LONDON, March 09, 2022 (GLOBE NEWSWIRE) -- IN3BIO Research Limited, a leader in developing cancer treatments that, based upon clinical data, show significant promise and appear to be more tolerable for patients, announces today that it has received Clinical Trial Application approval from the British Medicines & Healthcare Products Regulatory Agency (MHRA) to initiate a Phase I/II clinical trial of its colorectal cancer vaccine. This is the company's second global regulatory approval for the trial, having obtained approval to conduct the study in Bulgaria earlier this year. With these approvals, IN3BIO is one step closer to bringing its innovative cancer treatments to market. The company is in the process of a Series A financing round for the Phase I/II trial as well as for developing a second molecule to advance its global mission.
IN3BIO will trial its innovative anti-epidermal growth factor (EGF) vaccine, IN01, in combination with small molecule inhibitors (SMIs) in patients suffering from KRAS, NRAS, or BRAF mutated colorectal cancer (CRC). IN3BIO will enroll 30 subjects in two cohorts, and intends to conduct the trial in Eastern Europe, Spain, France, and the United Kingdom.
The initiation of this clinical trial in CRC patients comes after the company conducted its EPICAL trial in non-small lung cancer (NSCLC) patients with an EGF receptor (EGFR) mutation who received combination treatment between EGFR tyrosine kinase inhibitors (TKI) and targeting EGF. The median progression-free survival (PFS) achieved by the combination treatment was 17.5 months, whereas the median PFS of the EGFR TKI is 11 months. This is a significant improvement in delaying the onset of further or progressed symptoms.
Erik D'Hondt, CEO of IN3BIO, said, "This clinical trial is aimed to establish a new standard in treating CRC patients. IN3BIO confidently launches this trial following promising data in a combination clinical trial in NSCLC patients. Based upon this encouraging data, more clinical trials are planned in 2022 with IN3BIO proprietary molecules; combination trials aiming to augment the efficacy of current TKIs and SMIs. Notably, IN3BIO’s proprietary molecule appears to enhance existing targeted treatments significantly, while appearing to be well tolerated. We are excited to progress to these clinical trials with the aim of improving patient outcomes and their treatment experience."
IN3BIO is represented in intellectual property and regulatory matters by John C. Serio, a Partner in the Boston Intellectual Property and Technology Group at Withers Worldwide.
About IN01
The IN01 vaccine is a proprietary biological fusion molecule designed and developed by IN3BIO. It is administered after mixing with an adjuvant Montanide ISA 51 VG ST to produce an extemporaneous water in oil emulsion (W/O) known to enhance the immune response of therapeutic vaccines. The IN01 vaccination produces antibodies which capture EGF and prevent it from binding to its target, i.e. an EGF-receptor on a cell’s surface. This prevents the proliferation of tumour cells affected by EGFR mediated pathways. IN01 is manufactured in a contracted certified GMP facility in the EU. Extensive testing as a single molecule or in combination with SMIs showed no adverse effect in several preclinical studies.
About IN3BIO Research Limited
IN3BIO is a UK-based biotechnology company dedicated to developing new therapeutics that can provide cancer patients with new and effective treatments with emphasis on tolerability. The company has built a broad R&D platform that offers potential treatment for multiple indications of cancer, both as monotherapy and in combination with other treatments. It has immuno-therapy programs in NSCLC and a pipeline in other indications (head and neck, colorectal, and breast cancer).
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Trevi Communications, Inc.
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