On April 21, 2015 Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) reported presentation of data from the on-going Phase II clinical trial of the AE37 breast cancer vaccine correlating local immune response to a reduction in relapse (Press release, Generex, APR 21, 2015, View Source [SID:1234506588]). AE37 is being developed by Antigen Express, Inc. (www.antigenexpress.com), a wholly-owned subsidiary of Generex. The presentation was made at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting held in Philadelphia, PA from April 18 to 22.

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The abstract entitled ‘Correlation of robust local reactions prompting GM-CSF dose reduction to clinical response in a Phase II trial of the AE37+GM-CSF HER2 peptide vaccine’ by Julia Greene, et al was presented at the Clinical Trials in Progress session of the AACR (Free AACR Whitepaper) on April 20. The goal of the study was to establish the importance of the local reaction to immunization with AE37. The controlled, randomized and single-blinded trial is comparing the ability of AE37 plus the adjuvant GM-CSF versus the GM-CSF adjuvant alone to reduce recurrence of breast cancer in early stage patients. The study found that those patients receiving AE37 who had the largest responses (requiring reductions in the amount of GM-CSF) had a relapse rate of 5.9% versus a rate of 14.2% in those who did not require dose reduction. This indicates that a robust stimulation of the immune system by AE37, as evidenced by the need for dose reduction, results in positive anti-cancer activity.

The AE37 vaccine is designed to activate critical components of the immune system to combat cancer cells. Prior analyses have shown a trend toward reduction of relapse in patients receiving the vaccine, particularly those who are not eligible for the cancer drug Herceptin as well as those with triple negative breast cancer. The current study correlates the extent of immune response with reduction in relapse. A priority in all forms of cancer immunotherapy today is in establishing means of identifying which patients are more likely to respond to treatment.

The current results add to prior studies both from the ongoing Phase II trial as well as a completed Phase I study of AE37 in patients with prostate cancer showing robust yet specific immunological responses together with almost negligible toxicity. The distinguishing feature of AE37 is its ability to specifically activate CD4+ T helper cells, which govern both the quality and magnitude of an immune response to a novel target. The correlation of a robust immune response with reduced relapse confirms the importance of this type of immunological activity in combating cancer.

Encouraging results from both the breast and prostate cancer trials of AE37 warrant further clinical development of AE37, both as mono- and/or combination therapy. The current study provides important biomarker information relevant to identifying those patients who may be expected to benefit most from AE37. Similarly, the information may help guide possible combination studies; i.e., using agents that may enable all patients to respond robustly to AE37 (e.g., checkpoint inhibitors).

On April 20, 2015 Medigene AG (MDG1, Frankfurt, Prime Standard) reported that early clinical data of its dendritic cell (DC) vaccines were presented today at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Philadelphia, USA (Press release, MediGene, APR 20, 2015, View Source [SID:1234506589]). The clinical data were collected in an ongoing compassionate use program[1] conducted at the Department of Cellular Therapy at the Oslo University Hospital, Norway, under the responsibility of Prof. Gunnar Kvalheim. The poster presentation titled "A new generation of dendritic cells to improve cancer therapy shows prolonged progression free survival in patients with solid tumors" provides data from patients with various types of tumour which were included in this program.

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In summary, one lung cancer patient, one prostate cancer patient, four glioblastoma patients and three acute myeloid leukaemia (AML) patients have started treatment with dendritic cells so far. The new generation of dendritic cells characterized by superior in-vitro functionality when compared to commonly used dendritic cells could be produced from cells of all patients, regardless of the type of malignancy. The included patients suffering from solid tumours clearly showed a longer progression free survival than could be expected according to the stage of their disease, except for the patient with prostate cancer, who due to personal reasons prematurely dropped out of the program. The three AML patients which were included in this dendritic cell compassionate use program have been showing a promising course of disease, however these cases are still too early for evaluation.

Conclusion of this evaluation by Prof. Gunnar Kvalheim, Head of Department of Cellular Therapy, Oslo University Hospital: "Solid tumour patients suffering from advanced disease treated with these DC vaccines have a prolonged progression free survival, showing that this immunotherapeutic approach will be a promising alternative to current standard therapies."

More detailed information can be found in the abstract under the following link: View Source;sKey=eae2d342-dd5a-41ba-9eb4-63990d3122b8&cKey=1ff23671-9f76-44fd-891b-50b8fbfdd1b6&mKey=19573a54-ae8f-4e00-9c23-bd6d62268424

The Oslo University Hospital has an agreement with Medigene for use of Medigene`s new generation DC vaccines for their ongoing academic clinical studies.

Prof. Dolores J. Schendel, Chief Scientific Officer of Medigene AG: "These positive results encourage us in pursuing our DC vaccine development program for which we have recently started our own clinical AML trial, complementing the ongoing academic clinical studies."

About Medigene’s DC vaccines: The platform for the development of new generation antigen-tailored DC vaccines is the most advanced platform of the three highly innovative and complementary immunotherapy platforms of Medigene Immunotherapies. The DC vaccines are currently being evaluated in a company-sponsored clinical trial in acute myeloid leukaemia (AML) as well as in two ongoing clinical investigator-initiated trials: a clinical phase I/II trial in AML at the Ludwig-Maximilian University Hospital Großhadern, Munich, and a clinical phase II trial in prostate cancer at the Oslo University Hospital. Moreover, a compassionate use program is being conducted at the Department of Cellular Therapy at the Oslo University Hospital.

Medigene’s dendritic cell product platform allows the design of new generation dendritic cell vaccines. Dendritic cells can take up antigens efficiently, process them and present them on their surface in a form that can induce antigen-specific T cells to proliferate and mature. This way T cells can recognize and eliminate antigen-bearing tumour cells. Dendritic cells can also induce natural killer cells (NK cells) to become active and attack tumour cells. Scientists of Medigene Immunotherapies have developed new, fast and efficient methods for preparing autologous (patient-specific) mature dendritic cells which have relevant characteristics to activate both T cells and NK cells. The dendritic cells can be loaded with various tumour antigens to treat different types of cancer and are designed for treatment of minimal residual disease or use in combination therapies.

On April 17, 2015 Panther Biotechnology, Inc. ( OTC PINK : PBYA ), a biotechnology company specializing in the development of enhanced therapeutics for the treatment of neoplastic disorders reported that it has entered into an exclusive global license agreement with the University of Rochester (Press release, Panther Biotechnology, APR 17, 2015, View Source [SID1234517371]).

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Under the terms of the agreement, Panther has licensed from the University of Rochester, the rights to develop and commercialize a first in class new chemical entity with demonstrated powerful anti-leukemia activity. The licensed compound, called TDZD-8, is a small molecule engineered to kill leukemic stem cells. TDZD-8 has demonstrated broad and selective in vitro activity against many different types of leukemia. In addition, TDZD-8 has no significant toxicity in normal hematopoietic stem cells. The license is based on the pending US patent 12/374,002, pending EU patent 07810619.2, issued Australia patent 2007275686, and issued New Zealand patent 574619, all filed under "Thiadiazolidinone Derivatives."

"Leukemia is thought to arise from malignant stem cells that are relatively resistant to current chemotherapy and likely contribute to disease relapse and progression. Therefore, the identification of drugs that can efficiently eradicate leukemia stem cells is an important priority," stated Craig T. Jordan, PhD., the University of Rochester Medical Center leading inventor. "We believe that TDZD-8 uses a unique and previously unknown mechanism to rapidly target leukemia cells, including malignant stem and progenitor populations."

Studies of TDZD-8 were performed to determine the effects on different types of leukemia cells taken from patients (AML, bcCML, CLL and ALL), and on normal blood cells as well. All forms of leukemia cells were strongly inhibited and induced to die by TDZD-8, however, there was minimal effect on normal blood cells. Further, TDZD-8 was submitted for screening against the NCI60 panel and found to be selectively cytotoxic to leukemia cells and cells from related diseases. The compound does not greatly impact tumors derived from non-blood tissues.

TDZD-8 is a kinase inhibitor and induces oxidative stress, causing its striking ability to induce the leukemia cells to die after less than 2 hours of exposure to the drug.

"This license agreement represents an opportunity to augment our chemotherapeutics portfolio with drugs aimed at survival extension and low toxicity with a cutting edge, cancer stem cell targeting drug," stated Evan Levine, Chief Executive Officer of Panther. "As we continue advancing our programs, we look forward to moving TDZD-8 into the clinic to target cancer stem cells and complement our other drugs that target the bulk tumor." Mr. Levine added, "Panther has now established a robust pipeline and is continuing its acquisition strategy with the goal of adding more advanced clinical stage products."

"Even as targeted agents and immunotherapeutic approaches come of age, chemotherapy remains a staple of a large number of effective cancer treatment regimens — and will remain so for a long time. Improving chemotherapy by adding new compounds such as Numonafide and TRF-DOX (transferrin-doxorubicin conjugate) to the clinical toolbox will undoubtedly improve patient outcome," stated Jayesh Mehta MD, Professor of Medicine and Director of Hematopoietic Stem Cell Transplantation at the Northwestern University Feinberg School of Medicine. "With our new collaboration with the University of Rochester, Panther is now looking into the future and we are excited to complement our growing pipeline with TDZD-8, which is a state-of-the-art compound directed at the leukemic stem cell. This type of drug will eventually change the way we treat patients and improve response rates."

On April 16, 2015 Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company") reported that it has filed an application for a patent (European Patent Office priority application: EP15000132) on a novel method of manufacturing zoptarelin doxorubicin, its hybrid cytotoxic molecule that is the subject of a pivotal ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 clinical study in women with advanced, recurrent or metastatic endometrial cancer who have progressed and who have received one chemotherapeutic regimen with platinum and taxane (either as adjuvant or first-line treatment) (Press release, AEterna Zentaris, APR 16, 2015, View Source;q=653 [SID:1234506590]). The claimed manufacturing process is expected to result in a significant reduction in the cost of goods sold, providing a stronger competitive position for the Company.

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Zoptarelin doxorubicin is a complex molecule that combines a synthetic peptide carrier with doxorubicin, a well-known chemotherapy agent. The synthetic peptide carrier is a Luteinizing Hormone Releasing Hormone ("LHRH") agonist, a modified natural hormone with affinity for the LHRH receptor. The design of the compound allows for the specific binding and selective uptake of the cytotoxic conjugate by LHRH receptor-positive tumors. Potential benefits of this targeted approach include a better efficacy and a more favorable safety profile with lower incidence and severity of side effects as compared to doxorubicin alone.

Because zoptarelin doxorubicin is a complex molecule, it is expensive to synthesize. The patent application, which is entitled "Enzymatic process for the regioselective manufacturing of N-Fmoc-doxorubicin-14-O-dicarboxylic acid mono esters", may, if granted, make it difficult for generic manufacturers to produce the compound on a financially feasible basis after the Company’s composition of-matter patent on zoptarelin doxorubicin expires.

David A. Dodd, Chairman and Chief Executive Officer of the Company explained the significance of the patent application for the new synthesis process: "We believe that zoptarelin doxorubicin has the potential to become the first approved therapy in the U.S. for treating women within the targeted Phase 3 indication, as well as additional cancers that we might evaluate in the future. Our commitment is to ensure that patients and their physicians have such therapies that can potentially improve and extend the quality of lives. With the 2015 expiration date of the U.S. composition-of-matter patent on the horizon, we sought a means to maintain our advantage for this compound beyond the five-year period of exclusivity granted to new chemical entities, which we expect to apply to zoptarelin doxorubicin. The compound could be a very important oncology tool if our ZoptEC Phase 3 study achieves its endpoints. By reducing the complexity of production and cost of the compound, we will have greater flexibility in potentially ensuring that patients on a worldwide basis have access and can benefit from this therapy. We believe this patent, if granted, could provide that advantage by giving us a significant production and cost advantage in support of further development in additional indications. Finally, we are most proud that this manufacturing process was invented by our colleagues within the Company’s Frankfurt-based research and development staff."

The Company owns all rights to the new process. The Company intends to file a PCT patent application in January 2016, claiming priority of the filed EP patent application.

About Zoptarelin Doxorubicin

Zoptarelin doxorubicin represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. Zoptarelin doxorubicin is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, resulting in a more targeted treatment with less damage to healthy tissue. The Company is currently conducting a ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer, while zoptarelin doxorubicin is also in an investigator-initiated Phase 2 trial in prostate cancer. Aeterna Zentaris owns the worldwide rights to this compound except in China. On December 1, 2014, the Company entered into a Master Collaboration Agreement, a Technology Transfer and Technical Assistance Agreement and a License Agreement with Sinopharm A-Think Pharmaceuticals Co., Ltd for the development, manufacture and commercialization of zoptarelin doxorubicin in all human uses in the Peoples Republic of China, including Hong Kong and Macau. Sinopharm A-Think is a subsidiary of Sinopharm, the largest medical and healthcare group in China and on Fortune’s Global 500 list.

About Endometrial Cancer

Endometrial cancer is the most common gynecologic malignancy in developed countries and develops when abnormal cells amass to form a tumor in the lining of the uterus. It largely affects women over the age of 50 with a higher prevalence in Caucasians and a higher mortality rate among African Americans. According to the American Cancer Society, there will be more than 54,000 new cases of endometrial cancer in the U.S. alone in 2015, with about 20% of recurring disease.

TapImmune has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, TapImmune, APR 15, 2015, View Source [SID1234503017]).

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