An Australian-headquartered clinical stage biotechnology company, Imugene Limited (ASX: IMU) seeks to develop different novel immunotherapies to boost the efficacy of cancer treatments. Imugene’s product pipeline covers oncolytic viruses and several immunotherapy B-cell vaccine candidates targeted at treating a range of cancers in conjunction with novel immunotherapies and standard of care drugs.
Imugene has recently added an oncolytic virus CF33 to its existing platform that targets the development of B cell peptide vaccines. The B cell vaccines provide an exclusive opportunity to step in at various points in the immune system and form an immune memory, which improves the durability of response. Imugene holds market leadership in the development of B cell peptide cancer vaccines that could provide multiple potential benefits in terms of safety, efficacy, durability, usability and cost.
The company’s B cell vaccines namely B-Vaxx (anti-HER-2), HER-Vaxx (anti-HER-2), PD1-Vaxx (anti-PD-1) and a combination of B-Vaxx & PD1-Vaxx, have experienced significant developments in 2019 to-date.
Let us take a look at the key B-cell vaccine developments undertaken by Imugene in 2019:
HER-Vaxx, that focuses on cancers having an over expression of Human Epidermal Growth Factor Receptor (HER-2), is the company’s most progressed immunotherapy treatment from a clinical perspective. With several monoclonal antibody therapies that are currently available for use, HER-Vaxx would be the first vaccine to target HER-2. HER-Vaxx promotes the B cells of patients to produce natural antibodies to attack cells with HER-2 on their surface.
Phase Ib Trial
The Phase Ib clinical trial of the HER-Vaxx, completed in 2018, showed promising results. In 2019, the HER-Vaxx cancer vaccine trial data was presented at 2019 Annual Meeting of American Association for Cancer Research (AACR) in April and American Society of Clinical Oncology (ASCO) in June, and at ESMO’s World Congress on Gastrointestinal Cancer in July.
The Phase Ib study involved enrolment of 14 patients in the age group of 21 to 79 at advanced stages (IIIb or IV) of gastric cancer. These patients were divided into 3 cohorts and were provided three different dosage levels – 10 µg (three patients), 30 µg (six patients) and 50 µg (five patients) – in combination with cisplatin and 5-fluorouracil or capecitabine.
In July 2019, Imugene presented the latest Phase Ib trial results of HER-Vaxx at the ESMO’s World Congress on Gastrointestinal Cancer. The results highlighted that out of the 14 patients dosed, 11 were evaluable that demonstrated encouraging clinical responses as follows:
- One showed a complete response,
- Five patients showed a partial response with a reduction in tumor size by more than 30 per cent,
- Four showed a stable response with less than 20 per cent reduction in tumor size, and
- One showed a progressive disease.
All evaluable patients demonstrated increased antibody responses. The safety data indicated that IMU-131 (HER-Vaxx) is well-tolerated with no substantial systemic or local reactions. IMU did not observe any dose-limiting toxicities, IMU-131 related SAEs or any significant injection site reactions in the treatment.
Source: Company’s Report
Overall, the median tumour size decreased over the trial, with the most significant median decline being experienced by those patients receiving the highest dose (50 µg) of HER-Vaxx.
Phase II Trial
While only a small sample, the Phase Ib trial results presented were positive and provided a level of optimism for the Phase II trials. Imugene commenced HER-Vaxx Phase II study with the dosing of the first patient in March 2019. The company informed that the Phase II study will measure the response of 68 patients with HER2-positive gastric cancer. The patients will be provided the highest dose administered (50 micrograms) in Phase Ib trial.
Under the Phase II study, the patients will be tested in 2 groups: HER-Vaxx plus standard of care chemo, and standard of care chemo alone. According to Imugene, the primary endpoints of the study are progression-free survival and overall survival, while the secondary endpoints are tolerability and safety, and immune response. The results from the Phase II study are due to be completed in 2020.
In February 2019, the prestigious AACR journal, Clinical Cancer Research published the Phase I clinical trial data of Imugene’s B cell peptide cancer vaccine, B-Vaxx. The B-Vaxx also targets HER2-positive cancers and is well advanced. The B-Vaxx vaccine had shown positive Phase I results and is currently undergoing Phase II clinical development phase.
In Phase I clinical trial of B-Vaxx, 24 patients were enrolled out of which 14 evaluable late stage patients showed encouraging clinical responses. Out of 24, two demonstrated partial response while one showed progression free survival at 40+ months.
Acquired as a part of the licensing agreement from OSU in 2018, PD1-Vaxx aims to produce polyclonal antibodies that block PD-1 signalling proteins which stop the immune system from attacking cancer cells. The company obtained and acknowledged the minutes of Pre-IND (Investigational New Drug) meeting with the US FDA for its PD-1 targeting cancer immunotherapy in March this year.
In April 2019, a positive new data was also presented by Imugene and the Medical University Vienna on PD-1 mimotope cancer vaccine program at the AACR 2019 Annual Meeting. Imugene is likely to commence a Phase I clinical trial for PD1-Vaxx in 2020 after encouraging results from the pre-clinical studies.
B-Vaxx and PD1-Vaxx Combination
According to Imugene, the opportunities are increased through the potential use of IMU’s treatments in combination with existing commercialised immunotherapies to potentially improve response rates without increasing toxicity.
In April 2019, Imugene presented new data on its PD1-Vaxx and B-Vaxx at AACR 2019 Annual Meeting. The company highlighted that a combination of B-Vaxx and PD1-Vaxx had shown more effective cancer growth inhibition in colorectal cancer model in comparison to PD-1 Vaxx vaccine alone. Imugene notified that 90 per cent cancer growth inhibition was realised when the PD1-Vaxx was combined with the B-Vaxx agent, which was far greater than the outcomes from PD-1 agents on their own.
Source: Company’s Report
As discussed, Imugene has achieved a number of milestones in 2019 to-date. The company has demonstrated steady progress in its product pipeline till-date and is well-funded to continue with future developments.
Stock Performance: IMU is currently trading at AUD 0.024, up by 9.09% on 7 August 2019 (12:15 PM AEST). The stock has generated a YTD return of 25 per cent.
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