OPB-101 / Outpace Bio - LARVOL DELTA

A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Outpace Bio, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Platinum resistant • Oncology • Ovarian Cancer • Solid Tumor

A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Outpace Bio, Inc.

New P1 trial • Oncology • Ovarian Cancer • Solid Tumor

OPB-101: a mesothelin-specific CAR T cell therapy leveraging protein design to enhance T cell proliferation and persistence for the treatment of ovarian cancer (SITC 2024) - "Conclusions OPB-101 uses synergistic technologies aimed at increasing CAR-T functional persistence to enhance efficacy for the treatment of ovarian cancer. These data show that the OPB-101 technologies (OUTSPACER™ optimized MSLN CAR, OUTSMART™ IL-2/15, and OUTLAST™ OP1 regulated promoter) work together to enhance expansion, limit T cell exhaustion and allow elimination of i.p. models of ovarian cancer with as few as 50K CAR-T cells."

CAR T-Cell Therapy • IO biomarker • Oncology • Ovarian Cancer • Solid Tumor • CD8 • ENTPD1 • IL2 • MSLN • PD-1 • TIGIT

OPB-101: a mesothelin-specific CAR T cell therapy leveraging protein design to enhance T cell proliferation and persistence for the treatment of ovarian cancer (SITC 2024) - "Conclusions OPB-101 uses synergistic technologies aimed at increasing CAR-T functional persistence to enhance efficacy for the treatment of ovarian cancer. These data show that the OPB-101 technologies (OUTSPACER™ optimized MSLN CAR, OUTSMART™ IL-2/15, and OUTLAST™ OP1 regulated promoter) work together to enhance expansion, limit T cell exhaustion and allow elimination of i.p. models of ovarian cancer with as few as 50K CAR-T cells."

CAR T-Cell Therapy • IO biomarker • Oncology • Ovarian Cancer • Solid Tumor • CD8 • ENTPD1 • IL2 • MSLN • PD-1 • TIGIT

Outpace Bio to present new data on programmed CAR T cell candidate OPB-101 at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - "Outpace Bio will share updated preclinical efficacy results for OPB-101...these technologies increase CAR T persistence, enhance anti-tumor efficacy against large tumors, and support CAR T expansion across multiple MSLN-positive tumor xenograft models. In vivo tumor re-implant and CAR T serial transfer studies further demonstrate long-lived functional persistence, anti-tumor activity, and maintenance of stem and memory function in the OPB-101 cell product even after sustained anti-tumor activity in stringent xenograft mouse models."

Preclinical • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

Outpace Bio Announces $144M Oversubscribed Series B Financing to Advance AI-powered Cell Therapies into Clinical Development (GlobeNewswire) - "Outpace Bio...today announced that it has raised $144 million in an oversubscribed Series B financing....Proceeds from the financing will be used to advance multiple programmed T cell product candidates to early clinical proof-of-concept for the treatment of solid tumors. The company’s lead program OPB-101 is a mesothelin-specific chimeric antigen receptor (CAR) T cell enhanced by Outpace’s proprietary OUTSMART, OUTLAST, OUTSPACER, and OUTSAFE technologies, which is on track for IND clearance and first dosing in 2025 for patients with advanced platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. Additionally, the funds will support the expansion of Outpace’s future pipeline leveraging the company’s powerful plug-and-play technology platform."

Financing • New trial • Fallopian Tube Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

OPB-101: An optimized mesothelin-specific CAR T cell product expressing CD8-targeted IL-2/15 and engineered to resist T cell exhaustion (AACR 2024) - "In summary, OPB-101 using a regulated promoter (OP1) to dynamically express an optimized MSLN CAR, EGFRoptTM, and a CD8-targeted IL-2/15 cytokine enhances anti-tumor efficacy against solid tumors by promoting CAR expansion and persistence while limiting T cell exhaustion. These technologies allow for complete elimination of solid tumors at a low treatment dose (i.e., <250K cells) and may pave the way to more effective CAR T cell therapies for solid tumors."

CAR T-Cell Therapy • IO biomarker • Oncology • Solid Tumor • CD8 • ENTPD1 • IL2 • MSLN • PD-1 • TIGIT

Outpace Bio Announces Multiple Presentations at the 2024 American Association of Cancer Research (AACR) Annual Meeting (GlobeNewswire) - "Outpace Bio...announced that nonclinical data will be presented in three poster presentations at the upcoming 2024 American Association for Cancer Research (AACR) Meeting...The upcoming presentations highlight the Company’s progress in advancing lead pipeline program OPB-101...New data will also be presented on tumor-restricted IL-12, which is designed leveraging Outpace’s OUTSMART technology to enhance solid tumor T cell therapies and is being advanced through a collaboration between Lyell Immunopharma and Outpace...'OPB-101 is the company’s lead pipeline program and is on track for an IND submission in Q4 2024.'...A poster presentation...highlights an innovative tumor-restricted IL-12 (trIL-12) technology that delivers potent IL-12 stimulation at the tumor site while avoiding systemic exposure....trIL-12 was designed leveraging Outpace’s OUTSMART technology to rapidly auto-inactivate IL-12 after inducible secretion from engineered T cells..."

IND • Preclinical • Oncology • Solid Tumor

Building smart CAR T cell therapies: The path to overcome current challenges. (PubMed, Cancer Cell) - "We summarize the most promising technical strategies in creating an "ideal" ACT product, focusing on chimeric antigen receptor (CAR)-engineered cells. Since many requirements for effective ACT are common to most cancers, what we outline here might have a broader impact."

CAR T-Cell Therapy • Journal • Oncology

Outpace Bio to Present New Data on OutSmart IL-2/15, a CAR T Cell-Produced Designed Cytokine with Tumor-Localized Immune Cell Activity, at the 2023 Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (GlobeNewswire) - "Outpace Bio...today announced it will present advancements to its OutSmartTM platform during a poster presentation at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual meeting being held from May 16-20, 2023 in Los Angeles, CA....The data to be presented demonstrate that the OutSmart™ platform can enhance CAR T cell function via a single vector genetic module that provides both IL-2 and IL-15 activity, preferentially expanding anti-tumor immune effector cells such as NK cells and CD8+ T cells, while minimizing Treg activation via ablation of IL-2Rα binding. Precise control via novel promoters achieves local secretion of OutSmart™ IL-2/15 to enhance CAR T cell proliferation and survival, stimulates immune effector cells in the TME, and reduces potential side effects associated with systemic IL-2 exposure."

Preclinical • Oncology