On October 19, 2021 Scapa Healthcare, an SWM International (NYSE: SWM) business and the trusted strategic partner for the world’s leading companies in advanced wound care, consumer wellness, and medical device and fixation, and Synedgen Inc., a biotechnology company using glycochemistry to develop drugs that enhance and mimic the innate immune system, reported that they have signed an exclusive worldwide licensing agreement for two novel innovative wound care treatments developed using Synedgen’s proprietary glycochemistry technology platform (Press release, Synedgen, OCT 19, 2021, View Source;utm_medium=rss&utm_campaign=swm-internationals-scapa-healthcare-business-signs-exclusive-technology-licensing-agreement-for-novel-wound-care-technology-with-synedgen-inc [SID1234591667]). The agreement also gives Scapa Healthcare the right to use Synedgen’s glycopolymer technology in conjunction with other wound care technologies.

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Under the terms of the agreement, Scapa Healthcare has exclusive rights over Synedgen’s glycopolymer technology in the field of dermal wounds and surgical care applications both over the counter and in the professional setting.

The advanced glycopolymer-based wound cleanser and wound hydrogel formulae are proven to control infection and promote wound healing by limiting bacterial infection, disrupting mature biofilm, and reducing inflammation and scarring of acute and chronic wounds and surgical incisions. Developed with support from the Defense Health Agency (DHA) and the Defense Advanced Research Projects Agency (DARPA), these wound care products are FDA 510(k) cleared and offer substantial advances over existing wound cleansers and wound hydrogels products in the market.

In addition to the two market-ready products, this technology offers a wide range of possibilities for customized wound management solutions in combination with other advanced wound care technologies including hydrocolloids, hydrogels, collagen and medical foam materials.

"We are delighted to be entering into this agreement with Synedgen, a company that shares our commitment to deliver innovative medical solutions that truly enhance people’s lives" said John Petreanu, president of the Scapa Healthcare business. "This novel glycopolymer technology strengthens our portfolio of advanced wound care products and enables us to bring cutting-edge wound management solutions to our customers in a variety of formats leveraging our skin contact adhesive and topical technologies."

"This agreement with Scapa Healthcare will expand Synedgen’s effective approach to treating challenging wounds for patients worldwide," said Shenda Baker, PhD, President and CEO of Synedgen. "With a rich Defense heritage, we have been able to create a new class of wound care products for warfighter and civilian use. We are honored to partner with such a well-known, world industry leader that adds to the level of consumer trust and experience to expand the application and distribution of this technology."

With development and manufacturing facilities throughout North America and Europe, Scapa Healthcare offers single-source, dual supply to its partners. Scapa Healthcare’s facilities are ISO-certified and FDA-registered with cleanrooms and environmentally controlled rooms for full-scale production of finished goods. In April 2021, Schweitzer-Mauduit International, Inc., known as SWM International, acquired Scapa Group PLC, including the Scapa Healthcare business.

On October 19, 2021 Kureha Corporation reported that it has resolved at the meeting of the Board of Directors held to pay the following dividends to shareholders held in record as of September 30, 2021 (Press release, Kureha Corporation, OCT 19, 2021, View Source [SID1234591572]).

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1. Details of dividend payment

2. Reasons
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. From this standpoint, Kureha has determined to pay 85 yen per share for the FY2021 interim dividend, which is unchanged from its most recent forecast.

On October 19, 2021 Lucid Diagnostics Inc., a company that produces esophageal cancer tests based on Case Western Reserve University and University Hospitals research, reported that it has completed a $70 million initial public offering (IPO) on the Nasdaq Global Market; at the IPO price, the company’s estimated value would be $467 million (Press release, Case Western Reserve University, OCT 19, 2021, View Source [SID1234591567]).

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Gastroesophageal reflux disease (GERD) affects about 20% of people in the United States. Many individuals with chronic GERD develop Barrett’s esophagus, which can lead to highly lethal esophageal cancer, the sixth-most common cause of cancer deaths worldwide.

Lucid Diagnostics Inc. (Nasdaq: LUCD), a subsidiary of New York-based PAVmed Inc. (Nasdaq: PAVM), licensed the EsoCheck and EsoGuard technology through Case Western Reserve’s Technology Transfer Office (TTO) in 2018. The U.S. Food and Drug Administration awarded both products Breakthrough Device designation, granted to novel medical devices with the potential to provide more effective treatment and diagnosis of life-threatening or irreversibly debilitating diseases and conditions. EsoCheck received a 2020 Edison Award as one of the year’s most significant innovations in the Medical Testing category.

EsoGuard is a next-generation sequencing (NGS) DNA assay performed on surface esophageal cells collected with EsoCheck. It has been shown to be highly accurate at detecting esophageal precancer and cancer. EsoGuard is commercially available in the United States and has received European CE mark certification. EsoCheck is a U.S. Food and Drug Administration-cleared and European CE Mark-certified noninvasive swallowable balloon capsule catheter device capable of performing targeted and protected sampling of surface esophageal cells in a less-than-five-minute office procedure.

The underlying technology for EsoCheck and EsoGuard was co-invented by Sanford Markowitz, the Ingalls Professor of Cancer Genetics and Medicine at the School of Medicine and an oncologist at University Hospitals (UH) Seidman Cancer Center; Amitabh Chak, a professor of medicine at the School of Medicine, gastroenterologist at the University Hospitals Digestive Health Institute and the Brenda and Marshall B. Brown Master Clinician in Innovation and Discovery at UH Seidman Cancer Center; and Joseph Willis, a professor of pathology at the School of Medicine and pathology vice-chair for translational research at UH.

Photo of the Lucid Diagnostics founders the Nasdaq desk
(From left) Chak, Markowitz and Willis at Nasdaq.
Markowitz, Chak and Willis were at Nasdaq in New York on Friday to ring the ceremonial bell, marking the close of the day’s stock trading.

"This is a wonderful milestone on a path aimed at preventing death from a miserable cancer through enabling simple early detection of the silent and curable precursor lesions," Markowitz said. "It is a culmination of years of work from an incredibly talented and committed team and is a superb example of the inventive environment and culture that the university and its Technology Transfer Office have created and fostered."

The researchers developed the technology as part of the Case Comprehensive Cancer Center’s GI SPORE Program of Research Excellence and BETRNet (Barrett’s Esophagus Translational Research Network) programs, and was first tested in patients during a clinical trial led by Chak at University Hospitals.

Translational support for the founders’ research to develop the technology came from the National Cancer Institute’s GI SPORE and BETRNet programs, the Case-Coulter Translational Research Partnership, Clinical and Translational Science Collaborative, Ohio Third Frontier, Nottingham Spirk Design Collaborative, the Case TTO, and from University Hospitals Seidman Cancer Center funds in support of SPORE clinical trials.

"The continued research accomplishments focused on public and community benefit and clinical value brought by Sandy Markowitz and his team are not only unparalleled, but bring a scientific impact halo to this school and the university that will remain a shining star for a very long period to come," said Stan Gerson, dean of the School of Medicine and the Asa and Patricia Shiverick–Jane Shiverick (Tripp) Professor of Hematological Oncology.

"This remarkable achievement reflects the incredible hard work and dedication of our colleagues to combat esophageal cancer, a devastating illness," said Mukesh Jain, the Ellery Sedgwick Chair and Distinguished Scientist and vice dean and Distinguished University Professor at the School of Medicine and chief scientific officer for the University Hospitals Health System. "This milestone also reflects the importance of the robust partnership between the two institutions that is advancing the science of health to improve the lives of patients locally and globally."

"Drs. Sandy Markowitz, Amitabh Chak and Joe Willis have partnered with PAVmed Inc. and its CEO, Dr. Lishan Aklog, to bring this transformative technology—a unique device and genetic test combination—to patients for the earliest detection and treatment of esophageal cancer," said Daniel Simon, professor of medicine at the School of Medicine and president of academic and external affairs and chief scientific officer at University Hospitals. "Case Western Reserve University and University Hospitals are committed to create partnerships to advance the health of our patients and our community."

On October 19, 2021 MASORI Therapeutics, a company focused on the pharmaceutical industry is applying artificial intelligence to achieve competitive advantage through the creation of innovative market solutions and Vyant Bio, Inc. ("Vyant Bio") (Nasdaq: VYNT), an emerging global drug discovery company that identifies small and large molecule therapeutics to treat central nervous system ("CNS") and oncology-related diseases, reported they entered into an agreement to pursue co-development and out-licensing partnerships with pharmaceutical and biotechnology companies (Press release, Vyant Bio, OCT 19, 2021, View Source [SID1234591546]). The MASORI Therapeutics team has decades of experience in all areas of drug discovery and development, including building biopharmaceutical commercial infrastructures and partnerships from concept to consummation.

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MASORI Therapeutics combines healthcare and best-in-class digital expertise that enables life sciences companies to leverage artificial intelligence, machine-learning, and virtual reality to achieve brand growth and better analysis, targeting, and execution. The company’s work with Vyant Bio will initially focus in Japan and will center on providing key insights into the application and intersection of their technologies to accelerate partnership-based therapeutic discovery and development.

"I am inspired by Vyant Bio’s commitment to innovation and the discovery of cures for intractable diseases," said Dane Hallberg, founder, executive chairman and chief executive officer of MASORI Therapeutics. "Vyant Bio embodies the tenets of MASORI Therapeutics, and we look forward to helping both companies drive and advance the development of new therapies that have the potential to make the greatest impact on patients."

Vyant Bio couples highly functional, complex in vitro human-based organoid platforms with advanced analytics and in vivo preclinical and regulatory expertise to bring the most promising compounds through the discovery pipeline. The company incorporates patient biology early in the discovery process to identify, validate, and de-risk new targets and compounds prior to clinical trials.

"Partnerships are central to scientific advancement, and for patients with CNS and oncology diseases, time is of the essence to uncover new treatments as quickly as possible," said Jay Roberts, president and chief executive officer of Vyant Bio. "Our relationship with MASORI Therapeutics will identify and drive drug development partnerships that leverage our capabilities to accelerate the discovery and delivery of such treatments."

On October 19, 2021 Candel Therapeutics, Inc. (Nasdaq: CADL), a late clinical stage biopharmaceutical company developing novel oncolytic viral immunotherapies, reported it has appointed Mace L. Rothenberg, MD, as a senior advisor to its President and Chief Executive Officer, Paul Peter Tak, MD, PhD, FMedSci (Press release, Candel Therapeutics, OCT 19, 2021, View Source [SID1234591544]). Dr. Rothenberg, an industry veteran with more than 30 years of experience across government, academia and industry, will help support the company’s continued growth and acceleration.

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"I am delighted to welcome Mace as an advisor to Candel Therapeutics to further strengthen our team," said Dr. Tak. "His impressive background as a physician-executive along with his successful track record of regulatory approvals of numerous novel cancer therapies will bolster the company as it enters the next phase of development."

Prior to joining Candel, Dr. Rothenberg served as Chief Medical Officer of Pfizer. During that time, the company initiated, completed, and obtained emergency use authorization for its COVID-19 vaccine. Prior to that role, Dr. Rothenberg led clinical development for oncology at Pfizer for 10 years. In that period of time, his team developed and obtained regulatory approval for 11 new cancer medicines, including first-in-class medicines: IBRANCE (palbociclib) for patients with HR+/HER2- advanced breast cancer and XALKORI (crizotinib) for patients with ALK+ non-small cell lung cancer. Earlier in his career, Dr. Rothenberg was Professor of Medicine at Vanderbilt University and Ingram Professor of Cancer Research at the Vanderbilt-Ingram Cancer Center. He also served as an Associate Professor of Medicine at the University of Texas Health Science Center at San Antonio and Executive Officer of the Southwest Oncology Group.

Dr. Rothenberg is board-certified in Internal Medicine and Medical Oncology and is a Fellow of the American College of Physicians and the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). He received his BA magna cum laude from the University of Pennsylvania and his MD from the New York University School of Medicine. Dr. Rothenberg completed his post-graduate training in internal medicine at Vanderbilt University and in medical oncology at the National Cancer Institute.

"Candel is at the forefront of one of the most exciting approaches in cancer immunotherapy," said Dr. Rothenberg. "I am excited by the opportunity to help Paul Peter advance the company’s promising oncology pipeline. He has built a terrific clinical development organization and I look forward to working with them in advancing Candel’s promising pipeline of compounds."

About CAN-2409

CAN-2409, Candel’s most advanced oncolytic viral immunotherapy candidate, is a replication-deficient adenovirus that delivers the herpes simplex virus thymidine kinase (HSV-tk) gene to cancer cells. HSV-tk is an enzyme that locally converts orally administered valacyclovir into a toxic metabolite that kills nearby cancer cells. The intra-tumoral administration results in the release of tumor-specific neoantigens in the microenvironment. At the same time, the adenoviral serotype 5 capsid protein elicits a strong pro-inflammatory signal in the tumor microenvironment. This creates the optimal conditions to induce a specific CD8+ T cell mediated response against the injected tumor and uninjected distant metastases for broad anti-tumor activity.

Because of its versatility, CAN-2409 has the potential to treat a broad range of solid tumors. Monotherapy activity as well as combination activity with standard of care radiotherapy, surgery, chemotherapy, and immune checkpoint inhibitors have previously been shown in several preclinical and clinical settings. Furthermore, CAN-2409 presents a favorable tolerability profile; more than 700 patients have been dosed to date, supporting the potential for combination with other therapeutic strategies without inordinate concern of overlapping adverse events. Currently, Candel is evaluating the effects of treatment with CAN-2409 in localized, non-metastatic prostate cancer, non-small cell lung cancer, high-grade glioma, and pancreatic cancer in ongoing clinical trials.

About CAN-3110

CAN-3110 is an HSV replication-competent oncolytic virus engineered to enhance selective killing of cancer cells while sparing neighboring healthy cells. CAN-3110 selectively expresses ICP34.5, a key gene in HSV replication, in tumor cells that overexpress nestin, a cytoskeletal protein. Nestin is highly expressed in high-grade glioma cells and other tumor tissues, but it is absent in the healthy adult brain.

Candel is evaluating the effects of treatment with CAN-3110 in recurrent high-grade glioma. Encouraging clinical results of the ongoing phase 1 clinical trial were recently presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.