Abametapir

NEW YORK, Sept. 14, 2022 /PRNewswire/ -- Gameto, a biotechnology company using cell engineering to develop therapeutics for diseases of the female reproductive system, today announced that it has raised an additional $17 million in funding from global software investor Insight Partners, Future Ventures, Arcadia Investment Partners, Bold Capital Partners, Plum Alley, Myelin VC, TA Ventures, Gaingels, Korify Capital, and other existing investors. The new financing brings the total capital raised since inception to $40M. Gameto's underlying cell engineering platform was developed in stealth under a scientific research agreement with George Church's lab at Harvard Medical School. In January, Gameto announced plans for three sequenced programs. The first program, Fertilo, is a biologic for IVF and egg freezing, aiming to make the process shorter, safer, and more effective. The following programs include Deovo, an organoid of the female reproductive system, and Ameno, a cell-based therapeutic to ameliorate the health consequences of primary ovarian insufficiency and menopause. Fertilo is a biologic for egg maturation derived from engineered ovarian supporting cells to facilitate a lower hormonal burden during IVF and egg freezing. This will allow women to obtain eggs in a shorter, more natural process without the risk of ovarian hyperstimulation syndrome. Currently, egg maturation drugs are hormone-based and the process is long, and expensive, with potential side effects. Gameto aims to bring to market a new mechanism of action to both reduce the number of hormonal injections and improve the efficacy of the process. Fertilo has entered preclinical development in partnership with leading clinics in the US and in Spain, the largest ART [Assisted Reproductive Technology] market in Europe. Partner clinics include Extend Fertility, RMA, Pozitivf, Ovation Fertility, Clinica Tambre, and Hospital Ruber Internacional. Inception Fertility™ (Inception), the largest provider of comprehensive fertility services in North America, also recently launched a study with Gameto to identify new techniques to improve in-vitro maturation. Through its ancillary brands, Inception serves as a mechanism to draw participants from its ecosystem of companies to take part in this and other groundbreaking studies that will elevate sciences and advancements in ART. Inception's network of fertility clinics, The Prelude Network® (Prelude), is the largest network to partner with Gameto, as it has over 85 locations across North America. Prelude was also founded by Gameto co-founder and chairman Martin Varsavsky. "Gameto is developing novel treatments across fertility and women's health, leveraging its proprietary technology to create a robust pipeline of compelling products," said Dylan Morris, Managing Director at Insight Partners. "We are excited to partner with the Gameto team as they translate their transformational developments into therapies that will ultimately improve human lives." "We're thrilled to have Insight join us in our mission to create novel therapies that improve women's lives," said Dr. Dina Radenkovic, CEO of Gameto. "Infertility is one of the first manifestations of accelerated ovarian decline. I'm incredibly excited that Gameto's technology could enable much cheaper, safer, faster, and more effective egg freezing and IVF. Our program Fertilo could help give women the power to have families at our own pace, when and how we want to do so." In order to support preclinical testing, Gameto has significantly expanded its global footprint with a headquarters and laboratory in New York and a European office in Madrid. Simultaneously, Gameto has formed a Bioethics committee composed of Professor Alta Charo, the Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin–Madison and a leading American authority on bioethics; Leslie Schrock, author, entrepreneur, and angel investor working at the convergence of health and technology, primarily in women's and family health; and Andrew McLaughlin, former Deputy Chief Technology Officer of the United States, to ensure that Gameto's developments are used for positive change. About Gameto: Based in New York and Madrid, Gameto is a biotechnology company using cell engineering to develop therapeutics for diseases of the female reproductive system. Gameto brings together an experienced scientific management team with vision and passion to develop groundbreaking products for women's health. Gameto is led by physician-turned-entrepreneur Dina Radenkovic as CEO and serial entrepreneur and leader in the fertility space Martin Varsavsky as Chairman. For more information, go to gametogen.com or follow us on Twitter @gametogen. About Insight Partners: Insight Partners is a global software investor partnering with high-growth technology, software, and Internet startup and ScaleUp companies that are driving transformative change in their industries. As of June 30, 2022, the firm has over $80B in regulatory assets under management. Insight Partners has invested in more than 700 companies worldwide and has seen over 55 portfolio companies achieve an IPO. Headquartered in New York City, Insight has offices in London, Tel Aviv, and Palo Alto. Insight's mission is to find, fund, and work successfully with visionary executives, providing them with practical, hands-on software expertise to foster long-term success. Insight Partners meets great software leaders where they are in their growth journey, from their first investment to IPO. For more information on Insight and all its investments, visit insightpartners.com or follow us on Twitter @insightpartners. SOURCE Gameto

· 81.5% of subjects treated with Xeglyze™ Lotion were free of lice following a single application and without nit combing · Xeglyze™ Lotion demonstrated to be safe and well tolerated with no treatment related serious adverse events · New Drug Application with FDA expected in the first half of 2015 · Xeglyze™ Lotion registered as a new trademark MELBOURNE, Australia--(BUSINESS WIRE)--Specialty pharmaceutical company Hatchtech Pty Ltd today announced positive results from its two pivotal Phase 3 clinical studies evaluating Xeglyze™ Lotion (formerly DeOvo Lotion) as a potential treatment for head lice infestation. Both studies achieved the pre-defined primary and secondary endpoints and were conducted according to a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Hatchtech conducted two Phase 3 studies, enrolling a total of 704 subjects across 14 clinical study sites in the United States. The studies were double-blind, randomized, multi-center, vehicle-controlled, parallel-group and treated subjects with an active head lice infestation aged six months and older. The studies were designed to assess the efficacy, safety and tolerability of a single application of Xeglyze™ Lotion compared to a vehicle lotion, when applied to the scalp and hair for ten minutes at home. The results were assessed in follow up visits to the clinical study sites 1, 7 and 14 days following application. The Phase 3 studies demonstrated that a single, ten minute application of Xeglyze™ Lotion results in a statistically significant increase in the proportion of subjects who are cleared of lice compared with the vehicle lotion. They showed 81.5%1 of patients who received only one application of Xeglyze™ Lotion and without nit-combing remained lice free at all follow up visits through to the day 14 visit, which was the primary efficacy endpoint as agreed with the FDA. The secondary efficacy endpoint was the proportion of subjects who were lice free at the Day 1 visit and the Day 7 visit. The studies showed 90% of subjects were lice free after just one day following treatment with Xeglyze™ Lotion, and 88% were lice free after 7 days. There were no serious adverse events related to treatment with Xeglyze™ Lotion, and no subject discontinued either study due to an adverse event. Reported adverse events were predominantly mild or moderate in nature and the product was well tolerated. Based on research conducted at the University of Melbourne by Hatchtech’s founder Dr Vern Bowles, the active ingredient of Xeglyze™ Lotion, abametapir, was selected in 2005 as a lead compound, targeting key biological pathways of the lice life cycle, including the lice egg. Xeglyze™ Lotion is different to other head lice treatments by treating both eggs and the lice, meaning repeat applications and nit combing are not required. In addition, Xeglyze™ Lotion has a different mechanism of action with no known resistance. There is a need for novel treatments given that head lice have developed resistance to many currently available products. “The successful eradication of a head lice infestation involves treating the lice as well as the eggs. Nit combing has traditionally been the only truly effective way of controlling the eggs and thus reinfestation. The results of these studies demonstrate that Xeglyze™ Lotion is effective at eliminating a head lice infestation in 81.5% of subjects, but most importantly with only one application and without nit combing” commented, Dr Lydie Hazan, CEO of Axis Clinical Trials in Los Angeles, and a Principal Investigator on one of the Phase 3 studies. Dr Hazan is a respected head lice expert and has been involved in the development of a number of head lice products. Hatchtech CEO, Hugh Alsop said: “This is a very exciting result, providing clear evidence in support of the safety and efficacy of Xeglyze™ Lotion, as well as the superior commercial potential of the product. Success with these studies now places Hatchtech in a strong position to seek marketing approval in the US as well as accelerate our plans for the commercialisation of Xeglyze Lotion. The company remains on track to New Drug Application with the US Food and Drug Administration in the first half of 2015.” About Hatchtech Hatchtech Pty Ltd is an Australian specialty pharmaceutical product company developing technology for the control of invertebrate pests. The Company’s lead product is Xeglyze™ Lotion, a class-leading head lice control agent that aims to overcome the frustrating, costly and inconvenient cycles of re-treatment experienced currently by children and their parents. Hatchtech is a privately owned company whose investors include Uniseed, GBS Venture Partners, Queensland Biotechnology Fund, University of Melbourne Endowment Trust, Australian Super, Blue Sky Alternative Investments and the OneVentures Innovation Fund. The OneVentures Innovation Fund and GBS are supported by the Australian Government through the IIF program. About Xeglyze™ Lotion Hatchtech is developing Xeglyze™ Lotion, a single dose, single treatment, prescription product which addresses a significant unmet need for more effective head lice treatments. It is unique in that the product has been shown through clinical and in-vitro studies to kill both live lice and their eggs, in a single ten minute treatment – welcome news for any parent who has had to spend hours ‘nit combing’ their child’s hair following multiple lice treatments, as is often required with the products available on the market today. 1 81.1% for study 001 and 81.8% for study 002. Contacts For more information, please contact Hatchtech Pty Ltd Hugh Alsop, +61 (0) 439 080 353 CEO halsop@hatchtech.com.au or Buchan Consulting Gabriella Hold, + 61 3 8866 1203 ghold@buchanwe.com.au Help employers find you! Check out all the jobs and post your resume.