Breeze Bio, Inc.

With fresh funding and a new name, BreezeBio has hit a key inflection point, CEO Kunwoo Lee told FirstWord; the company is "shifting from platform validation to product advancement."Formerly GenEdit, the biotech raised a $60-million series B on Wednesday to advance its lead programme, BRZ-101, toward IND-enabling studies. The experimental diabetes treatment is designed to re-educate the immune system to stop attacking pancreatic beta-cell antigens and instead recognise them as "self." The strategy behind BRZ-101, Lee said, is to address the autoimmune driver of diabetes instead of its metabolic consequences. The candidate delivers mRNA-encoded autoantigens, along with tolerogenic co-factors, to antigen-presenting cells, promoting the induction of antigen-specific regulatory T cells without triggering broad immune suppression. "Our approach is mechanistically distinct in that it aims to intervene at the level of antigen-specific immune recognition," Lee said. "The therapeutic benefit is preservation of the remaining beta cells and some restoration of beta cell function."BreezeBio believes that if BRZ-101 is given to a patient with pre-diabetes, they may never need to use insulin. As a diabetes treatment, the company thinks it could help patients more easily maintain blood glucose levels with insulin, and have better long-term health outcomes. From platform to productAlongside its internal pipeline, BreezeBio is building out its NanoGalaxy platform, which features thousands of chemically distinct hydrophilic nanoparticles (HNPs) designed to overcome the capacity, selectivity, immunogenicity and manufacturing challenges faced by traditional methods of delivering genetic payloads such as viral vectors. The company has demonstrated targeted delivery to the immune, cardiac, pulmonary, and central nervous systems.Two years ago, the biotech struck a deal with Roche's Genentech unit to discover and develop HNPs to deliver nucleic acid-based medicines for autoimmune diseases, and simultaneously closed a $24-million series A1 round. Since then, BreezeBio has "advanced NanoGalaxy from a delivery-focused platform into the foundation of a product-driven company," Lee said. The firm also prioritised development of BRZ-101, but now with the programme nearing the clinic, BreezeBio has hit the point where it needs to re-up on funding, given the costs to scale manufacturing, finish preclinical testing and prepare for clinical development. The series B, led by new investors Yuanta Investment and DSC Investment, will help the company move BRZ-101 forward, advance additional programmes in autoimmune disease and oncology, and improve the precision and targeting capabilities of NanoGalaxy, Lee said. BreezeBio is expanding the platform's toolkit, conjugating the nanoparticles to ligands that can facilitate delivery to T cells, enabling in vivo CAR-T development (see – see Spotlight On: Big pharma's big bets on in vivo cell therapy). SV investment, Kiwoom Investment, STIC Ventures and Top Harvest Capital also participated in the round, alongside existing investors DAYLI Partners, Pathway Investment, Loftyrock Investment, Korea Investment Partners, WOORI Venture Partners, KDB Silicon Valley and ACVC Partners.

Dive Brief:Genetic medicines maker BreezeBio said Wednesday it raised $60 million in a Series B round, backed by more than a dozen investors across Asia and the U.S.Formerly known as GenEdit, the South San Francisco, California-based startup was built around an alternative method of delivering gene-based medicines that involves specialized nanoparticles. The company has changed its name to reflect a newfound push to develop its own treatments, with a focus on autoimmune diseases and oncology.BreezeBios lead program, codenamed BRZ-101, is designed to coerce the body into stifling the damaging autoimmune response in Type 1 diabetes. The company is advancing that therapy this year into the final preclinical studies that come before human testing.Dive Insight:BreezeBio has spent a decade sharpening a delivery technology it refers to as NanoGalaxy.Founded by CEO Kunwoo Ryan Lee and other researchers at the University of California, Berkeley, the startup was one of many to emerge with plans to broaden the reach of genetic medicine. Its goal was to develop a new way to send genetic cargo into the body one that could break beyond the limitations of modified viruses or tiny lipid spheres.As GenEdit, the company made progress on that front. It developed specialized polymer nanoparticles now known as NanoGalaxy able to shepherd genetic instructions to a range of different tissues in the body. Notably, those particles can be designed to precisely target specific organs, and have the potential to be dosed multiple times. The approach caught the attention of Sarepta Therapeutics, Editas Medicine and Genentech, all of which signed collaboration deals with the company.Kunwoo Ryan Lee is the CEO and co-founder of BreezeBio, formerly known as GenEdit.Permission granted by BreezeBioAccording to Lee, that work encouraged the startup to change course to develop its own therapies. The company raised funding to support that effort and has set its sights on autoimmune disease, an area its been focusing on with Genentech.“The biggest impact everyone is looking for is delivering therapeutics that can change the patient's life,“ Lee said. “We have been doing it with our partners, but now with the additional capital, we are going to our own pipeline as well.“BRZ-101 effectively delivers into certain immune cells blueprints for antigens and other substances that promote immune tolerance. Those cells then train the body to oppress the destructive inflammation occurring in Type 1 diabetes, Lee said. Type 1 diabetes occurs when the immune system mistakenly wipes out insulin-producing beta cells. No curative treatment currently exists.The Series B cash will also help BreezeBio broaden its technology, so it can start developing in vivo cell therapies as well. Such capabilities have become increasingly popular of late among both young biotechnology companies and large pharmaceutical firms seeking new ways to treat autoimmune conditions.The funding round was co-led by Yuanta Investment and DSC Investment, and included firms such as SV Investment, Kiwoom Investment and Dayli Partners. '

Resolution had previously raised £22m in Series A funding in 2020. Image credit: Watchara Ritjan / Shutterstock. Resolution Therapeutics has raised £63.5m ($83.3m) in a Series B financing round to develop its macrophage cell therapies. The UK-based company plans to use the money to finance the Phase I/II EMERALD trial for its lead candidate, RTX001, as a treatment for end-stage liver disease. Resolution also intends to direct the funds to expand its pipeline in other inflammatory and fibrotic indications, including graft-vs-host disease (GvHD) and lung fibrosis. RTX001 is an engineered autologous macrophage cell therapy. Macrophages act as effector cells of the innate immune system and play an important role in mediating inflammation and eliminating foreign organisms. RTX001 is designed to decrease fibrosis and inflammation in patients with end-stage liver disease. The open-label Phase I/II EMERALD trial will evaluate the therapy in the indication, with recruitment expected to start across the UK and Spain by the end of the year. The trial’s primary endpoint will measure clinical events including all-cause mortality. Resolution previously raised £22m in Series A funding in 2020. Both financing rounds were led by Syncona , a UK-based investment fund. Sycona has a portfolio of pharmaceutical startups , including iOncura, which raised $86m in Series B in June. See Also: BMS receives FDA approval for Opdivo to treat NSCLC Advancing Pharmaceutical Security: The Role of SECURtracers in On-Dose Authentication Another company developing macrophage therapies is Carisma Therapeutics . The company’s portfolio consists of chimeric antigen receptor macrophage and monocyte (CAR-M) therapies. In September, Carisma signed a discovery and licensing agreement with Moderna for two CAR-M therapies for treating autoimmune diseases. The cell and gene therapy market is forecasted to be worth over $81bn by 2029, as per GlobalData’s sales and forecast database. Multiple companies have invested in bolstering their cell and gene therapy pipeline. GlobalData is the parent company of Pharmaceutical Technology . In December 2023, AstraZeneca signed a $1.2bn deal to acquire China-based Gracell Biotechnologies. Gracell’s lead asset is a dual B cell maturation antigen (BCMA) and CD19-targeting CAR-T cell therapy, GC01F. The therapy is being investigated in multiple indications including multiple myeloma and systemic lupus erythematosus (SLE). Earlier this year, Genentech signed a $644m collaboration agreement with biotech GenEdit to use the latter’s non-viral delivery platform for gene editing therapies against autoimmune diseases. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy