On September 2, 2019 Benelux’ largest biotech investor Aat van Herk commits a €20 million investment in diagnostics company SkylineDx after reaching major milestones in 2018, financing SkylineDx’ market potential of over $1 billion annually based on their current progress in the melanoma (skin cancer) field (Press release, SkylineDx, SEP 2, 2019, View Source [SID1234539178]). This melanoma test is discovered by a renowned US hospital and further optimized and developed by SkylineDx. Based on the unique combination of genetic information from the primary melanoma cells and other patient and tumor characteristics, the test is able to accurately predict the risk of having metastases present in the lymph nodes without having to undergo a surgery to remove (part of the) lymph nodes. Expert physicians estimate that up to 80% of these biopsies could be safely avoided as they turn out to have no sign of cancerous cells.

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"This capital commitment is a very significant call of confidence," says Dharminder Chahal, CEO SkylineDx. "With the financial requirements secured and Professor Alexander Eggermont on board as our medical advisor, we can initiate the necessary clinical studies in collaboration with expert physicians, patient associations and other stakeholders, in order to get this test from bench to bedside and reimbursed."

Professor Alexander Eggermont is the general director of cancer center Gustave Roussy in Paris and a highly respected expert physician in the melanoma space.

"It is a great feeling that our efforts are lining up, getting our dream – to improve a patient’s quality of life by enabling them to benefit from personal insights at the genetic level of their disease – within reach," concludes Dharminder Chahal.

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.

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 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 1, 2019 Clinigen Group plc (AIM: CLIN, ‘Clinigen’ or the ‘Group’), the global pharmaceutical and services company, and CHEPLAPHARM Arzneimittel GmbH (‘CHEPLAPHARM’), the family-owned pharmaceutical company based in Germany, have signed an exclusive distribution agreement for chemotherapy products Etopophos and Vepesid in Australia and New Zealand (Press release, Clinigen Healthcare, SEP 1, 2019, View Source [SID1234539174]).

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CHEPLAPHARM acquired the global rights to the products from Bristol-Myers Squibb (BMS) in August 2018. CHEPLAPHARM has global capabilities in manufacturing and distribution and will continue to supply and provide access to these medicines for patients. Clinigen has been appointed by CHEPLAPHARM to distribute Etopophos and Vepesid via the Group’s extensive infrastructure in Australia and New Zealand as part of CHEPLAPHARM’S network of exclusive cooperation partners.

Etopophos and Vepesid are etoposide products, a drug which is included on the World Health Organization Model List of Essential Medicines and is considered an essential medicine for priority diseases. Etopophos and Vepesid are currently approved for the treatment of:

Small Cell Lung Cancer – in combination with other approved chemotherapeutic agents as first-line treatment in patients with small cell lung cancer
Hodgkin’s Disease
Malignant (non-Hodgkin’s) lymphomas, especially of the histiocytic variety
Acute non-lymphocytic leukaemia
Testicular tumours in combination regimens for the treatment of refractory testicular tumours
Etopophos is also indicated as part of first-line combination regimens for the treatment of testicular tumours.

Benjamin Miny, Senior Vice President of Commercial Medicines, Clinigen Group, said:

"This agreement is in line with our in-licensing strategy in Commercial Medicines to focus on value-added oncology products and to partner with pharmaceutical companies to distribute and provide access to their products utilising our global infrastructure.

"CHEPLAPHARM is an important partner in Australia and New Zealand and these products are a fantastic fit for our portfolio. The agreement will provide healthcare professionals in the region with access to important treatments for their patients."