APNmAb-005

Investment Supports APRINOIA’s Effort to Bring Precision Medicine to Neuroscience, Advancing APRINOIA’s Diagnostic and Therapeutic PipelinesFunding Supports APRINOIA’s Goal to Bring a Central Nervous System (CNS) Protein Degrader Candidate to Investigational New Drug (IND)-Enabling StudyProceeds also Intended to Advance APRINOIA’s Late-Stage Tau Positron Emission Tomography (PET) to a Global Single Pivotal Phase 3 Trial for Progressive Supranuclear Palsy (PSP) CAMBRIDGE, Mass., Sept. 11, 2023 (GLOBE NEWSWIRE) -- APRINOIA Therapeutics (“APRINOIA” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics and precision diagnostics for the treatment of neurodegenerative diseases, headquartered in Cambridge, MA, is pleased to announce the strategic investment by the Alzheimer’s Drug Discovery Foundation (ADDF) of approximately $4.4M. This funding is designed to advance APRINOIA’s late-stage diagnostic product candidate, a Phase 3 Tau PET tracer 18F-APN-1607 (INN: florzolotau (18F)) (“APN-1607”), as well as its emerging pre-clinical platform of CNS-targeting protein degraders, which target pathogenic tau proteins. “APRINOIA is taking a potentially promising approach to personalized medicine in Alzheimer’s disease (AD) through the development of a novel tau PET biomarker and CNS penetrant tau protein degraders that may be able to safely cross the blood-brain barrier,” says Howard Fillit, MD, Co-Founder and Chief Science Officer at the ADDF. “The ultimate goal in the treatment of Alzheimer’s is to develop new tools that support this precision medicine approach, and the advancement of new diagnostics and therapeutics in tandem will be essential to advancing the next generation of treatments for Alzheimer’s.” The microtubule-associated protein tau is one of the most abundant neuronal proteins with complex biology and pathophysiology. Accumulation of misfolded tau aggregates is a pathological hallmark of AD and several neurodegenerative diseases collectively known as tauopathies, including PSP. With the recent approval of lecanemab (LeqembiTM), the anti-amyloid antibody of Eisai Co., Ltd., and positive results from the Phase 3 trial of donanemab by Eli Lilly, another anti-amyloid antibody, patient disease staging and monitoring using tau PET imaging, will continue to grow in their importance to the field. There is a significant unmet need to develop biomarkers that can aid in the early diagnosis and differentiation of neurological disorders, attributed to the accumulation of abnormal forms of tau. With the exception of AD, there are no FDA-approved biomarkers for the diagnosis of any of the other tauopathies. Physicians, patients, and their families usually wait several years before a diagnosis can be made. APRINOIA is developing APN-1607 as a novel PET imaging agent that, unlike other tau tracers in development or approved, binds to different abnormal forms of tau with a high degree of selectivity and sensitivity. Based on a large body of clinical images acquired in over 3,000 patients with various tauopathies, APRINOIA plans to develop APN-1607 as a first-in-class PET imaging agent for the detection of tau aggregates in the brains of patients with tauopathies. Funding support from ADDF will enable APRINOIA to initiate a single pivotal, global Phase 3 study to develop APN-1607 as a novel biomarker for the early diagnosis of PSP and related tauopathies. Beyond innovative diagnostics, APRINOIA is developing innovative therapeutics. In addition to evaluating the safety of APN-mAb005 in healthy volunteers in a Phase 1 clinical trial, it is optimizing its protein degrader candidates to advance the treatment of neurodegenerative disorders. APRINOIA has assembled a library of proprietary small molecules that can bind to aggregates of tau and alpha-synuclein to enable their degradation inside brain cells. There are very few drug development efforts in neuroscience that are pursuing this potentially transformative approach. With the ADDF’s investment, APRINOIA plans to produce clinical-stage protein degraders capable of penetrating the blood-brain-barrier (BBB), to enter brain cells and clear toxic aggregated forms of tau. Specifically, the ADDF investment will support the screening and lead optimization of APRINOIA’s degrader library of small molecules that target tau in cellular assays as well as their evaluation of efficacy in animal models. The objective of this program is to select a lead candidate in preparation for IND-enabling studies in the next 12 months. ARPINOIA’s Chief Medical Officer, Bradford Navia, M.D., Ph.D., commented, “We are very excited to receive this generous investment and vote of confidence from the ADDF. This funding will further enable us to advance these critical programs toward their respective milestones. We believe both platforms will be first-in-class in the diagnosis and treatment of neurodegenerative disorders, including AD which afflicts over 50 million people worldwide. By combining highly selective diagnostics and therapeutics, we believe that precision medicine, which has transformed the diagnosis and treatment of cancer, may finally be realized for neurological disorders.” About The Alzheimer's Drug Discovery Foundation (ADDF) Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $250 million to fund over 720 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 19 countries. To learn more, please visit: http://www.alzdiscovery.org/. About APRINOIA Therapeutics Inc. APRINOIA Therapeutics Inc., is a global clinical-stage biopharmaceutical company, headquartered in Cambridge, MA, developing novel therapeutics and precision diagnostics for the treatment of neurodegenerative diseases of the brain. To learn more, please visit http://www.aprinoia.com and follow us on LinkedIn. APRINOIA Investor Contact Matt Hughesmhughes@allelecommunications.com

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.  Sanofi finds John Reed replacement to lead R&D amid wider exec changes Sanofi   Some six months after now ex-Sanofi R&D chief John Reed, M.D., Ph.D., announced his jump to Johnson & Johnson, the French pharmaceutical company has found his replacement, naming Houman Ashrafian, Ph.D., for the job. The men’s respective pedigrees are quite distinct from one another, adding to the intrigue of the new hire. Reed is an institutional R&D leader, with J&J marking the third such role in a row after Sanofi and Roche. Ashrafian is a cardiologist and investor who spent more than seven years at SV Health Investors before taking the new role. He’s been a visiting professor and head of experimental therapeutics at the University of Oxford since 2014.  Ashrafian’s appointment was one of a handful of other key exec changes made by Sanofi, with the company also parting ways with specialty care chief Bill Sibold after 12 years. Head of specialty care in North America, Brian Foard, was tapped to lead the unit on an interim basis while a search for a permanent replacement gets underway.  But that's not all! Sanofi named Emmanuel Frenehard as its new chief digital officer and created a new role for Madeline Roach, who will be the head of business operations. Fierce Pharma  Sage’s CSO and other execs depart amid large downsizing  Sage Therapeutics The writing had been on the wall for a couple of weeks that Sage would be undergoing a significant restructuring, following the FDA’s decision to greenlight Biogen-partnered lead asset zuranalone to treat postpartum depression (PPD) but not major depressive disorder (MDD). It’s a bit of quagimire in so much as the PPD approval represents the first oral treatment for people with this condition, but the MDD market had higher financial upside. In other words, the more significant breakthrough was not the more lucrative one.  Regardless, the company is laying off 40% of its team to focus resources on the commercial launch and after pausing “certain earlier-stage programs.” As part of the move, Chief Scientific Officer Al Robichaud, Ph.D., is heading for the exits, along with development chief Jim Doherty and Senior VP of Medical Affairs Mark Pollack, M.D. Replacing Robichaud is Mike Quirk, SVP of discovery research, while Doherty’s duties will be taken over by Chief Medical Officer Laura Gault, M.D., Ph.D. Fierce Biotech Ex-Editas CSO takes the helm of Aprinoia Aprinoia  Neurodegenerative-focused biotech Aprinoia is plucking a longtime industry scientist to lead the company, hiring Mark Shearman, Ph.D., as CEO. He had chaired the company’s advisory board since 2015.  The last eight years or so of Shearman’s career have been as a chief scientific officer, first at Applied Genetic Technologies Corporation and then Editas Medicine. He worked at the latter for less than two years before departing in March. Before the executive roles, Shearman spent almost six years at Merck KGaA’s healthcare wing, EMD Serono, ascending to senior vice president of global research and early development, leading the neurology therapeutic area. He also led a team of neuroscientists at Merck & Co. before that.  At Aprinoia, he’ll oversee a a pipeline of antibodies aimed at treating tau protein-based neurodegenerative diseases and associated imaging agents. The latter are farther along in development, though the company does have one phase 1-stage antibody in the works. Release > Ipsen's Howard Mayer is retiring, with Christelle Huguet set to take on his role as EVP and head of R&D on Sept. 22. Huguet has been with Ipsen since 2020, serving as SVP and head of research, external innovation and early development. Release > Flagship Pioneering has named David Khougazian as Growth Partner, helping scale the venture creation firm and its founded companies. He joins from Sanofi where he spent more than two decades in a variety of roles, including chief of staff to the CEO. Release > Boston-based Superluminal Medicines has emerged with $33 million and former Schrödinger executive Cony D'Cruz at the helm. D'Cruz, who previously served as Schrödinger's chief business officer, is also a co-founder of Superluminal and will be joined by co-founder and SVP, head of discovery Ajay Yekkirala, Ph.D.; SVP and head of engineering Yang-Ming Zhu; Senior Director of Biology Yamina Berchiche, Ph.D.; Director of Computational Chemistry Marek Orzechowski; and SVP and head of operations Murco Ringnalda. Release > After acquiring Intarcia Therapeutics’ pipeline of cardiometabolic candidates, i2o Therapeutics is also snagging the biotech’s CEO Kurt Graves as its own. With previous leadership experience at Vertex Pharmaceuticals, Novartis and Merck, Graves succeeds i2o co-founder and former CEO Ravi Srinivasan, Ph.D. Release > Almost exactly one year after taking on the top role at Evaxion Biotech, CEO Per Norlén, M.D., Ph.D., has resigned. In his place steps Christian Kanstrup, who has more than 25 years of experience in the life science industry, including the role as head of biopharma operations for Novo Nordisk. Release > Juan Pablo Frías, M.D., is joining Biomea Fusion as the company’s chief medical officer, taking the reins from Steve Morris, M.D., who will transition to the chief development officer role. Frías has held past leadership positions at Eli Lilly, Amylin Pharmaceuticals, Pfizer and Johnson & Johnson. Release > Elicio Therapeutics has hired Thian Kheoh, Ph.D., to serve as SVP of biometrics and Megan Filoon to serve as general counsel. Kheoh joins from Mirati Therapeutics, where he was VP of biometrics, while Filoon most recently served as general counsel and corporate secretary for Molecular Templates. Release > Apogee Therapeutics has appointed Rebecca Dabora, Ph.D., to be the biotech’s chief technical officer. Dabora has held similar positions at Invivyd, SwanBio Therapeutics, Aspyrian Therapeutics and Altus Pharmaceuticals and worked at Biogen and Merck earlier in her career. Release > Coeptis Therapeutics has chosen Colleen Delaney, M.D., to serve as chief scientific and medical officer. Delaney is currently a clinical professor in the pediatric hematology/oncology division of the University of Washington. Release > Clock.bio has launched out of stealth with Markus Gstöttner as CEO. Gstöttner joins the biotech focused on age-related diseases with experience as a co-founder of Meatable, a cultured meat company he started with clock.bio’s founder Mark Kotter. Release