Anti-CD3 ricin chain A conjugate/anti-CD7 ricin chain A conjugate(Xenikos)

World leading expert and key opinion leader in nephrology GLASGOW, Scotland, July 13, 2022 /PRNewswire/ -- Invizius Limited ("Invizius"), a biotechnology company developing treatments to suppress unwanted immune responses in haemodialysis, is pleased to announce the appointment of Professor Peter Stenvinkel to its Clinical Advisory Board. Professor Stenvinkel is a world-renowned expert senior lecturer at Karolinska University Hospital and Professor of Nephrology at Karolinska Institutet (KI), Stockholm, Sweden. Invizius is developing its H-Guard® Haemodialysis Priming Solution which comprises a novel protein that lines the inside of the dialysis filter and helps dialysis to take place undetected by the body's immune system. This suppresses the blood's foreign body response preventing a repetitive, hostile inflammatory reaction that increases the risk of cardiovascular and other complications. A leading expert in the field of nephrology, Prof Stenvinkel has over 610 original publications and reviews and more than 30 book chapters on various aspects of inflammation, wasting and metabolism in chronic kidney disease patients (CKD). He has given more than 400 invited lectures at various international meetings and congresses in more than 30 different countries. He conducts translational research with a focus on risk factors for metabolic, cardiovascular and nutritional complications in CKD. Prof Stenvinkel has been on the Scientific Advisory Boards of AstraZeneca, Baxter, Fresenius Medical Care, Reata Pharmaceuticals and Vifor Pharma. Richard Boyd, Chief Executive Officer of Invizius, said: "Prof Stenvinkel is one of the world's foremost authorities in nephrology and is focused on the translation of novel approaches into impactful treatments for renal patients. We are very privileged to have him join our Clinical Advisory Board. His expertise is particularly relevant to the work we are doing at Invizius and we look forward to his invaluable contributions as we accelerate the development of our programmes." Prof Stenvinkel, Senior lecturer at Karolinska University Hospital and Professor of Nephrology at Karolinska Institutet, added: "Invizius has been founded on world-class research and I am very impressed by its H-Guard technology which has the potential to improve quality of life and safety of patients on dialysis. I am very pleased to begin working with the talented team developing novel and improved therapeutic approaches to improve the quality of life for this expanding patient group." Prof Stenvinkel joins Invizius' Clinical & Scientific Advisors, Professor Sandip Mitra (Manchester Royal Infirmary), and Professor Paul Barlow (University of Edinburgh). Invizius recently announced it had been awarded two Innovate UK Biomedical Catalyst Grants to bring anti-inflammatory haemodialysis treatment to the clinic and to research peritoneal dialysis indication for its H-Guard® technology. About Invizius Invizius Limited is a late pre-clinical-stage biotechnology company developing treatments to suppress unwanted immune responses, focused initially on reducing the life-threatening inflammatory effects of dialysis. Founded in 2017, the University of Edinburgh spin-out is developing its proprietary H-Guard® Priming Solution, comprising a novel protein that lines the inside of the dialysis filter and helps dialysis to take place undetected by the body's immune system. This suppresses the blood's foreign body response, thereby preventing a hostile inflammatory reaction. The technology can also be used with other devices or treatments such as continuous renal replacement therapy (CRRT), extracorporeal membrane oxygenation (ECMO), cardiopulmonary bypass, organ transplants and immunomodulating therapeutics. The company is looking to expand its product pipeline into other, high-value indications. Invizius is supported by a strong syndicate of investors including Mercia, Downing Ventures, Old College Capital, Scottish Enterprise, Solvay Ventures, Calculus Capital and experienced life science entrepreneur and investor, Dr Jonathan Milner. For more information on Invizius, please visit: About Prof Stenvinkel MD, PhD, FASN Prof Stenvinkel has received numerous accolades and awards including the prize for the best Swedish thesis in diabetology (1994), Baxter Extramural Grant (1996), the Karolina Prize (2005) and Vizenca prize (2009), the Addis Gold medal by the International Society of Renal Nutrition and Metabolism (ISRNM) for nutritional research (2010) and was the National Kidney Foundation international awardee in 2012. As a fellow of the European Renal Association, he has also received the ERA-EDTA prize for outstanding educational contribution (2017). He is a member of the council of International Society of Nephrology and an associate Editor of Nephrology Dialysis Transplantation (NDT) as well as previously its editor-in-chief. He has received an honorary membership of the Australian and New Zealand Society of Nephrology 2010 and of the Polish Society of Nephrology in 2012. His Hirsch index is 92 according to PubMed and 118 according to Google Scholar. About Karolinska Institutet Karolinska Institutet is one of the world's leading medical universities. Its vision is to advance knowledge about life and strive towards better health for all. Karolinska Institutet accounts for the single largest share of all academic medical research conducted in Sweden and offers the country's broadest range of education in medicine and health sciences. The Nobel Assembly at Karolinska Institutet selects the Nobel laureates in Physiology or Medicine. For more information on Karolinska Institutet, please visit SOURCE Invizius

Italfarmaco Group, based in Milan, Italy, is making headway against Duchenne muscular dystrophy (DMD). The company announced positive results from the Phase III EPIDYS study assessing Givinostat, a histone deacetylase (HDAC) inhibitor that received a Rare Pediatric Disease Designation from the U.S. Food and Drug Administration. The study met its primary endpoint, a positive change from baseline in the time to climb four stairs at 18 months compared to placebo. The results demonstrated a slower decline in performing this functional task in the Givinostat-treated group. Additionally, the company noted that key secondary endpoints were also met, consistent with the primary endpoint. Givinostat continued to demonstrate a tolerability pro line with previous studies. In all, the study results show that the addition of Givinostat to steroid treatment leads to clinical benefits for DMD patients. Italfarmaco intends to submit the data to the FDA as well as European regulators for potential approval. Additionally, the company will present the results of the Phase III study for publication in a peer-reviewed journal. “These topline Phase III results in DMD add to the growing dataset we have collected over the last years which have shown positive outcomes with our investigational therapeutic candidate, Givinostat, when taken together with steroids in patients with DMD, providing new hope for boys with DMD, their families and the medical community,” Paolo Bettica, chief medical officer of Italfarmaco Group said in a statement. “There is a tremendous unmet medical need for additional drugs to treat this debilitating rare disease and with these positive results, we intend to meet with regulatory agencies to share these findings and discuss a path forward to submit the complete dataset in a marketing application for potential approval.” Elsewhere around the Globe: Clover Biopharmaceuticals: Based in Shanghai, Clover announced new positive clinical data in individuals who have received a third dose of SCB-2019 (CpG 1018/Alum) as a homologous booster against the Omicron variant of COVID-19. The third dose demonstrated a significant, 19-fold increase in neutralizing antibody levels against the Omicron BA.2 variant compared to pre-booster levels among baseline seronegative participants. Immutep Limited: Australia’s Immutep announced new data from second-line non-small cell lung cancer patients in the Phase II TACTI-002 trial will be presented at the IASLC 2022 World Conference on Lung Cancer in August. EnGeneIC: Also based in Australia, EnGeneIC, is conducting studies of its COVID-19 vaccine that it says provides immunity against all known variants. Trials have shown the novel vaccine works by stimulating an entirely different immune pathway from other vaccines, producing “high affinity” antibodies that neutralize all COVID-19 variants, EnGeneIC said. Thirty-two healthy participants received two doses three weeks apart. Of those, 27 have passed the 28-day safety assessment with no side effects. Critically, they all have high-affinity antibodies capable of neutralizing all COVID-19 mutants, including Omicron. Noema Pharma: Switzerland-based Noema’s Investigational New Drug Application for a Phase IIb study of the company’s PDE10A inhibitor gemlapodect has been greenlit by the U.S FDA. The company will evaluate the drug candidate in Childhood Onset Fluency Disorder, also known as stuttering. The Phase IIb study is expected to read out at the end of 2023. Treos Bio Limited: Based in London, Treos Bio announced the dosing of its first patient in the Phase II OBERTO 301 study of PolyPEPI1018, the company’s lead product candidate. In the trial, PolyPEPI1018 is being combined with atezolizumab, Roche’s PD-L1 inhibitor, for the treatment of patients with late-stage microsatellite stable metastatic colorectal cancer. Ixaka Ltd.: Also based in London, Ixaka Ltd. and Germany’s Minaris Regenerative Medicine GmbH have signed an agreement that enables technology transfer and clinical and commercial manufacture of REX-001, Ixaka’s lead autologous multi-cell therapy. REX-001 is being developed for the treatment of chronic limb-threatening ischemia in patients with diabetes. The scope of the manufacturing agreement includes the scale-up and technology transfer with the goal of supplying the Phase II clinical trials and supporting commercial supplies in the EU and later in the United States. Xenikos B.V.: Located in The Netherlands, Xenikos enrolled the first patient in its pivotal Phase III trial, comparing T-Guard with ruxolitinib for the treatment of patients with Grade III or IV steroid-refractory acute graft-versus-host disease following allogeneic hematopoietic stem cell transplant. Xenikos expects the data from this study to support the submission of a Biologics License Application in the U.S. based on Day 28 data from the first 150 patients. Cyxone: Sweden’s Cyxone filed a submission to the National Institute of Pharmacy and Nutrition, the Hungarian Medical Product Agency, for approval for a Phase IIb study assessing drug candidate rabeximod as a potential treatment for rheumatoid arthritis. Applications will follow this first submission to relevant regulatory authorities in other European countries, the company said. Transgene: Based in France, Transgene and Sweden’s BioInvent International AB announced positive safety and progress in the ongoing Phase I/IIa study assessing BT-001 in patients with solid tumors, including melanoma. The initial data generated in Phase I part A demonstrated that BT-001 alone is well tolerated, with first signs of anti-tumor activity in a hard-to-treat population. BT-001 is based on Transgene’s oncolytic vector and is encoding BioInvent’s proprietary anti‑CTLA‑4 antibody. Confo Therapeutics: Belgium’s Confo Therapeutics has been awarded a €1.7 million grant from Flanders Innovation & Entrepreneurship that will support its discovery programs for novel GPCR candidates with its proprietary ConfoBody technology. MRM Health: Also based in Belgium, MRM Health announced it received regulatory approval from the Federal Agency for Medicines and Health Products in Belgium to initiate a Phase II trial with the novel next-generation optimized consortium therapy, MH002, in patients with Pouchitis, inflammation of the surgically constructed pouch following colectomy. SciSparc Ltd.: Israel-based SciSparc announced that it completed the development of its top-tier drug candidate SCI-110, which will be used in its upcoming Phase IIb study. "Our singular objective in developing SCI-110 is to develop a safe and effective treatment for this devastating, unmet medical need as soon as possible; and this milestone brings us one step closer," SciSparc CEO Oz Adler said.