IMC001 / Immunofoco - LARVOL DELTA

Augmenting expansion and tumor infiltration of chimeric antigen receptor T cells with a novel dendritic cell vaccine for solid tumors (ESGCT 2024) - "Furthermore, T-booster expressing EpCAM was shown to enhance the in vitro and in vivo efficacy of EpCAM-targeting CAR-T cells, underscoring its potential as a platform technology for various TAA. Collectively, our findings suggest that T-booster may represent a novel strategy to enhance anti-tumor efficacy of CAR-T cell therapy in solid tumors."

CAR T-Cell Therapy • IO biomarker • Gastric Cancer • Oncology • Solid Tumor • CLDN18

Preclinical development and a phase I trial of IMC001, an EpCAM-targeted CAR-T cell therapy, in patients with advanced gastric cancer. (PubMed, Mol Ther) - "One patient underwent conversion surgery at week 27 and remains alive 31.5 months post-infusion. These findings demonstrate an acceptable safety profile and promising efficacy of IMC001 in advanced GC, supporting further clinical development for refractory GC patients."

Journal • P1 data • Preclinical • Gastric Cancer • Oncology • Solid Tumor

Phase 1 trial of HCB101, a novel Fc-based anti-SIRPα-CD47 fusion protein, in subjects with advanced cancers. (ASCO 2025) - P1 | "HCB101 demonstrated an acceptable safety profile and preliminary antitumor activity in heavily pretreated advanced cancer patients. These findings support its further clinical development, including expansion cohorts to evaluate efficacy in specific tumor types or in combination with other agents."

Clinical • Metastases • P1 data • Anemia • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • SIRPA

Combination casdatifan plus cabozantinib expansion cohort of phase 1 ARC-20 study in previously treated patients with clear cell renal cell carcinoma. (ASCO 2025) - P1 | "In previously treated patients with ccRCC, casdatifan 100 mg in combination with cabozantinib 60 mg had a manageable AE profile with promising clinical activity. These data support continued evaluation of this combination in the phase 3 PEAK-1 clinical trial."

Clinical • IO biomarker • P1 data • Anemia • Clear Cell Renal Cell Carcinoma • Fatigue • Genito-urinary Cancer • Oncology • Solid Tumor • EPAS1

Phase 1/1B Study to Evaluate the Safety Of OZTX-410, Allogenic IPS Cell Derived Islet Cell Sheet in Individuals with T1D: The OASIS-1 Study Protocol (IPITA 2025) - No abstract available

Clinical • P1 data

A phase 1 study of fixed-dose regimens of serplulimab, an anti-PD-1 antibody, in patients with advanced solid tumors. (ASCO 2025) - P1 | "Fixed-dose regimens of serplulimab showed favorable safety, PK, and PD characteristics and preliminary anti-tumor activity, supporting its further investigation."

Clinical • Metastases • P1 data • Colorectal Cancer • Esophageal Cancer • Head and Neck Cancer • Oncology • Solid Tumor • IL2

A phase 1 dose escalation and expansion study of ZG006, a trispecific T cell engager targeting CD3/DLL3/DLL3, as monotherapy in patients with refractory small cell lung cancer or neuroendocrine carcinoma. (ASCO 2025) - P1/2 | "ZG006 exhibited a promising antitumor activity with acceptable safety profiles. Phase 2 dose expansion studies have been initiated to further investigate the efficacy and safety of ZG006 in pts with SCLC or NEC."

Clinical • Monotherapy • P1 data • Trispecific • Anemia • Constipation • Dermatology • Endocrine Cancer • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Lung Cancer • Neuroendocrine Tumor • Oncology • Pneumonia • Pruritus • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • DLL3

Changes in proteinuria and kidney function in subgroups of patients with IgAN defined by baseline Gd-IgA1 levels in a Phase 1/2 study of zigakibart (ERA 2025) - P1/2 | "Following 76 weeks of zigakibart treatment patients achieved 74.4% mean percent reduction of Gd-IgA1. Zigakibart provides clinically meaningful treatment benefits in terms of proteinuria reduction and eGFR stabilisation in patients with IgAN, independent of their baseline Gd-IgA1 levels."

Clinical • P1/2 data • Glomerulonephritis • IgA Nephropathy • Inflammation • Lupus Nephritis • Renal Disease

Safety, Tolerability, and Efficacy of Mezagitamab (TAK-079) as Add-on to Standard of Care Therapy in Individuals with Primary IgA Nephropathy: Results from a Phase 1b Study (ERA 2025) - P1 | "Mezagitamab was generally well tolerated as an add-on to standard of care therapy in IgAN without any opportunistic infections or Grade 3 or higher infections. Rapid and sustained reductions in proteinuria, serum IgA, Gd-IgA1, and IgG were seen while renal function remained stable during the first year of this study."

Clinical • P1 data • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Lupus Nephritis • Pain • Renal Disease • Respiratory Diseases

Novel Bruton's Tyrosine Kinase Inhibitor EVER001 in Chinese Patients With Primary Membranous Nephropathy: Preliminary Results From a Phase 1b/2a Study (ERA 2025) - P1 | "Preliminary results showed that EVER001 was well tolerated and effective in patients with pMN, supporting its potential as a treatment for proteinuric autoimmune glomerular diseases."

Clinical • P1/2 data • Anemia • Glomerulonephritis • Hematological Disorders • Immunology • Infectious Disease • Renal Disease • Respiratory Diseases

Zigakibart-treated patients with IgAN achieved high rates of proteinuria remission and stable eGFR over 76 weeks in a Phase 1/2 study (ERA 2025) - P1/2 | "Following 76 weeks of zigakibart treatment, 29% and 45% of patients achieved UPE reductions below stringent thresholds of <300 and <500 mg/24 h, demonstrating robust, clinically meaningful proteinuria remission. Sustained eGFR stabilisation was observed independent of the achieved UPE remission thresholds. Taken together, these findings support the disease- modifying effect of zigakibart in IgAN."

Clinical • P1/2 data • Glomerulonephritis • IgA Nephropathy • Inflammation • Lupus Nephritis • Renal Disease

Safety and Tolerability of ABBV-CLS-628: Results From a Phase 1 First-in-Human Study (ERA 2025) - P1 | "ABBV-CLS-628 was safe and well tolerated in healthy adults in this phase 1 study. Overall, these results support further investigation in a larger study."

Clinical • P1 data • Autosomal Dominant Polycystic Kidney Disease • Genetic Disorders • Nephrology • Polycystic Kidney Disease • Renal Disease

Open-label, single-arm, single-center phase 1b/2 clinical study of fruquintinib combined with trastuzumab and XELOX in the first-line treatment of advanced HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. (ASCO 2025) - P4 | "The KEYNOTE-811 study suggested that the efficacy of adding pembrolizumab to trastuzumab and chemotherapy was superior to trastuzumab plus chemotherapy...The phase 3 study FRUTIGA demonstrated fruquintinib plus paclitaxel was superior to paclitaxel alone as second-line treatment in patients with G/GEJ cancer...The primary endpoint of the phase 2 study is PFS. The secondary endpoints include OS, ORR, DCR, DoR, safety, and molecular biomarker exploration."

Clinical • IO biomarker • Metastases • P1/2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1

Acute Kidney Injury is associated with a significant increase in mortality after Upper Gastro Intestinal cancer surgery (UKKW 2025) - No abstract available

Surgery • Acute Kidney Injury • Gastrointestinal Cancer • Nephrology • Oncology • Renal Disease • Solid Tumor

Pharmacokinetic and Electrocardiographic Drug-Drug Interactions between NYX-783 and Oxycodone among Recreational Users of Opioids: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study (CPDD 2025) - "In addition to previously documented safety of NYX, preliminary results ruled out DDI on ECG features and showed DDI in which 30 mg dose of oxycodone is associated with higher levels of NYX 150."

Clinical • P1 data • PK/PD data • Substance Abuse

Evaluation of Potentially Abuse-Related Adverse Events in a Phase 1 Study of AJA001 Oral Solution, a Full-Spectrum Hemp-Derived Botanical Drug Product for the Treatment of Autism Spectrum Disorder (CPDD 2025) - "AJA001 was safe and well-tolerated with relatively few ARAEs and no euphoria-related AEs at doses likely exceeding efficacious doses (i.e., supratherapeutic). Collectively, the results suggest that AJA001 may have relatively low abuse potential, appearing optimized for development as a new treatment for ASD."

Adverse events • P1 data • Autism Spectrum Disorder • Genetic Disorders • Mood Disorders • Psychiatry

Efficacy and safety of surufatinib (S) plus KN046 (K) and chemotherapy in first line (1L) advanced pancreatic cancer (PC): A single-arm, phase 1b/2 trial. (ASCO 2025) - P1/2 | "Funded by HUTCHMED, ALPHAMAB Clinical Trial Registration Number: NCT05832892 Background: Gemcitabine (G) and nab-paclitaxel (nP) are standard 1L regimen for patients (pts) with unresectable PC, yet the efficacy remains unsatisfactory... These preliminary results showed encouraging anti-tumor efficacy and an acceptable safety profile of S plus K and GnP chemotherapy as 1L treatment for advanced PC."

Clinical • IO biomarker • Metastases • P1/2 data • Tumor mutational burden • Cardiovascular • Hypertension • Leukopenia • Microsatellite Instability • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor • Thrombocytopenia • ARID1A • CHEK2 • CSF1R • FGFR1 • FLT1 • KRAS • MSI • TMB • TP53

Comparative analysis of PIK3CA mutation detection methods in the first-in-human phase 1/1b study of inavolisib. (ASCO 2025) - P1 | "These results, albeit from a small study, demonstrate the ability of both tissue- and blood-based PCR and NGS assays to robustly identify a similar patient population with PIK3CAmut HR+, HER2- mBC, who may benefit from an inavolisib-based therapy regimen. Differences in PIK3CAmut detection concordance between tissue- vs. blood-based assays may reflect mutational profiling of a single-biopsied lesion vs."

Biomarker • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA

SOUNDTRACK-E: A phase 1/2, open-label, multicenter study to evaluate the safety and efficacy of AZD0486 monotherapy or combination therapy in patients with mature B-cell malignancies. (ASCO 2025) - P1, P1/2 | "Substudy 1 evaluates SC AZD0486 in R/R CLL/small lymphocytic lymphoma and includes a monotherapy cohort (1A; ≥2 prior lines of therapy [pLOT] with Bruton tyrosine kinase inhibitor exposure) and a cohort that receives combination with acalabrutinib (1B; ≥1 pLOT)...In substudy 3, R-CHOP is administered once every 3 weeks for 6 cycles...Secondary objectives include efficacy endpoints, pharmacokinetics, and immunogenicity. Enrollment opened in October 2024."

Clinical • Combination therapy • Monotherapy • P1/2 data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • CNS Disorders • Diffuse Large B Cell Lymphoma • Epilepsy • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

A phase 1b/2, safety lead-in and dose-expansion trial of ivosidenib plus durvalumab and gemcitabine/cisplatin as first-line therapy in patients with locally advanced, unresectable or metastatic cholangiocarcinoma with an IDH1 mutation. (ASCO 2025) - P1/2 | "Finally, encouraging activity has been observed in treatment-naive mIDH1 patients administered with the mIDH1 inhibitor LY3410738 in combination with GEM/CIS...The primary objective is to evaluate the safety and tolerability of the quadruplet combination, and to determine the recommended combination dose (RCD). The expansion phase will enroll approximately 40 patients who will be treated with the RCD, with the primary objective being to assess the clinical activity of the combination, as determined by a primary endpoint of confirmed complete or partial response using RECIST v1.1 criteria."

Clinical • Metastases • P1/2 data • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor • IDH1

Phase 1b/2 study evaluating telisotuzumab adizutecan (ABBV-400; Temab-A) in combination with budigalimab in patients (pts) with advanced non-squamous (NSQ) non-small cell lung cancer (NSCLC) with no prior treatment for advanced disease and no actionable genomic alterations. (ASCO 2025) - P1, P1/2 | "Pts are randomized 1:1:1:1 to Temab-A at 1 of 2 doses determined in part 1 + budigalimab, to budigalimab + CT, or to SOC (pembrolizumab + CT) arms...Treatment continues until disease progression, intolerable toxicity, or other discontinuation criteria are met. The first dosing of the first patient enrolled is planned in March 2025."

Clinical • Combination therapy • IO biomarker • Metastases • P1/2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET • PD-L1

Telisotuzumab adizutecan (ABBV-400; Temab-A), a c-Met protein–targeting antibody-drug conjugate (ADC), in patients (pts) with advanced EGFR-mutated (MT) non-squamous (NSQ) non-small cell lung cancer (NSCLC): Results from a phase 1 study. (ASCO 2025) - P1 | "Temab-A has a manageable safety profile with promising clinical activity in pts with 3L+ NSQ EGFR MT NSCLC, meriting further investigation. aConfirmed responses. P, probability."

Clinical • Metastases • P1 data • Anemia • Interstitial Lung Disease • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • EGFR • MET

Prevalence and management of preoperative anemia and its outcomes in gastrointestinal cancer patients: preliminary results (Euroanaesthesia 2025) - "However, preliminary data were insufficient to draw conclusions regarding ABT rates or postoperative complications. The findings highlight the challenges of optimizing Hb levels in patients with active inflammation and active bleeding.Table 1: Demographic and clinical characteristics."

Clinical • Anemia • Anesthesia • Gastrointestinal Cancer • Inflammation • Oncology • Solid Tumor

Data + Perspectives: Clinical Investigators Discuss the Current and Future Clinical Care of Patients with HER2-Positive Gastrointestinal Cancers (ASCO 2025) - "Recall the design of ongoing clinical trials evaluating HER2-directed agents and strategies for advanced HER2-positive GI cancers, and appropriately counsel patients about availability and participation. Target Audience This activity is intended for medical oncologists, hematology-oncology fellows, surgeons and other healthcare providers involved in the treatment of gastrointestinal (GI) cancers."

Clinical • Biliary Cancer • Biliary Tract Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

Overview of the Latest Clinical Data on Biomarker-Based First-Line Treatment Options for Upper Gastrointestinal Cancers: Recent Safety and Efficacy Data (ASCO 2025) - "Sponsored by This event is organized and accredited by PRIME Education, LLC, and supported through an independent educational grant from Gilead Sciences, Inc. and Astellas"

Biomarker • Clinical data • Gastrointestinal Cancer • Oncology • Solid Tumor