Researchers identify effective drug combination against uveal melanoma

Medicalxpress | July 08, 2019

Uveal melanoma is a very aggressive type of melanoma that affects the eye. It is a rare disorder, affecting an estimated 2,500 people in the United States each year. However, nearly half of uveal melanoma patients will develop metastatic disease that migrates to other part of the body, primarily the liver. The prognosis for patients with metastatic uveal melanoma is very poor, with median survival of only 17 to 20 months. Researchers in Moffitt Cancer Center's Donald A. Adam Melanoma and Skin Cancer Center of Excellence are working to change that. They have identified a new drug combination that is effective against metastatic uveal melanoma cells in preclinical studies. Their findings were published in Clinical Cancer Research. The MAPK protein signaling pathway is commonly deregulated in melanoma of the skin and uveal melanoma. Drugs that target a protein called MEK, which is involved in the MAPK signaling pathway, have significantly improved the outcomes of patients with melanoma of the skin. However, a recent phase 3 clinical trial in uveal melanoma revealed that patients treated with a MEK inhibitor plus chemotherapy had no improvement in survival over those patients treated with chemotherapy alone. Many patients with uveal melanoma quickly develop resistance to MEK inhibitors. Moffitt researchers, in collaboration with scientists from the UF Health Cancer Center and Sylvester Comprehensive Cancer Center, wanted to determine how this resistance develops and identify additional drugs that could be used in combination with MEK inhibitors to target uveal melanoma cells for destruction.

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SiO2 Materials Science and Doosan Corporation Enter Into Strategic Partnership to Accelerate Market Development in Asia

SiO2 Materials Science | December 27, 2021

Doosan Corporation, founded in 1896, one of South Korea's largest diversified conglomerates, and SiO2 Materials Science, a privately-owned U.S. advanced materials science corporation introducing breakthrough disruptive technology for packaging biological pharmaceuticals and vaccines, announced an exclusive partnership to sell, market, and distribute SIO2's vial, syringes and blood collection tubes in Asia/Oceania. The partnership will focus initially on the pharmaceutical and diagnostics markets but will extend to other markets through the joint development of new technologies. As part of the strategic partnership, Doosan will invest $100 million into SiO2 and will additionally invest in substantial infrastructure and human resources for the acceleration of the business in Asia/Oceania. The partners have defined key volume milestones over a 15 year period. "The Asia and Oceania region represents a significant market opportunity for vials and syringes specifically designed for biologic drugs and vaccines. South Korea has become a world leader in biological drug manufacturing, so it makes sense to establish a strong presence with a respected partners in the market," says Lawrence Ganti, President of SiO2 Materials Sciences The SiO2 Materials Sciences technology platform combines the benefits of glass and plastic while eliminating the drawbacks of both. The technology has been commercially validated through the packaging of hundreds of millions of COVID-19 vaccine doses around the world and is working with more than 100 active projects with leading pharmaceutical and diagnostic companies to bring their products to market in a safer container. The company was a key collaborator and part of the US Government's COVID-19 Response (formerly known as Operation Warp Speed) and has expanded its manufacturing footprint in Auburn, Alabama, more than 12-fold in the last 18 months. "South Korea is a strategic hub for biologic drug manufacturing. Doosan believes that the SiO2 technology would greatly support the packaging of these new drugs and vaccines and are proud to exclusively represent the technology in Asia," says Han Lee, Vice President of Doosan. "There is so much potential in the SiO2 technology, and we will also jointly develop new technologies and products by bringing our existing technologies and engineering minds together," says Chief Business Officer of Doosan Corporation. About SiO2 Materials Science SiO2 Materials Science is an advanced materials science corporation introducing breakthrough disruptive technology serving the biopharma, molecular diagnostic, and consumer healthcare industries. The company is located in Auburn, Alabama. The company has deep partnerships with leading professors at the foremost research universities such as University of California - Santa Barbara, University of Chicago, and MIT / Harvard. About Doosan Doosan Corporation is Korea's oldest conglomerate, founded in 1896. The company operates across multiple divisions such as: Electro-Materials, Industrial Vehicles, Fuel Cell Power, Retail, and Digital Innovation. The company is always developing innovative new business in support of materials science.

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CASI PHARMACEUTICALS ANNOUNCES CNCT19 (CD19 CAR-T) GRANTED ORPHAN DRUG DESIGNATION BY THE U.S. FDA

CASI Pharmaceuticals, Inc. | January 19, 2022

CASI Pharmaceuticals, Inc. a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announced today, that the U.S. Food and Drug Administration as granted Orphan Drug Designation for CNCT19, an investigational CD-19 directed CAR-T therapy, for the treatment of patients with Acute Lymphoblastic Leukemia. CNCT19 is currently being developed independently by Juventas to meet the urgent clinical needs of patients with hematologic malignancies globally. The National Medical Products Administration has granted CTA approval for CNCT19 in two indications in Nov. 2019. Currently, the Phase II clinical trials of CNCT19 are in progress. Positive clinical data for adult and pediatric patients with relapsed/refractory B-ALL has been presented at the December 2021 ASH annual meeting, which further demonstrated its safety and efficacy profile. CNCT 19 is expected to be the first domestic CD19 directed CAR-T product in China with independent intellectual property rights. "Our partner Juventas continues to make encouraging progress in developing their CD19 CAR-T therapy. The Orphan Drug Designation, from the FDA, and the Breakthrough Designation status, granted by the China Center of Drug Evaluation (CDE) in December 2020, represent significant milestones that demonstrate our belief that CNCT19's commercialization will not only be successful in China, but potentially on a global scale. CASI has worldwide co-commercial rights of CNCT19, and will start the global commercialization process according to CNCT19's regulatory progress outside China." Dr. Wei-Wu He, CASI's Chairman, and CEO About Juventas Juventas is a biopharmaceutical company headquartered in China dedicated to the development and commercialization of cell therapies globally. Utilizing innovative and integrated technology platforms, the company has developed a diverse pipeline of cellular immunotherapies for treatment of hematological malignancies, solid tumors, and other non-oncological conditions both in China and globally. At present, the company is conducting two pivotal clinical trials of CNCT19 for treating adult r/r-B-ALL and r/r-B-NHL in China. CNCT19 has the potential to become the first launched domestically developed CD19 CAR-T therapy in China and the first CAR-T product for the treatment of adult R/R B-ALL in China. About CASI Pharmaceuticals CASI Pharmaceuticals, Inc. is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the greater China market leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., which is located in Beijing, China. The Company has built a commercial team of more than 100 hematology oncology sales and marketing specialists based in China.

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SS&C Partners with Xcentuate to Support Customer Digital Transformation Journeys

SS&C | June 23, 2022

SS&C Technologies Holdings, Inc. announced a new partnership in the EMEA and APAC regions with Xcentuate, an award-winning international provider of digital productivity and performance solutions to the financial services, agricultural, pharma and public sectors. The partnership follows SS&C's recent acquisition of Blue Prism, the leading Robotic Process Automation provider, further demonstrating its commitment to the intelligent automation solutions market. Xcentuate, based in Dublin, Ireland, will serve as a consulting and implementation partner, acting as an extended team to advise, implement, support and deliver complex projects. "We are delighted to partner with Xcentuate," said Gautam Moorjani, General Manager, SS&C Intelligent Automation Solutions. "The EMEA and the Asia Pacific regions are markets with a lot of appeal - with resilient and developing economies and talented, skilled workforce. In addition, the potential for operational automation to transform how businesses work is significant." The partnership will enable SS&C to leverage Xcentuate's vast experience to access new potential customers, take new value propositions to market, develop point solutions to address current market needs, and enhance its specialized professional services to our customers. "The SS&C partnership is of significant strategic importance to us regarding our offer to the market. The breadth and depth of SS&C's expertise in financial services and healthcare technology are unmatched. In addition, this new partnership further broadens the suite of services we can offer to firms in EMEA and the Asia Pacific with an ambitious digital transformation agenda." Ray Bowe, Xcentuate founder and CEO About Xcentuate Headquartered in Dublin, Ireland, Xcentuate serves a range of industries including financial services, agriculture, pharma and public sector. Xcentuate works with customers in EMEA and Asia-Pacific regions to transform their business operations using a suite of best-in-class technology to deliver sustainable advantage. Combined with award-winning operational expertise and a track record of delivery, they support businesses in transforming their customer experiences and enabling them to optimise control and productivity while building an engaged, enthused workforce. About SS&C Technologies SS&C is a global provider of services and software for the financial services and healthcare industries. Founded in 1986, SS&C is headquartered in Windsor, Connecticut, and has offices around the world. Some 20,000 financial services and healthcare organizations, from the world's largest companies to small and mid-market firms, rely on SS&C for expertise, scale and technology.

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TherapeuticsMD and EW Healthcare Partners Announce Definitive Agreement for EW Healthcare Partners to acquire TherapeuticsMD

TherapeuticsMD, Inc | June 01, 2022

TherapeuticsMD, Inc. an innovative, leading women’s healthcare company, announced that it has entered into a definitive merger agreement to be acquired by an affiliate of EW Healthcare Partners, a private equity firm dedicated to making investments in rapidly growing healthcare companies. Under the terms of the transaction, which has been unanimously approved by TXMD’s board of directors, EW Healthcare Partners will commence a tender offer to acquire all outstanding shares of TXMD common stock for $10.00 per share in an all-cash transaction, followed immediately by a merger. The purchase price represents a premium of 367.3% over TherapeuticsMD’s closing share price on May 27, 2022. “We are very pleased to enter into this agreement with EW Healthcare Partners. Together, we will continue empowering women of all ages through a therapeutic focus in family planning, reproductive health, and menopause management. We have a deep appreciation for EW Healthcare Partners’s depth of expertise and track record and know they will bring an incredible value of knowledge and strategic guidance.” Hugh O’Dowd, Chief Executive Officer of TherapeuticsMD EW Healthcare Partners is one of the largest and oldest private healthcare investment firms with over $4B of capital raised since its inception. EW Healthcare Partners has made investments in over 150 rapidly growing healthcare companies in the pharmaceutical, medical device, diagnostics, and technology-enabled services sectors in the United States and in Europe. “We are pleased to welcome TherapeuticsMD to the EW Healthcare Partners portfolio and are deeply committed to the Company's mission of advancing women’s health. EW Healthcare Partners has already made a significant investment in women’s health through its acquisition of Majorelle. TherapeuticsMD represents a unique opportunity for Majorelle to enter the US market and is a perfect fit with our ambitious plans to create a fast-growing, premier trans-Atlantic women’s health platform. We bring an extensive network and capital to fund the further growth of the combined company,” said Evis Hursever, Managing Director at EW Healthcare Partners. “We look forward to working together with the company’s management team to enhance the patient experience, improve operational efficiency and create one of a very few trans-Atlantic specialty pharma companies dedicated to women’s health,” said Olivier Bohuon, Senior Adviser with EW Healthcare Partners and Chairman of Majorelle. About TherapeuticsMD, Inc. TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. TherapeuticsMD’s products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. TherapeuticsMD is committed to advancing the health of women and championing awareness of their healthcare issues. About EW Healthcare Partners (“EW”) With over $4 billion raised since inception, EW Healthcare Partners is one of the largest and oldest private healthcare investment firms and seeks to make growth equity investments in fast growing commercial-stage healthcare companies in the pharmaceutical, medical device, diagnostics, and technology-enabled services sectors in the United States and in Europe. Since its founding in 1985, EW Healthcare Partners has maintained its singular commitment to the healthcare industry and has been a long-term investor in over 150 healthcare companies, ranging across sectors, stages and geographies. The team is comprised of over 20 senior investment professionals with offices in New York, Houston and London.

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