On September 3, 2019 Physicians’ Education Resource (PER), a worldwide leading resource for continuing medical education, reported that it will present the 4th Annual International Congress on Immunotherapies in Cancer: Focus on Practice-Changing Application on Saturday, Dec. 14, at the InterContinental New York Times Square in New York City (Press release, Physicians’ Education Resource, SEP 3, 2019, View Source [SID1234539237]).

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The program will be co-chaired by Naiyer A. Rizvi, M.D., professor of medicine; director, thoracic oncology; co-director, cancer immunotherapy program; and the Price Family Professor of Medicine, Columbia University Medical Center; and Mario Sznol, M.D., professor of medicine; leader, melanoma disease related translational team; co-director, YALE SPORE in skin cancer; and co-director, cancer immunology program, Yale Cancer Center.

"We look forward to this year’s International Congress on Immunotherapies in Cancer," said Phil Talamo, president of PER. "This annual educational program brings together oncologists, nurses and pharmacists to highlight the fundamental principles and pivotal advancements within the past year surrounding the evolving role of immunotherapies and their role in cancer treatment."

The 4th Annual International Congress on Immunotherapies in Cancer is a one-day interactive program that will provide attendees with a comprehensive review of the key data sets that are most relevant to the application of these novel strategies for the clinician who manages some of the most difficult-to-treat forms of cancer. Top experts will lead discussions that focus on the practical application of recent clinical trial results that have shaped current and evolving clinical management, evolving biomarker information, the latest basic science findings and the most highly anticipated clinical trials in the field. As an exciting, fast-paced congress, this meeting will provide a multimodule, curriculum-based program that focuses exclusively on immunotherapies and their application to the management of cancer.

On September 3, 2019 Kitov Pharma Ltd. ("Kitov") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported that Isaac Israel, CEO, and Gil Efron, Deputy CEO and CFO, will participate in the H.C. Wainwright 21st Annual Healthcare Conference that is being held in New York on September 8-10, 2019 (Press release, Kitov Pharmaceuticals , SEP 3, 2019, View Source [SID1234539254]).

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Mr. Israel will provide an overview of Kitov’s business strategy and pipeline during the live presentation. They will also participate in one-on-one meetings with investors who are registered to attend the conference.

Details of presentation are as follows:

H.C. Wainwright Annual Healthcare Conference

Presentation Date: September 10, 2019

Presentation Time: 12:05 p.m. – 12:30 p.m. ET

Location: Lotte New York Palace Hotel, New York, USA

The updated Kitov corporate presentation will be made available on the "Investor Relations" section on the Kitov website at View Source

On September 2, 2019 RIKEN (President: Hiroshi Matsumoto, Ph.D.) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that they have entered into a worldwide licensing agreement for the research, development and commercialization of cell therapy formulations applying RIKEN’s artificial adjuvant vector cell ("aAVC") technology in oncology (Press release, Astellas, SEP 2, 2019, View Source [SID1234539175]).

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Based on the agreement, Astellas has acquired the rights for the research, development and commercialization of cell therapy formulations applying RIKEN’s aAVC technology that targets selected cancer antigens. RIKEN retains the rights for the use of aAVC technology in the research, development and commercialization of cell therapy formulations etc. for antigens not covered by the agreement and the non-profit academic research. Astellas will make an upfront payment of 1 billion yen to RIKEN. Astellas may also make milestone payments depending on achievement of development and commercialization milestones, as well as royalty payments on any future product sales.

Both parties have been conducting the collaboration research for cell therapy formulations applying the aAVC technology. Astellas is currently proceeding with several programs gained through the collaboration research. Among them, the most progress has been made with ASP7517, an aAVC formulation loaded with WT1, an antigen highly expressed in patients with acute myeloid leukemia (AML) and other cancers. It is currently in the phase I/II clinical development stage for AML and myelodysplastic syndrome.

Cancer immunotherapy attacks cancer cells by activating immune systems, which are the defense mechanisms of the body. There are two types of immune systems: "innate immunity" that attacks cancer cells non-specifically in the early stage, and "adaptive immunity" that attacks cancer cells in an antigen-specific manner. Many conventional cancer immunotherapy agents exert their effects through activation of either innate or adaptive immunity. Among them, cancer peptide vaccines attack cancer cells by activating adaptive immunity. aAVC formulations contain modified human cells to which glycolipids and cancer antigens are loaded. The glycolipids activate innate immunity via natural killer T cells and the cancer antigens induce antigen-specific T cells to activate adaptive immunity, thus it is expected that aAVC could effectively attack cancer cells by activating both innate immunity and adaptive immunity. In addition, long-lasting anti-tumor effects can be expected by inducing antigen-specific memory T cells. These multiple immune activations depend on the full activation of dendritic cells (DCs) in the body.

In addition, the action of cancer peptide vaccines varies depending on patient’s human leukocyte antigen (HLA) types. The HLA type is a biological system to distinguish between self and non-self. Cancer peptide vaccines are applicable for patients with specific HLA types. On the other hand, aAVC loaded with full-length cancer antigens are applicable for many patients regardless of their HLA types.

The aAVC technology was developed by Shinichiro Fujii, M.D., Ph.D., Deputy Program Director, RIKEN Program for Drug Discovery and Medical Technology Platforms, RIKEN Cluster for Science, Technology and Innovation Hub, and Team Leader, Laboratory for Immunology, RIKEN Center for Integrative Medical Sciences. Regarding the collaboration, he said, "aAVC is a new type of unique cell therapy formulation with a different mechanism of action from previous immunotherapy agents. This press release states that we have transferred our aAVC technology to Astellas and advanced the technology to the clinical development stage. As a medical researcher, I have been aiming at delivering basic science to clinical research. I think this project is another bridge from academia to industry. We can also say that it has opened the new door in the development of immune cell-based agents in industry-academia collaboration originating in Japan."

"aAVC is a cell therapy technology that treats cancers based on activation of the immune system and has the potential as a new cancer immunotherapy platform. Astellas is committed to exploring all types of partnership opportunities to turn cutting-edge science and technological advances into VALUE for patients," said Naoki Okamura, Representative Director, Corporate Executive Vice President and Chief Strategy Officer, Astellas. "Going forward, we will press ahead with research and development in aAVC programs that may produce potential new therapies meeting the unmet medical needs of cancer patients around the world."

The impact of this agreement on Astellas’ financial results in the fiscal year ending March 31, 2020 will be limited.

On September 2, 2019 Xynomic Pharmaceuticals Holdings, Inc. ("Xynomic", stock ticker: XYNO), a clinical stage US-China oncology drug development company, reported encouraging interim data from an ongoing Phase 1b study of its lead candidate abexinostat, an orally dosed, hydroxamic acid-based small molecule histone deacetylase ("HDAC") inhibitor , in combination with Keytruda, for the treatment of multiple solid tumors (Press release, Xynomic Pharmaceuticals, SEP 2, 2019, http://xynomicpharma.com/en/xynomic-pharma-reports-encouraging-interim-data-from-phase-1b-study-of-abexinostat-combined-with-keytruda-in-multiple-solid-tumors/ [SID1234539176]). The trial is being conducted at University of California, San Francisco. The interim data will also be presented at the 3rd World-China Immunotherapy & Gene Therapy Congress 2019 to be held in Beijing from August 30th to 31st, 2019.

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This Phase 1b trial explores abexinostat in combination with pembrolizumab (trade name Keytruda) to treat patients with prior progression on Keytruda or other immune checkpoint inhibitor treatments. A total of 7 patients with prior progression on anti-PD1/PD-L1 treatment were enrolled in the Dose Escalation portion of the study. Tumor types included melanoma (N = 3), urothelial carcinoma (N = 2), neuroendocrine carcinoma (N = 1), and esophageal squamous cell carcinoma (N = 1). The median number of lines of prior systemic therapy was 3. Median age of patient population was 61. In the two dose levels tested (abexinostat 30 mg/m2 and 45 mg/m2 on days 1-4, 8-11 in combination with pembrolizumab 200 mg IV on day 1), there were no dose-limiting toxicities. The maximally tolerated dose was not reached, and the recommended Phase 2 dose is abexinostat 45 mg/m2 BID on days 1-4, 8-11 of a 21 day cycle in conjunction with pembrolizumab 200 mg IV on day 1. There were no treatment-related grade ≥ 3 or serious adverse events. The most common Grade 1-2 adverse events were diarrhea (N = 3), rash (n = 2), thrombocytopenia (n = 1), and dysgeusia (n = 1). 2 out of 7 patients (29%) experienced stable disease for > 6 months. 1 of these 2 patients has pembrolizumab-refractory urothelial carcinoma and remains on treatment for 6+ months with ongoing 20% reduction in tumor size from baseline.

Enrollment in Dose Expansion portion of this trial is ongoing to ascertain the response rate and disease control rate across tumor types. The trial is targeting to enroll a total of approximately 42 patients in the U.S.

"Abexinostat is known mechanistically to have potential synergy with immune checkpoint inhibitors. We are very pleased with the interim data reported today by UCSF, a world leader in solid tumor clinical research. The data reported today indicate the combination of abexinostat with Keytruda could be safe and well tolerated and there is preliminary evidence demonstrating efficacy and the potential to reverse resistance to immune checkpoint blockade. We expect to report additional data at a scientific conference early next year." Mr. Y. Mark Xu, Chairman and CEO of Xynomic commented.

On September 2, 2019 ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, and DuChemBio Co, Ltd. (DCB), a leading Korean radiopharmaceutical company, reported the conclusion of an exclusive licensing and development agreement for Solucin Targeted Radionuclide Therapy (TRT) in South Korea (Press release, ITM Isotopen Technologien Munchen, SEP 2, 2019, View Source [SID1234539177]). The agreement sets out terms concerning the local development, registration and subsequent commercialization by DCB of ITM’s proprietary brand Solucin for Targeted Radionuclide Therapy (TRT) in South Korea. Solucin patient doses will be manufactured and exclusively supplied to DCB by ITM.

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Within the framework of this collaboration, DCB and ITM plan to initiate a local clinical study for ITM’s Solucin TRT which is expected to begin recruiting patients in 2020. The study concept is based on ITM’s Phase III clinical trial COMPETE, which has recently seen a considerable increase in patients as a result of strong recruitment in the United States in particular. COMPETE involves 42 leading cancer centers in 12 countries, predominantly in Europe, North America, South Africa and Australia.

The COMPETE clinical trial is an international multi-center phase III clinical study evaluating the efficacy and safety of Targeted Radionuclide Therapy with no-carrier-added Lutetium-177-Edotreotide (Solucin). Its aim is to compare Solucin to Everolimus in patients with inoperable, progressive, somatostatin-receptor positive neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET). The study’s primary endpoint is progression-free survival (PFS).

"We are very excited about our partnership with DuChemBio," said Steffen Schuster, CEO of ITM. "The strong growth in patients recruited for our phase III clinical trial COMPETE in the recent months emphasizes the demand for effective treatment options for GEP-NET patients worldwide. In DCB we have found a reliable partner that is as committed as we are, to improving the outcome and quality of life for cancer patients. Together we want to establish Targeted Radionuclide Therapy as an alternative for cancer patients in South Korea."

"Duchembio is delighted to enter this partnership with ITM as a next step to expand our product portfolio into the Theranostics domain" said Jong-Woo Kim, President and CEO of DCB. "Whilst Duchembio – via its Nuc. Med. customers across the country – already supports the diagnosis of GEP-NET patients by means of PET imaging, the inclusion of an innovative radioligand therapy like Solucin TRT in DCB’s portfolio now provides a comprehensive solution for Korea’s leading cancer centers to manage GEP-NET patients."

Solucin is a TRT agent, which consists of the targeting molecule Edotreotide, an octreotide-derived somatostatin analogue and ITM´s EndolucinBeta (n.c.a. 177Lu). The radiopharmaceutical is administered as an intravenous infusion, specifically targeting and destroying the tumor cells in-situ with ionizing radiation.

In South Korea some 400-450 patients are diagnosed with GEP-NET every year. Treatment options are limited and Solucin PRRT will offer an alternative to patients with inoperable and progressive disease. DCB also intends to initiate a Compassionate Use Program (CUP) during the phase II local clinical trial to make Solucin TRT patient doses available to additional Korean patients suffering from GEP-NET.