Spinifex Pharmaceuticals Pty Ltd.

Focused on delivering highly effective vaccines against life-threatening respiratory viral infections Exclusive commercial licence to technology platform developed at The University of Queensland Industry leader Dr Emmanuel Hanon appointed Chief Executive Officer LONDON, July 21, 2022 /PRNewswire/ -- Vicebio Ltd ("Vicebio"), a biopharmaceutical company founded by medicxi in 2019, today announces its launch to accelerate the development of novel vaccines against life-threatening respiratory viral infections using its novel Molecular Clamp technology platform. This technology has been developed by Prof Paul Young, Dr Daniel Watterson, Dr Keith Chappell and their groups at The University of Queensland (UQ), Brisbane, Australia and licensed to Vicebio by UniQuest, the commercialisation company of UQ. Medicxi has so far committed €18M to progress this technology into the clinic. Dr Emmanuel Hanon, the former Head of Vaccines R&D at GSK, has been appointed as Chief Executive Officer. A vaccine's efficacy relies on its ability to stimulate the immune system with antigens in the correct conformation. Producing these proteins in such a conformation, in a form that allows long term storage and convenient administration, remains a major challenge. Vicebio is advancing its proprietary, second-generation Molecular Clamp technology capable of stabilising viral glycoproteins in "prefusion" conformation, to deliver highly protective and ready-to-use fully liquid vaccines. The Molecular Clamp technology is a patented protein tag that effectively stabilises a wide range of complex viral proteins. It has been applied to generate vaccine candidates for several viruses including SARS-CoV-2, respiratory syncytial virus (RSV), metapneumovirus and influenza. Clinical proof-of-concept has been achieved for SARS-CoV-2 with a previous version of this technology in a Phase 1 study conducted in Australia by UQ (Chappell et al., Lancet Infect Dis. 2021). Vicebio is progressing its RSV vaccine candidate (VXB-211) through preclinical and development activities with the objective to start a Phase 1 proof-of-concept clinical study during the second half of 2023. The ambition is to deliver an RSV vaccine with best-in-class efficacy as a ready-to-use fully liquid formulation. In the future, Vicebio will apply the Molecular Clamp technology to develop multivalent formulations targeting several respiratory viruses into ready-to-use single shot vaccines. Dr Emmanuel Hanon, Chief Executive Officer of Vicebio, said: "I am delighted to join Vicebio as we pursue this novel approach to vaccine development, targeting life-threatening respiratory viruses. I am impressed and grateful for the technology development and clinical data already generated by the UQ research team to advance the technology platform and am honoured to be taking their invention forward. I am truly excited about our Molecular Clamp technology, which is able to lock viral surface proteins into the optimal conformation with high immunogenicity, stability and manufacturing productivity, all crucial characteristics for vaccines that are difficult to obtain and to combine. With a strong team in place and a clinically proven technology, Vicebio has the potential to materially improve the options available to patients around the world." Dr Giovanni Mariggi, Chairman of Vicebio and Partner at medicxi, said: "We are proud of the progress to date and thankful for the fantastic work done by UQ during our collaboration since the creation of Vicebio, allowing us to attract Emmanuel, a highly respected leader in the industry and in vaccine development. Medicxi is dedicated to implementing a strategy focused on backing world-leading founders and technologies to deliver meaningful therapies and look forward to supporting Vicebio's contribution to creating the next-generation of vaccines." The Vicebio team has extensive experience in the research & development of innovative vaccines and has launched several commercially successful products using novel platform technologies. Dr Emmanuel Hanon spent 20 years at GSK and was global head of R&D at GSK Vaccines. A virologist and immunologist by training, he made critical contributions to next-generation adjuvants and their inclusion in successful vaccines for pandemic influenza, malaria and shingles. Expanding a world class team, Emmanuel is joined by UQ's Dr Keith Chappell as lead scientific advisor. Keith is an expert in structural vaccinology and one of the inventors of the Molecular Clamp technology. Two former GSK Vaccines Executives have joined Vicebio: Dr Giovanni Della Cioppa as Chief Medical Officer and Dr Jean Smal as Chief Technology Officer. Giovanni is an experienced R&D leader who led the clinical development of highly successful meningitis and influenza vaccines. Jean has global experience in vaccine R&D and manufacturing and contributed to the technical development of several highly successful vaccines as well as an adjuvant system technology platform. Dr Dean Moss, Chief Executive Officer of UniQuest, said: "This transformative UQ technology patented by UniQuest is a platform approach to develop vaccines for a range of human viruses. We are excited to see Vicebio launched out of stealth in the hands of this experienced team of vaccine leaders and with significant investment from medicxi to build a pipeline of vaccines for commercially relevant respiratory viral infections." About Vicebio Vicebio is developing novel vaccines with the aim of best-in-class efficacy and ready-to-use fully liquid formulations. Its unique Molecular Clamp technology is able to lock viral surface proteins into the optimal conformation for high immunogenicity, stability and manufacturing productivity, enabling the design of ready-to-use multivalent vaccines targeting life-threatening viruses. The Company's initial focus is on respiratory syncytial virus (RSV) targeting start of clinical studies in 2023. Vicebio was established with investment from medicxi and a licence to the Molecular Clamp technology from UniQuest, the commercialisation company of The University of Queensland, Australia. For more information, please visit: About medicxi Medicxi is a healthcare-focused investment firm with the mission to create and invest in companies across the full drug development continuum. Leveraging deep expertise in drug development and company creation spanning over two decades, medicxi invests in early and late-stage therapeutics with a product vision that can fulfill a clear unmet medical need. For more information, please visit: About UniQuest UniQuest is the commercialisation company of The University of Queensland (UQ). In partnership with UQ researchers, UniQuest creates impact through the commercialisation of UQ intellectual property. Established in 1984, UniQuest's commercialisation track record positions UQ as the leader of research commercialisation in Australasia. Notable successes include the blockbuster cervical cancer vaccine Gardasil® and start-up companies Spinifex Pharmaceuticals Inc and Inflazome Ltd, which were acquired in two of the largest university start-up exits in Australian history. UniQuest has also established the Queensland Emory Drug Discovery Initiative (QEDDI), a world-class small molecule drug discovery and development group, dedicated to translating academic biomedical research into drug candidates for partnering. For more information, please visit: SOURCE Vicebio

MELBOURNE, Australia, February 5, 2014 /PRNewswire/ -- Phase 2 trial met its primary endpoint, reduced pain in postherpetic neuralgia (PHN) versus placebo Significant patient response to EMA401 treatment and drop in pain intensity compared with placebo, meeting a key secondary endpoint First published demonstration of the therapeutic potential of angiotensin II type 2 (AT2)receptor antagonists EMA401 identified as a possible new treatment for neuropathic pain with a novel mechanism of action Spinifex Pharmaceuticals, an Australian pain drug development company, today announces that The Lancet has published the results of its Phase 2 clinical trial of its lead candidate, EMA401, in postherpetic neuralgia (PHN)[1]. EMA401 is a novel angiotensin II type 2 (AT2) receptor antagonist under development as a potential first-in-class oral treatment for chronic pain without CNS side effects. PHN is a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals. The Phase 2 trial met its primary endpoint by showing that patients randomised to EMA401 achieved a greater reduction in pain from baseline to the last week of 28 days of treatment than patients randomised to placebo. Analysing all patients randomised (intent to treat population), the mean pain intensity reduction from baseline after 4 weeks treatment was as follows: EMA401: -2.29; Placebo: -1.60; p = 0.007. A significantly greater proportion of patients on active treatment reported a more than 30% reduction in mean pain intensity score compared to baseline (i.e. responder rate) (EMA401: 57.6%; Placebo: 35.2%; p = 0.0023), meeting a key secondary endpoint. A subgroup of patients who had moderate or severe pain at study entry continued to take a single existing medicine for their PHN during the study (45% of patients in the EMA401 group and 40% of patients in the placebo group). In this subgroup, patients randomised to EMA401 achieved significantly greater pain reduction when compared to patients randomised to placebo. In addition, pain relief was also observed in those patients that were not taking a single existing medicine for their PHN. These results indicate that EMA401 may have the potential to provide relief for patients with PHN who don't achieve optimal pain relief with current treatments or who don't wish to continue with these medicines due to their side effects. EMA401 was generally safe and well tolerated with no serious treatment related adverse events reported. In a commentary also published in the Lancet[2], Dr Nanna Finnerup, of the Danish Pain Research Center, Aarhus University, described this first clinical study to evaluate the efficacy of an AT2 receptor antagonist in neuropathic pain as encouraging adding: "Most importantly, their work identifies a possible new drug for the treatment of neuropathic pain with a novel mechanism of action, and thus offers hope for patients who have insufficient pain relief with presently available drugs." 1. EMA401, an orally administered highly selective angiotensin II type 2 receptor antagonist, as a novel treatment for postherpetic neuralgia: a randomised, double-blind, placebo-controlled phase 2 clinical trial, Rice, A.S.C. et al., The Lancet, Published Online, February 5, 2014; (13)62337 2. Angiotensin II: from blood pressure to pain control, Finnerup, N. B. et al., The Lancet, Published Online, February 5, 2014; (13)62638-0 Andrew Rice, a Professor of Pain Research at Imperial College, Hon. Consultant in Pain Medicine at Chelsea and Westminster Hospital, and lead author of The Lancet paper said: "These results demonstrated EMA401 was able to significantly reduce pain in patients with postherpetic neuralgia and was well tolerated. This paper is the first publication of the clinical effects of any AT2 receptor antagonist and contributes to our understanding of the potentially important role of this new drug class in relieving chronic pain. These results are an exciting step in the development of a novel approach to the treatment of neuropathic pain and chronic pain more generally." Spinifex Pharmaceuticals' CEO Tom McCarthy said: "There is a clear need for new treatments that bring patients pain relief with fewer CNS side effects. The publication of the Phase 2 data with EMA401 in such a prestigious publication is an endorsement of the quality of our scientific development capabilities. We are pleased The Lancet, in the associated commentary, recognises the significant milestone we have achieved in translating basic science on a new pain pathway into clinical efficacy in patients. As stated in the commentary, in addition to PHN, we see broad potential for EMA401 to treat a range of chronic painful conditions such as pain due to osteoarthritis and diabetes. We look forward to delivering on the further development of EMA401." The paper is available via the following link: (13)62337/abstract. EMA401 EMA401 is an angiotensin II type 2 (AT2) receptor antagonist. The discovery that AT2 receptor antagonists offer an innovative approach to the treatment of neuropathic and inflammatory pain was originally made by Professor Maree Smith at The University of Queensland. Having acquired the technology, Spinifex has conducted a comprehensive pre-clinical and early clinical development program on EMA401. In addition to positive Phase 2 results, EMA401 has shown efficacy in a number of relevant pre-clinical models and good human safety and pharmacokinetics in Phase 1 studies. Spinifex's clinical program for EMA401 includes an ongoing Phase 2 study in the treatment of pain in patients with cancer chemotherapy. Spinifex continues to conduct research into the role of the AT2 receptor in nociceptive, inflammatory and neuropathic pain states and these fundamental studies support not only the EMA401 clinical program but also Spinifex's ongoing AT2 receptor antagonist drug discovery program. Spinifex Pharmaceuticals Spinifex Pharmaceuticals is an Australian biotechnology company developing new drug candidates for the treatment and management of pain. Established in 2005 and based in Melbourne, Spinifex has applied its world-class drug development capabilities to advance product candidates. Its lead product EMA401 is under development as a potential first-in-class oral treatment for chronic pain and related symptoms without CNS side effects. Spinifex's Phase 2 program for EMA401 includes clinical trials in a number of chronic pain conditions. Spinifex investors are GBS Venture Partners, Brandon Capital Partners, Uniseed and UniQuest. For more information please contact: Company Dr Tom McCarthy CEO Spinifex Pharmaceuticals Tel: +1-203-321-7130 Email: tom.mccarthy@spinifexpharma.com.au Media Chris Gardner/Sita Shah Citigate Dewe Rogerson Tel: +44(0)20-7638-9571 Email: sita.shah@citigatedr.co.uk SOURCE Spinifex Pharmaceuticals Help employers find you! Check out all the jobs and post your resume.