History of Accomplishments

Vaccines with our antigens prevent Cancer Metastases.

Results of Phase I and II clinical trials with E39 and E75 vaccine are better than

reported by the licensee.

February 15, 2015. MDACC reported $ 832,057.13 royalties received from E75, (Dr. Ioannides’ invention), for period ending 6/30/2014. Dr. Ioannides received $ 173,798.44

MDACC did not report $ 115,000.00 received from inventions E75 and E39. $ 75,000.00 E75-only royalty and $ 125,000.00 E75-trial fee due to MDACC from Galena Biopharma, (GALE) for period ending 3/2015.

The amount received and due-paid is 3 times higher than predicted by Zavitsanos, 2007,below.

(4 co-inventors received $ 516,193.00. Department of Defense received $ 497,656.25)

October 3, 2007: From 2007 to 2012 the Apthera agreements will provide approximately $740,000 in fees, roughly $390,000 of which will be owned by MDACC and Dr. Ioannides. In the event Apthera goes public and issues stock, MDACC will receive another $420,000.

Zavitsanos, AZALaw, (Ioannides’ counsel), prophetically advised MD Anderson Cancer Center, (“MDACC”), about the quality of Ioannides’ invention, E75.

“ .. the cancer vaccine developed by Apthera, (which was founded based on the discoveries of Dr. Ioannides and clinical discoveries of Colonel Dr. George E. Peoples), and partly owned by MDACC (6.5%), was formally approved by the Food and Drug Administration (FDA) to start Phase III trials.

These studies were supported by the Department of Defense. … The data has shown E75 can potentially protect a patient from metastases for up to 20 months. E75 will be used in patients that develop cardiopathy from Herceptin. Protection from metastases will be enhanced to 40 months if Herceptin and E75 are used together in a novel combination devised by Drs. Ioannides and Peoples.

November 17, 2007: Denial. Mendelsohn, 71, (President), ignored MDACC contracts in his answer to Zavitsanos:  

“Funding for your, (“ Ioannides”),  recent laboratory research appears to have primarily depended on grants awarded to foreign postdoctoral fellows ( “Japan”), who worked in your lab and from royalty payments (“Apthera”)  from companies. This is an unsatisfactory record."

Figure 1. Schwartz affidavit under oath: Lawsuit 3-13-cv-01745 - HA, Document 20 See falsified Clinical Trial Title: Document 20-2, Filled 11/22/13 Page 9, Page ID # 163. “SN-33 Phase 2 HER2 Negative, (N=45)”

The same Figure 1 published in 9/09/2014. Corrected title by Gale defendants Federal Lawsuit for securities fraud Protection from Metastases by E75 in vaccine lasts 45 months. 

Secret liquidation of property, Board of Regents stock in Apthera. April 11, 2011. Total Royalty $1,875.00. Henry Jackson Foundation, (25%): $ 468.75. MDACC: $ 1,406.25. Not reported to Texas and US Attorney General.

April 11, 2011. Secret sale of 843, 750. 00 shares of UT System Board of Regents stock in Apthera, for $ 1,406.25, paid to MDAC.Not reported, or  approved by Inventors, Attorney General and Federal Court.

Scholarly admissions of quality of E75 cancer-vaccine:

1. March 22, 2014. Dr. Peoples. Annals,Oncology. Final report, phase I/II clinical trial of E75

2. May 1, 2014.      Dr. Mittendorf admitted Zavitsanos correct. Herceptin + E75 prevents metastases.

3. November 19, 2014. Schwartz, (CEO, GALE), E75, works better than predicted.

                                     Corrected Figure 1, which tried to justify non-payments to MDACC

4. January 9,2015. Schwartz admitted the merit of Ioannides’ invention, E39,(GALE-301).

Leach, (CEO, MDACC) executed the overdue Amendment 6, License transfered to Galena

January 19, 2013:  Reported to inventors by President De Pinho.  

November 22, 2013:  Ioannides compelled GALE to repudiate secret deal Mendelsohn- Kennedy, (CFO, Apthera), 843,750.00 shares of Apthera for $ 1,406.25. Schwartz under oath:

 “ B. Galena acquired the Neu Vax, (TM) Vaccine.  9. …in view of the way in which the Merger took place   neither Apthera nor Galena were required to  purchase any Apthera shares that MDACC owned as a result of the License agreement or any amendments to it. Although the License Agreements and its agreements contemplate that Apthera or Galena would purchase shares in the event of a certain reverse merger,the proposed reverse merger did not took place and the company, (Apthera), was ultimately acquired in an unrelated transaction. Nor did Apthera or Galena purchase any Apthera shares from MDACC under the License agreement or any amendments to it, (3-13-cv-01745 - HA,Doc 20, 11/22/13 Page 3, ID # 134)”

February 25, 2014:  Federal Court Portland: GALE rights are under Ioannides’ contract with

MDACC.Restored MDACC and my rights under contracts ADM0345, ATT0286 and ADM0225,

(Decision Case 3:13-cv-01745, Doc. 34, 02/25/14, Page ID#: 619)…

“While contracting with MDCC, defendant, (“Ioannides”), co-invented the experimental breast cancer vaccine “NeuVax”. Defendant has never been to, or conducted business in, Oregon”.

Here, while it is clear that defendant knew Galena to be an Oregon corporation, it does not

appear that his comments were made with the intent of causing harm to Galena. Some of his

comments concerning Neu Vax, were in fact positive and could have benefited Galena. It is unclear why the comments were made, other than it is obvious defendant has a deep concern regarding Galena's activities.

March 22, 2014:  1st Admission. Annals of Oncology. Final report of phase I/II clinical trial of E75 (nelipepimut-S) vaccine with booster inoculations to prevent disease recurrence in high-risk breast cancer patients. EA, Mittendorf 1, GT, Clifton 2, JP, Holmes3, E. Schneble4, D. van Echo5, S. Ponniah6 & G. E. Peoples 4,6*

“ Because the trials began as dose- and schedule-finding trials, not all patients received the dose that was determined to be optimal (1000 μg nelipepimut-S + 250 μg GM-CSF). When evaluated by dosing, DFS was 94.6% for those who received the optimal dose, (n = 37) (P = 0.05 versus controls) (Figure 4C)….

A voluntary booster program was initiated after late recurrences were noted in vaccinated patients. Fifty-three patients (49.0%) received booster inoculations including 21 who were prospectively boosted after initiation of the program and received their initial booster 6 months after completing their primary vaccination series (i.e. ‘optimally boosted’). Optimally boosted and control patients were well matched except optimally boosted patients were more likely to be hormone receptor-negative and, therefore, less likely to receive adjuvant endocrine therapy…). The DFS rate for optimally boosted patients was 95.2% (P = 0.11 versus control patients).

1 bDepartment of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston; 2 Blanchfield Army Community Hospital, Fort Campbell; 3RedwoodRegional Medical Group, Santa Rosa; 4Department of Surgery, Brooke Army Medical Center, Ft Sam Houston; 5Department of Hematology Oncology,Walter Reed Army Medical Center, Washington; 6Department of Surgery, Cancer Vaccine Development Program, United States Military Cancer Institute, Uniformed Services University of the Health Sciences, Bethesda, USA.

May 1, 2014:  2nd Admission. Dr. Elisabeth Mittendorf admitted Zavitsanos correct: E75 with Herceptin prevents metastases: 

 “With support from an FY13, BCRP Breakthrough, funding level 3 Award that was recently recommended for funding, Dr. Mittendorf is about to begin recruiting for a phase II trial evaluating NeuVax™ in patients that express HER2 at high levels, (i.e. 3+ IHC), and designated clinically HER-2- positive) and are being treated with trastuzumab, ( Herceptin). This trial is based on encouraging results from earlier trials, to include the E75 phase II trial, evaluating MHC class I vaccines: 55 patients with HER-2 3+ tumors, who have received trastuzumab, (Herceptin) and then NeuVax™ have shown no recurrences after 3 years.

September 17,2014. Amendment 6. Grant of License of Ioannides inventions transferred from Apthera to Galena. Inventors-Owners and President De Pinho did not approve Amendment 6, because royalties and stock due to MDACC for inventions E39, E75, E75 + Herceptin are unpaid.

November 19, 2014:  3rd Admission. Dr. Mark Schwartz, (CEO, Galena Biopharma), admitted  Zavitsanos correct. E75 alone, worked better than predicted, Corrected Figure 1.

Neu Vax, (E75): “Special protocol assessment, (SPA) by Food and Drug Administration: Initiated 2007. Approved 2009. Validated at 24, (2010) and 36, (2011) month, landmark analyses p < 0.035 for patients without metastases to lymph nodes”

January 9, 2015:  4th Admission. Dr. Schwartz admitted the merit of E39, Ioannides invention (GALE-301): 

Regulatory compliance. We compelled Galena to comply, in part:

“Recent preliminary Phase 2a data of GALE-301 plus GM-CSF showed promising results with a 38% reduction in relative risk of recurrence, is well tolerated with primarily Grade 1 and 2 toxicities, and elicits a strong in vivo immune response. Enrollment, (Phase 2), completed ahead of schedule due to high demand." 

February 9, 2015:  Enrollment in Phase III Trial of patients with breast cancer with tumor in the lymph nodes with E75 completed.

May –June 2015:  Clinical Trial E39 Phase II Results to be reported

February – March 2016:  Interim results Phase III Trial E75 to be reported

*17.02.06. Recommendations to the Chairman of the Board of GALE Biopharma,
in support of continuation of Clinical Trials and Studies in Immunotherapy
Vaccines directed by Drs. Mittendorf and Peoples.*

*2.16.12.28R. Analysis of the, NeuVax, (or “E75”), Phase III Trial results
presented by GALE in, its, 3rd Quarter, 2016, report, (or “GALE Q3”). *