Imugene Limited (ASX:IMU) (OTCMKTS:IUGNF) has enjoyed a productive September quarter and is well-funded to pursue commercial and clinical milestones.
Quarterly research and development expenditure wasA$4.2 million and the company continues to monitor expenditure carefully ahead of the four clinical trials and associated expenditure planned for the remainder of 2020
Listed IMUOA options exercisable at A2.6 cents per option are currently in the money with IMU shares having closed at A5.3 cents per share, which is more than double the exercise price, on October 13, 2020, and the company has secured an agreement with existing institutional shareholders to underwrite the balance of the options not exercised by November 30, 2020, to total A$5.6 million.
Imugene had A$26.6 million in cash and cash equivalents on hand as of September 30, 2020.
Clinical trials progress
Guidance from the US FDA on the development pathway for VAXinia was received (US FDA guidance for CHECKvacc was previously received in early 2020) and progress for both CF33 oncolytic virotherapies, VAXINIA and CHECKvacc continues to enter into the clinic.
The PD1-Vaxx clinical trial is screening patients to enter into the clinical trial in Australia.
During the quarter, Imugene also received three Human Research Ethics Committee (HREC) approvals to commence the Phase I clinical trial of its checkpoint immunotherapy candidate, PD1-Vaxx in Australia.
Additionally, the first Institutional Review Board approval was received in the US in New Jersey for PD1-Vaxx.
HER-Vaxx continues to enrol into the open label Phase 2 study and the team is preparing and confirming all data to schedule the second interim analysis.
The Independent Data Monitoring Committee (IDMC) will review this data upon completion of the soft data lock.
B-Cell Immunotherapy Patent
The Growth Factor B-Cell Immunotherapy combination patent was recently granted in the United States.
This patents the method of composition and method of use of Imugene’s Ohio State University licensed vaccines from the laboratory of Professor Pravin Kaumaya.
The promising results protected in the patent support the rationale for dual targeting with HER-1, HER-2 and HER-3 or IGF-1R as an improved treatment regimen for advanced therapy tailored to different types of cancer.
Attaining the key US patent adds extra value to Imugene’s portfolio of B-cell immunotherapies and this will protect them in the world’s largest pharmaceutical market until 2035.
Chief medical officer appointment
During the quarter, Imugene appointed Dr Rita Lauefle to the team as the chief medical officer to lead the company’s global clinical development, regulatory and medical monitoring activities.
Dr Laeufle has extensive clinical development experience in immuno-oncology studies from Phase 1 to Phase 3 in breast and gastrointestinal cancers and registration pathways and has held senior-level clinical development, leadership and senior medical positions at top tier pharmaceutical companies, including Hoffman-La Roche AG, and Novartis Pharmaceuticals Corp.
Most recently she was the CMO at leading oncolytic virus company Oncolytics Biotech in San Diego CA, where she will be based.