Omomyc

BARCELONA, Spain, May 06, 2021 (GLOBE NEWSWIRE) -- Peptomyc, a Spanish clinical stage biotech company spin-off of the Vall d’Hebron Institute of Oncology (VHIO) and the Catalan Institute of Research and Advanced Studies (ICREA) in Barcelona, reported that on Tuesday 4th May the first patient has been dosed with OMO-103, its anti-MYC lead compound, in a Phase I/II study, under the supervision of Dr. Elena Garralda at the Hospital Universitari Vall d'Hebron in Barcelona. Patients with advanced solid tumors are currently being enrolled in 3 Spanish sites for a Phase I clinical study: the Hospital Universitari Vall d'Hebron in Barcelona, and the Hospital Universitario HM Sanchinarro and Hospital Fundación Jimenez Diaz in Madrid. In the Phase II part of the study, which will expand to additional hospital sites in Europe, at least 3 specific tumor entities will be included in the trial: TNBC, KRAS-mutated NSCLC and RAS-mutated CRC. The entire Phase I/II study will enroll up to 74 patients. The objective of this first in human Phase I/II study is to evaluate the safety of OMO-103, as well as its preliminary anti-tumor efficacy. Peptomyc’s CMO Manuela Niewel said, “We are thrilled to see our first patient already treated with OMO-103 and do hope that the safety and efficacy we saw preclinically will now translate into real benefit for our patients.” Peptomyc’s CEO and co-founder Laura Soucek, whose research work has been seminal for the development of OMO-103, commented: “Most cancer researchers dream of one day seeing their hard work at the bench finally impacting the clinical practice. This is our chance to do so and I have high expectations and hope for this study.” Finally, Dr. Elena Garralda, Director of the Research Unit for Molecular Therapy of Cancer (UITM) “la Caixa” and Principal Investigator of VHIO’s Early Clinical Drug Development Group, said: “Myc is a most wanted target in cancer therapy, but has always been considered impossible to attack with targeted therapies, so this trial is particularly interesting. If we confirm that the treatment is effective, it could be applied to many types of cancer.” PEPTOMYC S.L Office phone +34 932 543 450 (ext. 8636) Centre CELLEX - C/ Natzaret, 115-117 - Barcelona, Spain, 08035

BARCELONA, Spain, March 18, 2021 (GLOBE NEWSWIRE) -- Co-founded back in 2014 by VHIO’s Laura Soucek, CEO of the enterprise, and Marie-Eve Beaulieu, Chief Scientific Officer (CSO) of the company, VHIO-born spin-off Peptomyc S.L. has just announced that it has received approval from the Spanish Agency of Medicines and Medical Devices for conducting clinical trials in Spain (AEMPS), to initiate the first-in-human Phase I/II clinical trial with its first compound - a disruptive Myc inhibitor, Omomyc (OMO-103). Building on the proven preclinical efficacy and safety of the Omomyc cell-penetrating peptide (CCP) in mouse models, and Peptomyc’s company’s successful development of anti-Myc peptides for the treatment of several tumor types, this latest milestone represents a greatly anticipated ‘leap’ into the clinical research setting and an important step forward in becoming the first ever clinically viable and direct inhibitor of Myc – a protein implicated in the formation of most tumor types. Commenting for VHIO’s Global Communications, Laura Soucek, Principal Investigator of VHIO’s Mouse Models of Cancer Therapies and an ICREA Research Professor said, “MYC has been considered an ‘undruggable’ cancer target for many years. We have previously shown that Myc blockade has an excellent therapeutic effect in several mouse models, with mild side effects that are well tolerated and reversible. Now that we have received approval to initiate our early phase clinical trial, we can further progress in testing the safety and efficacy of our Omomyc-based therapy for the benefit of those who matter the most – our patients.” Over the last 20 years Laura’s determined research efforts have centered on proving countless cynics wrong in her ambitions to combat resistance to therapy and cancer regression through clinically inhibiting the Myc oncogene. Found deregulated in most, if not all tumor types, and as a key driver of cancer progression and maintenance, Myc is consequently a major contender as a cancer target and yet, its promise has not yet been successfully translated into benefits at the patient level. “At the preclinical level, we have reported the efficacy of Omomyc as a cell penetrating peptide – essentially, a mini-protein with the ability to enter cells and reach its target compartment, namely, the nucleus. The successful intravenous systemic administration of our mini-protein MYC inhibitor against lung cancer and other malignancies, has led to this week’s exciting development,” said Marie-Eve Beaulieu, Peptomyc’s Chief Scientific Officer. She added, “Our strategy differs immensely from other previous approaches aimed at inhibiting Myc. Our Omomyc mini-protein is large enough to accurately fold and adapt to Myc's disordered structure, which determines the specificity of inhibition. At the same time, it is small enough to penetrate tumor cells and nuclei in order to reach its target. By conducting our first-in-human early phase clinical trial, we hope to drive this novel therapy into the clinic for the more effective treatment of multiple tumor types”. Twenty patients with advanced solid tumors across various cancer types, whose disease has progressed after previous treatments, will be enrolled in the Phase I study. This clinical trial will be carried out at three different Spanish sites: our Vall d’Hebron University Hospital (HUVH), also located within the Vall d’Hebron Barcelona Hospital Campus, the HM Sanchinarro University Hospital, and the Fundación Jiménez Díaz University Hospital (Madrid). VHIO’s Elena Garralda, Director of our Research Unit for Molecular Therapy of Cancer (UITM) – “la Caixa” Foundation, and Head of Early Clinical Drug Development at our Institute, is the Principal Investigator of Peptomyc’s clinical study at Vall d’Hebron. She noted, “I am honored and privileged to participate in this study of a VHIO-developed molecule. Since Myc has traditionally been considered as an impossible drug target, this clinical trial represents a pivotal development. Confirmation of OMO-103’s safety and efficacy in patients would be extremely important for the future treatment of cancer”. “To get to where we are today has been a long and challenging journey. While we have had to overcome many obstacles, we have successfully proven our hypothesis about Myc by achieving amazing results in animal models. We very much hope that Omomyc will meet the same expectations in clinical research lso that we can ultimately provide new hope for cancer patients, particularly for those suffering from advanced disease,” concluded Laura Soucek.