Psychotic Disorders

None  Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.  Lonza nabs new CEO after snapping up Roche site Lonza From one Swiss CDMO to another. That’s the course Wolfgang Wienand is taking, with summer plans to jump from his role at Siegfried’s helm over to lead Lonza.  Lonza’s interim CEO Albert Baehny, who stepped up from his chair position in October after Pierre-Alain Ruffieux abruptly left, is set to retire from the CDMO giant after a transition period. The interim leader is expected to cede his chair title to Heineken Chair Jean-Marc Huët at Lonza’s annual shareholder meeting this May. Newly tapped Wienand will join Lonza after serving as Siegfried’s CEO for five years. He joined the CDMO in 2010 and held a variety of leadership roles before taking up the top spot, including chief scientific officer, head of global R&D and chief strategy officer.  The CEO announcement follows years of leadership turnover at Lonza and comes a few weeks after the CDMO unveiled a $1.2 billion acquisition of a large biologics manufacturing facility in California from Roche’s Genentech. Fierce Pharma  Amgen R&D leader jumps to Acadia Acadia Pharmaceuticals After leading R&D at Horizon Therapeutics, and then Amgen after Horizon’s $27.8 billion acquisition, Elizabeth H. Z. Thompson, Ph.D., is heading over to neuroscience-focused Acadia Pharmaceuticals.  Thompson is taking on the role of EVP and head of R&D at Acadia, which touts the only FDA-approved drug to treat hallucinations and delusions tied to Parkinson’s disease psychosis as well as the only FDA-approved drug for treating Rett syndrome. Thompson will focus on Acardia’s clinical-stage programs, which include a candidate for a genetic disorder called Prader-Willi syndrome and an Alzheimer’s disease psychosis program. Thompson joins from Amgen, where she was EVP of rare disease R&D after the October acquisition of Horizon, where Thompson led R&D activities. Years ago, from 2003 to 2014, Thompson had started her biopharma career at Amgen before going on to hold roles across AbbVie, Raptor and InterMune. Release  3 C-suite leaders depart I-Mab I-Mab I-Mab’s chief business officer Weimin Tang, chief communications officer Gigi Qi Feng and chief legal officer Richard Cheng Li have all chosen to exit the oncology biotech. The departures aren’t due to any disagreement with the company, according to a Securities and Exchange Commission filing, with all three leaders leaving to pursue other opportunities.  Lan Kang, a director of I-Mab’s board, has also resigned, citing personal reasons. Of late, the company has taken steps toward becoming a U.S.-focused biotech, beginning the process of divesting its China operations in February. I-Mab did not return Fierce Biotech’s request for comment as of the time of publication. Release  > Julie Clauss is joining Odyssey Therapeutics’ adventure as chief operating officer, the company announced this week. Joining her is Christopher Butler, who was named SVP and head of chemistry. Release  > Mosaic is painting an updated R&D future with two new hires. The biotech has named Malavi Madireddi, Ph.D., as SVP of drug discovery and Scott Glaser, Ph.D., as SVP of biologics discovery. Release  > Margaret Garin, M.D., has been named VP of clinical development at Trevi Therapeutics after working on the clinical development team at now-GSK-owned Bellus Health. Former Bellus CEO Roberto Bellini took to LinkedIn last month to advocate for his former employees following layoffs at the bought biotech. Release  > NewAmsterdam Pharma has appointed Juliette Audet to serve as the company’s chief business officer. Audet was most recently a partner at life sciences VC Forbion, where she helped build NewAmsterdam Pharma. “She was very instrumental in our founding—she and I worked together on the first financing, the series A, and has been very involved in the strategy for the company formation,” NewAmsterdam CEO Michael Davidson, M.D., told Fierce Biotech this week. “So it's exciting to see her with her talent and experience actually join the leadership team now.” Release > Zura Bio has tapped Robert Lisicki to replace founding CEO Someit Sidhu, M.D., who will stay on as a non-independent board director. Lisicki most recently worked a brief six-month stint as CEO of InCarda Therapeutics. Release  > After overseeing regulatory development at Samsung Bioepis, Luke Oh, Ph.D., is set to join NeoImmuneTech as CEO. Oh worked at the FDA prior to his executive position at Samsung. Release  > Ratio Therapeutics has called on Bill Cupelo to be chief business officer after he led the sales team at Invicro. The company also announced that D. Scott Holbrook would join its board of directors. Release  > Dutch biotech Prilenia Therapeutics has hired Jina Swartz, M.D., Ph.D., as its chief medical officer. She previously held the same role at fellow neurodegenerative-focused company, Exciva. Release  > CDMO KBI Biopharma is bringing aboard Peter Carbone as chief quality officer. He joins from the Center for Breakthrough Medicines, another CDMO where he was chief operating officer. Fierce Pharma > Former CEO of Seeker Biologics, Rand Sutherland, M.D., has been named the new CEO of Upstream Bio. The company also brought on Mike Gray as CFO and COO in addition to Lisa Fiering as SVP of people and culture. Release > Addex CEO Tim Dyer will lead a new spinout company, Neurosterix, according to an announcement this week. He has been at Addex for more than 20 years. Release > Ex-Heron Therapeutics CMO Chris Storgard, M.D., has been named chief medical officer of ADARx. Before that, he was the CMO of Fate Therapeutics. Release > Merck & Co. has a new head of human resources, naming Betty Larson for the job, according to an emailed press release. She most recently was chief people officer at GE HealthCare.  > It’s difficult to fully understand the human impact of biopharma layoffs, but Fierce Biotech calculated at least 2,398 people laid off from the 25 companies reporting numbers of employees affected for 2024’s first quarter. In total, 58 layoff rounds were recorded for the industry from January through March. Fierce Biotech

Investing in Oncology Forum 2024Van Lanschot Kempen Life Sciences Conference Swiss Biotech Day 2024LSX World Congress MADRID, Spain and BOSTON, April 05, 2024 (GLOBE NEWSWIRE) -- Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that its management will give an update on corporate progress at several international events in April. Oryzon has been invited to attend the Investing in Oncology Forum 2024, which will be held at the IVA Konferenscenter in Stockholm (Sweden) on April 10, where the company will provide a corporate update at 14:45 CET and will hold one-on-one meetings with global investors and pharmaceutical companies. Click on the link for more info about the Investing in Oncology Forum 2024 Oryzon will attend the Van Lanschot Kempen Life Sciences Conference, which will take place in Amsterdam (Netherlands) on April 16-17, where the company will maintain meetings with investors. Click on the link for more info about the Van Lanschot Kempen Life Sciences Conference Oryzon will attend the Swiss Biotech Day 2024, which will be held at the Markthalle in Basel (Switzerland) on April 22-23. The company will hold one-on-one meetings with pharmaceutical companies. Click on the link for more info about the Swiss Biotech Day 2024 Oryzon has been invited to the LSX World Congress 2024, which will be held in London (UK) on April 29-30. Oryzon will take part in the keynote plenary panel entitled “The inflation Reduction Act and its Potential Impact On EU Biotech & Pharma Companies: Demystifying the Future” on April 29 at 16:20 BST. Click on the link for more info about the LSX World Congress 2024 About OryzonFounded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company and the European leader in epigenetics, with a strong focus on personalized medicine in CNS disorders and oncology. Oryzon’s team is composed of highly qualified professionals from the pharma industry located in Barcelona, Boston, and San Diego. Oryzon has an advanced clinical portfolio with two LSD1 inhibitors, vafidemstat in CNS and iadademstat in oncology, in several Phase II clinical trials. The company has other pipeline assets directed against other epigenetic targets like HDAC-6, where ORY-4001 has been nominated as clinical candidate for the treatment of certain neurological disorders such as CMT and ALS. In addition, Oryzon has a strong platform for biomarker identification and target validation for a variety of malignant and neurological diseases. For more information, visit www.oryzon.com About Iadademstat Iadademstat (ORY-1001) is a small oral molecule, which acts as a highly selective inhibitor of the epigenetic enzyme LSD1 and has a powerful differentiating effect in hematologic cancers (see Maes et al., Cancer Cell 2018 Mar 12; 33 (3): 495-511.e12.doi: 10.1016 / j.ccell.2018.02.002.). A FiM Phase I/IIa clinical trial with iadademstat in R/R AML patients demonstrated the safety and good tolerability of the drug and preliminary signs of antileukemic activity, including a CRi (see Salamero et al, J Clin Oncol, 2020, 38(36): 4260-4273. doi: 10.1200/JCO.19.03250). Iadademstat has shown encouraging safety and efficacy data in combination with azacitidine in a Phase IIa trial in elder 1L AML patients (ALICE trial) (see Salamero et al., ASH 2022 oral presentation). Iadademstat is currently being evaluated in combination with gilteritinib in the ongoing Phase Ib FRIDA trial in patients with relapsed/refractory AML with FLT3 mutations. Beyond hematological cancers, the inhibition of LSD1 has been proposed as a valid therapeutic approach in some solid tumors such as small cell lung cancer (SCLC), neuroendocrine tumors (NET), medulloblastoma and others. In a Phase IIa trial in combination with platinum/etoposide in second line ED-SCLC patients (CLEPSIDRA trial), preliminary activity and safety results have been reported (see Navarro et al., ESMO 2018 poster). Iadademstat is being evaluated in a collaborative Phase II basket study with the Fox Chase Cancer Center (FCCC) in combination with paclitaxel in R/R neuroendocrine carcinomas, and the company is preparing a new trial in combination with immune checkpoint inhibitors (ICI) in SCLC. Oryzon has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI) to collaborate on potential further clinical development of iadademstat in different types of solid and hematological cancers; a first trial in combination with ICI in SCLC is under preparation. In total iadademstat has been dosed so far to more than 130 cancer patients in four clinical trials. Iadademstat has orphan drug designation for SCLC in the US and for AML in the US and EU. About Vafidemstat Vafidemstat (ORY-2001) is an oral, CNS-optimized LSD1 inhibitor. The molecule acts on several levels: it reduces cognitive impairment, including memory loss and neuroinflammation, and at the same time has neuroprotective effects. In animal studies vafidemstat not only restores memory but reduces the exacerbated aggressiveness of SAMP8 mice, a model for accelerated aging and Alzheimer’s disease (AD), to normal levels and also reduces social avoidance and enhances sociability in murine models. In addition, vafidemstat exhibits fast, strong, and durable efficacy in several preclinical models of multiple sclerosis (MS). Oryzon has performed two Phase IIa clinical trials in aggressiveness in patients with different psychiatric disorders (REIMAGINE) and in aggressive/agitated patients with moderate or severe AD (REIMAGINE-AD), with positive clinical results reported in both. Additional finalized Phase IIa clinical trials with vafidemstat include the ETHERAL trial in patients with Mild to Moderate AD, where a significant reduction of the inflammatory biomarker YKL40 has been observed after 6 and 12 months of treatment, and the pilot, small-scale SATEEN trial in Relapse-Remitting and Secondary Progressive MS, where anti-inflammatory activity has also been observed. Vafidemstat has also been tested in a Phase II in severe Covid-19 patients (ESCAPE) assessing the capability of the drug to prevent ARDS, one of the most severe complications of the viral infection, where it showed significant anti-inflammatory effects in severe Covid-19 patients. Vafidemstat is being investigated in neuropsychiatric disorders in two double-blind, randomized, placebo-controlled Phase IIb trials: one in schizophrenia, named EVOLUTION (recruitment ongoing), and another one in Borderline Personality disorder (BPD), named PORTICO, recently finalized, with topline data and in the process of completing the full data analysis. Based on PORTICO’s topline results, the company is planning to request an End-of-Phase II meeting with the FDA to discuss options for a registrational Phase III trial in BPD. The company is also deploying a CNS precision medicine approach with vafidemstat in genetically-defined patient subpopulations of certain CNS disorders and is preparing a clinical trial in Kabuki Syndrome patients. The company is also exploring the clinical development of vafidemstat in other neurodevelopmental syndromes. FORWARD-LOOKING STATEMENTS This communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates” and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish Comisión Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees, or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon on the date hereof. Except as required by applicable law, Oryzon does not undertake any obligation to publicly update or revise any forward‐looking statements, whether as a result of new information, future events, or otherwise. This press release is not an offer of securities for sale in the United States or any other jurisdiction. Oryzon’s securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of Oryzon’s securities to be made in the United States will be made by means of a prospectus that may be obtained from Oryzon or the selling security holder, as applicable, that will contain detailed information about Oryzon and management, as well as financial statements. IR, USIR & Media, EuropeSpainOryzonAshley R. RobinsonSandya von der WeidPatricia Cobo/Mario CorderaEmili TorrellLifeSci Advisors, LLCLifeSci Advisors, LLCAtreviaChief Business Officer+1 617 430 7577+41 78 680 05 38+34 91 564 07 25+34 673 33 97 65+34 93 515 1313arr@lifesciadvisors.comsvonderweid@lifesciadvisors.compcobo@atrevia.commcordera@atrevia.cometorrell@oryzon.com

MILWAUKEE, April 4, 2024 /PRNewswire/ -- The much-anticipated Inflammatory Brain Disorders Conference is back and being offered by Neuroimmune Foundation in collaboration with Neuroimmune Institute. Slated to captivate audiences virtually on June 22 – 23, 2024, esteemed experts, trailblazing researchers, and compassionate clinicians from across the globe will converge online to explore cutting-edge research, pioneering treatments, and collaborative endeavors aimed at revolutionizing the understanding and management of complex conditions. This year's event shines a spotlight on the forefront of medical innovation, spotlighting the burgeoning field of immunopsychiatry and recent breakthroughs in Pediatric Acute-onset Neuropsychiatric Syndrome (PANS). The conference will spotlight a transformative shift in medical understanding, acknowledging the emerging recognition of immune dysregulation in individuals grappling with OCD, psychosis, depression, anxiety, schizophrenia, and other mental health conditions traditionally approached solely from a psychiatric standpoint. Guests anticipate gaining a novel outlook on mental health, featuring discussions highlighting the role of neuroinflammation in certain psychiatric presentations, the repercussions of immune dysregulation on mental health, and innovative therapeutic approaches utilizing immunomodulation to address symptoms traditionally managed through psychotropic interventions. Enrollment for the Inflammatory Brain Disorders Conference is currently underway. We extend a warm invitation to researchers, clinicians, industry leaders, and individuals and families affected by these conditions to join us for this virtual gathering. Seize the chance to delve into cutting-edge insights at the crossroads of neuroimmunology and psychiatry. For further details and to reserve your place, please visit . About Neuroimmune Foundation: Founded in 2017, Neuroimmune Foundation is a 501(c)(3) non-profit organization dedicated to improving outcomes for individuals with inflammatory brain conditions. Neuroimmune Foundation has provided accredited Continuing Medical Education (CME) to over 5500 clinicians across the past five years and has served over 20,000 patients and families. Additionally, the Neuroimmune Foundation has funded two fellowships (UCSF and Stanford) and provided two grants to Stanford to research plaque microbiome in PANS and disease-modifying antirheumatic drugs (DMARDs) in PANS as well as funding to the Multidisciplinary Eating Disorders Research Collaborative (MEDRC) at MassGeneral Brigham (MGB) exploring inflammation-associated proteins in OCD and PANS/PANDAS. Press passes for the conference are available upon request. Contact: Kelly DeWeese Executive Assistant Neuroimmune Foundation (608)381-0367 [email protected] SOURCE Neuroimmune Foundation