ONO-7429 / LigaChem Biosci, Elthera, Ono Pharmaceutical - LARVOL DELTA

A Study of ONO-7429 in Participants With Unresectable Advanced or Recurrent Solid Tumors (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Ono Pharmaceutical Co., Ltd.

New P1 trial • Oncology • Solid Tumor

LigaChem ADC Research Head Chung Chul-woong: “Four next-generation ADCs to enter Phase 1 this year” (BioNews) - "In particular, the gastric cancer-targeted ADC 'LCB02A (Claudin 18.2 ADC),' expected to be administered to its first patient in the third quarter of this year...'LCB97 received IND approval from the Japanese regulatory authorities as planned, and we are currently preparing for a global IND submission.'...'An IND submission for SOT106 is planned for H2 2026.'"

IND • Trial status • Gastric Cancer • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma

Clinical momentum is lined up starting this year [Google translation] (eDaily) - "...the company plans to disclose LCB71's solid tumor phase 1 clinical trial data at the American Society of Clinical Oncology (ASCO) this year...LCB97, whose technology was transferred to Ono Pharmaceutical in October 2024, is also expected to complete preclinical trials as early as 2025 and submit a phase 1 clinical IND to the U.S. Food and Drug Administration (FDA)....'We expect to submit the phase 1 clinical IND for LCB97 to the FDA between 2025 and 2026.'"

IND • P1 data • Solid Tumor

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

Ono Enters into License Agreement for LCB97, an Antibody-Drug Conjugate, and Research Collaboration and License Agreement to generate novel ADC candidates by leveraging ConjuAll ADC platform with LigaChem Biosciences (Ono Pharmaceuticals Press Release) - "Ono Pharmaceutical...announced that it has entered into a license agreement with LigaChem Biosciences...for LCB97...as well as a research collaboration and license agreement to generate novel ADC candidates by leveraging LCB’s proprietary ConjuAll ADC platform....Under this Agreement, Ono will have an exclusive worldwide right to develop, manufacture and commercialize LCB97 for solid tumors. Ono will make an upfront payment to LCB, along with milestone payments based on research and development progress and sales, up to a maximum of 700 million US dollars, as well as tiered royalties based on net sales. In addition to this Agreement, Ono and LCB have separately entered into research collaboration and license agreement to generate novel ADC candidates by leveraging LCB's ConjuAll ADC platform. Under the agreement, Ono will have an exclusive global right to the ADC candidates to be generated against multiple targets selected by Ono by utilizing LCB’s ConjuAll ADC platform."

Licensing / partnership • Solid Tumor

LCB97, an antibody drug conjugate (ADC) targeting a novel tumor antigen for the treatment of multiple solid tumors (AACR 2023) - "Preliminary toxicity assessment in cynomolgus monkeys (an AFF4 cross reactive species) demonstrated that LCB97 was well tolerated within the estimated therapeutic index of ~20 for repeat dosing. In conclusion, LCB97, generated by combining theAFF4 monoclonal antibody of Elthera and the highly innovative ConjuAllTM platform technology of LegoChem Biosciences is a promising next-generation ADC for the treatment of various solid cancers, including BC, CRC, melanoma, OC and PaC."

Breast Cancer • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Neuroendocrine Tumor • Oncology • Ovarian Cancer • Pancreatic Cancer • Small Cell Lung Cancer • Solid Tumor • AFF4