CD4

Coya Therapeutics’ stock price $COYA fell more than 20% on Tuesday after the company reported Phase 2 data for its Alzheimer’s disease program, called COYA 301. Though Coya de-emphasized COYA 301 as part of an R&D reorganization last year, the company is still testing whether the program can work in combination with other therapies. COYA 301 is an IL-2 designed to “enhance the anti-inflammatory function of regulatory T cells,” or Tregs, Coya says . Researchers were measuring the drug’s safety and ability to expand the amount of Tregs in a patient’s system. The study enrolled 38 patients, with 22 in a cohort looking at every-four-week dosing and 16 in another cohort evaluating every-two-week dosing. Both cohorts had placebo arms. After 30 weeks, the every-four-week dose of COYA 301 induced significant increases in certain regulatory T cells, specifically CD4+ FOXP3+CD25 high Tregs, the company said. The p-value was p<0.05. The other dose did not see any statistically significant differences between the therapy and placebo. Whether those results translate to improvements in cognition — a more traditional Alzheimer’s biomarker — remains an open question. Coya looked at an Alzheimer’s measurement called the ADAS-Cog14 and, while it didn’t power the study for statistical significance, found a “slight” improvement of a 4.93-point difference between the every-four-week dose and placebo arms. That result was not statistically significant, clocking in with a p-value of 0.061. Coya is still evaluating the different combination therapies with which COYA 301 can best be utilized, execs said on a conference call Tuesday morning. In addition, the company is working on an IL-2/CTLA-4 program, COYA 302, that is being tested in ALS, frontotemporal dementia and Parkinson’s disease.

HOUSTON, Oct. 29, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc., (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 160+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, announced promising new findings from its artificial thymus organoid program. Recent results from the artificial thymus organoid program showed that fibroblasts and thymus-derived cell organoids can persist and function for over 50 days post-transplantation, with vascularization and the generation of a diverse array of mature T cells in animal models. The artificial thymus organoid has shown an ability to support distinct vascularization, critical for sustained functionality in vivo, while producing fully mature T cells expressing T cell receptors (TCR). Fully mature T cells differentiate into various types of cells, including CD4, CD8, T-regulatory, and gamma delta T cells, and contribute to a well-rounded immune response. The artificial thymus organoid also produces T cells with diverse TCR-beta chains that enable the recognition of a broad spectrum of antigens. "This data further supports our unique approach to using fibroblast-based organoids as potential therapeutics. Our findings to date underscore the potential of our artificial thymus organoid to restore and enhance immune function," said Hamid Khoja, Ph.D., Chief Scientific Officer. "The diverse TCR-beta repertoire, in combination with extended organoid functionality and vascularization, may provide an effective immune support platform for patients facing immune dysregulation, such as those with age-related immune decline or who have undergone chemotherapy. We are excited by this prospect and will continue our work to advance this technology toward clinical application." "We believe these findings set the stage for revolutionary advancements in immunotherapy," said Pete O’Heeron, Founder and Chief Executive Officer. "By potentially offering a fibroblast-based organoid approach capable of generating a wide array of mature and functional T cells, we aim to provide patients with a safer, more effective option than currently utilized immune modulation and restoration therapies." For more information, please visit FibroBiologics' website or email FibroBiologics at: info@fibrobiologics.com. Cautionary Statement Regarding Forward-Looking Statements This communication contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include information concerning the potential and capabilities of fibroblasts and artificial thymus organoids to persist and function post-transplantation, with vascularization and the generation of a diverse array of mature T cells, and to produce T cells with diverse TCR-beta chains, the potential of artificial thymus organoids to restore and enhance immune function and to provide for revolutionary advancements in immunotherapy, and a safer, more effective option than currently utilized immune modulation and restoration therapies. These forward-looking statements are based on FibroBiologics' management's current expectations, estimates, projections and beliefs, as well as a number of assumptions concerning future events. When used in this communication, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside FibroBiologics' management's control, that could cause actual results to differ materially from the results discussed in the forward-looking statements, including those set forth under the caption "Risk Factors" and elsewhere in FibroBiologics' annual, quarterly and current reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or furnished with the SEC and any subsequent public filings. Copies are available on the SEC's website, www.sec.gov. These risks, uncertainties, assumptions and other important factors include, but are not limited to: (a) expectations regarding the initiation, progress and expected results of our R&D efforts and preclinical studies; (b) the unpredictable relationship between R&D and preclinical results and clinical study results; (c) risks related to FibroBiologics' liquidity and its ability to maintain capital resources sufficient to conduct its business, and (d) the ability of FibroBiologics to successfully prosecute its patent applications. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and FibroBiologics assumes no obligation and, except as required by law, does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. FibroBiologics gives no assurance that it will achieve its expectations. About FibroBiologics Based in Houston, FibroBiologics is a cell therapy and regenerative medicine company developing a pipeline of treatments and seeking potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials. FibroBiologics holds 150+ US and internationally issued patents/patents pending across various clinical pathways, including disc degeneration, orthopedics, multiple sclerosis, wound healing, reversing organ involution, and cancer. FibroBiologics represents the next generation of medical advancement in cell therapy. For more information, visit www.FibroBiologics.com. Investor Relations:Nic Johnson Russo Partners212-845-4242fibrobiologicsIR@russopr.com Media Contact:Liz PhillipsRusso Partners(347) 956-7697Elizabeth.phillips@russopartnersllc.com General Inquiries:info@fibrobiologics.com

New non-human primate data show highly selective in vivo delivery of mRNA to T cells with a cell-targeted lipid nanoparticle (ctLNP) CAMBRIDGE, Mass., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Generation Bio Co. (Nasdaq:GBIO) a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, today presented data on its cell-targeted lipid nanoparticle (ctLNP) and immune-quiet DNA (iqDNA) platforms at the European Society of Gene and Cell Therapy (ESGCT) 31st Annual Congress. The company presented data showing that a single IV dose of its ctLNP delivered mRNA encoding a reporter protein to a majority of circulating T cells in non-human primates (NHPs). In the study, conducted as part of Generation Bio’s partnership with Moderna, Inc., NHPs received a single 1 mg/kg dose of ctLNP-mRNA, which transduced most T cells with balanced distribution to CD4+ and CD8+ cells. Untargeted LNPs did not elicit T cell transduction. The biodistribution of ctLNP-mRNA to the liver, spleen, lung, and monocytes was minimal. These results in NHPs confirm and improve on results from prior murine studies. Figure 1: Highly specific transduction of CD3+, CD4+, and CD8+ cells with T cell targeted ctLNP achieved following 1 mg/kg dose of ctLNP-mRNA, with no monocyte uptake above baseline “The robust and selective in vivo delivery to T cells in an NHP model gives us the conviction to pursue development of T cell targeted in vivo genetic medicines,” said Matt Stanton, Ph.D., chief science officer of Generation Bio. The company also presented updates on iqDNA, which is a partially single-stranded DNA molecule that avoids recognition by primary DNA sensors in mice and NHPs. Recent work on the iqDNA platform has focused on methods of improving protein expression, including priming second strand synthesis by encoding the promoter region as double-stranded and stabilizing iqDNA against degradation by exonucleases. Dr. Stanton added: “Our research on iqDNA continues to yield important insights into the characterization and behavior of this new molecule. We are pursuing increasingly focused areas of research to make iqDNA ready for the development of novel genetic medicines.” To learn more about the data presented at ESGCT, visit the Scientific Presentations page of Generation Bio’s website. Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for the company, including statements about the company’s strategic plans or objectives, technology platforms, research and clinical development plans, and preclinical data and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the conduct of research activities, the initiation and completion of preclinical studies and clinical trials and clinical development of the company’s product candidates; uncertainties as to the availability and timing of results from preclinical studies and clinical trials; uncertainties regarding our novel platforms and related technologies; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; challenges in the manufacture of genetic medicine products; whether the company’s cash resources are sufficient to fund the company’s operating expenses and capital expenditure requirements for the period anticipated; as well as the other risks and uncertainties set forth in the “Risk Factors” section of the company’s most recent annual report on Form 10-Kand quarterly report on Form 10-Q, which are on file with the Securities and Exchange Commission, and in subsequent filings the company may make with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof. The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date on which they were made. About Generation Bio Generation Bio is innovating non-viral genetic medicines to provide durable and redosable treatments for hundreds of millions of patients living with rare and prevalent diseases. The company is developing two distinct and complementary platforms: a potent, highly selective cell-targeted lipid nanoparticle (ctLNP) delivery system and a novel immune-quiet DNA (iqDNA) cargo produced by a scalable capsid-free manufacturing process that uses proprietary cell-free rapid enzymatic synthesis (RES). With these platforms, Generation Bio aims to develop the next wave of non-viral genetic medicines to support its mission to extend the reach of genetic medicine to more people living with more diseases, around the world. For more information, please visit www.generationbio.com. Investors and Media ContactMaren KillackeyGeneration Biomkillackey@generationbio.com857-371-4638 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3c098872-7ae4-4b14-979b-2062296d6ad2