Université Libre de Bruxelles

Claude Nicaise, M.D. appointed Chairman of the BoardAUSTIN, Texas, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced it has concluded its search for a Chief Executive Officer and that its Board of Directors has named Richard (Rick) Barry as CEO. Mr. Barry has served as a director of Cassava since June 2021. On July 17 of this year, the Board appointed him Executive Chairman of the Board and the Company’s principal executive officer and while undertaking a now completed search for a permanent CEO. In keeping with the company’s pledge to follow good governance principles, the Company is separating the positions of CEO and Chairman by appointing Claude Nicaise, M.D. as its Chairman. Dr. Nicaise has served as a director of Cassava since December 2023. During his career, he has held clinical and regulatory leadership roles that have resulted in 14 new drug approvals in various diseases areas, including neuroscience. Dr. Nicaise was a Senior Vice President of Strategic Development and Global Regulatory Affairs at Alexion Pharmaceuticals from 2008 to 2014. From 1983 to 2008, Dr. Nicaise served in various positions of increasing responsibility at Bristol-Myers Squibb, including senior positions such as Vice President of Global Development and Vice President of Worldwide Regulatory Science and Strategy. Dr. Nicaise received his M.D. from the Université Libre de Bruxelles in Belgium. Commenting on the Board’s unanimous appointment of Mr. Barry as CEO, Dr. Nicaise said: “To say Rick hit the ground running would be an understatement. He has strengthened the Company’s policies and procedures to ensure that the Company is acting with transparency, accountability, and the highest ethical business practices, while never losing sight of the company’s purpose—the development of a potentially effective treatment for Alzheimer’s disease. Mr. Barry added, “There are few things I can think of that would be as important as working on a treatment for Alzheimer’s disease. Since being named the Company’s principal executive officer, I have received countless communications from the families of Alzheimer patients expressing the importance of our work to them and to their families. We are acutely aware of this at Cassava, and that fact drives us every day.” “According to the National Library of Medicine, an estimated 6.7 million Americans aged 65 and older are living with Alzheimer's dementia today. This number could grow to 13.8 million by 2060 barring the development of medical breakthroughs to prevent, slow, or cure the disease. Alzheimer's remains the fifth-leading cause of death among Americans aged 65 and older. More than 11 million family members and other unpaid caregivers provided an estimated 18 billion hours of care to people with Alzheimer's or other dementias in 2022. The total number of people who have been touched by this disease—the families of those with Alzheimer’s—is significantly higher,” he said. “As I have learned from my prior work and investments in life sciences, the people who succeed are those who put patients first,” Mr. Barry added. “I have witnessed this firsthand at Cassava. I could not be more impressed by the people here who have dedicated their careers to improving the lives of Alzheimer’s patients and their families. “Our first Phase 3 trial,” he continued, “is expected to read out by year end 2024, with 804 patients randomized 1:1 between simufilam and placebo. Top-line results for the second Phase 3 trial of 1,125 patients (randomized 1:1:1 between two dose levels of simufilam and placebo) is expected by mid-2025.” “While we believe in our science and that we will be successful, ultimately the data will determine that.” About Cassava Sciences, Inc.Cassava Sciences is a clinical-stage biotechnology company based in Austin, Texas. Our mission is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. For more information, please visit: https://www.CassavaSciences.com For More Information Contact: Sitrick And Company1-800-550-7521Mike_Sitrick@Sitrick.comSeth Lubove: slubove@sitrick.comNY: Rich Wilner: rwilner@sitrick.com 800-699-1481 Cautionary Note Regarding Forward-Looking Statements: This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that may include but are not limited to statements regarding: the design, scope, conduct, continuation, completion, intended purpose, or future results of our on-going Phase 3 program of simufilam in patients with Alzheimer's disease; the treatment of people with Alzheimer’s disease dementia; the safety or efficacy of simufilam in people with Alzheimer’s disease dementia; comments made by our employees regarding simufilam, drug effects, and the treatment of Alzheimer’s disease; and potential benefits, if any, of our product candidates. These statements may be identified by words such as “anticipate,” “believe,” “could,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” and other words and terms of similar meaning. Such statements are based largely on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct or complete clinical studies on expected timelines, the ability to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates, the apparent ability of simufilam to favor patients with mild Alzheimer’s disease; the apparent safety or tolerance of simufilam in our open-label clinical trials; our current expectations regarding timing of clinical data for our Phase 3 studies; any expected clinical results of Phase 3 studies; the treatment of people with Alzheimer’s disease dementia; and comments made by our employees regarding simufilam, drug effects, and the treatment of Alzheimer’s disease; potential benefits, if any, of our product candidates and including those described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 and Quarterly Report on Form 10-Q for the period ended June 30, 2024, and future reports to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this news release. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC's website at www.sec.gov. All our pharmaceutical assets under development are investigational product candidates. These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety, efficacy or other desirable attributes, if any, have not been established in any patient population. Consequently, none of our product candidates are approved or available for sale anywhere in the world. Our clinical results from earlier-stage clinical trials may not be indicative of future results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish. We are in the business of new drug discovery and development. Our research and development activities are long, complex, costly and involve a high degree of risk. Holders of our common stock should carefully read our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q in their entirety, including the risk factors therein. Because risk is fundamental to the process of drug discovery and development, you are cautioned to not invest in our publicly traded securities unless you are prepared to sustain a total loss of the money you have invested.

NEW YORK, April 9, 2024 /PRNewswire/ -- Gameto, a female-led biotechnology company with a mission to redefine women's healthcare, today provided an update on its clinical program for their lead asset, Fertilo, their novel investigational in vitro maturation (IVM) solution containing engineered ovarian support cells (OSC-IVM) to mature eggs outside of the body, and recent additions to its management team and scientific and clinical advisors. Clinical highlights Following productive discussions with the U.S. Food and Drug Administration (FDA), Gameto received tentative approval to proceed to Phase 3 trials, subject to the completion of certain assay and manufacturing requirements. This Phase 3 trial is a critical step toward a Biologic License Application (BLA) approval, with pregnancy assessed at 12 weeks of gestation as the primary efficacy endpoint. "This is a significant milestone in our journey to bring innovative treatment options to patients, and we are fully committed to meeting the rigorous standards set by the FDA to advance our product through the final phases of clinical development," said Dr. Dina Radenkovic, Chief Executive Officer and co-founder of Gameto. "IVF is a relatively new field and navigating the regulatory pathways in this industry poses unique challenges. We are grateful to the agency for their guidance and excited to have a defined path towards a potential BLA approval and market authorization in the U.S." As part of its discussions with the FDA, Gameto submitted preclinical animal data showing use of Fertilo did not lead to abnormalities in live births of mice. Mice born from eggs matured with Fertilo showed no genetic, developmental, or behavioral abnormalities, and overall no significant differences between live births compared to traditional IVM. Gameto presented these initial results at the 2023 American Society for Reproductive Medicine Congress. The manuscript describing these data is available on a preprint server at https://www.biorxiv.org/content/10.1101/2024.04.04.588122v1 and Gameto is submitting it for scientific peer-review for potential publication. Strengthened management team with appointment of Carlos Lejtik, M.D., as Medical Director Dr. Lejtik is a gynecologist and obstetrician, specializing in human reproduction, with over 20 years of experience. He leads the clinical adoption and medical teams at Gameto. Prior to Gameto, he had extensive experience in Medical Management at Pfizer. While at Pfizer, he planned and developed in-person and digital medical education programs for primary care physicians and specialists, collaborated with national and international key opinion leaders to develop diagnostic guidelines for various medical specialties (e.g., Women's Health, Contraception, Oncology, Central Nervous System, Dermatology, Infectious Diseases, Vaccination, and Rheumatology), successfully launched and positioned female health products such as "Duavive and Sayana," and established relationships with key associations, colleges, and medical boards. Welcoming leading reproductive medicine experts Pietro Bortoletto, M.D., M.Sc., and Michel de Vos, M.D., Ph.D., as scientific and clinical advisors Dr. Bortoletto is a board-certified reproductive endocrinologist. He is currently a Reproductive Medicine Specialist, Director of Reproductive Surgery, and Co-Director of Oncofertility Program at Boston IVF in Boston, Massachusetts. He is on staff at the Beth Israel Deaconess Medical Center Department of Obstetrics & Gynecology and a clinical instructor at the Harvard Medical School. In addition to his clinical role, Dr. Bortoletto currently serves as the Interactive Associate in Chief for Fertility & Sterility as well as Media Editor for F&S Reports. Dr. de Vos has worked as a gynecologist since 2006 and currently is a senior medical director at the Centre for Reproductive Medicine at Universitair Ziekenhuis Brussel, Belgium and an associate professor in reproductive medicine at Vrije Universiteit Brussel. In 2011, ESHRE and the European Board and College of Obstetrics and Gynaecology (EBCOG) recognized him as a subspecialist in reproductive medicine and surgery. He is a principal investigator of the FOTO (Freezing Ovarian Tissue and Oocytes) consortium, encompassing oncofertility research projects at three universities in Brussels: Vrije Universiteit Brussel (VUB), Université Libre de Bruxelles (ULB) and Université Catholique de Louvain (UCL) and he is a founding member of the Belgian Fertility Education Initiative (BFEI). "We are excited to welcome Carlos, Pietro, and Michel to the Gameto team," added Dr. Christian Kramme, Chief Scientific Officer of Gameto. "All three bring deep expertise in human reproduction, endocrinology, and women's health. They will be instrumental as Gameto enters commercial markets around the world, accelerates its growth and prepares to meet the FDA's conditions for Phase 3 trial initiation. Their experience is a great complement to our team and will help us realize our mission of filling the massive gaps in fertility medicine and improving the female reproductive journey." About Fertilo Fertilo, Gameto's lead investigational program, is a solution derived from induced pluripotent stem cells (iPSC) and designed to mature eggs outside of the body as part of minimal hormonal stimulation cycles for in vitro fertilization and egg freezing. Gameto's goal in developing Fertilo is to make fertility treatments more convenient, safer, and accessible for a wider patient population. Fertilo has received different regulatory classifications in foreign jurisdictions, and after consultation with national regulators, has been cleared for commercialization in Australia and in large markets in Latin America. About Gameto Gameto is a biotechnology company developing novel treatment solutions for women's health, starting with infertility. Gameto brings together an experienced scientific management team with the vision and passion to develop a product suite to support women throughout their reproductive journeys. Gameto's lead program, Fertilo, aims to make IVF and egg freezing shorter, safer, and more accessible through reduced hormonal injections by maturing eggs outside of the body. Gameto is led by physician-turned-entrepreneur Dina Radenkovic as CEO and serial entrepreneur and founder of North America's largest fertility network Prelude Fertility, Martin Varsavsky, as Chairman. For more information, go to gametogen.com or follow us on Twitter and Instagram @gametogen and on LinkedIn.

Awarding ceremonies to be held on June 11 at the 15th Annual IMWG Summit in Madrid, SpainMADRID, Spain, June 11, 2024 (GLOBE NEWSWIRE) -- The International Myeloma Foundation (IMF) and the International Myeloma Working Group (IMWG) are proud to announce the recipients of this year’s Robert A. Kyle Achievement Award and Brian G.M. Durie Outstanding Achievement Award. The in-person awards ceremony will be held on Tuesday, June 11, at the 15th Annual International Myeloma Working Group (IMWG) Summit in Madrid, Spain. The Robert A. Kyle Lifetime Achievement and Brian G.M. Durie Outstanding Achievement Awards are presented each year to outstanding and deserving individuals who have made significant contributions in the field of myeloma research. Both Dr. Robert A. Kyle and IMF Founder, Chief Scientific Officer, and IMWG Chairman Dr. Brian G.M. Durie warmly congratulate the 2024 Awardees and look forward to the official awards ceremony on June 11, when full recognition will be given to Drs. Kumar and Gay. “The Dr. Kyle Lifetime Achievement and Dr. Durie Outstanding Achievement Awards are prestigious awards in the field and are presented annually to investigators who have made huge contributions to the field,” said IMF Chairperson of the Board Dr. S. Vincent Rajkumar. This year’s Robert A. Kyle Lifetime Achievement Awardee is Shaji K. Kumar, MD, Professor of Medicine and Chair of the Myeloma, Amyloid, and Dysproteinemia Group at the Mayo Clinic in Rochester, MN. A Media Snippet accompanying this announcement is available by clicking on this link. Dr. Kumar has had a long and sustained impact on the field of myeloma and related disorders. He has over 600 peer-reviewed publications in the field, and has led numerous phase I, II, and III clinical trials advancing new treatments for patients with the disease. His laboratory research contributions are extensive, and include development of new targeted therapies as well as several biomarkers for response assessment and prognosis. Of particular note, he led the development of the International Myeloma Working Group response criteria, as well as established the currently used definitions for Minimal Residual Disease (MRD) in myeloma. Dr. Kumar’s research accomplishments also include contributions to understanding the role of tumor microenvironment in myeloma, mechanisms of disease progression, risk stratification of plasma disorders. In 2021, Dr. Kumar was recognized at this event with the 2021 Brian G.M. Durie Outstanding Achievement Award. “It is a great honor to be chosen for an award that bears the name of Prof. Robert A. Kyle, who is a teacher, a mentor, a colleague, and a friend to most of us in the field of plasma cell disorders and an inspiration for generations of myeloma clinicians and researchers. This recognition is, without doubt, the highlight of my career, and I am humbled by the fact that all my work has been built on the foundation laid by many individuals over decades. I am forever grateful to my mentors and colleagues at Mayo; without their help and constant encouragement, I would not have been able to succeed, and I accept this award on behalf of the entire Mayo team,” said Dr. Kumar. This year’s Brian G.M. Durie Outstanding Achievement Awardee is Prof. Francesca Gay, MD, PhD—an Associate Professor at the Department of Molecular Biotechnology and Health Sciences in the University of Torino, and a Hematologist at the SSD Clinical trials in onco-hematology and multiple myeloma, Division of Hematology, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Italy. Dr. Gay has over 150 peer-reviewed publications and has led multiple phase I, II, and III clinical trials for the treatment of myeloma. She has worked on several international multi-center projects and data analyses. Dr. Gay’s research contributions include the use of new biological molecules, monoclonal antibodies, immunotherapeutic agents, CAR T cells, and stem-cell transplantation techniques. In 2019, the International Myeloma Society presented Dr. Gay with the Bart Barlogie Young Investigator Award. She was also the recipient of the COMy Woman in Multiple Myeloma Achievement Award in 2022. “I am flattered, it is a great honor for me to receive this award. Dr. Durie dedicated his life to myeloma research and patient care and is a model to all researchers. It is a privilege for me to work with many colleagues to improve the outcome of myeloma patients. This award acknowledges the work we have been doing and goes to the whole team,” said Dr. Gay. “I think this award is a recognition for all the trials Francesca was able to design. She is brilliant and able to foresee where the myeloma therapy is headed to, and then to plan the right trial at the right moment. This is the reason why the trial she designed has been selected for the plenary last ASH,” said IMF Board Member and 2008 Dr. Kyle Lifetime Achievement Awardee Prof. Mario Boccadoro, who is also the Head of the Hematology of the Oncology Division at the University of Torino, Italy and founder of the Italian Myeloma Study Group. Dr. Rajkumar applauded Dr. Gay's exceptional achievements stating, “Dr. Gay has had a huge impact on the field, with her enduring contributions through a series of well-designed laboratory and clinical trials. I am particularly pleased that we were able to work together on several research projects on the treatment of myeloma.” IMF President & CEO and 28-year myeloma patient Yelak Biru extends his warmest congratulations and appreciation to this year’s Kyle and Durie Achievement Awardees. On Dr. Kumar receiving the Dr. Kyle Achievement Award, Yelak remarked: “As Dr. Shaji Kumar's patient, I'm overwhelmed with joy to see him honored with the Robert A. Kyle Lifetime Achievement Award by the IMF. Dr. Kumar's impact goes far beyond groundbreaking research. His empathy and care are unparalleled. He takes the time to understand his patients truly, explains complex situations in a clear and comforting way, and is always available to address any concerns. His methodical and thoughtful approach instills confidence in his patients. Dr. Kumar's research is prolific and highly respected by his colleagues – a testament to his collaborative spirit, which embodies the essence of Dr. Robert A. Kyle's legacy. This award is a well-deserved recognition of Dr. Kumar's exceptional contributions that have given hope and improved the lives of countless myeloma patients, including myself.” Yelak praised Dr. Gay for being this year’s Dr. Durie Outstanding Achievement Awardee: “On behalf of the International Myeloma Foundation (IMF) and the entire myeloma community, I am thrilled to congratulate Dr. Francesca Gay on receiving the Brian G.M. Durie Outstanding Achievement Award. Dr. Gay's dedication to research, particularly in the area of new treatment options for newly diagnosed myeloma patients undergoing autologous stem cell transplantation (ASCT), is truly inspiring. It's especially noteworthy that Dr. Gay is only the second woman to receive this prestigious award. This highlights the growing influence of female researchers in the field of myeloma, paving the way for a more inclusive and diverse future. Her collaborative spirit, evident in her work with EMN and leadership roles within multiple professional organizations, reflects the essence of Dr. Durie's legacy. The IMF is proud to recognize Dr. Gay's outstanding achievements, and we celebrate her as a role model.” ABOUT THE IMF KYLE AND DURIE ACHIEVEMENT AWARDS The Robert A. Kyle Lifetime Achievement Award honors individuals whose work have resulted in significant advances in research, treatment, and care of myeloma patients. Dr. Robert A. Kyle (Mayo Clinic—Rochester, MN) is a world-renowned myeloma expert whose “groundbreaking research has led to the discovery of significant hematologic entities—monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM),” states the American Society of Clinical Oncology (ASCO). The Brian G.M. Durie Outstanding Achievement Award recognizes excellent achievements in multiple myeloma research. Professor of Medicine, Hematologist/Oncologist, and Honoree MD at the University of Brussels, Dr. Brian G.M. Durie is the Chief Scientific Officer of the IMF. Dr. Durie is also the Chairman of the IMWG and leads the IMF’s Black Swan Research Initiative®(BSRI). ABOUT THE INTERNATIONAL MYELOMA FOUNDATION 
Founded in 1990, the International Myeloma Foundation (IMF) is the first and largest global foundation focusing specifically on multiple myeloma. The Foundation's reach extends to more than 525,000 members in 140 countries worldwide. The IMF is dedicated to improving the quality of life of myeloma patients while working toward prevention and a cure by focusing on four key areas: research, education, support, and advocacy. The IMF has conducted more than 250 educational seminars worldwide, maintains a world-renowned InfoLine, and in 2001, established the International Myeloma Working Group (IMWG), a collaborative research initiative focused on improving myeloma treatment options for patients. In 2012, the IMF launched the Black Swan Research Initiative®, a groundbreaking research project aimed at curing myeloma. The IMF can be reached at (800) 452-CURE (2873). The global website is www.myeloma.org. Media Contacts: Peter AntonPanton@myeloma.org Jason LondonJlondon@myeloma.org