28 Sep Progress in the maturity of the start-ups: the clinical phases
The start-ups Oxolife, Peptomyc and aptaTargets, with which GENESIS Biomed collaborates, are advancing in their maturity with the initiation and development of clinical phases and are approaching an exit scenario.
The begining and progress of clinical phases are an important moment in the development of a drug, where, if the results are favourable, the probabilities of the drug reaching the market increase, leading to a valuation of the project that will allow exit scenarios for investors. For this reason, GENESIS Biomed follows with special interest the progress of the start-ups with which it collaborates or has collaborated, and it gives us great satisfaction to see the progress towards maturity of companies such as Oxolife, Peptomyc and aptaTargets.
The biotech company is developing ApTOLL, a novel and potent immunomodulator and anti-inflammatory capable of reducing brain damage in stroke. The company completed Phase Ia in March 2020. In October 2020, the Spanish Medicines and Medical Devices Agency, AEMPS, authorised the company to initiate the APRIL trial, a Phase Ib/IIa clinical trial. Phase Ib of the first part of the study ended in June 2021. Both Phase I studies have shown an excellent patient safety profile.
In addition, aptaTargets has just closed a second round of investment, with the participation of Inveready and the CDTI, through its INNVIERTE programme, which would mobilise up to 5 million euros between 2020 and 2022. With these funds, aptaTargets aims to complete a clinical proof of concept in patients with acute ischaemic stroke and close a licensing agreement.
Peptomyc is another start-up which GENESIS Biomed has collaborated with, and currently has the drug OMO-103, developed jointly with the Vall d’Hebron Institute of Oncology. Peptomyc’s main objective is to develop a drug that inhibits Myc, a key gene for tumour cell proliferation.
In 2021, the company has initiated a phase I-IIa trial to evaluate the safety of the treatment in humans and to see if it achieves the same results as in animal models, where it has been shown to be a better therapeutic option in terms of results and side effects, especially in some types of cancer such as non-microcytic lung cancer.
The study foresees 5 levels of “dose escalation” of the drug, the first three of which have been completed without adverse effects, and the other levels will begin shortly, and we hope it be able to identify also some sign of efficacy on this clinical phase through pharmacodynamic biomarkers that are being developed and validated.
Oxolife has also successfully taken its OXO-001 to the clinical phase. Oxolife is a biotech company focused on female fertility that is developing OXO-001, a drug to improve embryo implantation in women, which in turn restores ovulation. To date, five Phase I clinical trials have been conducted, two of them with volunteers of childbearing age, demonstrating that OXO-001 is safe and well tolerated. The next step is to test its efficacy in a Phase II clinical trial with the aim of recruiting 350 patients, which will study whether OXO-001 increases pregnancy rates in “in vitro” fertilisation cycles.