An Overview Of IMU’s B-Cell Vaccines’ Clinical Trials

An Australian-based biotechnology company, Imugene Limited (ASX: IMU) focuses on the development of cancer immunotherapies targeted at activating the immune system of cancer patients. The company’s exceptional platform technology helps in stimulating the patient’s immune system to produce antibodies against tumors. Imugene’s technology intends to achieve an identical or greater effect than synthetically produced monoclonal antibody therapies.

The company has a robust pipeline of novel B cell vaccines (including HER-Vaxx (anti-HER-2), PD1-Vaxx (anti-PD-1), B-Vaxx (anti-HER-2) and a combination of HER-2 & PD-1 Vaccine) that are in various stages of development. Two of its therapies, HER-Vaxx and B-Vaxx are already in Phase 2 studies, while others are undergoing earlier stage development. The company is adequately funded and well resourced, to deliver on its clinical and commercial milestones. A number of key clinical and preclinical catalysts are anticipated in 2019.

Overview of Clinical Studies

Let us have a look at the clinical research programs undertaken by the company for its B cell vaccines to date:

HER-Vaxx (anti-HER-2)

The company’s HER-Vaxx is a B-cell peptide cancer vaccine that stimulates a polyclonal antibody response to HER-2/neu. After the successful completion of the Phase 1 clinical trial of HER-Vaxx in breast cancer patients, the company conducted a clinical trial in patients with HER-2 positive gastric cancer. The dosing of the first patient under Phase 1b/2 clinical study was commenced in August 2017.

Phase 1b Trial Data Presented at AACR Annual Meeting

In April this year, the company presented positive new data on its HER-Vaxx cancer vaccine Phase 1b trial at the 2019 Annual Meeting of American Association for Cancer Research (AACR). Up to 18 patients were tested with 3 escalating doses of the HER-Vaxx vaccine in the trial. 11 out of 14 were evaluable for the tumor response assessment and vaccine-specific immune responses. The HER-2/neu peptide vaccine was administered with 5-fluorouracil or capecitabine chemotherapy and cisplatin in the trial. The trial demonstrated safety, clinical response and immunogenicity in the patients with HER-2 positive gastric cancer. All the patients (cohort 3, 50 microgram dose) had a rise in HER-2-specific antibody levels subsequent to vaccination. Out of the 11 patients, five of them had a partial response, one patient saw a complete response, and four patients observed a stabilisation of their disease.

Updated Phase 1b Trial Data Presented at ASCO Annual Meeting

In June this year, the data of HER-Vaxx cancer vaccine’s Phase 1b study was presented at the 2019 Annual Meeting of American Society of Clinical Oncology. It was reported that the Phase 1b study that concluded enrolment last year had met all its primary endpoints. In order to sustain high levels of cancer targeting antibodies, the patients are being dosed with HER-Vaxx vaccine every three months.

It was found that the patients that received the highest dose of B-cell vaccine HER-Vaxx had shown continuous progress. Their tumors have either stabilized or shrunk further by 182th day of the trial. It was observed in one patient that the tumor got shrunk by over 70 per cent since the patient joined the trial. The patients in the highest dose category have received 266 doses already. The results with day 266 data were presented at ESMO GI in Barcelona in an oral presentation on 3rd – 6th July 2019.  The patient who’s tumor had shrunk by 70% at day 182 shrunk further (80%) by day 266.

Phase II HER-Vaxx Study

After successful completion of Phase 1b trials, Imugene marked the beginning of the open-label, randomised multi-centre Phase II study by announcing dosing of the first patient in March 2019. The patient with HER-2 positive gastric cancer was dosed with HER-Vaxx (IMU-131) cancer vaccine. The Phase 2 HER-Vaxx study is designed by Imugene to measure the safety, efficacy and immune response in sixty-eight patients suffering from metastatic gastric cancer, overexpressing the HER-2 protein.

B-Vaxx (anti-HER-2)

Another B cell peptide cancer vaccine that stimulates a polyclonal antibody response to HER-2/neu is B-Vaxx. The Phase 1 clinical trial of B-Vaxx has been successfully completed, and the vaccine is currently undergoing Phase-2 clinical trial.

Phase 1 Clinical Trial of B-Vaxx

The Phase 1 clinical trial data of B-Vaxx was published in the prestigious AACR journal ‘Clinical Cancer Research’. The combination of two chimeric HER-2 B-cell peptide vaccines engineered to depict the pertuzumab and trastuzumab binding sites was evaluated under Phase 1 to test the optimal immunologic/biologic dose, safety profile and immunogenicity of the vaccines. The study showed positive results with 14 out of 24 late-stage patients with encouraging clinical response. Out of 24, two patients had a partial response, and one patient had progression-free survival at more than 40 months. No serious dose-limiting toxicities or adverse reactions were observed in the trial.

PD1-Vaxx (anti-PD-1)

PD1-Vaxx seeks to stimulate the body to generate such polyclonal antibodies which inhibit PD-1/PD-L1 binding. The vaccine generates an anticancer effect identical to monoclonal antibodies, Opdivo and Keytruda. The vaccine has shown encouraging responses in preclinical studies and Phase 1 trial of the vaccine is expected to commence in 2020.

Preclinical Results of PD1-Vaxx

The preclinical results of PD1-Vaxx were announced by the company in July 2018. It was observed that the vaccine demonstrated inhibitory cancer growth activity in validated models of colorectal (colon) cancer. In validated models of colorectal (colon) cancer, the vaccine showed superior cancer growth inhibition relative to an industry-standard monoclonal antibody. In April this year, Imugene presented positive new data on one of its PD-1 mimotope based cancer vaccine at the AACR 2019 Annual Meeting. The tumor growth was successfully inhibited with PD-1 targeting B-cell cancer vaccines in a syngeneic mouse model of HER-2+ breast cancer, as indicated by the research.

HER-2 & PD-1 Vaccine Combination

Imugene’s B-cell vaccine candidates are targeted to treat a range of cancers in combination with emerging immunotherapies and standard of care drugs. While looking for novel combinations, the company tested the combination of HER-2 Vaxx & PD1-Vaxx Vaccines in inhibiting cancer growth. The data on the B-Vaxx and PD1-Vaxx cancer vaccine programs was presented at the AACR 2019 Annual Meeting by Imugene in April this year.

It was found that the combination of B-Vaxx & PD1-Vaxx has the potential to increase response rates in HER-2+ cancers and is more effective (90 per cent cancer growth inhibition) in reducing tumor growth than the PD1-Vaxx vaccine alone. The combination was tested in an industry-recognised mouse model of colon carcinoma and showed no safety or toxicity issues.

Overall, it can be seen that Imugene is aiming to charge high with its diverse suite of new treatments in cancer immunotherapy.

Stock Performance: The company’s stock closed higher at AUD 0.019 on 22nd July 2019, up by 11.76 per cent relative to the last closed price.


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