IMC001 / Immunofoco - LARVOL DELTA

Phase 1 study results of JNJ-78278343 (pasritamig) in metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2025) - P1 | "Pre-medication with dexamethasone (16 mg) was required in SU and 1st TD...Pts had a median of 4 prior therapies (range 1-13; 99.4% ARPI, 78.2% taxane chemotherapy, 17.2% lutetium Lu 177 vipivotide tetraxetan)...In the RP2D safety population (n=45; 3.5 mg [Day 1], 18 mg [Day 8], 300 mg Q3W or Q6W IV), the most common TRAEs were infusion-related reactions (22.2%; Gr 1/2), fatigue (15.6%; Gr 1/2), and CRS (8.9%; all Gr 1, no tocilizumab was administered), no TRAEs led to treatment discontinuation, no ICANS was observed, and 2 serious TRAEs (Gr 1 CRS) were reported... Pasritamig was very well tolerated (<10% of pts experienced CRS [all Gr1] at the RP2D) with promising antitumor activity, demonstrating proof of concept for KLK2 as a target amenable to T-cell redirection. These results address an unmet need for a targeted T-cell based therapy that is safe to administer in an outpatient setting with clinically meaningful benefit in mCRPC. Phase 3 trials are planned."

Metastases • P1 data • Castration-Resistant Prostate Cancer • Fatigue • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • KLK2

Ficerafusp alfa with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma: Updated results from an expansion cohort of an open-label, multicenter, phase 1/1b trial. (ASCO 2025) - P1 | "Ficerafusp alfa combined with pembrolizumab continues to show promising efficacy relative to historical data on the current standard of care, particularly in HPV-negative HNSCC. Median PFS and 12-month OS, ORR, and CR rates are encouraging relative to historical benchmarks in pts with HPV-negative HNSCC. 24-month OS and mature OS/DOR outcomes are anticipated."

Clinical • Metastases • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR • PD-L1 • TGFB1

Onkoras-101: A phase 1a/1b open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of BBO-8520 in subjects with advanced KRASG12C mutant non-small-cell lung cancer. (ASCO 2025) - P1 | "BBO-8520 will also be evaluated in combination with pembrolizumab in an expansion cohort of patients with advanced NSCLC and no prior treatment with immune checkpoint or KRASG12C inhibitors. The primary objective of Phase 1b is to verify safety and tolerability of BBO-8520 monotherapy and in combination with pembrolizumab and evaluate antitumor activity (objective response rate evaluation)."

Clinical • Metastases • P1 data • PK/PD data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

IMproveMF update: Phase 1/1B trial of imetelstat (IME)+ruxolitinib (RUX) in patients (pts) with intermediate (INT)-1, INT-2, or high-risk (HR) myelofibrosis (MF). (ASCO 2025) - P1, P2 | "In part 1 of IMproveMF, no DLTs were observed and the RP2D dose of 9.4 mg/kg IME was determined. AEs were consistent with those observed in other IME clinical trials, and preliminary efficacy was positive, demonstrating the potential of IME+RUX in this pt population with high unmet needs. Part 2 of this trial is ongoing across the US at 6 sites."

Clinical • P1 data • Anemia • Fatigue • Hematological Disorders • Infectious Disease • Leukopenia • Myelofibrosis • Neutropenia • Pain • Pneumonia • Respiratory Diseases

Precemtabart tocentecan (M9140), an anti-CEACAM5 ADC with exatecan payload, in patients with metastatic colorectal cancer (mCRC): Results from the dose optimization of the phase 1 PROCEADE CRC-01 study. (ASCO 2025) - P1, P1/2 | " This global Phase 1 study in 3L adult patients with locally advanced/mCRC (ECOG PS ≤1; previous irinotecan therapy) evaluates clinical activity, safety, and tolerability of precemtabart tocentecan... These preliminary results corroborate the encouraging efficacy and safety data from the dose escalation part of the PROCEADE CRC-01 study, with no new relevant safety findings. ORR was higher at 2.8 mg/kg, with similar tolerability at both doses. The ORR of 24.1% (13.8% confirmed) at 2.8 mg/kg compares favorably with current monotherapy SoCs (ORRs 1-2%) and recent phase 3 data with trifluridine–tipiracil + bevacizumab (ORR 6.1%) in 3L+ mCRC."

Clinical • Metastases • P1 data • Anemia • Colorectal Cancer • Febrile Neutropenia • Leukopenia • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • CEACAM5

γ9δ2 T-cell activation (γδTCA) with ICT01 combined with azacitidine-venetoclax (AV) for older/unfit adults with newly diagnosed (ND) AML: Preliminary efficacy and dose selection in phase 1/2 study EVICTION. (ASCO 2025) - P1/2 | "For AV combination, the recommended Phase 2 dose is 10 mg ICT01 Q4W. Both ICT01 regimens were safe and very well tolerated and generated very high CR and CR/CRi rates in older/unfit ND-AML pts. The high response rates seen in adverse risk pts warrant further clinical investigation."

Clinical • P1/2 data • Acute Myelogenous Leukemia • Febrile Neutropenia • Hematological Disorders • Neutropenia • ASXL1 • DNMT3A • IDH1 • IDH2 • IFNG • JAK2 • NPM1 • NRAS • RUNX1 • SF3B1 • SRSF2 • STAG2 • TNFA • TP53 • U2AF1

Zanzalintinib (zanza) + nivolumab (nivo) ± relatlimab (rela) in patients (pts) with previously untreated clear cell renal cell carcinoma (ccRCC): Results from an expansion cohort of the phase 1b STELLAR-002 study. (ASCO 2025) - P1 | "First-line zanza had acceptable tolerability in combination with nivo or nivo/rela with a low rate of PPE; zanza+nivo showed promising preliminary activity in pts with adv/met ccRCC."

Clinical • P1 data • Clear Cell Renal Cell Carcinoma • Dermatology • Genito-urinary Cancer • Hypertension • Oncology • Solid Tumor • AXL

Phase 1 study of gotistobart (BNT316/ONC-392) in combination with lutetium Lu 177 vipivotide tetraxetan (Lu 177) in patients with metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2025) - P1/2 | "With known limitations in sample size during dose escalation, gotistobart in combination with Lu 177 demonstrated a manageable safety profile and promising preliminary PSA50 rates in patients with mCRPC during the dose escalation phase. Overall findings support combination regimens with gotistobart doses less than 10 mg/kg in the ongoing Phase 2 randomized dose optimization study."

Clinical • Combination therapy • Metastases • P1 data • Castration-Resistant Prostate Cancer • Fatigue • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Immunology • Oncology • Prostate Cancer • Solid Tumor

Belantamab mafodotin plus lenalidomide/dexamethasone in newly diagnosed intermediate-fit & frail multiple myeloma patients: Long-term efficacy and safety from the phase 1/2 BELARD clinical trial. (ASCO 2025) - P1/2 | "As has also been shown in the DREAMM-7/-8 studies, belamaf exhibits substantial clinical activity, with rapid, deep & durable responses in an unfit pt population, with only 2 PDs observed after a median of ~2 years FU. Only a few high-grade OAEs were recorded, that resolved quickly & no new safety signals were observed. Moving forward, the BelaRd combination, with the extended belamaf dosing schedule, warrants further investigation in larger pt numbers."

Clinical • P1/2 data • CNS Disorders • Fatigue • Hematological Malignancies • Infectious Disease • Insomnia • Multiple Myeloma • Oncology • Ophthalmology • Pneumonia • Respiratory Diseases • Sleep Disorder

9MW2821, a novel Nectin-4 antibody-drug conjugate (ADC), combined with toripalimab in treatment-naïve patients with locally advanced or metastatic urothelial carcinoma (la/mUC): Results from a phase 1b/2 study. (ASCO 2025) - P1/2, P3 | "9MW2821 combined with Toripalimab in treatment-naïve patients with la/mUC demonstrated remarkable efficacy and well-tolerated safety profile. A pivotal phase 3 study is ongoing currently. Clinical trial identification: NCT06592326."

Clinical • Metastases • P1/2 data • Bladder Cancer • Breast Cancer • Cervical Cancer • Esophageal Cancer • Oncology • Solid Tumor • Urothelial Cancer • NECTIN4

Efficacy and safety of cafelkibart (LM-108), an anti-CCR8 monoclonal antibody, in combination with anti-PD-1 therapy in patients with pancreatic cancer: Results from phase 1/2 studies. (ASCO 2025) - P1/2 | "Treatment regimens included LM-108 at doses of 3 mg/kg Q3W, 3 mg/kg Q2W, 10 mg/kg Q3W, or 10 mg/kg Q2W, in combination with pembrolizumab (400 mg Q6W) or toripalimab (240 mg Q3W)... LM-108 in combination with anti-PD-1 therapy demonstrated encouraging antitumor activity and a manageable safety profile in patients with pancreatic cancer who had progressed on or after prior systemic therapies. These findings support further investigation of LM-108 in combination with anti-PD-1 therapy as a potential treatment option for pancreatic cancer."

Clinical • Combination therapy • IO biomarker • P1/2 data • Anemia • Gastrointestinal Disorder • Oncology • Pancreatic Cancer • Solid Tumor • CCR8

Sigvotatug vedotin (SV), an investigational integrin beta-6 (IB6)–directed antibody‒drug conjugate (ADC), and pembrolizumab combination therapy: Initial results from an ongoing phase 1 study (SGNB6A-001). (ASCO 2025) - P1, P3 | "SV+P demonstrated manageable safety and encouraging preliminary efficacy. These data support the ongoing phase 3 Be6A-Lung-02 study (NCT06758401) comparing SV+P vs P as first-line treatment for pts with PD-L1 high (TPS≥50) advanced NSCLC."

Combination therapy • P1 data • Head and Neck Cancer • Interstitial Lung Disease • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Clinical activity of EBC-129, a first-in class, anti N256-glycosylated CEACAM5 and CEACAM6 antibody-drug conjugate (ADC), in patients with pancreatic ductal adenocarcinoma (PDAC) in a phase 1 study. (ASCO 2025) - P1 | "EBC-129 shows promising clinical activity in heavily treated PDAC patients with a manageable tolerability profile, consistent with MMAE-based ADCs. Further evaluation of EBC-129 in PDAC, both as monotherapy and in combination with chemotherapy, is planned. (NCT05701527)."

Clinical • P1 data • Anemia • Neutropenia • Oncology • Pain • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CEACAM5 • CEACAM6

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

NVL-330, a selective HER2 tyrosine kinase inhibitor, in patients with advanced or metastatic HER2-altered non-small cell lung cancer: The phase 1 HEROEX-1 study. (ASCO 2025) - P1 | "The antibody drug conjugate (ADC) trastuzumab deruxtecan (T-DXd) has received FDA accelerated approval for HER2-mutant NSCLC, but no tyrosine kinase inhibitors (TKIs) are currently approved for this indication...Analyses will be performed to evaluate tumor and blood-based biomarkers of response and other relevant biomarkers. The study is open to accrual."

Clinical • IO biomarker • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2

A phase 1b study of combined treatment with dupilumab (anti-IL-4Ra) and cemiplimab (anti-PD-1) in patients with early-stage, resectable NSCLC. (ASCO 2025) - P1/2 | "Secondary endpoints include time to surgery, pathological complete response rate, event-free survival, and overall survival. Comprehensive correlative studies will characterize the immune response through serial blood sampling (days 1, 4, 8, 15, surgery, and 30 days post-op), matched proteomic and transcriptomic tumor tissue analysis (pre-treatment and operative samples), and stool microbiome profiling to identify potential biomarkers of response."

Clinical • IO biomarker • P1 data • Allergic Rhinitis • Asthma • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • IL4 • IL4R

A phase 1b study of Plk1 inhibitor onvansertib in combination with paclitaxel in metastatic triple-negative breast cancer (mTNBC) patients. (ASCO 2025) - P1/2 | "The combination of onvansertib and P demonstrated a safe toxicity profile and promising clinical activity in pretreated mTNBC pts and warrant further exploration of the combination at the RP2D. Best response per RECIST 1.1 among different DL."

Clinical • Combination therapy • IO biomarker • Metastases • P1 data • Anemia • Breast Cancer • Fatigue • Oncology • Solid Tumor • Triple Negative Breast Cancer • PLK1

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

Phase 1/2 Duravelo-1 study: Preliminary results of nectin-4–targeting zelenectide pevedotin (BT8009) plus pembrolizumab in previously untreated, cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer. (ASCO 2025) - P1/2, P2/3 | "Zelenectide pevedotin (zele, previously BT8009) is a highly selective Bicycle Toxin Conjugate (BTC) targeting Nectin-4 and conjugated to MMAE, and has shown an objective response rate (ORR) of 45% and a generally tolerable safety profile as monotherapy in previously treated, enfortumab vedotin-naïve pts with mUC in the ongoing Phase 1/2 study (NCT04561362, Duravelo-1; Reig et al., 2024)... Zelenectide pevedotin + pembro shows promising anti-tumor activity as a first-line treatment in a cohort of cisplatin-ineligible pts with la/mUC including a large proportion of pts with PS = 2. The combination of zele + pembro was generally tolerable and broadly consistent with the existing safety profiles of each respective agent. No new safety signals were observed with the combination."

Clinical • Metastases • P1/2 data • Diabetes • Genito-urinary Cancer • Infectious Disease • Neutropenia • Oncology • Ophthalmology • Pain • Pneumonia • Respiratory Diseases • Solid Tumor • Urothelial Cancer • NECTIN4

A phase 1, first-in-human study of regorafenib plus temozolomide with or without radiotherapy in patients with newly diagnosed MGMT methylated, IDHwt glioblastoma: The REGOMA-2 trial. (ASCO 2025) - P1 | "The MTD of REG for cohort A was 160mg, for cohort B 120mg with a weak PK interaction between the two drugs. The MTD of 120mg can be considered the recommended dose of REG in combination with standard Stupp therapy for the phase 2 study. Preliminary activity analyses are ongoing."

Clinical • P1 data • Brain Cancer • Cardiovascular • CNS Tumor • Glioblastoma • Hematological Disorders • Hepatology • Hypertension • Oncology • Pain • Solid Tumor • Thrombocytopenia • MGMT

Carfilzomib, iberdomide, and dexamethasone (KID) in patients with transplant-eligible newly diagnosed multiple myeloma (NDMM): Updated results from phase 1/2 study. (ASCO 2025) - P1/2 | "Iberdomide, a cereblon modulator, enhances immune stimulatory activity in vitro compared to thalidomide analogs... Induction therapy with KID appears safe and effective leading to deep responses and adequate stem cell collection despite short tx duration and 42% harboring high-risk cytogenetics. Long-term follow-up is needed to determine durability of response. Correlative studies are underway to evaluate immune phenotype and microbiome changes pre/post-tx."

Clinical • P1/2 data • Anemia • Dermatology • Hematological Malignancies • Multiple Myeloma • Neutropenia • Oncology • Pruritus • Thrombocytopenia • Transplantation • CRBN • TP53

Phase 1 study of B440, an oral Bifidobacterium-engineered WT1 cancer vaccine, in patients with metastatic urothelial cancer. (ASCO 2025) - P1 | "B440 exhibited a favorable safety profile and no DLTs up to 1,600 mg. The induction of WT1-specific immunity correlated with improved PFS during B440 therapy and enhanced responses upon pembrolizumab rechallenge. These data support further investigation of B440 in larger, randomized trials and potential combination with other immunotherapies in WT1-expressing malignancies."

Clinical • Metastases • P1 data • Bladder Cancer • Genito-urinary Cancer • Head and Neck Cancer • Kidney Cancer • Oncology • Oral Cancer • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer • Wilms Tumor • IFNG • IL6 • WT1

Phase 1 dose escalation results of the WEE1 inhibitor, azenosertib (A), in combination with encorafenib (E) and cetuximab (C) in patients (pts) with previously treated BRAF V600E mutant metastatic colorectal cancer (mCRC). (ASCO 2025) - P1 | "The combination of A+E+C was well tolerated at the MTD and yielded response rates in BRAFi-naïve mCRC pts which exceeded the historical data from the E+C doublet."

Clinical • Combination therapy • Metastases • P1 data • Atrial Fibrillation • Cardiovascular • Colorectal Cancer • Fatigue • Neutropenia • Oncology • Solid Tumor • BRAF • CYP2C19 • CYP3A4

Safety, tolerability, and preliminary efficacy results of a phase 1 study of LB2102, a dnTGFβRII armored DLL3-targeted autologous CAR-T cell therapy, in patients with relapsed or refractory small cell lung cancer (SCLC) and large cell neuroendocrine carcinoma (LCNEC). (ASCO 2025) - P1 | "All subjects undergo 3-day lymphodepletion (LD) with fludarabine (30 mg/m2), and cyclophosphamide (300 mg/m2)... LB2102 has been well tolerated with no DLT observed up to DL3 (2 x 106 CAR+ T cells/kg). There appears to be a dose-dependent efficacy signal observed at higher doses with responses correlating to CAR-T expansion, although the data is limited. Given no DLTs and preliminary efficacy signal up to DL3, further exploration of higher dose levels is warranted."

CAR T-Cell Therapy • Clinical • P1 data • Anemia • Endocrine Cancer • Large Cell Carcinoma • Leukopenia • Lung Cancer • Neuroendocrine Tumor • Neutropenia • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3 • TGFB1

STARLITE-1: Phase 1b/2 study of combination 177Lu girentuximab plus cabozantinib and nivolumab in treatment naive patients with advanced clear cell RCC. (ASCO 2025) - P1/2 | "The combination of nivolumab plus cabozantinib was approved for first-line treatment of ccRCC based on the CheckMate 9ER phase 3 study demonstrating improved progression-free survival (PFS) and objective response rate (ORR) in comparison to sunitinib...The sample size was chosen for reasonable operating characteristics to distinguish a desirable CR rate of 18% as better than the standard CR rate of 9%. To explore the effects of the treatment on inducing activated T cell infiltration, patients will undergo pre/post-treatment PET scan with 18F-AraG radiotracer and biopsies will be obtained for single cell, spatial transcriptomics, and proteomics studies."

Clinical • Metastases • P1/2 data • Clear Cell Renal Cell Carcinoma • Renal Cell Carcinoma • CA9