Imugene advances clinical trial activity over busy June quarter

Imugene advances clinical trial activity over busy June quarter

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Imugene Ltd has capped off the June quarter with A$29.5 million in the bank as it prepares to advance a series of clinical trials in FY22’s first quarter. The clinical-stage immuno-oncology company has reached the highest dose cohort in its first-in-human phase one study of PD1-Vaxx, one of Imugene’s two B-cell immunotherapies, and presented on its HER-Vaxx and CF33 CHECKVacc therapy candidates at an annual symposium run by the American Association for Cancer Research (AACR). In its quarterly update, Imugene also updated the market on its financial performance, with A$3.6 million spent on research and development activities over the June quarter. It brings the total amount spent on research and development activities over FY21 to just over A$15.6 million. Imugene also brought in just shy of A$8.7 million from an options exercise during the June quarter, offsetting its operating and investing expenses. Imugene’s three novel technology platforms. HER-Vaxx After completing phase two trial recruitment in January 2021, Imugene’s chief medical officer Dr Rita Laeufle was able to present on the HER-Vaxx B-cell cancer immunotherapy program at the 2021 AACR Annual Meeting in April. In addition, earlier this month, data on the therapy candidate was presented at the ESMO World Congress on Gastrointestinal Cancer 2021 Annual Meeting. Overall, the ESMO presentation highlighted new data: HERVaxx treatment resulted in a 50% overall response rate (ORR) compared to 29% in patients treated with chemotherapy alone; The ORR measures the percentage of patients who responded to treatment with a partial response (PR) or better; Treatment with HERVaxx clearly demonstrates patients develop high levels of HER2-specific antibodies early in the treatment protocol and are maintained during treatment and maintenance phase with only a few booster injections; Tumour response is correlated with the amount of antibody levels. Patients with antibody levels higher than 1050ng/ml received greater than 50% tumour reduction and may serve as a potential biomarker; and In contrast to patients on chemotherapy alone, the reduction of tumour size is substantially higher in patients that received HERVaxx + chemotherapy. Overall, this data demonstrates HER-Vaxx may provide treatment benefits consistent with traditional monoclonal antibodies with a corresponding adaptive immune response without added toxicity. Phase one clinical trial data for Imugene’s B-cell peptide cancer immunotherapy was published in the prestigious American Association for Cancer Research journal Clinical Cancer Research. Imugene's deep pipeline. PD1-Vaxx The first-in-human, phase one, multi-centre, dose-escalation study of PD1-Vaxx is currently recruiting patients with non-small cell lung cancer who have progressed from previous therapies. Essentially, medical investigators are testing three different doses of PD1-Vaxx. The primary goal of the phase one trial is to determine safety and an optimal biological dose as a monotherapy (mOBD). Efficacy, tolerability and immune response will also be measured. The determination of mOBD will be made by the Cohort Review Committee (CRC) and requires successive dosing within cohorts of at least three patients each. The phase one study is currently enrolling in cohort three, the highest dose after successful completion of cohort two. Phase one trials are generally designed to look for safety, tolerability and early response signals to determine the optimal dose for further development. The company is encouraged to see what it considers positive signals at such an early stage of its PD1-Vaxx phase one trial, even in this late-stage patients. All six sites — three in Australia and three in the US — are open for recruitment. To date, clinicians have reported no safety, toxicity or tolerability issues with PD1-Vaxx. Imugene anticipates these results will continue in the highest dose of PD1-Vaxx. Imugene CEO Leslie Chong spoke to Proactive's Andrew Scott about the company's anti-cancer programs in June. onCARlytics licensed One of Imugene’s key quarterly activities occurred in May, when Imugene licensed the novel onCARlytics™ combination immunotherapy from the California-based City of Hope® clinical research centre. The therapy unleashes a CD19 expressing oncolytic virus to enable CD19 directed chimeric antigen receptor (CAR) T cell therapies to target solid tumours, which are currently otherwise difficult to treat with CAR T cell therapy alone. The worldwide exclusive licence of the patents covering the cell therapy technology — which includes CF33-CD19, known as onCARlytics, or an agent that tags cancer cells for CAR T cell destruction — was developed at City of Hope. City of Hope’s Dr Yanghee Woo MD presented on the CF33 oncolytic virus program at the American Association for Cancer Research (AACR) 2021 Annual Meeting during the June quarter. How the CF33 mechanism of action works. IND approval for CHECKvacc phase one trial On the last day of the June quarter, Imugene achieved a major milestone after City of Hope secured Investigational New Drug (IND) approval for an upcoming phase one trial of the ASX-lister’s oncolytic virotherapy candidate. Together, the companies hope to investigate the safety and efficacy of Imugene’s CHECKvacc drug candidate — formally known as CF33-hNIS-antiPDL1 — against metastatic, triple-negative breast cancer (TNBC). Now, with US Food and Drug Administration (FDA) approval in tow, Imugene and City of Hope can start patient recruitment and dosing a phase one clinical trial for TNCB patients. A key appointment In mid-June, Imugene appointed Dr Monil Shah as its chief business officer (CBO) and a member of the company's executive management team. Shah will lead the company’s global business development and partnering activities and support its clinical development. The new CBO has more than 20 years of pharmaceutical and biotechnology industry experience in oncology drug development. Speaking to the appointment at the time, Imugene managing director and CEO Leslie Chong said: “We look forward to the valuable contribution Dr Shah will make to advance our important immuno-oncology programs and I’m excited by someone of his calibre and experience in cellular therapy is joining Imugene as a chief business officer.”

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