Imugene progresses clinical trials supported by strong cash runway
Latest release from Proactive Investors 30th July 2024
Imugene Ltd is in a strong cash position with A$93 million as of June 30, 2024, excluding an expected R&D tax rebate of ~A$11 million, to continue progressing four Phase 1/1b/2 clinical trials which are recruiting in the US, Australia and the UK. This financial position provides a runway to support the company's clinical pipeline and operations into late 2025.
Clinical trial updates
Azer-cel continues to enrol in Phase 1b study
Azer-Cel (azercabtagene zapreleucel) is an off-the-shelf (allogeneic) cell therapy which targets CD19 to treat blood cancers.
The ongoing Phase 1b allogeneic (allo) CAR T study is a multi-centre clinical trial in patients who suffer from a difficult-to-treat subset of non-Hodgkin’s lymphoma called Diffuse-Large Bcell lymphoma that have relapsed after autologous CAR T therapy.
These patients have limited therapeutic options and are an unmet medical need.
Once the Phase 1b study is complete 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; MAST trial higher dose cohort open for enrolment
Imugene launched its Phase 1 bile tract cancer (cholangiocarcinoma) trial during the quarter, 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.
The patient has been in the trial for over 630 days.
A second patient with bile tract cancer, 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.
Fast Track Designation was granted by the FDA 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 emphasises its role in addressing the significant challenges associated with treating bile tract cancer, an aggressive form of cancer with limited effective treatments for patients.
Subsequent to the end of the quarter, the first patient was dosed at St Vincent’s Hospital in Melbourne. It was also 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.
Phase 1 onCARlytics trial doses first patient in IV combination arm in OASIS trial
Late in the June 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®. 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 trial aims to recruit 40-45 patients with advanced solid tumours and is being conducted at three sites in the US, with the potential to expand to 10 sites. 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% of cancers, while solid cancers make up 90% 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.
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