AB821 / Asher Biotherap - LARVOL DELTA

Phase 1 clinical trial investigating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of AB821 in adult patients with locally advanced or metastatic melanoma and other solid tumor malignancies (NCT 07027488). (ASCO 2026) - P1 | "Accrual is ongoing. Specific dose levels and inclusion/exclusion criteria will be presented."

Clinical • First-in-human • IO biomarker • Metastases • P1 data • PK/PD data • Melanoma • Oncology • Solid Tumor • CD4 • CD8 • IL21 • IL21R

Asher Bio will also present the trial design from the ongoing phase 1 study of AB821, an investigational CD8-targeted IL-21 immunotherapy candidate designed to selectively deliver IL-21 activity to CD8+ T cells…at the ASCO 2026 Annual Meeting (GlobeNewswire) - "The ongoing study is evaluating AB821 as monotherapy in patients with recurrent locally advanced or metastatic melanoma and other immune-responsive solid tumors. Preliminary findings from approximately 10 patients enrolled to date suggest promising pharmacokinetic, pharmacodynamic, tolerability and clinical activity. Emerging results are consistent with preclinical data, including evidence of cis-targeting and pharmacodynamic effects on CD8+ T cells. An amendment evaluating AB821 in combination with AB248 is in development."

Clinical protocol • P1 data • Melanoma

Asher-BioAB821: AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Yale University | Not yet recruiting ➔ Recruiting

Enrollment open • Melanoma • Oncology • Solid Tumor

Asher-BioAB821: AB821 in Adult Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Yale University

New P1 trial • Melanoma • Oncology • Solid Tumor

AB821 is a CD8+ T cell selective IL-21 with enhanced bioavailability that reduces CD8+ T cell exhaustion to induce potent antitumor activity (SITC 2023) - "Overall, data from mouse and human tumors demonstrated that AB821 can specifically restore cytotoxic potential to IL-21R-expressing, exhausted CD8+ T cells. Clinical development of AB821 is planned."

IO biomarker • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • CD8 • GZMB • IL21 • IL21R • PRF1

Asher Bio Presents Promising New Preclinical Data for Cis-targeted Cancer Immunotherapy AB821 at SITC Annual Meeting (Businesswire) - "Asher Biotherapeutics...today announced new preclinical data for AB821, its CD8-targeted interleukin-21 (IL-21) immunotherapy. The data will be presented at the Society for Immunotherapy in Cancer (SITC) 38th Annual Meeting, being held in San Diego, CA on November 1-5, 2023...'We look forward to advancing AB821’s clinical development and remain on track to file an IND in the fourth quarter of 2023.'...A murine surrogate of AB821 (muAB821) demonstrated potent antitumor activity both as a monotherapy and in combination with anti-PD-1 therapy in anti-PD-1 refractory mouse tumor models....High levels of IL-21R were observed in the exhausted CD8+ T cell subset in mouse tumors and in human tumor-infiltrating lymphocytes (TILs)."

IND • Preclinical • Oncology

AB821 is a CD8+ T cell selective IL-21 with enhanced bioavailability that mediates potent anti-tumor activity, cytotoxicity, and expansion of memory CD8+ T cells (SITC 2022) - "AB821 promotes cytotoxicity and memory CD8+ T cells in the context of antigen activation and synergizes with PD1 blockade in PD1-resistant tumors. Clinical development of AB821 is planned."

IO biomarker • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor • CD4 • CD8 • GZMB • IL21 • STAT3

Asher Bio Presents New Preclinical Data at SITC 2022 Further Supporting Advancement of AB248 and AB821 as Highly Differentiated Cis-targeted Cancer Immunotherapies (Businesswire) - "In STAT3 assays with human blood leukocytes, AB821 potently activated CD8+ T cells, with 1000-fold selectivity over other IL-21 target cell types, including B cells, NK cells and CD4+ T cells. In human CD8+ T cells, AB821 activity synergized with T cell receptor (TCR) stimulation to increase CD8+ T cell cytotoxic functionality and support T cell memory. AB821’s murine surrogate, muAB821, demonstrated potent single-dose monotherapy activity down to 0.1 mg/kg in MC38 colon cancer and T3 sarcoma tumor models, and showed synergistic anti-tumor activity with anti-PD1 therapy in multiple PD1-resistant tumor models."

Preclinical • Oncology

Asher Bio to Present New Preclinical Data for CD8+ T Cell Targeted Immunotherapies, AB248 and AB821, at SITC 2022 (Businesswire) - "Asher Biotherapeutics, Inc....announced that it will present preclinical data for two of its cis-targeted immunotherapies, AB248 and AB821, at the Society for Immunotherapy in Cancer (SITC) 37th Annual Meeting, being held in Boston, Massachusetts, on November 8-12, 2022...Asher Bio plans to investigate the use of AB248 in multiple solid tumor indications as monotherapy and in combination with PD(L)-1 checkpoint inhibitors and expects to initiate a Phase 1 clinical trial in the fourth quarter of 2022....Asher Bio expects to file an investigational new drug application for AB821 in the second half of 2023."

IND • New P1 trial • Preclinical • Oncology • Solid Tumor

Asher Bio to Unveil Two New Immunotherapy Programs, a CD8+ T Cell Targeted IL-21 and a Cis-Targeted IL-2 for Cell Therapy Augmentation, at AACR Annual Meeting (Businesswire) - "Renee Greer, Ph.D., Senior Scientist, Immunology at Asher Bio, shared foundational nonclinical proof-of-concept data, demonstrating that AB821 exhibits greater than 1000-fold selectivity for CD8+ T cells over other cell types. In addition, a single dose of murine CD8-IL21 surrogate demonstrated activity in multiple syngeneic tumor models without inducing body weight loss."

Preclinical • Oncology

Asher Bio to Showcase Continued Progress with Lead Program AB248 and Growing Pipeline of Precisely-Targeted Immunotherapies at AACR Annual Meeting 2022 (Businesswire) - "Asher Biotherapeutics...today announced plans to present new data for multiple research programs across its portfolio of cis-targeted immunotherapies at the American Association for Cancer Research (AACR) Annual Meeting 2022, being held in New Orleans, Louisiana, April 8-13, 2022....Asher Bio expects to file an investigational new drug application...for AB821, its CD8-targeted IL-21 immunotherapy, in the second half of 2023."

Clinical data • IND • Oncology • Solid Tumor