Notice of FY2021 Year-End Dividend

On April 19, 2022 Kureha Corporation reported that it has resolved at its board of directors meeting held today to pay the following dividend to shareholders held in record as of March 31, 2022 (Press release, Kureha Corporation, APR 19, 2022, View Source [SID1234612468]).

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1. Details of dividend payment
2. Reasons behind the decision regarding dividend payment

Kureha’s basic policy regarding dividend distribution is to pay a steady dividend to shareholders over a long period of time, while strengthening the Company’s financial structure to sustain long-term growth and future business development.

With this policy in mind, Kureha has decided to raise its yearly dividend for the fiscal year ended March 31, 2022 (FY2021) in view of expected year-on-year increases in revenue and operating profit. We will therefore pay a year-end dividend of 125 yen per share, a 40 yen increase from the previous year’s, as we recently announced.

[Reference] Recent dividend payments

Labcorp Enhances Cell and Gene Therapy Development Support Through Collaboration With Xcell Biosciences

On April 19, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported that collaborating with Xcell Biosciences, Inc. (Xcellbio), a leading developer of cell and gene therapy technologies, to advance critical work that helps clients effectively bring innovative cell and gene therapies to market (Press release, LabCorp, APR 19, 2022, View Source [SID1234612487]).

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Through their collaboration, Labcorp and Xcellbio will work on a series of projects focused on improving the safety and efficacy of cell and gene therapies (CGTs). This strengthens Labcorp’s commitment to growing its global, comprehensive suite of CGT capabilities, and it supports pharmaceutical and biotechnology companies’ efforts to expedite therapeutic development.

"Labcorp is firmly committed to helping our clients bring new treatment options to patients in need while revolutionizing the future of medicine with cell and gene therapies," said Dr. Maryland Franklin, vice president and enterprise head of cell and gene therapy at Labcorp. "By pairing the scale and breadth of our enterprise-wide CGT solutions with Xcellbio’s powerful technology, we have an opportunity to enhance and accelerate the CGT development experience. It’s another way Labcorp is carrying out its mission to improve health and improve lives."

CGTs modify a person’s genes to treat disease by inactivating or replacing a disease-causing gene, or introducing a new or modified cell or gene. CGTs are being tested for use in the treatment of many diseases, including Parkinson’s disease, an array of rare diseases, and both solid tumors and blood-based cancers. The projects included in the collaboration will use Xcellbio’s AVATAR incubator system to grow and expand research-grade CAR-T cell material used to attack cancer cells. This work helps demonstrate the power of understanding the parameters of the tumor microenvironment in the creation of CAR-T cells with improved performance. In addition, the technology will be used to acclimate cancer cells to more physiologic conditions and expand 3D modeling for in vitro CAR-T testing.

"We’re continuously striving to advance cell and gene therapy development through technology innovations that enable the precise control of cell populations to enhance the potency and persistence needed for optimal patient outcomes," said Brian Feth, CEO of Xcellbio. "The exciting projects we’re undertaking with Labcorp allow our shared clients to harness the institutional knowledge and resources of a global organization to craft innovative approaches to develop potentially curative treatments."

The collaboration—the latest in Labcorp’s string of recent CGT-focused relationships—follows the company’s strategic investment in Xcellbio in November 2021. It also underscores Labcorp’s efforts to address the unique needs of complex CGT development through industry connectivity. Labcorp is committed to enhancing its CGT solutions across the entire development continuum through investments in its people, operations and technology, and through external collaborations.

Labcorp is offering clients access to a dedicated team of CGT leaders with deep expertise in all aspects of the development process. Clients are further supported by a multi-disciplinary group of operational, medical and regulatory members from across the enterprise, providing comprehensive and strategic insights that enable increased efficiency and reduced risk through critical development milestones.

With more than 20 years of experience in delivering development solutions for advanced therapies such as CGT products, Labcorp employs a personalized approach to bring clients customized solutions on a global scale. These range from preclinical discovery and development to comprehensive clinical trials and commercialization services. The company has helped support the development of all six U.S. Food and Drug Administration (FDA)-approved CAR-T cell therapies, as well as both FDA-approved gene replacement therapies.

Learn more about Labcorp’s CGT capabilities and the collaboration with Xcellbio during an upcoming thought leadership workshop, "Strategies and Approaches to Optimize Your Non-clinical and Clinical Development for Cell and Gene Therapies," to be held on Monday, May 16, 2022, during the annual meeting of the American Society of Gene and Cell Therapy. More information is available here.

PharmaCyte Biotech Announces More Positive Tests Results for Its Pancreatic Cancer Clinical Trial Product Candidate to Satisfy FDA Requirements

On April 19, 2022 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that the empty capsule material that comprises its pancreatic cancer clinical trial product candidate does not cause systemic toxicity (Press release, PharmaCyte Biotech, APR 19, 2022, View Source [SID1234612504]).

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "Another important study has been conducted and concluded. This time the study evaluated the potential toxicity of the capsule component of our CypCaps clinical trial product candidate. We are pleased to announce that there was no evidence of toxicity in this animal study in any of the parameters examined and that the study confirms previous data that the capsule material is inert."

The study, which was performed by a third-party Contract Research Organization, involved the ISO compliant testing of an extract of empty cellulose sulphate capsules provided by Austrianova for potential acute systemic toxicity in mice, according to ISO 10993-11: 2017(E), an FDA recognized consensus standard. Upon intraperitoneal injection of capsule extract, the mice were observed for clinical signs of toxicity at 30 to 40 min, 1 hour, 2 hours and 4 hours post dosing on day 1. On days 2, 3, 7 and 14, all of the animals were observed once daily for clinical signs and twice daily for mortality.

The body weight of the mice was recorded prior to administration of the capsule extract on day 1 and on days 2, 3, 4, 7 and 14 during the observation period. At the end of observation period, all the animals were examined for signs of toxicity. The analyses revealed that none of the mice died or showed any clinical signs of toxicity or gross pathological changes as compared to control mice. Moreover, no treatment related changes were noted in body weight and percent change in body weight with respect to day 1 values and all animals revealed a normal increase in body weight during the observation period.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

University of Camerino Signs Strategic Partnership with CureLab Veterinary to Revolutionize Cancer Treatment for Companion Animals

On April 19, 2022 The University of Camerino (UniCam) reported that has extended its strategic business partnership with CureLab Oncology Inc., a clinical-stage biotech company, to develop anti-cancer immunotherapy for humans, and has signed a similar agreement with CureLab Veterinary Inc. to reapply this medicine for treatment of companion animals (Press release, CureLab Oncology, APR 19, 2022, View Source [SID1234612855]).

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In 2012, the university signed a strategic partnership agreement with CureLab Oncology for researching the DNA plasmid coding p62/SQSTM1 gene (p62) that resulted in patents being granted in more than 20 countries. Subsequently, initial p62 plasmid clinical trials have shown great promise in treating the deadliest forms of ovarian and breast cancer. Given this success, CureLab Oncology and UniCam have agreed to extend their partnership./p>

As a first result of the prolonged partnership agreement, scientists from UniCam and CureLab just published a paper in the journal General and Comparative Endocrinology, one of the top scientific journals focused on animal science and zoology. The choice of a journal was based on a concomitant agreement that UniCam signed with CureLab Veterinary, which licensed the p62 IP for application in cats, dogs, and horses. Earlier, this scientific team successfully treated 10 out of 11 dogs with breast cancer.

"UniCam has a well-established School of Biosciences and Veterinary Medicine," said Prof. Guido Favia, director of the school. "This new partnership with CureLab Veterinary, based on both scientific and clinical strength, brings attractive development opportunities for the entire school."

"We are very pleased to continue our partnership with CureLab Oncology," said Prof. Maria Giovanna Sabbieti of the School of Biosciences and Veterinary Medicine at UniCam. "The new clinical data released by CureLab Oncology paves the road to even more new discoveries in our laboratory, while at the same time, our lab data helps CureLab target new applications for its p62 product."

"Our partnership with CureLab Veterinary opens up new opportunities for the research on bone and inflammatory-based diseases of domestic and farm animals," said Dr. Dimitrios Agas of the School of Biosciences and Veterinary Medicine at UniCam.

"CureLab Veterinary is very pleased to be working with the University of Camerino to explore translational studies in the areas of osteoarthritis, cancer, aging and age-associated diseases to improve and extend the lives of our four-legged family members," said Robert Devlin, DVM, MBA, of CureLab Veterinary.

Regeneron to Acquire Checkmate Pharmaceuticals and Its Investigational Immune Activator for Potential Use in Multiple Tumor Types

On April 19, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI), a clinical stage biopharmaceutical company focused on proprietary technology to harness the power of the immune system to combat cancer, reported a definitive agreement for the acquisition of Checkmate by Regeneron at an all-cash price of $10.50 per share of Checkmate common stock (Press release, Regeneron, APR 19, 2022, View Source [SID1234612469]). The proposed acquisition values Checkmate at a total equity value of approximately $250 million.

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Checkmate’s lead investigational candidate is vidutolimod, an advanced generation CpG-A oligodeoxynucleotide Toll-like receptor 9 (TLR9) agonist delivered in a virus-like particle.

"As we continue to advance and expand our research efforts in immuno-oncology, the acquisition of Checkmate will add a promising new modality to Regeneron’s toolkit of potential approaches for difficult-to-treat cancers," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "The unique combination of a differentiated Toll-like receptor 9 with other antibody-based oncology agents may result in increased clinical benefit and provide new treatment options for patients in need. We look forward to welcoming the Checkmate team and their complementary scientific acumen to the Regeneron family."

"We are thrilled that Checkmate will become part of Regeneron, a biotechnology leader that shares our deep appreciation for science, hunger for ground-breaking discoveries and commitment to helping patients defeat cancer," said Alan Bash, President and Chief Executive Officer of Checkmate.

"We believe that the data we have generated with vidutolimod positions Checkmate at the forefront of the innate immune activator field. It is our hope that Regeneron’s resources and expertise will help accelerate the development of vidutolimod and realization of the full potential of our virus-like particle (VLP) platform for immunotherapy," said Art Krieg, M.D., Checkmate’s Founder and Chief Scientific Officer.

Vidutolimod is administered into the tumor and is believed to induce and expand anti-tumor T cells and induce tumor regression as a monotherapy in patients whose tumors previously progressed on PD-1 checkpoint inhibition. In the Phase 1b program, documented abscopal responses were seen in distant, un-injected lesions. Vidutolimod is an investigational therapy and has not been approved by U.S. Food and Drug Administration or any other regulatory agency.

The merger agreement provides for Regeneron, through a subsidiary, to initiate a tender offer to acquire all outstanding shares of Checkmate at an all-cash price of $10.50 per share of Checkmate common stock. The closing of the tender offer will be subject to certain conditions, including the tender of at least a majority of the outstanding shares of Checkmate common stock, the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. Upon the successful completion of the tender offer, Regeneron will acquire all shares not acquired in the tender through a second-step merger. The transaction is expected to close in mid-2022.

Regeneron’s legal advisor for the transaction is Wachtell, Lipton, Rosen & Katz. Centerview Partners is serving as Checkmate’s financial advisor and Goodwin Procter LLP is serving as its legal advisor.

About Vidutolimod
Vidutolimod works by two complementary mechanisms that together have a unique ability to drive a strong systemic anti-tumor T cell response. First, the virus-like particle (VLP) activates an immune response to the VLP, leading to the production of antibodies that deliver the VLP into plasmacytoid dendritic cells (pDC) and other immune cells via specialized receptors called FcRs. This provides an initial stimulatory signal to pDC and brings the CpG-A to TLR9 (the receptor for CpG DNA) inside the pDC. Second, CpG-A stimulates TLR9 in a manner that induces pDC to release significantly higher levels of IFN-α and other type I interferons than other innate immune activators, resulting in a stronger anti-tumor T cell response.

Animal models and in vitro experiments suggest that, when activated by vidutolimod by this combination of signals, pDC recruit and coordinate a variety of other immune cells, culminating in the generation of a strong anti-tumor T cell response.