- Imugene Limited (ASX:IMU) has announced a new clinical trial supply agreement with Roche to evaluate PD1-Vaxx in combination with atezolizumab in NSCLC patients.
- The Phase1b trial of PD1-Vaxx will be undertaken at sites in the United States and Australia.
- The Company has won an HER-Vaxx immunotherapy patent in Europe.
Clinical-stage immuno-oncology player Imugene Limited (ASX:IMU) has achieved two significant milestones with regard to its B-cell activating immunotherapies – HER-Vaxx and PD1-Vaxx.
Imugene has entered into a new clinical trial supply agreement with Roche to evaluate the efficacy and safety of PD1-Vaxx in combination with Tecentriq® (atezolizumab), in patients with non-small cell lung cancer (NSCLC). Tecentriq® is an immune checkpoint inhibitor targeting PD-L1, which has previously demonstrated clinically meaningful benefit in different types of lung cancer, with six currently approved indications in the United States.
Moreover, the Company has been granted an HER-Vaxx immunotherapy patent in Europe, a major oncology market. HER-Vaxx is Imugene’s B-cell activating immunotherapy designed to treat tumours over-expressing the HER-2/neu receptor, like pancreatic, ovarian, gastric, breast, and lung cancers.
Clinical trial supply agreement - PD1-Vaxx
Roche and Imugene have signed a clinical trial supply agreement for the supply of atezolizumab for a period of up to five years. As part of the agreement, Imugene will sponsor the study and fund the clinical study from existing resources and budgets. Besides, Roche will supply atezolizumab for the duration of the clinical study.
Imugene has planned Phase 1b study of PD1-Vaxx to determine efficacy, safety, and optimal dose of PD1-Vaxx in combination with atezolizumab as either first-line therapy in ICI pretreated patients or ICI treatment - naïve NSCLC patients. The trial will be carried out at sites in Australia and the United States.
In line with the terms of the supply agreement, all data generated in the performance of the clinical trial shall be the property of Imugene as the sponsor. Moreover, all rights to all discoveries and inventions made or conceived during the clinical trial relating to the combination of PD1-Vaxx and atezolizumab shall belong jointly to Imugene and Roche.
Tecentriq or atezolizumab is the first approved cancer immunotherapy for adjuvant NSCLC, and the first approved cancer immunotherapy for front-line treatment of adults suffering from extensive-stage SCLC (small cell lung cancer) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in advanced non-small cell lung cancer as either a single agent or in combination with chemotherapies and/or targeted therapies.
New patent - HER-Vaxx
Imugene has received a Notice of Grant from the European Patent Office (EPO) for Patent Application number 16779340.5. The new patent (granted patent number 1111/3283105) protects the Company’s HER-Vaxx immunotherapy, currently in development for HER-2+ gastric cancer.
The latest patent is titled “A VACCINE COMPOSITION AND USES THEREOF”. It protects the method of composition as well as the method of use of the Company’s advanced HER-Vaxx immunotherapy to 2036.
Earlier in January 2022, the Company also won the HER-Vaxx immunotherapy patent in South Korea, which has one of the highest incidence rates of gastric cancer worldwide. About 75% of all gastric cancer diagnoses are in Asia, which makes South Korea a very massive market for gastric cancer medications.
Following the key updates, Imugene shares rallied by over 9% to A$0.312 as of 3:21 PM AEDT.