EG1206A (pertuzumab biosimilar) / EirGenix - LARVOL DELTA

EirGenix Inc. Officially Submits EG1206A Phase III Clinical Trial Application to Georgia Health Authority (Zonebourse) - "EirGenix has officially submitted the Phase III clinical trial application for EG1206A to the Mexican Health Authority. New drug name or code: EG1206A (biosimilar of pertuzumab). Indication: Early-stage breast cancer (ESBC) and metastatic breast cancer.... After completing the Phase III clinical trial for the development product EG1206A (pertuzumab biosimilar), the company will submit a marketing application to the regulatory body."

New P3 trial • HER2 Breast Cancer

EGC102: Efficacy and Safety Study of EG1206A (EirGenix' Pertuzumab) Compared with EU-sourced Perjeta® (Pertuzumab) in Patients with HER2-positive Hormone Receptor Negative Early Breast Cancer. (clinicaltrials.gov) - P3 | N=380 | Not yet recruiting | Sponsor: EirGenix, Inc.

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Solid Tumor

Tai Kangsheng’s second-generation breast cancer biosimilar drug has been approved by the FDA to conduct Phase III clinical trials [Google translation] (stock.yahoo) - "Tai Kangsheng...announced on the 24th that its second-generation biosimilar drug EG1206A for the treatment of early-stage breast cancer and metastatic breast cancer has been approved by the US FDA for Phase III clinical trials. The original drug of EG1206A is Perjeta (pertuzumab)."

IND • New P3 trial • Breast Cancer

"Biomedical Stocks" Taikang Biotech's phase 3 clinical trial plan for biosimilar drug EG1206A submitted to the US FDA [Google translation] (stock.yahoo) - "Taikang Biotech...announced that the third phase clinical trial plan for the biosimilar drug EG1206A (pertuzumab biosimilar) under development has been successfully submitted to the US FDA...The new drug EG1206A (pertuzumab biosimilar) is used to treat early-stage breast cancer and metastatic breast cancer....Taikang Biotech stated that after the EG1206A product completes the third phase of human clinical trials, it will submit an application for drug inspection registration review to regulatory authorities."

Clinical protocol • New P3 trial • Breast Cancer

Taikang Biotech’s second similar breast cancer drug to be licensed in Europe and the United States to finalize at the end of the year, with potential orders of US$1 billion [Google translation] (stock.yahoo) - "Taikang Biotech...held a press conference on the 18th. Chairman Liu Lizheng said that the first breast cancer biosimilar drug Trastuzumab EG12014 150 mg, the US FDA is expected to inspect the third party factory at the end of October. If everything goes well, It is expected to obtain a U.S. drug license before the end of this year, and the second similar breast cancer drug, Pertuzumab (EG1206A), is expected to finalize European and American market authorization by the end of this year....The second R&D product/Pertuzumab biosimilar drug EG1206A has held two scientific consultation meetings with the EMA and one with the FDA before the launch of the Phase III clinical trial. The Phase III clinical trial will open nearly 100 acceptance points, it is expected to be completed clinically in one and a half years, and the first patient will be admitted in the first quarter of next year."

EMA approval • FDA approval • New P3 trial • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor

Popular Stock - Taiwan Kangsheng's revenue surges, legal support [Google translation] (stock.yahoo) - "Tai Kangsheng is developing a Herceptin biosimilar drug EG12014 for the treatment of breast cancer. The U.S. drug license application is still filling in the missing parts such as freeze-drying equipment. The market expects that after completing the supplements, it can obtain the U.S. drug license in the second half of the year, and there will be a milestone by then. Jin Keyi notes; the second-generation EG1206A will also have opportunities for external licensing before the end of the year."

FDA approval • Licensing / partnership • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

The board of directors of Taikang Biotechnology has decided to sign a commissioned research case for the phase III trial of EG1206A product with clinical CRO and other companies. [Google translation] (MoneyDJ) - "...The Company The board of directors decided to sign a commissioned research case for the clinical phase III trial of EG1206A product with clinical CRO and other companies....This case is planned according to the research and development schedule of its own product EG1206A. Phase III clinical trials will be carried out and the board of directors will authorize the chairman to have full authority to sign the contract. The contract amount involves future international licensing negotiation information, which may affect the authorization amount. In order to protect the company and investors rights and interests, so they will not be disclosed publicly."

Licensing / partnership • Breast Cancer • Oncology • Solid Tumor

Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer (clinicaltrials.gov) - P2 | N=16 | Recruiting | Sponsor: University of Washington | Trial primary completion date: Oct 2023 ➔ Oct 2024

Surgery • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • CD4 • ER • HER-2 • PGR

Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: National Cancer Institute (NCI)

New P2 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer (clinicaltrials.gov) - P1/2 | N=2 | Terminated | Sponsor: National Cancer Institute (NCI) | N=12 ➔ 2 | Recruiting ➔ Terminated; Inadequate accrual rate

Combination therapy • Enrollment change • Metastases • Trial termination • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • PIK3CA • PTEN

Tai Kangsheng CDMO plans to return to growth next year; EG1 will be supplemented by the end of 2014 [Google translation] (MoneyDJ) - P1 | N=135 | NCT05471648 | Sponsor: EirGenix, Inc. | "Affected by the vaccine stock solution and the general environment, Taikang Biotech (6589)'s professional drug manufacturing (CDMO) business declined significantly in the first eight months...As for the self-owned drugs, the date for the replacement of the anti-breast cancer drug EG12014 has been postponed to the end of this year. If everything goes well, it will be certified in the third quarter of next year. The other EG1206A will strive to be authorized before the second quarter of next year....The market is paying more attention to the progress of the more competitive EG1206A. With phase I clinical data showing positive results, it plans to launch phase III trials in the third quarter of next year and complete authorization before the second quarter."

Commercial • New P3 trial • P1 data • Breast Cancer • Oncology • Solid Tumor

SMMART Adaptive Clinical Treatment (ACT) Trial (clinicaltrials.gov) - P1 | N=25 | Not yet recruiting | Sponsor: OHSU Knight Cancer Institute | Phase classification: P2 ➔ P1 | N=131 ➔ 25

Enrollment change • Phase classification • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatology • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • BRCA1 • BRCA2 • HER-2

Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer (clinicaltrials.gov) - P2 | N=16 | Recruiting | Sponsor: University of Washington | Trial primary completion date: Jun 2023 ➔ Oct 2023

Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • CD4 • ER • HER-2 • IFNG • IGFBP2 • IL10 • PGR

EirGenix's Second Breast Cancer Biosimilar EG1206A Successfully Reaches Phase 1 Clinical Trial Objectives (PRNewswire) - "EirGenix...announced on 28th of April that it has completed the phase 1 clinical trial (EGC101) of its second breast cancer biosimilar EG1206A in Europe. Comparing EG1206A to Roch's Perjeta® US and EU, results of the clinical data analysis show that the main test indicators have met the pharmacokinetics bioequivalence standard....EG1206A will soon begin its multi-country, multi-center global phase 3 clinical trials. After the initiation of the phase 3 clinical trials, it is expected that the evaluation of the primary end point indicators will be completed within two (2) years. Concurrently, EirGenix has been negotiating with global pharmaceutical companies for licensing marketing rights of EG1206A to further fast-track the launch of the biosimilar into the global market."

New P3 trial • P1 data • Trial completion • Breast Cancer • Oncology • Solid Tumor

NCI-MATCH: Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (clinicaltrials.gov) - P2 | N=6452 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Biomarker • Enrollment closed • Metastases • Biliary Cancer • Bladder Cancer • Brain Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • CNS Tumor • Colon Cancer • Colorectal Cancer • Endocrine Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Glioma • Head and Neck Cancer • Hematological Malignancies • Hepatology • Kidney Cancer • Liver Cancer • Lung Cancer • Lymphoma • Melanoma • Multiple Myeloma • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Refractory Ovarian Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Thyroid Gland Carcinoma • Urothelial Cancer • Uterine Cancer • CD4 • MSI

A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers (clinicaltrials.gov) - P1 | N=135 | Completed | Sponsor: EirGenix, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jun 2023 ➔ Jan 2023

Trial completion • Trial completion date • Breast Cancer • Oncology • Solid Tumor

NRG-BR004: Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov) - P3 | N=600 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jan 2023 ➔ Apr 2024 | Trial primary completion date: Jan 2023 ➔ Apr 2024

Metastases • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Psoriatic Arthritis • Solid Tumor • ER • IL2 • PGR

A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers (clinicaltrials.gov) - P1 | N=135 | Active, not recruiting | Sponsor: EirGenix, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Oncology • Solid Tumor

A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers (clinicaltrials.gov) - P1 | N=135 | Recruiting | Sponsor: EirGenix, Inc.

New P1 trial • Breast Cancer • Oncology • Solid Tumor