On May 14, 2021 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs ("Regulus"), reported that Jay Hagan, President and Chief Executive Officer of Regulus, will present at the Oppenheimer Rare & Orphan Disease Summit on Friday, May 21, 2021 at 11:35 A.M. ET (Press release, Regulus, MAY 14, 2021, View Source [SID1234580022]).

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A live webcast of the presentation will be available on the investor relations section of the Company’s website at www.regulusrx.com. A replay of the webcast will be archived for 30 days following the presentation date.

On May 14, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and the National Cancer Center Japan (Headquarters: Tokyo, President: Hitoshi Nakagama, "National Cancer Center") reported that both parties have entered into a joint research and development (R&D) agreement concerning "Basic research on the drug discovery and development to accelerate development of anticancer drugs in treatment of patients with rare cancers and refractory cancers", and that research activities have commenced (Press release, Eisai, MAY 14, 2021, View Source [SID1234579977]). This R&D project is to be carried out with funding under the program "Cyclic Innovation for Clinical Empowerment (CiCLE)" established by the Japan Agency for Medical Research and Development (AMED).

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Rare cancer is a disease for which it is difficult for pharmaceutical companies to develop new drugs solo due to the extremely small number of patients, and there are only a limited number of drugs for rare cancers that can be approved for manufacturing and marketing. Also, among certain types of cancer with a large number of patients, refractory cancers, for which standard treatment has not been established, face barriers to creating new drugs due to difficulty of research and development. In order to promptly deliver effective treatments to patients with rare or refractory cancers, it is essential to provide predictability of clinical outcomes with high accuracy and efficiency in non-clinical research that confirms in advance the effectiveness of the drug, to transfer seamlessly non-clinical research to clinical studies, and moreover to elucidate the mechanism of drug resistance, actual therapeutic effects and side effects. Both parties aim to realize these capabilities in this R&D project using Patient-Derived Xenografts (PDX) library, a model in which cancer tissue derived from patients is transplanted into immunodeficient mice with high predictability of clinical outcomes, as well as cancer genome data.

Eisai is advancing the research and development of new anticancer drugs, targeting cancer genomics and the tumor microenvironment, with its experience and knowledge from globally approved in-house discovered compounds: microtubule dynamics inhibitor eribulin mesylate (product name: Halaven) and multiple receptor tyrosine kinase inhibitor lenvatinib mesylate (product names: Lenvima).

The National Cancer Center is a leading institution in basic research, epidemiological research, and clinical studies for all cancer types including rare cancers in Japan. As of May 2020, with a grant from AMED CiCLE, the National Cancer Center has established a large-scale PDX library,"J-PDX", derived from Japanese cancer patients with information on clinical outcomes, and has also completed the development of research infrastructure and framework. More than 410 types of PDX, including rare cancers and refractory cancers, have already been established in J-PDX (as of March 2021).

In research and development under the agreement, Eisai and the National Cancer Center will jointly conduct tumor-agnostic non-clinical research on new drug candidates created by Eisai, using J-PDX with relevant clinical and biological information, and will determine the drugs and the target cancer types to be transferred to clinical studies. After that, investigator-initiated studies will be conducted for rare cancers and refractory cancers in order to confirm clinical benefits of these new drugs, with the aim to apply for approval of them. Further, both parties will consider expanding into new drug discovery research, with establishment of PDX with tumor tissues taken from patients before and after treatment, comparative analyses of drug responsiveness and cancer genome, as well as search for new drug discovery targets and elucidation of drug resistance mechanisms. Through these efforts, both parties aim to establish a drug discovery and development research system that accelerates the development of new anticancer drugs in Japan.

Through research and development based on the agreement, Eisai and the National Cancer Center will work to develop therapeutic drugs for rare cancers and refractory cancers with high unmet medical needs, thereby aiming to make continuous efforts to meet the diversified needs of and increase the benefits provided to patients with cancer, their families, and healthcare professionals.

On May 14, 2021 Fresenius Medical Care, the world’s leading provider of products and services for individuals with renal diseases, reported that it has agreed to issue bonds with an aggregate principal amount of USD 1.5 billion across two tranches (Press release, Fresenius, MAY 14, 2021, View Source [SID1234579978]):

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USD 850 million bonds with a maturity in December 2026 and an annual coupon of 1.875% and
USD 650 million bonds with a maturity in December 2031 and an annual coupon of 3.000%.
The proceeds will be used for general corporate purposes, including the refinancing of outstanding indebtedness.

The expected settlement date is May 18, 2021.

On May 14, 2021 Southern Research, the groundbreaking scientific discovery and research institution headquartered in Birmingham, on Thursday reported that its board of directors has appointed Josh Carpenter, Ph.D., as its new president and CEO, and Allen Bolton as its new executive vice president for Strategy and Finance (Press release, Southern Research Institute, MAY 14, 2021, View Source [SID1234580024]).

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Both appointments are effective June 1.

Founded in the Magic City in 1941, Southern Research is an independent, non-profit scientific research organization where more than 400 scientists and engineers work across three divisions: Life Sciences, Engineering, and Energy & Environment. Southern Research has attracted national research partnerships with leading industries in the fields of pharmaceuticals, biotechnology, defense, aerospace, the environment and energy.i

"Josh and Allen are forward-thinking leaders who are ready to chart a bold new course for Southern Research," stated University of Alabama at Birmingham President Ray L. Watts, who is chairman of the Southern Research board of directors. "They have the full support of the Board as they begin to lead an amazing team of scientists, engineers and innovators who are working to solve problems and change the world for the better."

Southern Research generates over $150 million in annual economic impact and supports more than 1,000 Alabama jobs.

"The work of Southern Research results in life-changing advancements and innovative solutions," said Southern Research board member Mark Crosswhite, who also serves as the chairman, president and CEO of Alabama Power Company. "Josh and Allen’s vision and expertise will play an important role in leading this institution forward as a continued center of excellence."

Carpenter most recently served as director of Innovation and Economic Opportunity for the City of Birmingham, where he led the City’s efforts in workforce development, COVID recovery and business expansion. Previously, he served as the director of External Affairs at UAB. He earned his doctorate in political economy from the University of Oxford where he studied on a Rhodes Scholarship.

"I am truly honored to take the helm of Southern Research and lead this incredible team that is finding solutions to improve people’s lives around the world. Southern Research has had 80 successful years, but I know the best is yet to come," commented Carpenter.

Bolton most recently served as senior vice president for Finance and Administration at UAB, where he was also a member of the board for Southern Research. He was previously an executive in finance and strategy at the Medical College of Wisconsin, and was senior associate dean for Administration and Finance at the UAB School of Medicine as well as executive administrator at the Comprehensive Cancer Center, the largest research center in the University of Alabama System.

"Discoveries made at Southern Research have provided breakthroughs in cancer research, pushed the boundaries of science and saved lives. I am grateful for this opportunity to work alongside dedicated and talented people who have an unmatched passion for science and discovery," concluded Bolton.

On May 14, 2021 Genenta Science, a clinical-stage biotechnology company pioneering the development of an investigational hematopoietic stem progenitor cell immuno-gene therapy for cancer (Temferon), reported that it will present new clinical data from a Phase I/IIa study of Temferon in patients affected by glioblastoma multiforme (GBM) in an oral presentation at the 2021 American Society for Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, taking place virtually on May 11-14, 2021 (Press release, Genenta Science, MAY 14, 2021, View Source [SID1234579979]).

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The data presented at ASGCT (Free ASGCT Whitepaper) are from Genenta’s ongoing trial of Temferon in patients with GBM. The presentation focuses specifically on patients who have undergone a follow-up surgical procedure for their cancer. In addition to being a treatment option, follow-on surgery provides investigators with an opportunity to understand the impact of therapies at a cellular and molecular level.

The ASGCT (Free ASGCT Whitepaper) presentation shows that genetic markers of Genenta’s Temferon were detectable in tumor specimens from all four patients with progressive disease who underwent follow-on surgery. Furthermore, the expression of interferon- (IFN) responsive gene signatures in those tumors was increased compared with pre-treatment levels, which suggests that interferon-α (IFN-α) had been released locally in the tumor by cells derived from Genenta’s investigational treatment.

Carlo Russo, Chief Medical Officer at Genenta Science, said: "These preliminary results provide exciting indications that Temferon acts in the way we anticipated even in the relatively inaccessible setting of glioblastoma multiforme. The data are encouraging and in line with our pre-clinical results, with early evidence that Temferon delivers biological effects that may impact the progression of individual lesions."

One of the four patients had two lesions removed at the second surgery; one was a prior lesion that had not been removed during the first surgery and was stable; the other was a relapsing progressing lesion that had developed at the first surgery site. Compared with the progressing tumor, the stable lesion displayed a higher proportion of T cells and Tie2 Expressing Monocytes (TEMs) within the myeloid infiltrate and had a higher IFN-response signature.

The data presented at ASGCT (Free ASGCT Whitepaper) also supported the initial safety and tolerability profile of Temferon. Concentrations of IFN-α in the plasma and cerebrospinal fluid of patients remained low, while IFN-α responses were identified in myeloid cells that infiltrate tumors. Temferon-derived differentiated cells also persisted in peripheral blood and bone marrow for up to 18 months at lower levels, indicating the potential durability of the intervention. No dose limiting toxicities have been identified.

Presentation Details:

Title: Changes in the Tumor Microenvironment in Patients with Glioblastoma Multiforme Treated with IFN-a Immune Cell & Gene Therapy (TEM-GBM_001 Study)

Time: Friday May 14, 2021 at 1.30 PM Eastern Time (7.30 PM CET)

Presenting: Carlo Russo, CMO