IMM-101 in combination with nivolumab was well-tolerated and demonstrated encouraging efficacy data
Primary endpoints were met, including 73% Overall Response Rate (ORR) in treatment-naïve patients with advanced melanoma
Uxbridge, UK, 7 June 2022 – Immodulon Therapeutics Limited, the immuno-oncology company, announces that data from the Phase II clinical trial of IMM-101 in combination with checkpoint inhibitors in patients with advanced melanoma was presented yesterday in a poster at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, U.S. Following the conclusion of the meeting the poster will be available on the Company’s website at: https://www.immodulon.com/news-publications/publications/
Principal Investigator, Dr Alberto Fusi, St. George`s University Hospitals NHS Foundation Trust, London, said: “IMM-101 in combination with nivolumab is well tolerated and shows encouraging antitumor activity based on actual ORR in treatment-naïve patients with advanced melanoma. This is promising early data for these patients which needs to be confirmed in larger studies.”
Dr. Cellia Habita, Chief Executive Officer of Immodulon, added: “We are delighted to see these encouraging data when combining IMM-101 with checkpoint inhibitors and hope to confirm them in additional programmes. Immuno-oncology is a cornerstone treatment for cancer, and we believe that IMM-101 has the potential to become the backbone therapy across multiple tumour types supporting the four major pillars of cancer therapy: immunotherapy, chemotherapy, radio/ablation therapy, and surgery and improve the lives of patients.”
IMM-101 is a multimodal immunomodulator containing heat-killed whole cell Mycobacterium obuense which activates dendritic cells and other cells of the innate immune system, predominantly via Toll-like receptor 2. Its unique mechanism of action should make this product applicable to a range of cancers and, in combination with immune checkpoint inhibitors and other standard-of-care cancer therapies, and potentially improve patient outcomes.
The poster titled ‘A phase II study to evaluate the safety and efficacy of IMM-101 in combination with checkpoint inhibitors in patients with advanced melanoma: Final results of the IMM-101-015 trial’ details the open-label Phase IIa study of the combination of IMM 101 with nivolumab in 16 patients with advanced melanoma who were either treatment-naive (cohort A) or who had progressed during PD-1 blockade (cohort B). Patients in cohort B had the option to change to ipilimumab and IMM-101 if their disease continued to progress.
The study met its primary endpoints including an ORR of 73% in treatment-naïve patients in cohort A after a maximum of 18 months of treatment by RECIST 1.1. IMM-101 in combination with nivolumab was well-tolerated in the studied population. Patients who had disease progression during previous checkpoint inhibitor treatment in cohort B received no clinical benefit from the introduction of IMM-101.
The study (NCT03711188) was sponsored by Immodulon Therapeutics Limited and conducted at The Christie Hospital NHS Foundation Trust and at St. George`s University Hospitals NHS Foundation Trust with the support from the Institute for Cancer Vaccine & Immunotherapy (ICVI).
1. Crooks J et al. SITC Annual Meeting, National Harbour (USA), 2016
About Immodulon Therapeutics
Immodulon Therapeutics Ltd. (London, UK) is a privately-owned, clinical-stage, immuno-oncology company primarily focused on the development of safe, effective and novel treatments for cancer with an emphasis on pancreatic cancer. Its lead drug candidate, IMM-101, containing heat-killed Mycobacterium obuense which activates dendritic cells and other cells of the innate immune system predominantly via Toll-like receptor 2, has shown promise in early clinical trials. It is Immodulon’s vision that IMM-101 will become a backbone immunotherapy across multiple tumour types in combination with immune checkpoint inhibitors and any other standard-of-care treatment of the four major pillars of cancer therapy – immunotherapy, chemotherapy, radio/ablation therapy and surgery. For more information about Immodulon, please visit www.immodulon.com.