On December 16, 2019 Astellas Pharma Inc. (TSE:4503, Headquarters: Tokyo, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that it has commenced, through its indirect, wholly-owned subsidiary Asilomar Acquisition Corp. ("Asilomar"), a tender offer ("Tender Offer") for all of the issued and outstanding shares of common stock of Audentes Therapeutics, Inc. (NASDAQ: BOLD, Headquarters: San Francisco, Chairman and CEO: Matthew R. Patterson, "Audentes") for a price of US$60.00 per share, net to the seller in cash, on December 16, 2019, New York City time (Press release, Astellas, DEC 16, 2019, View Source [SID1234552380]). The Tender Offer is scheduled to expire at 12:00 midnight, New York City time, at the end of the day on January 14, 2020, unless extended or earlier terminated.

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The Tender Offer was commenced pursuant to the definitive agreement dated December 2, 2019, by and among Astellas, Asilomar and Audentes, and promptly upon successful completion of the Tender Offer, Asilomar will be merged into Audentes, with Audentes surviving the merger as a subsidiary of Astellas.

On December 15, 2019 N. N. The Alexandrov National Cancer Centre reported that begins phase II case-control clinical trial of its immuno-oncology agent, Elenagen (Press release, N N The Alexandrov National Cancer Centre, DEC 15, 2019, View Source [SID1234553262]). Inoperable late-stage cancer patients with triple-negative breast cancer, ovarian cancer, stomach cancer or prostate cancer will be randomized and then subsequently receive either standard chemotherapy or chemotherapy combined with Elenagen. For each disease, the experimental and control groups will be compared for time to disease progression, overall survival, as well as tumor regression and the dynamics of clinical conditions. One can also expect a reversal of a tumor grade to an operable stage, which would make the tumor surgically removable.

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"We have conducted a comprehensive worldwide search for the most promising adjuvants to standards of care and selected Elenagen", said prof. Oleg Sukonko MD, Ph.D., D.Sc., Head of the Alexandrov National Cancer Centre, "We assessed hundreds of potential products according to the following criteria: high safety as demonstrated in phase I/IIa clinical trial, encouraging first signs of synergistic effects with chemo-, radio- and immunotherapies, the economic feasibility of the future product and its accessibility for the healthcare system, and scientific novelty. Elenagen satisfied all of these criteria".

Elenagen was developed by, CureLab Oncology, Inc., a Boston-based biotech startup which provided the product to Belarussian colleagues. Aldevron, Inc. (Fargo, ND) was the contract manufacturer for the product. "Although in the coming year we are planning to start phase II clinical trials of Elenagen in breast and ovarian cancers in the US and multiple other countries, it was very important for us to begin with Belarus, the country which was the most hit by Chernobyl", said Dr. Alex Shneider, CEO of CureLab Oncology.

"We are very thankful to our colleagues from NYU and MD Andersen Cancer Centers who donated their ideas and expertise, went with us through multiple iterations of the clinical protocol, and helped to create the final version which we will now implement in our studies. Without their generous assistance and continuous expert support, we would not be where we are now", said prof. Sergey Krasny MD, Ph.D., D.Sc., deputy director of the Alexandrov National Cancer Centre and corresponding member of the Belarus National Academy of Science. The study is unanimously approved by the Belarus Ministry of Health. The team of clinical scientists conducting the trial in Belarus will maintain constant contact and consistently exchange information with their colleagues in the US, EU, and Israel serving as observers and scientific co-authors to the study.

On December 15, 2019 Ally Bridge Group ("ABG"), a leading global life science investment group, reported that it has announced that it recently led investments in three new medical technology companies (Press release, Ally Bridge Group, DEC 15, 2019, View Source [SID1234552379]). Each of the three companies is a commercial-stage, leading innovator re-setting the standard of care in its respective category. They include:

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Imperative Care (Campbell, CA) — A company that is singularly dedicated to improving the way stroke is treated by advancing medical technology, equipping healthcare providers to evolve best practices and elevate the standard of care for stroke patients. Imperative Care has received FDA approval for its first families of access and aspiration catheters. Website: View Source
Venclose Medical (Santa Clara, CA) — A commercial-stage company developing next-generation solutions for the treatment of venous reflux disease, also known as chronic venous insufficiency. Venclose has been commercializing in the US and Europe since 2018. Website: View Source
Mavrik Dental Systems (Tel Aviv, Israel) — A company with proprietary technologies and products for in-office teeth whitening with unparalleled efficiency and outcomes, and gum care. Mavrik represents ABG’s first investment in an Israel-based company. Website: View Source
"Medtech, as with biotech, remains a must-invest sector for ABG, where we focus on best-in-class technologies to disrupt current standards of care," said Frank Yu, CEO and CIO of Ally Bridge Group. "The closing of these investments brings the aggregate amount of ABG-led private life science investments to above $500 mm over the last 18 months, which include ABG’s lead role in investments in Grail (early cancer detection), Pulmonx (interventional pulmonology), Quantum Surgical (interventional oncology). All of these companies, with the exceptions of one in Israel and one in France, are based in Silicon Valley, California, USA."

"Our active investments that leverage powerful synergies across private and public markets, coupled with our M&A knowhow and cross-border value-add, position ABG uniquely as a leading investor in late-stage best-in-class life science technologies", adds Yu.

On December 13, 2020 Ultimovacs reported that the universal cancer vaccine UV1 will be investigated in a randomized, multi-center phase II trial in mesothelioma. The trial, named NIPU, investigates UV1 in combination with the checkpoint inhibitors nivolumab and ipilimumab as second-line treatment in mesothelioma. Oslo University Hospital (‘OUS’) is the sponsor of the study (Press release, Ultimovacs, DEC 13, 2019, View Source;lang=en-GB&companycode=no-ulti&v= [SID1234598614]). Bristol-Myers Squibb (‘BMS’) and Ultimovacs have entered into agreements with OUS to support the preparations and execution of the trial. A total of 118 patients will be included in the study. Half of the patients will be treated with the combination of UV1, nivolumab and ipilimumab, whereas the other half will receive nivolumab and ipilimumab only. The study is planned to be conducted at 6 hospitals in 5 countries (Norway, Sweden, Denmark, Finland, and Australia). The study is about to be initiated and patient inclusion is expected to start in Q1 2020. The primary endpoint of the trial is progression-free survival (PFS) and the PFS read-out is expected mid-2022. The necessary approvals from the Norwegian Medicinal Agency and the ethics committee in Norway are in place to initiate the trial. Ultimovacs will cover the costs associated with its participation in the study from existing funds. Dr. Åslaug Helland, Oslo University Hospital, principal investigator of the study, says: "We are enthusiastic about the initiation of this clinical trial which will be run with the support from BMS and Ultimovacs. Malignant pleural mesothelioma is the most common type of mesothelioma and is a disease with a high unmet medical need. The immunotherapy combination of nivolumab, ipilimumab and UV1 could represent a highly interesting treatment regime where the different mechanisms of action of the three drugs could provide synergistic effects that could be of clinical benefit to patients. " Øyvind Kongstun Arnesen, CEO of Ultimovacs, says: "We are pleased to take part in this exciting clinical trial with our universal therapeutic cancer vaccine, UV1. As we have previously seen, the combination of UV1 and ipilimumab provided rapid and durable immune responses in our phase I melanoma trial suggesting a synergistic immunological activity. The simultaneous administration of another checkpoint inhibitor, nivolumab, may further support the immune system’s ability to recognize and effectively kill the cancer cells. " The initiation of the NIPU trial brings UV1 in clinical investigation in its fourth cancer type to date. Previously, UV1 has been tested within prostate cancer, non-small cell lung cancer, and malignant melanoma. In Q1 2020, Ultimovacs expects to include the first of 154 patients in a randomized trial in malignant melanoma where UV1 is combined with nivolumab and ipilimumab. Øyvind Kongstun Arnesen, CEO of Ultimovacs, adds: "The fact that UV1 will be investigated in two large randomized clinical trials in different cancer types and with a total of 272 patients is a major step forward for Ultimovacs and the development of UV1. This will enhance the opportunities for successful clinical results in an additional cancer indication and support that UV1 may be broadly applicable across cancer types." About NIPU NIPU is an investigator-initiated, Oslo University Hospital sponsored, randomized, multi-center, open-label, proof of concept study comparing the efficacy and safety of nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) with and without UV1 in patients with inoperable malignant pleural mesothelioma (MPM) who have progressed after first-line platinum-based chemotherapy. Biological material will be sampled, and there will be several explorative analyses aiming at identifying biomarkers and revealing mechanisms of action. In total, 118 patients will be randomized into two patient groups treated with ipilimumab and nivolumab with or without UV1 together with sargramostim (GM-CSF) as vaccine adjuvant. The objective of the study is to induce a meaningful progression-free survival (PFS) benefit in patients with MPM after progression on first-line standard platinum doublet chemotherapy. The study sites are planned to be Oslo University Hospital in Norway, Karolinska University Hospital and Skåne University Hospital Lund in Sweden, Rigshospitalet in Denmark, Helsinki University Hospital in Finland, and Sir Charles Gairdner Hospital in Perth, Australia. About Malignant Pleural Mesothelioma Malignant pleural mesothelioma (MPM) is a rare malignant tumor originating from the cells lining the mesothelial surface in the lungs. MPM is the most common type of mesothelioma and is a disease with a high unmet medical need with a median overall survival of approximately 1 year. Most patients are treated with palliative chemotherapy. Patients with disease progression after first-line therapy have few therapeutic options. Asbestos exposure is heavily linked to the development of the disease. It may take 10-50 years for symptoms of mesothelioma to manifest after initial asbestos exposure. Even though the use of asbestos to a large extent is banned today, new incidences of mesothelioma will continue to be a medical challenge for decades. About Ipilimumab Ipilimumab is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Ipilimumab binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. About Nivolumab Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, nivolumab has become an important treatment option across multiple cancers. About UV1 UV1 is a peptide-based vaccine inducing a specific T cell response against the universal cancer antigen telomerase. UV1 is being developed as a therapeutic cancer vaccine which may serve as a platform for use in combination with other immunotherapy which requires an ongoing T cell response for their mode of action. With its mechanism of action, UV1 is potentially a universal cancer vaccine that can be applied across most cancer types.

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On December 13, 2019 Susan G. Komen, the world’s leading breast cancer organization, reported the results of the INFORM trial that were announced at the 2019 San Antonio Breast Cancer Symposium (Press release, Susan G Komen, DEC 13, 2019, View Source [SID1234552378]). The Komen-funded INFORM trial led by Dr. Nadine Tung shows that HER2-negative patients with a BRCA1/2 gene mutation have multiple effective treatment options.

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Dr. Tung and colleagues sought to determine if cisplatin chemotherapy is a more effective treatment than the current, standard of care treatment, chemotherapy with doxorubicin and cyclophosphamide (commonly referred to as "AC"). Prior retrospective studies, which looked at treatment that has already occurred as part of the study, had indicated that cisplatin chemotherapy might work better than AC. The INFORM clinical trial was the first prospective study, or a study that evaluates treatment moving forward, to actually test this idea.

"For HER2-negative breast cancer patients with BRCA1/2 mutations, the INFORM trial confirmed that cisplatin chemotherapy is not more effective than standard chemotherapy with doxorubicin and cyclophosphamide. The results suggest that BRCA carriers may respond to both types of chemotherapy – which kill cancer cells by damaging DNA – giving them multiple options to treat their cancer," said Dr. Tung. Prospective studies are essential for improving clinical practice.

She added, "Funding from Susan G. Komen was essential for this work." Funded in part by a Komen Opportunity Grant, the INFORM trial is also part of the Translational Breast Cancer Research Consortium (TBCRC), which has been supported by Komen for more than 10 years.

Victoria Wolodzko, senior vice president of Mission at Susan G. Komen, added, "Patients with BRCA mutations face many challenges, especially those in rural or underserved areas. This work confirms that physicians have more options for these patients. Patients won’t need to wait for a specific treatment to ensure they are getting the best care no matter where they live."