Biopharma companies are preparing to unveil new data for various oncology programs at the American Association for Cancer Research (AACR) Annual Meeting in New Orleans next month.
Biopharma companies are preparing to unveil new data for various oncology programs at the American Association for Cancer Research (AACR) Annual Meeting in New Orleans next month. BioSpace takes a peek at some of the planned announcements.
Amgen – California-based Amgen will share the long-term outcomes from its CodeBreak 100 trial assessing Lumakras (sotorasib), the only KRASG12C inhibitor approved for patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Lumakras received the green light under accelerated approval from the U.S. Food and Drug Administration last year for the elusive mutation. David M. Reese, MD, head of research and development at Amgen, said the long-term data would demonstrate the clinical benefit Lumakras provides for patients. When Lumakras was approved, the company said it would continue to assess the drug in confirmatory clinical studies.
In addition to Lumakras, Amgen will provide preclinical results from AMG 794, which is a half-life extended (HLE) bispecific T-cell engager (BiTE) molecule that targets Claudin 6 (CLDN6) in NSCLC and epithelial ovarian cancer. The company will also share data on TNB-928b, a T-cell engaging bispecific antibody that uses a bivalent tumor-selective folate receptor alpha binding arm to treat ovarian cancer.
Checkmate Pharmaceuticals – Based in Cambridge, Massachusetts, will present biomarker data at the conference highlighting transcriptional signatures associated with antitumor activity in vidutolimod (vidu)-treated patients who have anti-PD-1-refractory melanoma and NSCLC. The data will be shared in a poster presentation.
Scorpion Therapeutics – Boston-based Scorpion will present preclinical proof-of-concept data for STX-H1047-PI3Kα, the company’s lead program that targets the H1047X-mutant form of phosphoinositide 3-kinase alpha (PI3Kα). Axel Hoos, MD, Ph.D., chief executive officer of Scorpion Therapeutics, noted that PI3Kα is an established cancer target and one of the most highly mutated targets in cancer. The data presented at AACR is expected to bolster the company’s plans to submit an investigational New Drug Application for STX-H1047-PI3Kα in 2023.
Gritstone bio – California’s Gritstone bio will hold an oral presentation at AACR to discuss how translational immunology data-enabled iterative development of an optimized, KRAS-specific version of an “off-the shelf” vaccine candidate. That candidate, dubbed SLATE-KRAS, is being assessed in a Phase II study in solid tumors. SLATE-KRAS includes KRASmut epitopes. Gritstone will also present two posters at the conference that review data from the individualized neoantigen program, GRANITE, and the “off-the-shelf” neoantigen vaccine program, SLATE.
Transgene – Based in France, Transgene will present a poster showing promising preliminary Phase I data for TG405, the company’s neoantigen cancer vaccine. TG405 is the first candidate from Transgene’s myvac platform, a viral vector individualized immunotherapy platform. The candidate is being assessed in two ongoing Phase I studies in patients with ovarian cancer and head and neck cancer.
Ascentage Pharma – China’s Ascentage Pharma will present the latest results from six different preclinical studies assessing the company’s five drug candidates. Ascentage’s candidates are the Bcl-2 inhibitor lisaftoclax (APG-2575) and the MDM2-p53 inhibitor alrizomadlin (APG-115) and the FAK inhibitor APG-2449, the EED inhibitor APG-5918 and the KRAS Inhibitor APG-1842.
Eli Lilly – At AACR, pharma giant Eli Lilly will present data from its pirtobrutinib and Verzenio (abemaciclib) development programs. Lilly will present data from the Phase Ib BRUIN study assessing pirtobrutinib, a non-covalent BTK inhibitor, combined with venetoclax with and without rituximab in relapsed/refractory chronic lymphocytic leukemia. Lilly said it would also present in vitro data on mechanistic insights into resistance to the therapeutic combination of CDK4/6i plus endocrine therapy. The company will showcase the ability of Verzenio to overcome that resistance when combined with endocrine therapy for the treatment of palbociclib resistant breast cancer cell lines.
Adagene Incorporated – San Diego-based Adagene will present four different posters that highlight preclinical results that showcase the potential best-in-class profiles of three differentiated preclinical product candidates: ADG138, ADG206 and ADG153. ADG138 is a HER2xCD3 bispecific TCE for solid tumors and ADG206 is an Fc engineered anti-CD137 therapy. The three candidates are in IND-enabling studies. The fourth presentation promises to introduce a new capability for Adagene’s proprietary bispecific T-cell engagers (TCEs) with CD28. The company said the presentations highlight the capabilities of its AI-drive technology platform.
Gracell Biotechnologies – A poster presentation will showcase early clinical results of a first-in-human investigator-initiated trial of Gracell’s GC502, an allogeneic CD19/CD7 dual-directed CAR-T cell therapy. GC502 is in Phase I development for multiple B-cell malignancy indications, including B-cell acute lymphoblastic leukemia (B-ALL). Gracell said GC502 leverages the dual-directed CAR design of its proprietary TruUCAR platform. The platform allows the CD19 CAR to target malignant cells, while the CD7 CAR is designed to suppress host-versus-graft rejection response.
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