AB-2100 / ArsenalBio - LARVOL DELTA

AB-2100, an Integrated Circuit T (ICT) Cell Therapy in Patients With Recurrent Clear-cell Renal Cell Carcinoma (ccRCC) (clinicaltrials.gov) - P1/2 | N=130 | Recruiting | Sponsor: Arsenal Biosciences, Inc. | Trial completion date: May 2027 ➔ Jun 2028 | Trial primary completion date: Feb 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

ArsenalBio Announces $325 Million Financing to Advance Programmable Cell Therapy Programs Through Clinical Development (Businesswire) - "Arsenal Biosciences, Inc...announced the close of an oversubscribed $325 million Series C financing round....Proceeds from the financing will be used to advance ArsenalBio’s lead programs through development as the company continues to build its pipeline of therapeutic candidates for solid tumor cancers based on its proprietary T cell engineering technology, including logic gating....The fundraising follows ArsenalBio’s recent entry into clinic with its second T cell product candidate, AB-2100, being studied in a Phase 1/2 clinical trial for clear-cell renal cell carcinoma (ccRCC). The candidate has been granted Fast Track designation by the U.S. Food and Drug Administration."

Fast track • Financing • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

AB-2100: A Novel Investigational Cell Therapy for Clear Cell Renal Cell Carcinoma (KCRS 2024) - No abstract available

Genito-urinary Cancer • Oncology • Solid Tumor

ArsenalBio Announces Presentation of Four Abstracts at ASGCT Annual Meeting Highlighting New Mechanisms for Leveraging CAR T Cells to Address Solid Tumor Cancers (Businesswire) - "Arsenal Biosciences...announced the presentation of four abstracts at the American Society of Gene + Cell Therapy (ASGCT) annual meeting in Baltimore, Md., May 7-11, 2024....Abstract 811....AB-2100 is designed to treat relapsed/refractory clear cell renal cell carcinoma (ccRCC)....These T cell functions were tested in xenograft models to study the specificity of the logic gate in addressing tumors expressing CA9 as well as both PSMA and CA9 (as the CAR T cells are designed to do). This approach was shown to be successful in overcoming the suppressive mechanisms of the tumor microenvironment and addressing ccRCC expressing both PSMA and CA9 in xenograft models."

Preclinical • Clear Cell Renal Cell Carcinoma

Arsenal Biosciences Announces First Patient Dosed in Phase 1/2 Clinical Trial of AB-2100 in Development as a Treatment for Clear-cell Renal Cell Carcinoma (Businesswire) - "Arsenal Biosciences...announced that the first patient has been dosed with AB-2100 in a multi-center, open-label Phase 1/2 clinical trial for patients with clear-cell renal cell carcinoma (ccRCC). AB-2100 utilizes ArsenalBio’s CITE (CRISPR Integration of Transgenes by Electroporation) technology to engineer T cells to selectively target the tumor and overcome the suppressive tumor microenvironment....The Phase 1/2 trial (NCT06245915) is a dose escalation study that will evaluate the safety and efficacy of AB-2100 in patients with ccRCC that either came back or did not improve after treatment with a checkpoint inhibitor and a VEGF inhibitor."

Trial status • Clear Cell Renal Cell Carcinoma

Development of AB-2100, a PSMA-Inducible Anti-CA9 Car T Cell Therapy Intended for the Treatment of ccRCC (ASGCT 2024) - "These data demonstrate that AB-2100 selectively targets tumors expressing both PSMA and CA9, and can overcome multiple suppressive mechanisms in the TME. Based on these promising preclinical data, AB-2100 is being evaluated in a phase 1/2 clinical trial for the treatment of advanced or metastatic ccRCC."

CAR T-Cell Therapy • Clear Cell Renal Cell Carcinoma • CA9 • TGFBR2

AB-2100, a PSMA-inducible CA9-specific CAR T cell product for the treatment of ccRCC provides long-term tumor responses in preclinical mouse model (AACR 2024) - "In summary, preclinical data demonstrate that AB-2100 selectively targets tumors co-expressing PSMA and CA9, and can overcome multiple suppressive mechanisms in the tumor microenvironment. These results support the evaluation of AB-2100 in the clinic for the treatment of advanced or metastatic ccRCC."

CAR T-Cell Therapy • IO biomarker • Preclinical • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor • CA9

Arsenal Biosciences Announces Presentation of Four Abstracts at AACR Annual Meeting Highlighting New CAR T-Focused Research (Businesswire) - "AB-2100 will be studied in a phase 1/2 clinical trial as a potential therapy for clear cell renal cell carcinoma (ccRCC)...AB-2100 encodes a transcriptionally regulated sequential “AND” logic gate that comprises a priming receptor (PrimeR) specific for PSMA and an inducible CAR targeting CA9 antigen, which is widely expressed on local and metastatic lesions. By targeting both, the logic gate is intended to improve the safety profile of AB-2100, because PSMA and CA9 are not often co-expressed in normal tissues. Further, AB-2100 is designed with additional functionality including short-hairpin RNAs (snRNA) against Fas and TGFBR and a synthetic pathway activator (SPA) that drives enhanced antitumor activity. This approach was shown to be successful in the eradication of ccRCC targets in xenograft models."

New P1/2 trial • Preclinical • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

AB-2100, an Integrated Circuit T (ICT) Cell Therapy in Patients With Recurrent Clear-cell Renal Cell Carcinoma (ccRCC) (clinicaltrials.gov) - P1/2 | N=130 | Recruiting | Sponsor: Arsenal Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

AB-2100, an Integrated Circuit T (ICT) Cell Therapy in Patients With Recurrent Clear-cell Renal Cell Carcinoma (ccRCC) (clinicaltrials.gov) - P1/2 | N=130 | Not yet recruiting | Sponsor: Arsenal Biosciences, Inc.

New P1/2 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Development of AB-2100, an autologous integrated circuit T (ICT) cell therapy targeting CA9 intended for the treatment of ccRCC. (ASCO-GU 2024) - "These data demonstrate that AB-2100 selectively targets tumors co-expressing PSMA and CA9, and can overcome multiple suppressive mechanisms in the TME. These results support the evaluation of AB-2100 in the clinic for the treatment of advanced or metastatic ccRCC."

IO biomarker • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • CA9 • TGFBR2

Preclinical development of AB-2100, a PSMA neovasculature-inducible CA9 CAR resistant to FASL and TGFb mediated suppression for the treatment of ccRCC (SITC 2023) - "Conclusions Preclinical data demonstrate that AB-2100 can selectively target antigens that cannot be safely targeted by conventional CARs, and overcome multiple suppressive mechanisms in the tumor microenvironment. These results support the evaluation of AB-2100 in the clinic for the treatment of advanced or metastatic ccRCC."

Preclinical • Clear Cell Renal Cell Carcinoma • Oncology • CA9 • FASLG • TGFBR2

Discovery of synthetic signaling pathway receptors that increase the potency of CAR-T cells through optimized STAT activity (SITC 2023) - "SPA-expressing T cells exhibit increased expansion and retention of effector function in the presence of chronic antigen, leading to complete clearance of large xenograft tumors at very low T cell doses. Our lead class I SPA has been incorporated into AB-2100, an Integrated Circuit T cell drug candidate designed to treat clear cell renal carcinoma (ccRCC)."

CAR T-Cell Therapy • IO biomarker • Clear Cell Renal Cell Carcinoma • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

ArsenalBio Announces Presentations Highlighting Preclinical Data on AB-1015 and AB-2100 at ASGCT Annual Meeting (Businesswire) - "Arsenal Biosciences, Inc...announced that it will present preclinical data on its integrated circuit T cell therapies, AB-1015 and AB-2100, in an oral abstract session and three posters at the American Society of Gene and Cell Therapy (ASGCT) annual meeting in Los Angeles, Calif., May 16-20, 2023....ArsenalBio’s oral abstract session will detail preclinical data on AB-1015, currently in phase 1 clinical development (NCT05617755) for patients with ovarian cancer, that incorporates ArsenalBio’s technologies designed to address the barriers to successful adoptive T cell therapy. The three posters will disclose features and findings on AB-2100, a novel integrated circuit T cell therapeutic candidate engineered for the treatment of kidney cancer. AB-2100 is ArsenalBio’s second pipeline program which is targeting the initiation of a phase 1 trial in 2024."

New P1 trial • Preclinical • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Gynecologic Cancers • Kidney Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor

A PSMA Neovasculature-Inducible CA9 CAR Resistant to FASL and TGFB Mediated Suppression for the Treatment of ccRCC (ASGCT 2023) - "Furthermore, FAS/TGFBR shRNA containing ICTs demonstrated enhanced anti-tumor activity in multiple xenograft RCC models. Collectively, these results demonstrate that PSMA x CA9 ICT cells can (i) selectively target antigens that cannot be safely targeted by conventional CARs and (ii) overcome multiple suppressive mechanisms in the tumor microenvironment."

IO biomarker • Clear Cell Renal Cell Carcinoma • CA9 • FASLG • TGFBR2

A neovasculature-inducible CA9 CAR resistant to FASL and TGFb mediated suppression for the treatment of ccRCC (AACR 2023) - "Furthermore, FAS/TGFBR shRNA containing ICTs demonstrated enhanced antitumor activity in multiple xenograft RCC models. Collectively, these results demonstrate that PSMAxCA9 ICT cells can (i) selectively target antigens that cannot be safely targeted by conventional CARs and (ii) overcome multiple suppressive mechanisms in the tumor microenvironment."

IO biomarker • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • CA9 • FASLG • TGFBR2

ArsenalBio Announces Presentation of Six Abstracts at AACR Annual Meeting Highlighting Programmable Cell Therapy Progress (Businesswire) - "Arsenal Biosciences, Inc...announced the presentation of six abstracts at the American Association for Cancer Research (AACR) annual meeting in Orlando, Fla., April 14-19, 2023....ArsenalBio will disclose features and findings of AB-2100, a novel integrated circuit T cell therapeutic candidate engineered for the treatment of clear cell renal cell carcinoma. This is the company's second pipeline program which is targeting the initiation of a phase 1 trial in 2024."

New P1 trial • Preclinical • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor