Cell Therapeutics Inc. /Angelos/

To date Sernova reports 7 patients in its Phase I/II type 1 diabetes clinical trial achieved freedom from insulin injections and demonstrate blood sugar control in the non-diabetic range (HbA1c <6.5%); 6 patients have reached between 5.5 and 50 months of sustained insulin independence and freedom from severe hypoglycemic episodes; Completion of enrollment in Cohort 2 LONDON, Ontario; BOSTON, Massachusetts – June 25, 2024 – Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage biotechnology company, today announces developments in its Phase I/II clinical trial investigating a novel treatment for Type 1 Diabetes (T1D). To date a total of 7 patients across Cohorts 1 and 2 have achieved insulin independence following transplants of human donor islets via Sernova’s proprietary Cell Pouch System™ and a marginal portal vein top up. Additionally, the study, which is being conducted at the University of Chicago, completed full enrollment of the second cohort of patients with the last patient being enrolled June 24, 2024. At baseline, all patients in the study were dependent on multiple daily insulin injections with average HbA1c levels (a measure of glucose control over the prior 2 to 3 months) greater than 6.5% across the study population. In addition, prior to enrollment in the study, patients had a history of severe hypoglycemic events (a potentially life-threatening drop in blood sugar leading to impaired cognition and consciousness) and undetectable plasma levels of C-peptide (a marker of natural insulin production). Insulin independence in these first 7 patients has been accompanied by freedom from severe hypoglycemic events, sustained HbA1c levels in the non-diabetic range (HbA1c <6.5%), and persistent transplant-mediated insulin production measured by plasma C-peptide. The trial, which focuses on Sernova’s Cell Pouch technology, demonstrates that insulin independence and additional clinically meaningful patient outcomes were achieved with lower than traditional islet masses infused intra-portally, indicating an important contribution of the islet grafts in Cell Pouch to the observed favorable blood glucose control. Sernova continues to be the first and only company to announce positive patient outcomes in a clinical trial for T1D that combines donor islets transplanted via an implantable delivery vehicle that also has full payload containment and retrievability capabilities should it be required, as evidenced by the first patient in Cohort 2. Interim data from this study indicates that Cell Pouch is generally safe and well tolerated and, when transplanted with donor islets, contributes to the reversal of T1D, potentially minimizing the long-term comorbidities that include heart and kidney disease, blindness and amputation. The Company anticipates announcing additional trial results for the remaining 5 patients in Cohort 2, later in the year. Cynthia Pussinen, CEO of Sernova, expressed "we are excited with and encouraged by the impressive progress of our ongoing Phase I/II clinical trial with donor islets and Cell Pouch. The ability to achieve sustained insulin independence, HbA1c levels in the non-diabetic range and reductions in severe hypoglycemic events in patients, using a retrievable payload device, signifies a transformative step forward in the treatment – and essentially functional cure - of Type 1 Diabetes. Sernova remains committed to advancing the potential of our Cell Pouch technology to significantly improve the lives of patients and their families worldwide.” Sernova Corp continues to collaborate closely with leading academic, pharmaceutical and clinical institutions to expand the scope and impact of its technology. The company anticipates further advancements as it progresses through additional cohorts and trials, with the goal of offering a scalable solution for insulin-dependent diabetes plus other chronic diseases. About Sernova Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead technology, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. Sernova partnered with Evotec to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova’s development pipeline that uses its Cell Pouch System also includes: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A. About Sernova’s Cell Pouch for use with Cell Therapeutics On implantation, The Cell Pouch forms a natural, vascularized tissue environment in the body allowing long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago. The Cell Pouch technology integrates with the body's natural biological processes, creating a biocompatible environment for the delivery of therapeutic cells previously missing from the body including cells, hormones, blood factors and tissues. This innovative approach aims to provide a durable and sustainable treatment option for Sernova’s lighthouse program to treat individuals living with T1D, with additional future therapeutic programs to follow for hypothyroidism and hemophilia A. For further information, please contact: Christopher Barnes VP, Investor Relations Sernova Corp. Tel: +1 519-902-7923 Email: christopher.barnes@sernova.com Website: Forward Looking Information: This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

“To improve and expand our company-creation toolbox, we have brought together a group of experienced investors and entrepreneurs," the VC firm said. Venture capital firm Sofinnova Partners has launched a new investment strategy specifically aimed at setting up and accelerating biotech startups across Europe. The strategy, dubbed Biovelocita, will involve a newly formed team assembled with the aim of providing “a hands-on, robust framework for startups, combining direct management, financial backing and access to Sofinnova’s extensive infrastructure and network,” the firm explained in a Dec. 13 release. The name and strategy both “draw inspiration” from BiovelocITA, Italy’s first biotech accelerator, which was co-founded in 2015 by Sofinnova Partners along with Gabriella Camboni, M.D., and Silvano Spinelli. Camboni co-founded the biotechs EOS and Novuspharma, which went on to be acquired by Clovis Oncology and Cell Therapeutics, respectively. She will be one of the key partners in the new Europe-wide initiative, alongside AdBio Partners founder Matthieu Coutet, former Alchemab CEO Alex Leech and Zhizhong (Joel) Yao, Ph.D. This team of “serial entrepreneurs and investors” will partner with “leading academic institutions to identify the most innovative ideas and create the biotech champions of tomorrow,” the VC firm explained in the release. “To improve and expand our company-creation toolbox, we have brought together a group of experienced investors and entrepreneurs who have been collaborating with Sofinnova for over a decade, some nearly two decades,” Sofinnova Partners managing partner Graziano Seghezzi said in the release. “With this top-tier team, we look forward to strengthening one of Sofinnova’s strategic pillars: acceleration, which is already making rapid strides in the medical device space with Sofinnova MD Start, our in-house medtech accelerator.” Sofinnova Partners—not to be confused with its U.S.-based “cousin” Sofinnova Investments—employs around 80 people spread across its Paris headquarters as well as offices in London, Milan and Luxembourg. The VC firm oversees $2.5 billion and has a portfolio of 100 companies spread across six segments including biotech, medtech and digital medicine—of which the latter closed its first $200 million fund in October. The same month, one of Sofinnova’s European biotechs achieved that rarest of feats in 2023—a successful IPO. France’s Abivax raised over $235 million from its Nasdaq listing, which the Paris-based company will partly use to complete the phase 3 development of ulcerative colitis med obefazimod. Speaking to Fierce Biotech on the sidelines of the Jefferies London Healthcare Conference last month, Sofinnova’s chairman Antoine Papiernik said there remains “optimism” among investors around the European biotech sector.

SUZHOU, China, Nov. 20, 2023 /PRNewswire/ -- On November 20, 2023, Porton Advanced announced a strategic partnership with Ascle Therapeutics to jointly develop and produce NK cells, assist in the development and innovation in gene and cell therapy, and accelerate the application of NK cells in cancer prevention, beauty, and anti-aging. Continue Reading Porton Advanced is committed to providing end-to-end gene and cell therapy CDMO services, covering fields such as plasmids, cell therapy, gene therapy, and mRNA therapy. Currently, Porton Advanced has successfully assisted customers in completing CMC and global declaration services for multiple gene and cell therapy drugs. Ascle Therapeutics specializes in the research and production of breakthrough immune cell therapy products, mainly focusing on the field of NK/CAR-NK anti-tumor immune cell therapy drugs. Ascle Therapeutics has also established a comprehensive immune cell therapy research and production system and it has three major technology platforms: universal CAR-NK, allogeneic NK/CAR-NK, and mRNA-LNP. According to the agreement, Porton Advanced will provide services of development, production, and declaration in China for Ascle Therapeutics' NK cell project, supporting the application of NK cells in cancer prevention, anti-aging, and beauty. Dr. Li Huashun, founder and chairman of Ascle Therapeutics, stated, "CAR-NK cell therapy has a significant effect on cancer treatment. This therapy modifies NK cells by using genetic engineering to improve their ability to identify and kill tumor cells while reducing damage to normal cells. In the field of solid tumor treatment, CAR-NK cell therapy has significant advantages. In addition, NK cells have demonstrated outstanding efficacy in anti-aging. A single dose of two billion young and healthy cells can reduce circulating senescent cells by up to 80-100%[1], and the efficiency can last for 3 to 18 months. Ascle Therapeutics has profound accumulation and technological advantage in the field of NK cells. We have developed the Ascle-NK platform, which cultures exceptional and powerful NK cells. Meanwhile, Porton Advanced has achieved remarkable accomplishments in the research, development, production, and project declaration of gene and cell therapy drugs. I believe that with its rich experience and professional technology, Porton Advanced can provide important support for Ascle Therapeutics to promote the application of NK cells in anti-aging, beauty, and cancer prevention." Dr. Wang Yangzhou, CEO of Porton Advanced said: "We are very pleased to reach a strategic partnership with Ascle Therapeutics. The R&D pipeline of Ascle Therapeutics has deep accumulation and advantages, especially in the NK field. Porton Advanced has established an end-to-end gene and cell therapy CDMO platform, with excellent process development capabilities and sterile drug production workshops, as well as production capabilities and experience in high-quality GMP cell products, and can achieve customized production according to customers' requirements. Moreover, Porton Advanced also has internationally advanced analytical development technology and platforms to ensure the quality and safety of future products, empowering and supporting the R&D and production projects of Ascle Therapeutics with international production, inspection, and release standards. We are looking forward to closely collaborating with Ascle Therapeutics to jointly promote the CMC and declaration in China of NK cell projects. Through Porton Advanced's CDMO platform, we can swiftly support Ascle Therapeutics in making new progress in NK cell anti-aging, beauty, and cancer prevention." Reference [1] Yousefzadeh, M. J., Flores, R. R., Zhu, Y., Schmiechen, Z. C., Brooks, R. W., Trussoni, C. E., Cui, Y., Angelini, L., Lee, K. A., McGowan, S. J., Burrack, A. L., Wang, D., Dong, Q., Lu, A., Sano, T., O'Kelly, R. D., McGuckian, C. A., Kato, J. I., Bank, M. P., Wade, E. A., … Niedernhofer, L. J. (2021). An aged immune system drives senescence and ageing of solid organs. Nature, 594(7861), 100–105. About Ascle Therapeutics Ascle Therapeutics is an innovative biopharmaceutical company engaged in the R&D and production of breakthrough immune cell therapy products, primarily focusing on the field of NK/CAR-NK anti-tumor immunotherapy drugs. Ascle Therapeutics has developed a comprehensive R&D and production system for immune cell therapy, with three major technology platforms: universal CAR-NK, allogeneic NK/CAR-NK, and mRNA-LNP. It covers core technologies such as antibody screening and expression identification, CAR structure design, CRISPR/Cas gene editing, non-viral vector gene delivery, large-scale cell production, and quality inspection and release, with the aim to develop safe, effective, and cost-controlled products for immune cell therapy, anti-cancer, anti-aging, and beauty, benefiting more patients and customers. About Porton Advanced Porton Advanced is a subsidiary of the globally recognized CDMO Porton Pharma Solutions Ltd. (SZSE Stock Code 300363), founded in 2018. Located in Suzhou, China, Porton Advanced offers a cGMP-compliant manufacturing platform for plasmids, cell therapy, gene therapy, and mRNA therapy, enabling different development stages for global companies. Porton Advanced operates on a "Customer First" approach to Gene and Cell Therapeutics (GCT) manufacturing, anchored by its core principles of "Compliance, Expertise, and Open Collaboration". The company operates to rigorous, internationally harmonized Quality Management and IP protection standards, bringing innovative manufacturing solutions to the complex challenges in the GCT space. For more information about Porton Advanced, please visit: . SOURCE Porton Advanced Solutions