On July 31, 2024 Imugene Limited (ASX:IMU), a clinical-stage immuno‐ oncology company, reported its Quarterly Cash Flow report (Appendix 4C) for the quarter ended 30 June 2024 (Press release, Imugene, JUL 31, 2024, View Source [SID1234645177]).
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CLINICAL TRIAL UPDATES
Azer-cel continues to enrol in the Phase 1b study. Azer-Cel (azercabtagene zapreleucel) is an off-the-shelf (allogeneic) cell therapy which targets CD19 to treat blood cancers.
The Phase 1b allogeneic (allo) CAR T study is an ongoing multi-centre clinical trial in patients who suffer from a difficult to treat sub-set of non-Hodgkin’s lymphoma (NHL) called Diffuse-Large Bcell lymphoma (DLBCL) that have relapsed after autologous CAR T therapy. These DLBCL patients have limited therapeutic options and are an unmet medical need.
Following completion of the Phase 1b study there is potential to start a registrational Phase 2/3 study in 2025 and become the first approved allogeneic CAR T cell therapy for cancer. VAXINIA Bile Tract Cancer trial opened, and the VAXINIA MAST trial higher dose cohort opened for enrolment.
Imugene launched its Phase 1 bile tract cancer (cholangiocarcinoma) trial, which aims to enrol 10 patients. In the Phase 1 MAST trial, one patient with bile tract cancer who had failed three prior lines of therapy received a mid-dose of IT-administered monotherapy VAXINIA, achieved a complete response, meaning the disappearance of all signs of cancer in response to treatment, and the patient has been in the trial for over 630 days. A second patient with bile tract cancer (cholangiocarcinoma), who has also progressed on prior drug therapies, achieved stable disease, meaning their cancer neither increased nor decreased and no new tumours appeared for more than four months upon receiving IV administered VAXINIA.
The results seen in these patients provided the rationale for Imugene to open a VAXINIA trial in this specific patient population. The FDA granted Fast Track Designation to the VAXINIA program in November 2023, accelerating the development and potential approval process due to the urgent need for new treatments. The MAST trial, which began by administering low doses to patients with advanced solid tumours, has progressed through several dose escalation cohorts without safety concerns.
This bile tract cancer trial not only supports the ongoing evaluation of VAXINIA’s efficacy, but also emphasizes its role in addressing the significant challenges associated with treating bile tract cancer, an aggressive form cancer with limited effective treatments for patients. Subsequent to the end of the quarter, Imugene announced that the first patient had been dosed at St. Vincent’s Hospital in Melbourne.
Additionally, it was confirmed that the fifth cohort of both arms of the Phase 1 MAST monotherapy dose escalation trial have now cleared, with the sixth high dose cohort of each arm having opened.
Imugene Phase 1 onCARlytics trial doses first patient in Intravenous (IV) combination arm in the OASIS trial.
Late in the quarter, the first patient was dosed in the intravenous (IV) combination arm of the Company’s Phase 1 onCARlytics clinical trial. The trial, known as OASIS, is pioneering in its combination of a CD19-expressing oncolytic virus with a CD19-targeting drug called BLINCYTO (blinatumomab). CD19 is used in blood cancers, but solid cancers like breast, lung, gastric, bile tract, and colon, etc. don’t have a common target on their cell surface; the goal of onCARlytics is to present a target for CD19 therapies. The CD19-expressing CF33 oncolytic virus marks or paints the tumour target with CD19 on the cell surface, followed by treatment with a CD19 targeting therapy. The trial aims to recruit 40-45 patients with advanced solid tumours and is currently being conducted at three sites in the US, with the potential to expand to 10 sites.
The first patient, who has bile tract cancer, was dosed at City of Hope in California. The primary objective of the trial is to evaluate the safety and efficacy of onCARlytics when administered either intratumorally (IT) or intravenously (IV), alone or in combination with blinatumomab, a CD19-targeting bispecific monoclonal antibody.
Preliminary early combination data are expected in the fourth quarter of 2024, subject to patient enrolment rates. If successful, onCARlytics could significantly expand the market for CD19-targeting therapies. CD19 therapies are currently only approved in blood cancers, which only make up 10 percent of cancers, while solid cancers make up 90 percent of the cancer market. If successful onCARlytics could make CD19 targeted therapies an option to treat patients with solid cancers. This could potentially impact a market which is estimated to be valued at approximately US$532 billion by 2032.
CORPORATE UPDATES:
Imugene and Kincell Bio Announce Strategic Manufacturing and Process Development Partnership for azer-cel. In April, Imugene and Kincell Bio established a strategic partnership focused on manufacturing and process development. Under this agreement, Kincell Bio acquired Imugene’s manufacturing facility in North Carolina. Additionally, this strategic shift ensures continued clinical supply of azer-cel, Imugene’s advanced allogeneic CAR T cell therapy while Imugene retains all rights to azer-cel.
VAXINIA selected for Oral and Poster Presentations at 2024 Cholangiocarcinoma Foundation Annual Conference.
Imugene presented its VAXINIA technology at the 2024 Cholangiocarcinoma Foundation Annual Conference in April in Salt Lake City, Utah. In both an oral and a poster presentation, the company discussed the effectiveness and safety of VAXINIA as a treatment for gastrointestinal malignancies, including bile tract cancer (cholangiocarcinoma), highlighting its potential as a monotherapy treatment in a field where early detection and treatment options are limited. This conference provides a platform for healthcare professionals and researchers to exchange insights on advancing the treatment and understanding of bile tract cancer.
Presentation at Bell Potter Emerging Leaders Conference.
Imugene CEO & Managing Director Leslie Chong presented at the Bell Potter Emerging Leaders Conference in May 2024. A copy of the presentation can be viewed here.
FINANCIALS
At the end of the June quarter Imugene has A$93.1 million in cash or equivalents (Excluding R&D tax rebate of ~$11 million expected imminently), providing a runway to support its clinical pipeline and operations into late 2025. Net cash used in operating activities for the quarter amounted to A$19 million, with direct research and development costs accounting for 57% of total costs. In accordance with Listing Rule 4.7C, payments made to related parties and their associates included in items 6.1 of the Appendix 4C include payments for remuneration of director fees to executive and non-executive directors in the normal course of business at commercial rates, excluding reimbursements of out-ofpocket expenses. Options granted to directors that are included in Imugene’s Remuneration Report under share-based payments, are non-cash amounts and represent valuations using the Black-Scholes methodology. Share-based payments relating to option grants to directors are therefore not included in item 6.1 of the Appendix 4C.