EVOLVE-104 / EvolveImmune Therap - LARVOL DELTA

EVOLVE104, a differentiated T cell engager targeting the novel antigen ULBP2/5/6, exhibits potent preclinical efficacy for the treatment of squamous tumors (AACR 2025) - "Thus, preclinical data demonstrate safety and efficacy of EVOLVE104 and support the upcoming Phase I clinical study.EVOLVE104, a trispecific TCE with integrated affinity-tuned CD3 binding and CD2 co-stimulation, optimizes effector T cells for anti-tumor activity. The enriched expression of its tumor antigen target, ULBP2/5/6, in primary and metastatic squamous tumors and transitional bladder cancers, together with its compelling in vitro and in vivo pharmacology and nonclinical safety profile, position EVOLVE104 as a first-in-category immunotherapy to address underserved patient populations with high unmet needs."

IO biomarker • Preclinical • Bladder Cancer • Genito-urinary Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Urothelial Cancer • CD2 • NKG2D • ULBP2

EvolveImmune Therapeutics Announces Translational Research Collaboration to Evaluate Expression of Novel Tumor Target in Muscle-Invasive Bladder Cancer (GlobeNewswire) - "EvolveImmune Therapeutics...today announced a translational research collaboration with Memorial Sloan Kettering Cancer Center (MSK) to investigate the expression of a novel tumor target, UL Binding Protein 2 (ULBP2) in muscle-invasive bladder cancer. The collaboration will leverage MSK’s world-leading capabilities in translational medicine with EvolveImmune’s expertise in T cell engager immunobiology, to accelerate the development of treatment options that address unmet medical needs in urothelial malignancies....The collaboration with MSK will generate unique observations to inform the clinical development of EVOLVE104, EvolveImmune’s first-in-class ULBP2-targeted T cell engager asset....We anticipate that insights from this collaboration will play an important role in shaping the clinical program for EVOLVE104, which remains on track to begin in 2025."

Licensing / partnership • New trial • Bladder Cancer • Urothelial Cancer

EvolveImmune Therapeutics Presents New Preclinical and Translational Data Highlighting Pipeline Progress for EVOLVE T Cell Engager Platform at 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (GlobeNewswire) - "In a second poster presentation (abstract #1339), researchers highlighted the emerging favorable preclinical pharmacokinetic and toxicity profile for EVOLVE104. While differences in the tissue expression of cynomolgus ULBPs were detected, EVOLVE104 binds with similar affinities to human and cynomolgus T cells and sustained in vivo T cell engagement of EVOLVE104 was confirmed. No safety or tolerability findings were identified, including no overt cytokine excursions even at supra-pharmacologic exposures, and no evidence for non-specific T cell activation was observed."

Preclinical • Oncology • Solid Tumor

EvolveImmune Therapeutics Presents New Preclinical and Translational Data Highlighting Pipeline Progress for EVOLVE T Cell Engager Platform at 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (GlobeNewswire) - "One poster presentation (abstract #1326) detailed EvolveImmune’s precision therapeutic strategy for its lead development candidate, EVOLVE104, a novel multi-functional T cell engager with integrated CD2 co-stimulation which conditionally targets ULBP2/5/6....Squamous cell cancers showed elevated immune infiltration compared to adenocarcinomas, and an enhanced proportion of CD2+ tumor-infiltrating lymphocytes (TILs) compared to other costimulatory receptors. Taken together these findings highlight bladder cancer, NSCLC, and head and neck cancers as among the malignancies most likely to respond to EVOLVE104, even following relapse or recurrence, and support the company’s strategy of targeting these indications in planned clinical studies."

Preclinical • Bladder Cancer • Head and Neck Cancer • Non Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma

EVOLVE104, a first-in-class ULBP2/5/6-targeting T-cell engager with integrated CD2 co-stimulation, demonstrates a favorable preclinical safety and toxicity profile in cynomolgus monkeys (SITC 2024) - "These data support the clinical development of EVOLVE104 for the treatment of solid tumors where significant unmet medical needs remain. These favorable safety and tolerability features highlight EVOLVE104's differentiated profile as a promising option for solid tumor treatments."

Preclinical • Oncology • Solid Tumor • CD2 • NKG2D • ULBP2

Precision oncology strategy for EVOLVE104, a differentiated T cell engager for the novel solid tumor target ULBP2/5/6 (SITC 2024) - "EVOLVE104 mediates T cell-redirected tumor cell lysis at H-scores comparable to those seen in most patient tumor samples. These data support the hypothesis that EVOLVE104 represents a differentiated therapeutic strategy for the treatment of bladder, lung and head and neck cancers where significant unmet medical needs remain."

Bladder Cancer • Cervical Cancer • Genito-urinary Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Urothelial Cancer • CD2 • NKG2D • ULBP1 • ULBP2

EvolveImmune Therapeutics to Present New Preclinical Data Highlighting Pipeline Progress for EVOLVE T Cell Engager Platform at 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (GlobeNewswire) - "EvolveImmune Therapeutics...announced that new preclinical data highlighting EVOLVE, the company’s novel costimulatory T cell engager platform, will be presented at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), which is being held November 6-10, 2024, in Houston, Texas....In two poster presentations, EvolveImmune will highlight the latest preclinical safety and efficacy data for EVOLVE104, a novel multi-functional T cell engager with integrated CD2 co-stimulation which conditionally targets ULBP2/5/6....EvolveImmune continues to progress its chemistry, manufacturing, and control (CMC) activities for EVOLVE104, with the goal of advancing the program into the clinic in 2025....In addition, the company will deliver an oral presentation highlighting the discovery and profiling of EVOLVE205, a highly potent CD20-targeted CD2 co-stimulatory T cell engager designed in a 2:1 bispecific format."

Preclinical • Oncology • Solid Tumor

EvolveImmune Therapeutics Provides Corporate and Program Update Highlighted by Closing of $37 Million Financing (GlobeNewswire) - "EvolveImmune Therapeutics...provided a corporate and program update related to the advancement of its pipeline of first-in-category precision immuno-oncology agents. The company announced the closing of a $37 million financing round, which was supported by existing investors including Pfizer Ventures, Solasta Ventures, and Takeda Ventures, Inc., along with new strategic investor Bristol Myers Squibb. EvolveImmune intends to use the proceeds from this fundraising to support continued platform and pipeline development including the advancement of its lead multi-functional T-cell engager program, EV-104."

Financing • Oncology

EvolveImmune Therapeutics Presents New Preclinical and Translational Data on Novel CD2 Costimulatory T Cell Engager Platform at 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (GlobeNewswire) - "EvolveImmune Therapeutics...announced that new preclinical and translational data highlighting EV-104 and EV-106, two programs utilizing EVOLVE, the company’s proprietary costimulatory T cell engager platform were presented at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)....EV-104 showed robust single-agent anti-tumor activity in patient-derived tumor models of bladder and lung cancer and demonstrated promising activity in combination with anti-PD1 therapy in pre-clinical models with patient-derived tumors, providing rationale for combination treatment approaches with checkpoint inhibitors....New findings demonstrated robust single-agent anti-tumor activity by EV-106 lead molecules in three different preclinical breast cancer cell assay systems that was superior to B7-H4-targeted CD3 T cell engagers being advanced by competitors which do not employ integrated CD2 costimulation."

Preclinical • Bladder Cancer • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Genito-urinary Cancer • Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

EVOLVE-104, a novel ULBP2-targeted T cell engager that integrates CD2 costimulation for the treatment of basal and squamous lineage tumors (SITC 2023) - "The superiority of EVOLVE-104 extended to > 1000 and > 100-fold improvements in tumor-killing IC50s compared to cisplatin and gemcitabine respectively, for 7 of 7 ULBP2 bladder cancer cell models across a range of ULBP2 surface expression levels with tumor-antigen dependent T cell activation and cytokine induction...In in vitro tumor rechallenge assays, where additional tumor cells were added during co-culture, EVOLVE-104 displayed impressive combination activity with pembrolizumab, providing a strong rationale for anti-PD-1 combination approaches...Conclusions EVOLVE-104 is highly developable as evidenced by its optimal biophysical properties, favorable pharmacokinetics, and absence of cytokine release syndrome or toxicity in cynomolgus monkeys at efficacious dose levels. EVOLVE-104 represents a first-in-category precision immunotherapeutic strategy to address aggressive solid tumors of basal and squamous lineages."

IO biomarker • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CD2 • HLA-E • ULBP2

EvolveImmune Therapeutics to Present New Preclinical and Translational Data Highlighting Precision Medicine Potential of its Novel Costimulatory T Cell Engager Platform at 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (GlobeNewswire) - "EvolveImmune Therapeutics...announced that new preclinical and translational data highlighting EVOLVE, the company’s novel costimulatory T cell engager platform, will be presented at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), which is being held November 1-5, 2023, in San Diego, California....In two poster presentations, EvolveImmune will highlight how the differentiated aspects of the EVOLVE platform are being applied to two solid tumor programs, EV-104 and EV-106."

Preclinical • Breast Cancer • Oncology • Solid Tumor

EvolveImmune Therapeutics Reports First Results from CRISPR-Cas9 T Cell Exhaustion Screening Platform at American Association for Cancer Research (AACR) Annual Meeting 2023 (GlobeNewswire) - "New data demonstrated the potential of EV-104 to rejuvenate exhausted T cells to drive more potent tumor cell killing than matched CD3 bispecific antibody controls that lack costimulatory activity. Researchers observed a 100% complete response rate for EV-104 treated animals in a CORL105 lung cancer xenograft model expressing high levels of the EV-104 tumor antigen, whereas the matched CD3 control showed limited anti-tumor efficacy. Additionally, EV-104 was well tolerated at efficacious dose levels in non-human primate studies and demonstrated acceptable pharmacokinetics."

Preclinical • Oncology • Solid Tumor

EvolveImmune Therapeutics Reports Preclinical Data Highlighting Deep and Durable Anti-Tumor Efficacy with EV-104 in Presentation at 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (GlobeNewswire) - "EvolveImmune Therapeutics...announced that new preclinical data highlighting EVOLVE™...were presented at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)....Data from in vivo models of lung cancer presented at SITC demonstrated the ability of EV-104 to generate significant and durable anti-tumor efficacy that was superior to matched CD3-bispecific antibody controls. The efficacy of EV-104 correlated with the sustained presence of activated effector tumor-infiltrating lymphocytes...Moreover, no evidence of peripheral human T cell activation and cytokine release was observed, supporting EV-104’s safety profile....'We look forward to progressing EV-104 into the clinic by early 2024'."

New trial • Preclinical • Lung Cancer • Oncology • Solid Tumor