RGC-1501 / ABVC BioPharma, Rgene Corp - LARVOL DELTA

Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined With Pemetrexed + Cisplatin Therapy (clinicaltrials.gov) - P1/2 | N=32 | Not yet recruiting | Sponsor: Rgene Corporation | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined With Pemetrexed + Cisplatin Therapy (clinicaltrials.gov) - P1/2 | N=32 | Not yet recruiting | Sponsor: Rgene Corporation | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Jan 2026 ➔ Dec 2026

Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

ABVC BioPharma Executes a Global Licensing Definitive Agreement for the Treatment of NSCLC, Expecting Aggregate Income of $13.75M and Royalties of up to $12.50M (GlobeNewswire) - "ABVC BioPharma, Inc...announced today that the Company, together with its affiliate Rgene Corporation entered into a comprehensive licensing agreement with OncoX, a private company registered in the British Virgin Islands that specializes in dietary supplements for Oncology. We are hopeful that this agreement will facilitate the advancement of treatments for Non-Small Cell Lung Cancer (NSCLC) since it covers the license for the clinical trial, registration, manufacturing, supply, and distribution rights of ABVC's single-herb botanical drug extract from the dry fruit body of Maitake Mushroom (Grifola Frondosa) for treatment of Non-Small Cell Lung Cancer....Under the terms of the agreement, ABVC grants OncoX exclusive rights for one of ABVC's four products in its Oncology pipeline to develop, manufacture, and commercialize BLEX 404, a promising therapeutic agent for the treatment of NSCLC."

Licensing / partnership • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ABVC BioPharma Executes a Global Licensing Term Sheet for Oncology/Hematology Products, Expecting Licensing Income of $55M and Royalties of up to $50M (GlobeNewswire) - "ABVC BioPharma, Inc...announced today that the Company together with its affiliates BioLite, Inc., and Rgene Corporation entered into a term sheet with OncoX BioPharma, Inc. (OncoX) for the Company's Oncology/Hematology pipeline(the 'Licensed Products')....Under the proposed agreement, ABVC would grant OncoX an exclusive global rights license to develop and commercialize the Licensed Products within the Field of Use. ABVC would also grant OncoX the right to sublicense to a third party, pre-agreed by ABVC....The terms discussed or agreed upon are conditional and not final until a formal Definitive Agreement is executed by all parties involved."

Licensing / partnership • Breast Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lung Cancer • Myelodysplastic Syndrome • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer

ABVC BioPharma Provides 2023 Pipeline Update (GlobeNewswire) - "While the company’s additional oncology medicines have yet to be determined, ABVC anticipates clinical studies for ABV-1519 for non-small cell lung cancer and ABV-1501 for triple negative breast cancer will be initiated in Q3 2023. The clinical study for ABV-1702 for myelodysplastic syndrome is expected to start in Q4 of 2023. In addition, ABVC intends to submit ABV-1703’s Phase II clinical trial IND to the Taiwan FDA after commencing clinical trials in the United States."

New P2 trial • New trial • Breast Cancer • Hematological Malignancies • Lung Cancer • Myelodysplastic Syndrome • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

FDA Approves IND Submission Allowing ABVC BioPharma to Proceed With Clinical Study of ABV-1519 for Treatment of Non-Small Cell Lung Cancer (GlobeNewswire) - "ABVC BioPharma...announced that the US Food & Drug Administration notified the company that the IND application for the proposed clinical investigation of BLEX 404, the primary active ingredient in ABV-1519, for advanced inoperable or metastatic EGFR-mutated non-small cell lung cancer has been approved and the study can proceed. The treatment, which is being co-developed by BioKey, Inc., a wholly owned subsidiary of ABVC based in Fremont, California and by the Rgene Corporation was submitted to the FDA by Rgene on November 30, 2022. The application, designated IND 161602, was approved on December 30, 2022."

IND • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

ABVC Provides Oncology Pipeline Updates (GlobeNewswire) - "ABVC BioPharma, Inc...today provided an update on its development of oncology medicines for the treatment pancreatic cancer (ABV-1703), non-small cell lung cancer (ABV-1519), triple negative breast cancer (ABV-1501) and myelodysplastic syndrome (ABV-1702). The Company expects to initiate the first Phase II clinical trials for ABV-1703 in the second quarter of 2023 by Dr. Andrew E. Hendifar at the Cedars-Sinai Medical Center in Los Angeles, California....While the sites and principal investigators for the Company’s additional oncology medicines have yet to be determined, ABVC anticipates clinical studies for ABV-1519 for non-small cell lung cancer and ABV-1501 for triple negative breast cancer will be initiated in Q3 2023. The clinical study for ABV-1702 for myelodysplastic syndrome is expected to start in Q4 of 2023. The Company plans to submit ABV-1703’s Phase II clinical trial IND to the Taiwan FDA after commencing clinical trials in the United States."

New P2 trial • New trial • Non-US regulatory • Breast Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lung Cancer • Myelodysplastic Syndrome • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer

ABVC BioPharma Expands Co-Development Partnership With Rgene Corporation (GlobeNewswire) - "ABVC Biopharma, Inc...announced that it has expanded its co-development partnership with Rgene Corporation. BioKey...has entered into a Clinical Development Service Agreement with Rgene to guide three Rgene drug products, RGC-1501 for the treatment of Non-Small Cell Lung Cancer (NSCLC), RGC-1502 for the treatment of pancreatic cancer and RGC 1503 for the treatment of colorectal cancer patients...Under the terms of the new Services Agreement, BioKey is eligible to receive payments totaling $3.0 million over a 3-year period with each payment amount to be determined by certain regulatory milestones obtained during the agreement period....BLEX 404, the new drug under clinical development covered by the service agreement...with breast cancer and myelodysplastic syndromes (MDS) patients."

Licensing / partnership • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lung Cancer • Myelodysplastic Syndrome • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor