On April 21, 2015 Blend Therapeutics, Inc., a biopharmaceutical company discovering and developing two distinct classes of targeted anti-cancer medicines to advance the treatment of patients with solid tumor cancers, presented preclinical data today on BTP-114, a novel personalized cisplatin prodrug, with demonstration of improved and sustained tumor growth inhibition in preclinical models as compared to the conventional platinum cytotoxic cancer drug, cisplatin (Press release, Tarveda Therapeutics, APR 21, 2015, View Source [SID:1234508888]). Results from preclinical studies were presented in a poster entitled "BTP-114: An albumin binding cisplatin prodrug with improved and sustained tumor growth inhibition" at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Philadelphia, Penn.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BTP-114 is Blend’s lead product candidate for which the company plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration in Q2 2015. Once administered, BTP-114 rapidly conjugates to serum albumin in blood with a high degree of specificity, and is preferentially taken up by cancer cells with certain molecular profiles, resulting in enhanced DNA damage and cell death.

"We are excited by the novel mechanism of action of BTP-114 that leverages our growing understanding of disregulated cancer metabolism and the molecular underpinning of cancers, enabling the development of the first personalized platinum marking a major advance in the field of platinum anti-cancer agents," said Richard Wooster, PhD, President of Research and Development of Blend. "Designed to overcome limitations of conventional platinum therapies which are the largest class of oncology drugs today, BTP-114 has the potential to increase the proportion of patients who respond and their duration of response to platinum-based therapies."

The data presentation at AACR (Free AACR Whitepaper) describes BTP-114’s novel mechanism as a platinum prodrug of cisplatin that covalently attaches to serum albumin in the blood giving a 15-fold increase in exposure and a predicted human plasma half-life of 10 days. The therapeutic dose of platinum was increased by up to 2-fold, resulting in a 15-fold increase in platinum accumulation in multiple xenograft models. BTP-114 was shown to improve efficacy in models of lung and ovarian cancer compared to cisplatin, while reducing key dose limiting toxicities of cisplatin.

BTP-114 was developed by researchers at Blend Therapeutics and builds on the breakthroughs in platinum chemistry pioneered by the company’s scientific co-founder, Professor Stephen J. Lippard of Massachusetts Institute of Technology (MIT).

About Blend Therapeutics

Blend Therapeutics, Inc., is a biopharmaceutical company discovering and developing two distinct classes of targeted anti-cancer medicines to advance the treatment of patients with solid tumor cancers. Blend’s pipeline includes its lead drug candidate, BTP-114, a novel, personalized cisplatin prodrug derived from the company’s R&D heritage in platinum drugs, as well as BTP-277 and other novel drug conjugates from the company’s proprietary Pentarin platform. Blend’s first Pentarin drug candidate, BTP-277, represents the proprietary components of Blend’s miniaturized biologic drug conjugate (mBDC) technology – a novel targeting ligand conjugated to a potent cell-killing agent with a chemical linker – incorporated into nanoparticles to enable the penetration of the conjugates deep in to the tumor tissue where they selectively bind to tumor cells. Blend’s strategy includes developing its own proprietary Pentarins as well as applying the Pentarin platform to enhance the therapeutic capabilities of the targeting protein scaffolds or payloads of pharmaceutical collaborators.

The company was founded by three leaders in the fields of chemistry and nanomedicine from the Brigham and Women’s Hospital (BWH)–Harvard Medical School (HMS), and Massachusetts Institute of Technology (MIT): Dr. Omid Farokhzad of BWH–HMS, and Dr. Robert Langer and Dr. Stephen J. Lippard of MIT. Blend has attracted top-tier investors including Eminent Venture Capital, Flagship Ventures, NanoDimension, and New Enterprise Associates.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!