Imugene completes Phase 1a monotherapy dose escalation of PD1-Vaxx and adds industry leaders to management team – Proactive Investors USA

Our Phase 1a trial has been open 12 months and Im pleased with both the pace of development and the early responses seen. Its particularly gratifying to have followed a patient in the trial for over 12 months where their tumour burden has been reduced to zero.

Imugene Ltd (ASX:IMU, OTC:IUGNF)has successfully completed Phase 1a monotherapy dose escalation of PD1-Vaxx and will now proceed to combination dose escalation.

The clinical-stage immuno-oncology company is developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours.

Finalisation of the dose escalation of PD1-Vaxx was confirmed by the Cohort Review Committee (CRC), following the Phase 1a monotherapy dose escalation performed with 10, 50 and 100g of PD1-Vaxx in non-small cell lung cancer (NSCLC) patients who progressed on one or more immune checkpoint inhibitors (ICIs).

The primary objective of the phase 1 trial is to determine safety and optimal biological dose as monotherapy and in combination with ICIs. Plans are now being finalised to combine PD1-Vaxx with Roche/Genentechs PD-L1 targeting blockbuster ICI atezolizumab (Tecentriq) as first-line in ICI treatment nave NSCLC patients.

CRC reviewed monotherapy safety, tolerability and biomarker data. It then advised IMU to proceed to the combination phase of clinical development of PD1-Vaxx.

Phase 1 trials are generally designed to look for safety, tolerability and early response signals to determine the optimal dose for further development, Imugene MD & CEO Leslie Chong said.

I am encouraged that we are seeing positive signals at such an early stage of our PD1-Vaxx Phase I trial and we are now progressing to the Phase 1b combination studies in treatment nave patients.

Our Phase 1a trial has been open 12 months and Im pleased with both the pace of development and the early responses seen. Its particularly gratifying to have followed a patient in the trial for over 12 months where their tumour burden has been reduced to zero.

Dual targeting of the PD-1/PD-L1 axis is an area of considerable interest with ongoing clinical results creating strong interest inside the pharma industry.

Combination with PD1-Vaxx may overcome treatment resistance to ICIs with dual inhibition of the PD-1/PD-L1 axis extending the treatment benefit of atezolizumab.

In contrast to combination of two monoclonal antibodies, PD1-Vaxx has the advantage that it induces a unique polyclonal immune response which may increase response rates for the combination therapy.

Imugenes PD1-Vaxx is a B-cell activating immunotherapy designed to treat tumours such as lung cancer by interfering with PD-1/PD-L1 binding and interaction and produce an anti-cancer effect similar to Tecentiq, Keytruda, Opdivo and the other immune checkpoint inhibitor monoclonal antibodies that are transforming the treatment of a range of cancers.

Full study details can also be found on clinical trials.gov under study ID: NCT04432207.

While it has been conducting these promising trials, IMU has also been strengthening its management team.

Today, it not only announced the successful completion of Phase 1a monotherapy dose escalation of PD1-Vaxx, IMU also informed the market that it has appointed industry leaders Ursula McCurry and Dr Nimali Withana to its senior management team.

The former Roche/Genentech employees and experts in oncology clinical development started with IMU at the beginning of January 2022, with McCurry appointed as the senior vice president of Clinical Operations and Dr Nimali Withana appointed senior director of Clinical Science.

Ursula and Nimali add critical and considerable clinical development capability to our senior management team, and I am delighted to welcome them to Imugene, Chong said.

About Ursula McCurry

McCurry is a well-regarded clinical operations leader with more than 20 years of global clinical development experience across a number of established and emerging biotech and pharmaceutical companies including Genentech, Exelixis (NASDAQ:EXEL), Astex, QLT Inc and Amunix.

She has led global clinical operations programs spanning a variety of therapeutic areas and all phases of clinical development, contributing to in excess of20 programs and subsequent multiple regulatory approvals at both small and large biotech companies.

McCurrys significant partnership and alliance management experience are expected to be invaluable to IMU as it progresses its therapies.

Prior to joining Imugene, Ursula served as the VP of Clinical Operations at Amunix Pharmaceuticals and was a Clinical Program director at Genentech, leading multiple programs from entry into the clinic to phase three development, including taselisib and GDC-9545.

She has also led the Drug Safety teams, ensuring quality, compliance, pharmacovigilanceand safety reporting.

About Dr Nimali Withana

Dr Withana has more than18 years of drug development experience spanning both academia and industry and most recently was the Lead Country medical manager for the Breast Cancer and Cancer Immunotherapy portfolios including bevacizumab, trastuzumab emtansine, ipatasertib and atezolizumab at Hoffman-La Roche New Zealand.

Prior to that, Dr Withana was the clinical scientist lead across Phase I III global oncology trials at Genentech.

Dr Withana received her academic training at Stanford University and The Peter MacCallum Cancer Centre, majoring in Immunology and Molecular Medicine.

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Imugene completes Phase 1a monotherapy dose escalation of PD1-Vaxx and adds industry leaders to management team - Proactive Investors USA