CPTX2309 / Capstan Therap - LARVOL DELTA

AbbVie to Acquire Capstan Therapeutics, Further Strengthening Commitment to Transforming Patient Care in Immunology (AbbVie Press Release) - "AbbVie...and Capstan Therapeutics...announced a definitive agreement under which AbbVie will acquire Capstan, including CPTX2309, a potential first-in-class in vivo tLNP anti-CD19 CAR-T therapy candidate, currently in Phase 1, in development for the treatment of B cell-mediated autoimmune diseases. Additionally, AbbVie will acquire Capstan's proprietary tLNP platform technology designed to deliver RNA payloads, such as mRNA, capable of engineering specific cell types in vivo....Under the terms of the agreement, AbbVie will pay up to $2.1 billion in cash at closing to acquire Capstan, subject to certain customary adjustments."

M&A • Immunology

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Wilms Tumor, Version 2.2025. (NCCN)

NCCN guideline • Wilms Tumor

Capstan Therapeutics Announces Initiation of Phase 1 Trial of Lead In Vivo CAR-T Therapy, CPTX2309, for Treating Autoimmune Disease (Businesswire) - "Capstan Therapeutics, Inc...announced successful dosing of the first participants in its Phase 1 trial of CPTX2309, Capstan’s lead anti-CD19 in vivo CAR-T candidate, for the treatment of B cell-mediated autoimmune disorders...The Phase 1 trial will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic activity (i.e., peripheral B cell depletion and recovery) of CPTX2309 treatment in healthy volunteers at various dose levels. Preclinical studies demonstrated rapid, deep, and transient B cell depletion in blood and tissues, which supported the clinical evaluation of CPTX2309 at the planned dose levels and regimens."

Trial status • Immunology

A Study of CPTX2309 in Healthy Participants (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: Capstan Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open

A Two-Infusion Regimen with a Novel In Vivo Non-Viral Chimeric Antigen Receptor (CAR) Achieves up to 90% CD8+ T Cell Engineering and Tissue Depletion of Target Cells in Non-Human Primates (NHPs) (ASGCT 2025) - "Two infusions of CPTX2309(S), 3 days apart, resulted in rapid and deep B cell depletion in in blood evident within 24 hrs post 1st dose, paralleled by global depletion of B cells in tissues including bone marrow, spleen and lymph nodes measured on day 10 (Fig 3). A single dose of 2mg/kg appeared less effective than 2 lower-dose infusions (1mg/kg, or 1.5mg/kg, or step up dosing with 1mg/kg followed by 2mg/kg) in achieving global B cell depletion. In the effective 2-dose regimen, B cells began to recover within 3 weeks, predominantly with naïve B cells, in 5/6 animals, maintaining this profile skewed toward naïve B cells and not reaching the pre-treatment levels of total or memory B cells during the 6-week observation period (Fig 3B)."

IO biomarker • Preclinical • Immunology • CD4 • CD8 • ICOS • PD-1

Capstan Therapeutics to Participate in Upcoming Scientific Conferences and Present New Preclinical Data in Support of Lead Anti-CD19 In Vivo CAR-T Candidate, CPTX2309 (Businesswire) - "Capstan Therapeutics, Inc...announced that the Company will present at upcoming scientific conferences and showcase new preclinical data on CPTX2309, Capstan’s lead anti-CD19 in vivo CAR-T candidate, at the American Society of Gene & Cell Therapy (ASGCT) 28th Annual Meeting in New Orleans, LA."

Preclinical • Immunology

A Study of CPTX2309 in Healthy Participants (clinicaltrials.gov) - P1 | N=38 | Not yet recruiting | Sponsor: Capstan Therapeutics

New P1 trial

Profound B Cell Depletion and Repopulation with Predominantly Naïve B Cells in Non-Human Primates Achieved Through a Novel In Vivo CD8-Targeted Lipid Nanoparticle mRNA CAR (ACR Convergence 2024) - "CPTX2309 is a non-viral in vivo CAR therapy that brings together the unprecedented potency of CAR constructs with the scalability and feasibility of this novel tLNP-mRNA platform. CPTX2309-S rapidly and efficiently delivers a therapeutic anti-CD20 CAR mRNA payload to cynomolgus macaque effector T cells in vivo, resulting in highly functional CAR-engineered T cells and deep B cell depletion that is transient and featured returning cells that were predominantly of a naïve phenotype. These findings demonstrate the feasibility of this novel in vivo CAR technology and support its translation to clinic, highlighting the potential to reset the immune system in patients with B cell involved autoimmune diseases to achieve a durable, drug-free clinical response"

IO biomarker • Lipid Nanoparticle • Preclinical • Immunology • Oncology • CD27 • CD4 • CD8

A Novel Product Candidate (CPTX2309) for In Vivo mRNA Engineering of Anti-CD19 CAR T Cells Utilizing Novel CD8-Targeted Lipid Nanoparticles (ACR Convergence 2024) - "CPTX2309 is a novel in vivo CAR therapy aimed to bring together the unprecedented potency of CAR constructs with scalability and feasibility of this novel tLNP-mRNA platform. CPTX2309 rapidly, efficiently, and specifically delivers a therapeutic anti-CD19 CAR mRNA payload to human T cells resulting in highly functional CD8+ anti-CD19 CAR T cells in vitro and in vivo. These data support the development of CPTX2309 for a broad range of B cell disorders including autoimmune diseases."

CAR T-Cell Therapy • Lipid Nanoparticle • Preclinical • Immunology • Oncology • CD34 • CD8

Effective Engineering of CD8+ T Cells from Autoimmune Disease Patients Utilizing a CD8-Targeted Lipid NanoparticleEncoding an Anti-CD19 CAR mRNA(CPTX2309) (ACR Convergence 2024) - "CPTX2309 effectively engineered CD8+ T cells from autoimmune disease patients irrespective of prior treatments including immune suppressive agents, to highly express anti-CD19 CAR, and rapidly eradicate primary B cells in vitro. This may allow for broadening the applicability of CAR technology to B cell involved autoimmune diseases through in vivo engineering of anti-CD19 CAR T cells using a scalable and tunable technology devoid of cells, viral vectors or components, and obviating the need for lymphodepleting conditioning."

Clinical • Lipid Nanoparticle • Dermatomyositis • Immunology • Inflammatory Arthritis • Lupus • Myositis • Oncology • Rare Diseases • Systemic Lupus Erythematosus • CD19 • CD8

Capstan Therapeutics Presents Preclinical Data on Lead In Vivo CAR-T Candidate, CPTX2309, at American College of Rheumatology (ACR) Convergence 2024 (Businesswire) - "Capstan Therapeutics....today announced preclinical data on CPTX2309, Capstan’s lead in vivo CAR-T candidate, at the American College of Rheumatology (ACR) Convergence 2024 in Washington, D.C....'These data provide strong support to advance CPTX2309 into clinical trials in mid-2025.'...ACR Presentation Data Highlights: Treatment with CPTX2309 resulted in robust and preferential engineering of functional CD8+ CAR T cells in vitro and in small and large animal models, with up to 80% of CD8+ T cells reprogrammed to express CAR in non-human primate (NHP) models. Minimal CAR engineering was observed in CD4+ T cells and B cells....CPTX2309 effectively engineers CD8+ T cells obtained from patients with myositis, systemic lupus erythematosus, rheumatoid arthritis, scleroderma, Sjogren’s syndrome, and multiple sclerosis comparably with healthy donor cells, and irrespective of prior therapies including broadly utilized immune suppressive agents. "

New trial • Preclinical • Immunology • Multiple Sclerosis • Myositis • Rheumatoid Arthritis • Scleroderma • Sjogren's Syndrome • Systemic Lupus Erythematosus

Capstan Therapeutics to Present Preclinical Data on Lead In Vivo Chimeric Antigen Receptor (CAR)-T Candidate, CPTX2309, at American College of Rheumatology (ACR) Convergence 2024 (Businesswire) - "Capstan Therapeutics...today announced it will present preclinical data on CPTX2309, Capstan’s lead in vivo CAR-T candidate, at the American College of Rheumatology (ACR) Convergence 2024, taking place between November 14-19, 2024 in Washington, D.C....'Data presented at the conference will support the development of CPTX2309 for a potentially broad range of B cell-mediated autoimmune diseases, with the therapeutic goal of resetting a patient’s immune system in order to achieve a durable, drug-free clinical response.'"

Preclinical • Immunology

Capstan Therapeutics Announces $175M Oversubscribed Series B Financing (Businesswire) - "Capstan Therapeutics, Inc...announced the successful closing of a $175M oversubscribed Series B financing....The proceeds from the Series B financing will be used to advance CPTX2309, Capstan’s lead in vivo chimeric antigen receptor T cell (CAR-T) candidate, to early clinical proof-of-concept in autoimmune disorders, and to further develop Capstan’s tLNP pipeline."

Financing • Immunology