MEDICAL

Debiopharm Announces First Patient Dosed in Investigator-initiated, Randomized Phase II, Open-label Clinical Trial for its Antiviral Alisporivir

Debiopharm | January 18, 2021

Debiopharm , a Swiss biopharmaceutical organization, reported the principal patient dosed in a investigator-initiated, randomized phase II, open-label clinical trial for its antiviral alisporivir (Debio 025). The examination will be led by the AP-HP to assess the adequacy and wellbeing of the cyclophilin inhibitor in the therapy of beginning phase, hospitalized COVID-19 patients who don't need clinical ventilation and have not shown indications of intense respiratory distress syndrome. The essential goal of this 'proof-of-concept' preliminary is to assess the decrease in COVID-19 viral burden in alisporivir treated patients. The secondary objective includes the analysis of clinical and radiological efficacy, wellbeing and decency of the compound in addition to Standard of Care (SOC) contrasted with SOC alone. Patients in the investigational arm will get alisporivir either orally or by means of a nasogastric tube, at the portion of 600mg twice every day for 14 days during the preliminary drove by Prof. Jean-Michel Pawlotsky, virologist, Head of the Biology and Pathology Department of the Henri Mondor Hospital Group, Greater Paris University Hospitals. The trial, upheld by both the hospital group gathering and Debiopharm, will be done in numerous centers in France including the Henri Mondor Hospital Group.

Medical perceptions have indicated that viral infections , for example, COVID-19 can be life-threatening because of an overcompensation of the body's immune defense system. Part of the cyclophilin inhibitor class of antivirals, this macrocyclic cyclophilin inhibitor could end up being an important extra therapy to SOC because of its non-immunosuppressive nature.

Spotlight

NCI-COG Pediatric MATCH is a nationwide cancer treatment clinical trial for children and adolescents, from 1 to 21 years of age, that is testing the use of precision medicine for pediatric cancers. In this trial, patients with solid tumors that are not responding to treatment are assigned to an experimental treatment based on the genetic changes found in their tumors rather than on their type of cancer or cancer site.

Spotlight

NCI-COG Pediatric MATCH is a nationwide cancer treatment clinical trial for children and adolescents, from 1 to 21 years of age, that is testing the use of precision medicine for pediatric cancers. In this trial, patients with solid tumors that are not responding to treatment are assigned to an experimental treatment based on the genetic changes found in their tumors rather than on their type of cancer or cancer site.

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CELL AND GENE THERAPY

Phytolon and Ginkgo Bioworks Collaborate to Take Biological Production of Vibrant Food Colors to the Next Level

Phytolon; Ginkgo Bioworks | February 28, 2022

Phytolon, a growing startup company making natural food colorants, announced a partnership today with Ginkgo Bioworks the leading horizontal platform for cell programming, to produce vibrant cultured food colors via fermentation of yeast. Under this partnership, Phytolon is leveraging Ginkgo's ability to engineer biology at scale to work together on the production of vibrant betalain pigments, the healthy and colorful compounds found in foods like beets and cactus fruit. The project aims to take Phytolon's colors across the full 'yellow-to-purple' spectrum to the next level, and to potentially maximize the business opportunity of Phytolon's vibrant colors for applications in the food and cosmetics industries. Scientists have developed hundreds of artificial food dyes by using the tools of synthetic chemistry to convert petrochemical sources into a wide range of colors. Biotechnology offers an opportunity to tap into the vibrant colors of biology to produce more sustainable, yet equally vibrant, colors. While artificial dyes are visually appealing and cheap to manufacture, many have been banned in food and feed due to health concerns. As consumers increasingly seek out more sustainable and nature-derived products, the food industry is working to find food colors that have equivalent pigment vibrancy to those found in synthetic chemical dyes but which come from biological rather than petrochemical sources. Phytolon has developed a proprietary process for producing betalain pigments through precision fermentation of certain yeast strains. Together, Phytolon and Ginkgo are partnering with the goal of maximizing the production efficiency of purple and yellow betalain-producing strains. "We're excited to work with Ginkgo to develop natural food colors that can potentially outperform conventional artificial dyes in cost and performance. We believe biotechnology makes it possible to produce a wider range of colors than ever before that may outperform current benchmark colorants, and we look forward to building products that may meet and even exceed consumer expectations for healthier, sustainable foods, all while aiming to maintain industry requirements for high quality and cost-efficiency." Dr. Tal Zeltzer, Co-founder and CTO of Phytolon "We love enabling growing startups like Phytolon through our platform, using biotechnology to challenge industry norms and attempt to build a fundamentally better product than what's on the market today," said Jennifer Wipf, Head of Commercial, Cell Engineering at Ginkgo Bioworks. "The planet needs new sustainable solutions, and we are excited to partner with Phytolon to support a more sustainable food system." About Phytolon Phytolon is a biotechnology startup company that is taking food coloring to the next level by leveraging a novel technology for production of natural pigments via precision fermentation of yeast. Phytolon's products have been successfully validated by global leaders in the food industry, and Phyloton expects to enter into commercialization agreements with initial strategic partners in the near term. Phytolon is supported by partners such as The Trendlines Group Millennium Foodtech, EIT-Food, Consensus Business Group, Arkin Holdings and others. About Ginkgo Bioworks Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery.

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MEDICAL

Sesen Bio Partners with Hikma Pharmaceuticals for the Registration and Commercialization of Vicineum

Sesen Bio | December 02, 2020

Sesen Bio, a late-stage clinical organization creating focused on combination protein therapeutics for the therapy of patients with cancer, and Hikma Pharmaceuticals, a worldwide pharmaceutical organization and driving permitting partner in the Middle East and North Africa ("MENA") area spend significant time in the turn of events and commercialization of an expansive scope of great medicines, today declared that the organizations have gone into exclusive licensing agreement for the registration and commercialization of Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer ("NMIBC") and different sorts of cancer in MENA. Vicineum, a privately managed combination protein, is Sesen Bio's lead product competitor presently in the subsequent phase of a Phase 3 enrollment preliminary for the treatment of high-hazard, BCG-unresponsive NMIBC. In December 2019, the Company started the BLA submission for Vicineum to the FDA under Rolling Review. Under the details of the understanding, Sesen Bio granted Hikma a exclusive license to register and commercialize Vicineum in all of the 19 MENA markets in a course of action foreseen to convey equivalent worth offer to the two players. Monetary terms of the arrangement are secret and incorporate a forthright installment to Sesen Bio, deals related achievement installments, and eminences on net deals in the locale for the term of the understanding. Sesen Bio holds full turn of events and commercialization rights for Vicineum for the treatment of NMIBC in the US and the remainder of the world barring Greater China and MENA.

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CELL AND GENE THERAPY

Shoreline Biosciences Announces $140M Financing To Advance Pipeline Of Next Generation Cell Immunotherapies

Shoreline Biosciences | November 02, 2021

Shoreline Biosciences, Inc. (Shoreline), a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized, and targeted induced pluripotent stem cells (iPSC) derived natural killer (NK) and macrophage cellular immunotherapies, today announced the completion of a $140M financing, led by Ally Bridge Group, with participation from new investors Eventide Asset Management, BeiGene, Irving Investors, Kingdon, NS Investment, Piper Heartland Healthcare Capital, and Superstring. Existing investors Boxer Capital, BVF Partners, L.P., Commodore Capital, Cormorant Asset Management, Janus Henderson Investors, Kite, a Gilead Company, Stork Capital, Wedbush Healthcare Partners and an undisclosed leading global investment firm, also participated. In connection with the financing, Frank Yu, Founder, CEO and CIO of Ally Bridge Group, joined the Shoreline Board of Directors. "We are proud of Shoreline's tremendous progress over the past year, including next generation, more persistent and more effective iPSC-derived NK cells, enhancing our core technologies, advancing our preclinical programs, establishing transformative and validating partnerships with Kite and BeiGene, creating smart manufacturing methods, and attracting exceptional talent to support our next phase of development and growthWith this financing and our corporate partnerships, Shoreline has now more than $300 million to continue building our pipeline of safe, effective and affordable cellular immunotherapies for both solid tumors and hematologic malignancies." Kleanthis G. Xanthopoulos, Ph.D., Shoreline's co-founder, Chairman and Chief Executive Officer "Having invested in – and followed closely for several years -- the iPSC-derived NK cells-based therapeutics field which has made highly encouraging progress in the clinic, we are convinced of the true differentiation demonstrated by the Shoreline technology platform. Ally Bridge Group, a leading investor in best-in-class cell therapy companies from oncology to autoimmune diseases, expects Shoreline to be a new category leader," said Frank Yu, Founder, CEO and CIO of Ally Bridge Group. The proceeds from the financing will allow Shoreline to continue the advancement of its proprietary iPSC platform focused on developing next generation natural killer (NK) cell and macrophage-cell therapies, create potent and persistent NK cell-specific Chimeric Antigen Receptors (CARs) as well as switchable CAR-NK cell engagers and macrophage-specific CARs to treat blood cancers, solid tumors, and other health conditions. With the close of this financing, Shoreline is well-capitalized with greater than $300 million, including committed partnership R&D funding, to execute on its goals and advance its pipeline. About Shoreline Biosciences Shoreline is dedicated to creating next-generation cellular immunotherapies for cancer that overcome the current limitations of first-generation cell therapy products. Shoreline is building a pipeline of natural killer cell and macrophage-cell therapy candidates derived from its deep expertise in iPSC differentiation methods and genetic reprogramming of disease relevant pathways. Shoreline has strategic partnerships with Kite, a Gilead Company, and BeiGene, a global biotechnology company, Contract Development and Manufacturing Organization partnerships with well-established organizations, and is supported by high-quality investors. Shoreline Biosciences is headquartered in San Diego, CA.

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