Neurogenic Inflammation

Cole, who has 25-plus years of biopharmaceutical R&D experience and was previously SVP and Head of Chemistry for 1910, will lead the company’s research in small and large molecule drug discovery BOSTON--(BUSINESS WIRE)-- 1910 Genetics, the only biotech advancing small and large molecule drug discovery with an automated, multimodal AI platform, today announced the appointment of Bridget Cole to Chief Scientific Officer. Cole, who previously served as SVP and Head of Chemistry, will lead the biotech’s scientific research operations, set and advance research priorities, and work closely with 1910’s AI leadership to guide model and platform development with her drug development expertise. This press release features multimedia. View the full release here: Bridget Cole, Chief Scientific Officer at 1910 Genetics (Photo: Business Wire) Cole has over 25 years of drug discovery and clinical development experience, helping advance compounds from lead identification through late-stage clinical trials across a wide range of therapeutic areas. Her background as a chemist and leader of medicinal chemistry teams has made her a critical part, and cultural fit, for 1910 Genetics which is focused on generating drugs with both an optimal pharmacological pro molecular basis determined upfront. “Our ambition to generate small and large molecule drugs, using a multimodal AI and data-intensive platform, requires a seasoned but progressive drug developer and team leader like Bridget,” said Jen Nwankwo, Ph.D., Founder and CEO. “As Chief Scientific Officer, Bridget will take over additional research responsibilities internally and externally, engage directly with partners on scientific R&D, and support our vision to become the next Genentech – a true innovator in advancing modern drug discovery.” Before 1910 Genetics, Cole was SVP of Drug Discovery at Nocion Therapeutics where she led lead optimization programs to develop novel therapies for conditions associated with neurogenic inflammation, including a phase 2 drug candidate for chronic cough. Prior to Nocion, Cole held several biopharmaceutical R&D leadership positions including: VP of Medicinal Chemistry at Axial Biotherapeutics, where she developed microbiome-inspired therapies for neurodegenerative conditions; VP at Flatley Discovery Lab, where she led discovery programs and helped develop two clinical candidates for cystic fibrosis; VP at Surface Logix where she directed medicinal chemistry and supported development of three clinical programs; and Associate Director of Chemistry at Pfizer. A Boston native, Cole received her bachelor's degree in chemistry from Boston University, her Ph.D. in organic chemistry from Brandeis University, and completed postdoctoral training at Boston College. She is also the co-inventor on 30 issued U.S. patents. “After an already rewarding career serving companies like Pfizer and Nocion to advance new medicines for patients, I was drawn to 1910 Genetics because of their unique approach to leveraging both wet lab data and AI methodologies for drug discovery, and, importantly, their highly talented team. I have never met anyone like Jen Nwankwo, and I love working with her and my 1910 colleagues to develop innovative solutions to merge technology with empirical biology to drive drug discovery programs,” said Bridget Cole. “I look forward to continuing to guide and grow this team as we engineer better treatments for patients and make undruggable targets a thing of the past.” Since launching in 2021, 1910 Genetics has raised $26.1 million in funding from M12-Microsoft’s Venture Fund, Playground Global, OpenAI CEO Sam Altman, and other leading investors. 1910 is currently one of the only biotech companies using Microsoft’s Azure Quantum Elements to bring quantum computing power to scientific discovery. The company continues to advance a pipeline of novel drug candidates on its own and in partnership with pharma and tech leaders. About 1910 Genetics 1910 Genetics is the only biotech company advancing small and large molecule drug discovery with an automated, multimodal AI platform. We integrate AI with three proprietary data streams – computational data, wet lab gold standard biological data and wet lab proxy biological data – to deliver novel drug candidates to leading pharma and tech partners, and advance our own pipeline for neurological, autoimmune diseases, and cancer. 1910 was launched in 2021 with a combined seed and Series A funding of $26.1M backed by M12-Microsoft’s Venture Fund, Playground Global, OpenAI’s Sam Altman, and other leading investors. We have since established our HQ and lab facilities in Boston’s Seaport District and continue to hire a world-class team. To learn more visit 1910genetics.com.

- Preclinical data demonstrates AB126, an unmodified exosome derived from neural stem cells, shows native therapeutic activity and evidence of anti-inflammatory and neuroprotective properties – - First IND anticipated in Q3 2023 for acute ischemic stroke with plans to expand AB126 platform to other neurological indications - BOSTON and ATHENS, Ga., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Aruna Bio, Inc., a leader in the development of neural exosome-based therapeutics for the treatment of neurodegenerative diseases, today announced an oral presentation at the Exosome Based Therapeutic Development Summit, being held in Boston, MA from September 5-7, 2023. The presentation features proof-of-concept data from lead program, AB126 that highlights the treatment opportunities for neural exosomes to address both acute and chronic neurological indications. AB126 is an unmodified neural-derived exosome with an innate ability to cross the blood brain barrier and shows evidence of anti-inflammatory and neuroprotective properties. “We are encouraged by our growing dataset demonstrating the potential of AB126 in its native form to reduce neuro-inflammation, provide neuroprotection, and stimulate neuro-regeneration to overcome existing challenges of CNS treatments,” said, Steven Stice, Ph.D., Founder and Chief Scientific Officer at Aruna Bio. “The pharmacology data in preclinical models, and notably in our unique pig stroke model, which we believe has more direct translation to the human condition, further de-risks and supports our clinical development path. Plans for our Phase 1b trial in patients with acute ischemic stroke are underway and we are on track to file our first IND in Q3 2023 for stroke as a model indication for acute neurological conditions. We look forward to leveraging our in-house GMP manufacturing expertise for clinical scale-up, expanding the applications of AB126 across other neurological indications and more broadly, exploring the therapeutic applications of our neural exosome platform for drug delivery.” Details and key takeaways from the presentation are as follows: AB126 degrades extracellular ATP, a major inflammatory mediatorIn a pig model for acute ischemic stroke, AB126 preserved brain tissue leading to improved functional outcomeTransient stroke model in rats demonstrated AB126 was well tolerated and showed evidence of improved outcome in GLP toxicology studiesAfter IND filing in 2023, the first-in-human Phase 1b study will be conducted in acute ischemic stroke patientsBroader application of neural exosomes: Amyotrophic lateral sclerosis (ALS) and Glioblastoma multiforme (GBM) Pilot SOD1-ALS mouse study shows that AB126 prolonged survival and reduced inflammation in the spinal cordProof-of-concept GBM mouse study demonstrates evidence that a small molecule drug can be delivered at therapeutic levels via intranasal route of administration Conference and presentation details are as follows: Presentation Title: Therapeutic Neural Exosomes for Acute & Chronic Neurological ConditionsPresenter: Emily Baker, Director, Nonclinical Research, Aruna BioSession: Assessing Approaches to IND Filing & Optimizing Analytical Methods for Clinical SuccessPresentation Date and Time: Wednesday, September 6 at 2:15 p.m. ET About Aruna Bio Aruna Bio is a leader in the development of neural exosomes for the treatment of neurodegenerative diseases. The company is utilizing its proprietary neural exosome platform and manufacturing capability to develop a pipeline of neural exosome-based therapeutics able to cross the blood brain barrier and enhance the body's anti-inflammatory, self-repair and protective mechanisms to treat a range of neurodegenerative disorders where significant unmet medical need exists today. Additionally, the company's neural exosome platform can be combined with therapeutics, such as small molecules, siRNAs and proteins, to cross the blood brain barrier and to the site of disease. Investor Contact: Corey Davis, Ph.D.LifeSci Advisors212-915-2577cdavis@lifesciadvisors.com

-Company on track to begin enrolling healthy volunteers in the second half of 2023- SAN DIEGO--(BUSINESS WIRE)-- Pipeline Therapeutics a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, today announced that the U.S. Food and Drug Administration (FDA) cleared the company to initiate its Phase 1 clinical trial of PIPE-791 in healthy volunteers. The Company’s wholly owned program, PIPE-791, is a potent, selective and brain-penetrant small molecule antagonist of the lysophosphatidic acid 1 receptor (LPA1). LPA1 is a critical element in bioactive phospholipid signaling, and is a powerful mediator of both nervous system and systemic inflammatory conditions. Specifically, LPA1 inhibition has important therapeutic potential through augmentation of remyelination and mitigation of neuro-inflammation. Multiple sclerosis (MS) is a leading indication for PIPE-791, as there are no currently approved medicines designed to prevent neuronal loss and mitigate clinical disability in MS patients. “The FDA clearance of PIPE-791’s IND marks another significant milestone for Pipeline and demonstrates our team’s continued focus and commitment to bringing precision therapies to patients with neurological diseases,” said Carmine Stengone, President and CEO of Pipeline. “PIPE-791 is our second clinical program and our first to address both remyelination and neuro-inflammation. We look forward to evaluating our first-in-class approach to LPA1 inhibition with PIPE-791, with the goal to deliver meaningful benefit to individuals with MS, as well as other neurological and systemic diseases.” Stephen Huhn, M.D., Chief Medical Officer and Senior Vice President of Clinical Development of Pipeline, added, “We are excited to initiate the Phase 1 study of PIPE-791, which is designed to assess the safety and tolerability of PIPE-791 compared to placebo in healthy volunteers. We expect to commence dosing in the second half of 2023.” The Phase 1 clinical trial of PIPE-791 will be conducted as a randomized, double-blind, placebo-controlled dose-ranging study, and enroll approximately 80 healthy volunteer subjects. About PIPE-791 The Company’s wholly owned program, PIPE-791, is advancing toward clinical development for remyelination and neuro-inflammation. PIPE-791 is a potent, selective, brain-penetrant small molecule antagonist of the LPA1 receptor that has demonstrated activity in in vitro and in vivo models and was tolerated in IND-enabling studies. Lysophosphatidic acid (LPA) is a pro-inflammatory lipid, upregulated in the plasma, peripheral blood mononuclear cells and cerebrospinal fluid of MS patients. LPA activates the G-protein coupled LPA1 receptor on both oligodendrocyte precursor cells (OPCs) and microglia resulting in a local neuroinflammatory response limiting remyelination. PIPE-791 has demonstrated in vitro evidence of oligodendrocyte differentiation, myelination, and protection from cytokine-induced oligodendrocyte cell death. In pre-clinical in vivo models, PIPE-791 has demonstrated evidence of central nervous system LPA1 receptor occupancy, increased remyelination, and inhibition of neuro-inflammation. About Pipeline Therapeutics Pipeline Therapeutics is a clinical-stage biopharmaceutical company pioneering the development and commercialization of first-in-class therapies for precision neuroregeneration including myelin restoration, synaptogenesis and axonal repair. The Company has a broad pipeline of programs to address multiple CNS disorders. In April 2023, Pipeline announced that it entered into a global license and development agreement with Janssen Pharmaceutica NV (Janssen) for its lead program, PIPE-307, a highly selective M1 antagonist, in central nervous system disorders. The Company’s second program, PIPE-791, an LPA1 receptor antagonist, has received FDA clearance of its IND and is advancing into Phase 1 testing. For more information, please visit and engage with us on LinkedIn.