Imugene achieves phase-II clinical trial milestone for HER-Vaxx cancer immunotherapy
The important clinical endpoint of Progression Free Survival (PFS) has been met after the statistically significant required number of PFS events has occurred.
Company
ASX:IMU
Imugene Ltd is a clinical stage immuno-oncology company developing a range of new treatments that seek to activate the immune system of cancer patients to identify and eradicate tumours. The company's unique platform technologies seek to harness the body’s immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies. Imugene is supported by a leading team of international cancer experts with extensive experience in developing new cancer therapies with many approved for sale and marketing for global markets.
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The important clinical endpoint of Progression Free Survival (PFS) has been met after the statistically significant required number of PFS events has occurred.
The company presented on the HER-Vaxx cancer immunotherapy program and the CF33 oncolytic virus program during the meeting.
The company’s cohort review committee has confirmed that its Phase 1 NSCLC trial for checkpoint immunotherapy candidate PD1-Vaxx may proceed to the third and final dose cohort.
PD1-Vaxx has been deemed safe with no dose-limiting toxicities (DLTs) and no serious adverse reactions observed at mid-dose (50μg) level and will now escalate to the final highest dose (100μg) cohort.
In the near-term, the company expects to release the HER-Vaxx results, progress phase 1 of the PD1-Vaxx clinical trial and start the VAXinia and CHECKvacc clinical programs in the US.
The company will present on the CF33 oncolytic virus program and on the HER-Vaxx cancer immunotherapy program during the prestigious association's annual meeting.
The company is a clinical-stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours.
The CRC unanimously agreed that PD1-Vaxx is safe with no dose-limiting toxicities (DLTs) and has recommended to proceed to the next dose escalation due to safety and tolerability.
The Phase 2 trial represents a clinical proof-of-concept for HER-Vaxx to indicate that B-cell activating immunotherapy platform can induce clinically active antibody responses.
The clinical-stage immune-oncology company has enrolled the first three patients in the first low dose PD1-Vaxx cohort with non-small cell lung cancer.
Receiving the $4,823,466 million in additional funding will further support the company's commercial and clinical milestones.
Bell Potter has raised its valuation of Imugene to 17 cents from 5 cents and has maintained its buy (speculative) recommendation.
The first-in-human, Phase 1, multi-centre, dose-escalation study of PD1-Vaxx is recruiting patients with non-small cell lung cancer.
The IDMC provided guidance that it is scientifically and ethically appropriate to reduce the overall number of patients required to complete the study, given the strong signal observed in the data.
US FDA approval of the IND allows Imugene to initiate patient recruitment and dosing in its USA Phase I clinical study in non-small cell lung cancer (NSCLC) patients.
During the September quarter, the clinical-stage immuno-oncology company continued to progress clinical programs and remains well-funded to cater for an expected increase in expenditures.
Imugene's oncolytic viruses are designed to infect, replicate in, and kill cancer cells, leaving healthy cells essentially unharmed.
The company recently boosted its balance sheet with a $5.7 million underwriting agreement to support four continuing clinical programs - CF33, PD1, Vaxx and HER-Vaxx as well as provide funding for IP and milestone payments.
The company recently entered into an agreement to underwrite outstanding listed options which provides holders with an option to purchase shares in the company at 2.6 cents per share.
The agreement with Bell Potter further strengthens the company’s financial position building on the existing cash balance of $30.1 million as of June 30, 2020.