer patients and 40 control prostate cancer patients) Patient population will be in the active surveillance category, where standard surgical or radiation therapy are not yet indicated
  16. 16. CONTACT Jonathan F. Head, Ph.D. OncBioMune Pharmaceuticals 11441 Industriplex Blvd. Suite 190 Baton Rouge, LA 70809 (225) 227-2384
  17. 17. Patient Number PSA Doubling Time Before Vaccine (Days) PSA Doubling Time After Vaccine (Days) Improvement in Doubling Time Increase in Immunity to PSA After Vaccine Increase in Immunity to PAP After Vaccine Increase in Immunity to PSMA After Vaccine Increase in Immunity to CEA After Vaccine Increase in Immunity to CA-125 After Vaccine 1p 121 54 NO --- --- --- --- --- 2 478 302 NO YES YES YES YES YES 3 522 1235 YES YES YES YES YES YES 4 324 429 YES NO YES YES NO NO 5pr 259 807 YES YES YES YES NO YES 6 659 672 YES YES YES YES YES NO 7* --- --- --- --- --- --- --- --- 8 314 511 YES YES YES NO NO --- 9 76 70 NO YES YES NO YES YES 10 463 657 YES YES YES YES YES YES 11 579 167 NO YES YES NO NO NO 12** --- --- --- --- --- --- --- --- 6/10 8/9 9/9 6/9 5/9 5/8 *Patient Withdrew **No Data Yet OncBioMune

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