LNCB74 / NextCure, LigaChem Biosci - LARVOL DELTA

NextCure Announces Closing of $21.5 Million PIPE Financing in Advance of First Half 2026 Phase 1 POC Data Readouts (GlobeNewswire) - "NextCure intends to use the net proceeds from the offering for general working capital needs, extending the company’s cash runway into the first half of 2027, which is beyond the planned first half of 2026, proof of concept data readouts of its two antibody drug conjugate (ADC) programs, SIM0505 (CDH6 ADC) and LNCB74 (B7-H4 ADC)."

Financing • Solid Tumor

LNCB74 (B7-H4 ADC) (GlobeNewswire) - "Received Food and Drug Administration (FDA) acceptance of a protocol amendment giving us the ability to add higher dose escalation cohorts. Proof of concept data readout in the first half of 2026."

Clinical protocol • P1 data • Biliary Tract Cancer • Breast Cancer • Endometrial Cancer • Non Small Cell Lung Cancer • Ovarian Cancer

NextCure Provides Business Update and Reports Second Quarter 2025 Financial Results (Nasdaq) - "LNCB74 (B7-H4 ADC): First patient dosed in January 2025 in the Phase 1 trial, cleared cohort 3 in June 2025. Currently treating patients in cohort 4. Plan to initiate backfill cohorts in the second half of 2025. Plan to provide a program update by the fourth quarter of 2025 and proof of concept data readout in the first half of 2026."

P1 data • Trial status • Biliary Tract Cancer • Breast Cancer • Endometrial Cancer • Non Small Cell Lung Cancer • Ovarian Cancer

LigaChem Biosciences plans 20 ADC drug candidates by 2027, CEO announces progress (Chosun Biz) - "Kim Yong-joo, CEO of LigaChem Biosciences, announced plans to secure a total of 20 antibody-drug conjugate (ADC) candidates by 2027....LCB84 has completed Phase 1 trials for solid cancer patients, including those with triple-negative breast cancer and non-small cell lung cancer, and is expected to announce results within this year. LCB14...is preparing to enter Phase 2 trials in patients who received the ADC cancer drug 'Enhertu' (ingredient name trastuzumab deruxtecan) but relapsed. LNCB74, which is being co-developed with NextCure, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA), and CS5001, currently developed with ABL Bio in Korea, is undergoing global Phase 1b trials."

New P2 trial • P1 data • Pipeline update • Trial status • Non Small Cell Lung Cancer • Triple Negative Breast Cancer

A phase 1 dose escalation and dose expansion study for LNCB74, a B7-H4 targeted antibody drug conjugate, as monotherapy in participants with advanced solid tumors. (ASCO 2025) - P1 | "Clinical Trial information: NCT06774963. Research Sponsor: NextCure Inc."

Metastases • Monotherapy • P1 data • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • VTCN1

NextCure and LigaChemBio to Present Trial in Progress Poster for LNCB74, a B7-H4 Targeted Antibody-Drug Conjugate, as Monotherapy in Participants with Advanced Solid Tumors at ASCO 2025 (GlobeNewswire) - "NextCure...together with LigaChem Biosciences...announced that a trial in progress poster from the Phase 1 study evaluating LNCB74, a B7-H4 targeted antibody-drug conjugate (ADC), will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The Phase 1 study is evaluating LNCB74 as monotherapy in participants with advanced solid tumors, including platinum-resistant ovarian cancer, treatment-refractory breast cancer, endometrial cancer, biliary tract cancer, and squamous non-small cell lung cancer. The trial includes dose escalation and dose expansion and optimization phases. The study is currently enrolling in dose escalation."

Platinum resistant • Trial status • Biliary Tract Cancer • Breast Cancer • Endometrial Cancer • Lung Non-Small Cell Squamous Cancer • Ovarian Cancer

Next-gen Korean cancer fighters to showcase innovation at ASCO 2025 (Korea Biomedical Review) - "Onconic Therapeutics...will present two trial designs for its investigational dual-target PARP inhibitor, nesuparib. One study is focused on metastatic pancreatic cancer, and the other is an investigator-led phase 2 trial in endometrial cancer evaluating nesuparib with Keytruda. Both studies aim to address indications with high unmet needs and limited therapeutic options; Early-stage trial designs will also be presented by Ligachem Biosciences, which is jointly developing an ADC candidate, LNCB74, with U.S.-based NextCure. The program targets B7-H4 and is currently in phase 1; Aptabio will present the design of a first-in-human study for APX-343A, a novel immunotherapy in development for advanced solid tumors, both as monotherapy and in combination with Keytruda."

Clinical protocol • pMMR • Endometrial Cancer • Pancreatic Cancer • Solid Tumor

NextCure Provides Business Update and Reports First Quarter 2025 Financial Results (GlobeNewswire) - "Business Highlights and Near-Term Milestones: LNCB74 (B7-H4 ADC): (i) Dosed our first patient in January 2025 in the Phase 1 trial, cleared cohort 2 in April 2025 and currently dosing cohort 3; (ii) Expanded clinical footprint for the LNCB74 study with a total of 10 active trial sites; (iii) Plan to initiate backfill cohorts in the second half of 2025; (iv) Plan to provide a proof of concept data readout in the first half of 2026."

P1 data • Trial status • Biliary Tract Cancer • Breast Cancer • Endometrial Cancer • Non Small Cell Lung Cancer • Ovarian Cancer

NextCure Provides Business Update and Reports Full Year 2024 Financial Results (GlobeNewswire) - "Business Highlights and Near-Term Milestones - LNCB74 (B7-H4 ADC):...Dosed our first patient in January 2025 in the Phase 1 trial, clearing cohort 1 in February 2025 and currently dosing cohort 2. We plan to initiate backfill cohorts in the second half of 2025."

Trial status • Solid Tumor

LNCB74-01: A Phase 1 Study of LNCB74 in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=145 | Recruiting | Sponsor: NextCure, Inc.

Monotherapy • New P1 trial • Biliary Cancer • Breast Cancer • Endometrial Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

NextCure Announces First Patient Dosed in the Phase 1 Study of LNCB74 (B7-H4 ADC) as Therapeutic for Treating Multiple Cancers (GlobeNewswire) - "NextCure, Inc...today announced the first patient has been dosed in its Phase 1 study of LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) as a therapeutic for treating multiple cancers."

Trial status • Solid Tumor

NextCure Announces Acceptance of IND Application for LNCB74 (GlobeNewswire) - "NextCure...announced that the U.S. Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) application for initiation of a Phase 1 clinical trial to evaluate LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) as a therapeutic for treating multiple cancers."

IND • Solid Tumor

LNCB74 is a B7-H4 targeting antibody-drug-conjugate with a β-glucuronide linker-MMAE payload system to enhance the therapeutic index in B7-H4 expressing cancers (SITC 2024) - "Conclusions Together, these data show that LNCB74 is a potent and safe ADC for treating ovarian, breast and other B7-H4 positive cancer patients in need of new, effective therapies. Ethics Approval All mouse tumor model studies were performed with the approval of the Animal Care and Use Committee at NextCure, Inc."

Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • VTCN1

NextCure Provides Business Update and Reports Third Quarter 2024 Financial Results (GlobeNewswire) - "Business Highlights and Near-Term Milestones: LNCB74 (B7-H4 ADC):...Planned submission of an Investigational New Drug (IND) application in the fourth quarter of this year."

IND • Solid Tumor

NextCure Reports Preclinical Data for LNCB74…at Society for Immunotherapy of Cancer Annual Meeting (GlobeNewswire) - "Key findings:...LNCB74 shows specific binding to B7-H4 expressing tumor cells and is rapidly internalized in a target-dependent manner by cancer cells. LNCB74 mediates potent cytotoxicity, with sub-nanomolar to low nanomolar EC50 values on multiple B7-H4-positive cancer cell lines. LNCB74 demonstrates strong anti-tumor activity in multiple CDX and PDX tumor models. A single dose of 3 mg/kg resulted in durable tumor regression in multiple tumor models, suggesting activity comparable or superior to published B7-H4 targeting ADCs. LNCB74 demonstrates favorable PK and stability in rodents."

Preclinical • Oncology

Ligachem Bio to Enter Three Clinical Trials This Year… Expectations for ADC Phase 2 Next Year [Google translation] (Medipana) - "The HER2-ADC candidate LCB14 began phase 1a clinical trial patient administration at the end of last year through the company's partner, Iksuda Therapeutics...The results of the phase 1b trial are expected to come out in the second half of next year...Ligachem Bio is also preparing a pipeline that will enter additional phase 1 clinical trials next year. The LCB41 and LCB97 candidates are expected to enter phase 1 next year."

New P1 trial • P1 data • Oncology • Solid Tumor

LNCB74 is a potent and safe next-generation antibody-drug-conjugate utilizing a cancer selective linker for the treatment of B7-H4 expressing cancers (AACR 2024) - "A rapid and durable anti-tumor response has been demonstrated in multiple cell-line derived (CDX) and patient-derived xenograft (PDX) tumor models. In summary, LNCB74 is a promising ADC enabling specific targeting of B7-H4 positive cancers across a spectrum of indications."

Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • VTCN1

NextCure and LCB Present Preclinical Data on B7-H4 Antibody Drug Conjugate at AACR 2024 (GlobeNewswire) - "NextCure, Inc...announced the presentation of new preclinical data on LNCB74, a B7-H4-targeting antibody drug conjugate (ADC) developed in partnership with LigaChem Biosciences (LCB), formerly LegoChem Biosciences, (KOSDAQ: 141080), at the 2024 American Association for Cancer Research (AACR) Annual Meeting in San Diego, CA....LNCB74 was engineered for an improved safety profile and therapeutic index with increased stability in circulation, tumor selective payload release, and a reduction in off-target release of active payload, mitigating toxicity compared to traditional vedotin ADCs. A single 3 mg/kg dose of LNCB74 resulted in durable tumor regression in multiple CDX and PDX tumor models, suggesting activity comparable or superior to competitor B7-H4 targeting ADCs. LNCB74 was well tolerated in cynomolgus monkeys following 2 doses of up to 10 mg/kg, showing a superior safety profile compared to traditional MMAE bearing ADCs."

Preclinical • Breast Cancer • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

NextCure Provides Business Update and Reports Full Year 2023 Financial Results (GlobeNewswire) - "LNCB74 (B7-H4 ADC): Pre-filing feedback from the FDA supports moving forward to planned submission of an IND application by this year-end."

IND • Oncology

NextCure Provides Year-End Clinical Pipeline Updates (Yahoo Finance) - "The Phase 1b combination trial of NC410 with pembrolizumab is ongoing....Clinical data, including results from additional patients, are expected in the first half of 2024....Based on a comprehensive preclinical data package, we plan to initiate a dose range-finding toxicology study and GMP manufacturing for LNCB74 in early 2024. NC525 (LAIR-1 mAb): The Phase 1a dose escalation study in subjects with acute myeloid leukemia remains ongoing with the fourth cohort now enrolled....Clinical data are expected in the first half of 2024."

P1 data • Preclinical • Acute Myelogenous Leukemia • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Leukemia • Microsatellite Instability • Oncology • Solid Tumor