AB-1015 / ArsenalBio - LARVOL DELTA

AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients with Platinum Resistant Epithelial Ovarian Cancer (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: Arsenal Biosciences, Inc. | N=60 ➔ 19

Enrollment change • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor • BRCA1 • BRCA2 • MUC16

AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients with Platinum Resistant Epithelial Ovarian Cancer (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: Arsenal Biosciences, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor • BRCA1 • BRCA2 • MUC16

AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients With Platinum Resistant Epithelial Ovarian Cancer (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Arsenal Biosciences, Inc. | Trial primary completion date: Mar 2024 ➔ Dec 2024

Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor • BRCA1 • BRCA2 • MUC16

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 782:...To better understand the performance characteristics of AB-1015 ICT cells in human tissue, a custom multiplex immunofluorescence (mIF) assay was developed using the RNAScope platform to detect CD3 protein and mRNA transcripts of both the PrimeR and CAR portion of the circuit by in situ hybridization (ISH). After validation in xenograft models, the assay was used to detect ICTs in one on-trial tumor biopsy sample of an AB-1015 patient."

Preclinical • Ovarian Cancer

Development of a Microscopy-Based IF/ISH Assay for Detection of ICT Cells in Patients Treated with AB-1015 (ASGCT 2024) - "To date, the assay has been used to detect ICTs in one on-trial tumor biopsy sample of an AB-1015-101 patient. In conclusion, a mIF panel capable of detecting AB-1015 product in tissue was developed, with the intention of deploying this assay in future on-treatment samples for the AB-1015-101 clinical trial in ovarian cancer."

Clinical • Obesity • Oncology • Ovarian Cancer • Solid Tumor

Characterization of AB-1015 logic-gated CAR induction (ON kinetics), receptor turnover (OFF kinetics), and logic gate sensitivity to ALPG/P and MSLN (AACR 2024) - P1 | "Finally, the in vivo specificity of AB-1015 for ALPG+/MSLN+ tumors was established using a dual flank specificity model. Together, these data support the continued development of AB-1015 in a phase I clinical trial (NCT05617755)."

Oncology • Ovarian Cancer • Solid Tumor • ALPG • MSLN

Arsenal Biosciences Announces Presentation of Four Abstracts at AACR Annual Meeting Highlighting New CAR T-Focused Research (Businesswire) - "To better characterize CAR induction and receptor turnover, we conducted a series of assays, ultimately demonstrating preclinically that all PrimeR ICT cells have the potential to induce CAR. Leveraging a reductionist in vitro model system, we were also able to analyze CAR induction and receptor turnover."

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

Development of a robust manufacturing process for AB-1015, an integrated circuit T cell (ICT) products, using targeted, CRISPR integration of transgenes by electroporation (CITE) editing (SITC 2023) - "Billions of ICT cells can be generated from a single healthy donor in a semi-closed, semi-automated fashion and these ICT cells display potent anti-tumor activity in vitro and in vivo with high specificity in preclinical studies. AB-1015 is currently in Phase 1 clinical trials."

Oncology • Ovarian Cancer • Solid Tumor • CCR7 • CD4 • CD8 • IFNG

Preclinical development of AB-1015, an integrated circuit T cell therapy containing an ALPG/MSLN logic gate and FAS/PTPN2 shRNA-miR, for the treatment of ovarian cancer (SITC 2023) - P1 | "Conclusions AB-1015 is specific for ALPG/P+MSLN+, demonstrates superior potency compared with logic gated T cells alone, and is resistant to ovarian TME suppression in preclinical studies. Based on these promising preclinical data, AB-1015 is being studied in a phase I clinical trial (NCT05617755)."

Preclinical • Oncology • Ovarian Cancer • Solid Tumor • ALPG • FASLG • MSLN • PTPN2

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

Preclinical Development of AB-1015, an Integrated Circuit T Cell Therapy Containing an ALPG/MSLN Logic Gate and FAS/PTPN2 shRNA-miR, for the Treatment of Ovarian Cancer (ASGCT 2023) - P1 | "As a result, AB-1015 is capable of completely clearing these otherwise difficult-to-treat tumors in this model.In summary, AB-1015 is specific for ALPG/P+MSLN+, demonstrates superior potency, expansion, and persistence compared with logic gated T cells alone, and is resistant to ovarian TME suppression in preclinical studies. Based on these promising preclinical data, AB-1015 is being studied in a phase I clinical trial (NCT05617755) to assess the safety, pharmacokinetics, immunogenicity, and efficacy for patients with platinum-resistant ovarian cancer."

Preclinical • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • ALPG • FASLG • MSLN • PTPN2

Arsenal Bio Announces First Patient Dosed in Phase 1 Clinical Trial of AB-1015 in Development as a Treatment for Ovarian Cancer (Businesswire) - "Arsenal Biosciences, Inc...announced that the first patient has been dosed with AB-1015 in a Phase 1, first-in-human clinical trial for patients with ovarian cancer that is resistant to platinum-based regimens....Dr. Drazan will provide a business overview and update inclusive of information about the clinical trial during the company’s upcoming presentation on January 10th at the 41st Annual J.P. Morgan Healthcare Conference."

Clinical data • Trial status • Gynecologic Cancers • Oncology • Ovarian Cancer

AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients With Platinum Resistant Epithelial Ovarian Cancer (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Arsenal Biosciences, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor • ALPG • BRCA1 • BRCA2 • MSLN • MUC16

AB-1015, an Integrated Circuit T (ICT) Cell Therapy in Patients With Platinum Resistant Epithelial Ovarian Cancer (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Arsenal Biosciences, LLC

New P1 trial • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor • ALPG • BRCA1 • BRCA2 • MSLN • MUC16

CRISPR/Cas9-based integration of a large and modular cassette into a safe harbor site to improve CAR T cell therapy efficacy and safety (SITC 2022) - "Our first ICT clinical program, AB-1015, is an autologous cell product for the treatment of ovarian cancer...Conclusions CITE editing at GS94 is specific and generates highly functional ICT cells. This novel approach to engineering tumor-specific T cells enables the generation of exceptional clinical candidates that both target new cancer types and improve efficacy."

CAR T-Cell Therapy • Clinical • Oncology • Ovarian Cancer • Solid Tumor • MSLN • PTPN2

Arsenal Biosciences Closes $220 Million Series B Financing to Advance Programmable Cell Therapy Programs into Clinical Development (Businesswire) - "Arsenal Biosciences...announced the close of a $220 million Series B financing round....Proceeds from the financing will help the company expand its programmable cell therapy research activities and grow its pipeline of therapeutic candidates for solid tumor malignancies across a range of cancer indications. The fundraising comes as the company begins planning for clinical trials of its lead program AB-1015, an ovarian cancer candidate for which FDA IND clearance and first patient dosing are targeted for later this year."

Financing • IND • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor