Pictured: a conceptual drawing of the small extracellular vesicles, including exosomes/iStock, KS Kim Imagine a future where, instead of drugs that carry the risk of allergic responses and adverse events, materials made naturally by the human body can be used as medicine. A novel modality, exosomes might be on the cusp of making that future a reality, experts told BioSpace.Exosomes are membrane-bound sacs measuring tens of nanometers in diameter. They are produced by cells and may contain molecules such as RNA and enzymes to communicate with other cells. Since the 2010s, scientists have known that exosomes also have the potential to treat many conditions, particularly inflammatory ones.Over the past five years, investors have poured hundreds of millions of dollars into exosome-based therapeutics. Since 2018, the database clinicaltrials.gov has logged more than 100 trials involving exosomes, many of which are assessing therapeutics tailored to specific conditions like cancer.This boom has been fueled by incremental advances in research and a growing discontent with traditional cell therapies, which can be invasive, expensive and immunogenic, said Steven Stice, co-founder and CSO at Aruna Bio, which recently won FDA approval to begin clinical trials of its exosome, AB126. Exosomes appear to be compatible with the body and unlikely to be treated by the immune system as a foreign particle, potentially making them a safer alternative to cell therapy. But not everyone agrees. Are Exosomes Ready for the Clinic?Experts are divided on whether or not exosomes are ready to be used as therapeutics.Theresa Whiteside, a professor of immunology at the University of Pittsburgh who studies the use of exosomes as tumor biomarkers, does not believe exosome-based therapeutics are ready for clinical study

HOUSTON & AUSTIN, Texas--(BUSINESS WIRE)--Good Works II Acquisition Corp. (Nasdaq: GWII) (“Good Works II”), a publicly traded special purpose acquisition company (“SPAC”), and Direct Biologics, LLC (“Direct Biologics”), a late-stage biotechnology company, today announced the signing of a definitive agreement that, upon the satisfaction of all closing conditions, will result in Direct Biologics becoming a publicly traded company. Upon transaction close, which is expected to occur in the first half of 2023, the combined company will be named Direct Biologics, Inc. and shares of its common stock are expected to trade on the Nasdaq Capital Market. Cary Grossman, Chief Executive Officer of Good Works II, commented, “We formed Good Works II with the objective of partnering with an innovative private company that would benefit from our cash resources and public listing, while holding strong potential to deliver long-term returns for our shareholders. We believe Direct Biologics has all of these qualities with its proprietary extracellular vesicle technology platform designed to treat numerous conditions that involve inflammation or require tissue repair. Moreover, we believe the late stage clinical development and the clinical experience with the product candidate reduce the risk to our shareholders. In addition, we have confidence in the Direct Biologics management team to execute their strategy and advance its product candidate to clinical use with the goal of having a positive impact on human health.”