Periodic Reporting for period 3 - MYCure (Innovative cancer therapy through Myc inhibition: taking OMO-103 to market)
Reporting period: 2021-06-01 to 2022-12-31
Cancer is a global challenge with 9 million (M) deaths annually and new cases projected to rise by 70% in the next 20 years. Hence, there is a clear need for more effective therapies. We have expanded the scope of the MYCure project, now focusing on the major contributors to these numbers: Non-Small Cell Lung Cancer (NSCLC), Pancreatic Ductal Adenocarcinoma (PDAC) and Colorectal cancer (CRC). NSCLC is the most widespread and lethal cancer, with 2M new cases/year, increasing incidence and mortality; PDAC is the most common form of pancreatic cancer (460,000 new cases in 2018) and is expected to become the 2nd most common cause of cancer death within the next 10 years. Finally, CRC is the 3rd most common cancer worldwide, with 1.8M annual cases, and the 2nd by number of deaths. Unfortunately, despite considerable recent advances in treatments, current treatments are still often ineffective or highly toxic.
Peptomyc is a unique biotech SME that is revolutionizing cancer treatment with its ground-breaking innovative Myc-inhibiting therapies. Our patented product OMO-103 is able to enter cells, attack Myc and kill cancer cells. In contrast, most current therapies are directed to redundant proteins in cancer, which then evolves to develop resistance. In fact, drug resistance is responsible for most relapses and deaths.
The overall objective of this project is to market our first product OMO-103 by completing Clinical Trials (CTs) and reach a licensing agreement with a pharmaceutical company. This SME Instrument project allows us to achieve our overarching goal through the following aims:
1. Produce OMO-103 at large scale and package it in vials for use in CT.
2. Perform non-clinical regulatory safety studies to confirm the preclinical safety of OMO-103.
3. Achieve approval of the OMO-103 CT at Spanish and other national regulatory agencies.
4. Perform a first-in-human Phase I CT.
5. Reach a license or a co-development agreement with a pharmaceutical company.
Peptomyc is a unique biotech SME that is revolutionizing cancer treatment with its ground-breaking innovative Myc-inhibiting therapies. Our patented product OMO-103 is able to enter cells, attack Myc and kill cancer cells. In contrast, most current therapies are directed to redundant proteins in cancer, which then evolves to develop resistance. In fact, drug resistance is responsible for most relapses and deaths.
The overall objective of this project is to market our first product OMO-103 by completing Clinical Trials (CTs) and reach a licensing agreement with a pharmaceutical company. This SME Instrument project allows us to achieve our overarching goal through the following aims:
1. Produce OMO-103 at large scale and package it in vials for use in CT.
2. Perform non-clinical regulatory safety studies to confirm the preclinical safety of OMO-103.
3. Achieve approval of the OMO-103 CT at Spanish and other national regulatory agencies.
4. Perform a first-in-human Phase I CT.
5. Reach a license or a co-development agreement with a pharmaceutical company.
Peptomyc’s team has achieved important milestones to accomplish the overarching goal of the project. Thanks to the MYCure project, Peptomyc has evolved from a preclinical to a clinical stage company. One of the most remarkable achievements during this period has been the successful production of GMP batches of OMO-103 to be used in CTs. Long term stability studies have revealed an outstanding stability and thus an excellent shelf life.
We have successfully finished all the preclinical safety-toxicology studies for OMO-103 and we have been able to select the NOAEL (No Observed Adverse Events Effect Level) dose, and thus to determine the starting dose of our Phase I clinical trial. Methods to determine the levels of OMO-103 and anti-drug antibodies in serum have been set up and validated. We have also performed additional studies to assess the potential immunogenicity risk of OMO-103 for humans, and we have demonstrated that OMO-103 has a very low risk of causing an unwanted first infusion reaction.
Peptomyc’s team, in collaboration with our regulatory consultants, has written a comprehensive Investigational Medicinal Product Dossier (IMPD), a Briefing Book (IB), the clinical protocol, and the study synopsis. These documents were submitted in the Clinical Trial Application (CTA) to the Spanish and German regulatory agencies to request authorization to conduct a first-in-man Phase I/II clinical trial with OMO-103. Official approval was received in March 2021. Now, the Phase I of the study has been concluded with excellent safety results and the Recommended Phase 2 Dose (RP2D) has been established. Importantly, drug activity was strongly supported by target engagement in patient biopsies, fact that has never been shown before with any other anti-MYC therapeutic. In addition, we have been able to identify both a predictive and a pharmacodynamic biomarker signature for OMO-103. One signature has already been patent-protected and the other one will be by March 2023. The clinical trial results were presented in October 2022 in an international congress and attracted lots of media attention. Participation in communication events promoted networking, as well as project and company’s visibility. Throughout the project, Peptomyc has been in close contact with Pharma companies, which have confirmed their high interest for our clinical-stage MYC inhibitor.
In addition, this project has led to several scientific publications in peer-reviewed journals and a scientific publication has been submitted to the prestigious journal Nature Medicine to disseminate MYCure results.
We have successfully finished all the preclinical safety-toxicology studies for OMO-103 and we have been able to select the NOAEL (No Observed Adverse Events Effect Level) dose, and thus to determine the starting dose of our Phase I clinical trial. Methods to determine the levels of OMO-103 and anti-drug antibodies in serum have been set up and validated. We have also performed additional studies to assess the potential immunogenicity risk of OMO-103 for humans, and we have demonstrated that OMO-103 has a very low risk of causing an unwanted first infusion reaction.
Peptomyc’s team, in collaboration with our regulatory consultants, has written a comprehensive Investigational Medicinal Product Dossier (IMPD), a Briefing Book (IB), the clinical protocol, and the study synopsis. These documents were submitted in the Clinical Trial Application (CTA) to the Spanish and German regulatory agencies to request authorization to conduct a first-in-man Phase I/II clinical trial with OMO-103. Official approval was received in March 2021. Now, the Phase I of the study has been concluded with excellent safety results and the Recommended Phase 2 Dose (RP2D) has been established. Importantly, drug activity was strongly supported by target engagement in patient biopsies, fact that has never been shown before with any other anti-MYC therapeutic. In addition, we have been able to identify both a predictive and a pharmacodynamic biomarker signature for OMO-103. One signature has already been patent-protected and the other one will be by March 2023. The clinical trial results were presented in October 2022 in an international congress and attracted lots of media attention. Participation in communication events promoted networking, as well as project and company’s visibility. Throughout the project, Peptomyc has been in close contact with Pharma companies, which have confirmed their high interest for our clinical-stage MYC inhibitor.
In addition, this project has led to several scientific publications in peer-reviewed journals and a scientific publication has been submitted to the prestigious journal Nature Medicine to disseminate MYCure results.
MYCure focuses on the most frequently diagnosed and deadliest neoplasms worldwide: NSCLC, PDAC and CRC. A potent new therapy against these diseases, like the one proposed in this project, would have a very notable effect. In fact, the MYCure project could change the paradigm of cancer treatment, as it will unveil new interventional strategies for the treatment of these underserved cancer patients, and will address one of the main goals in oncology: to achieve durable responses to treatment. In this context, Peptomyc proposes a revolutionary approach: to attack Myc, an essential function conserved in the majority of tumours. With MYCure, OMO-103 will provide a safer and more effective therapeutic option for NSCLC, PDAC and CRC cancer patients that will significantly increase their life expectancy and quality of life.
The OMO-103 CT consisting of a combined Phase I/II study was approved in March 2021. The Phase I CT has demonstrated the excellent safety of OMO-103 in solid tumour patients and positive signs of efficacy, thus reaching a major de-risking milestone and making OMO-103 really attractive to large pharmaceutical companies. As OMO-103 is expected to treat previously untreatable cancer subtypes, and can be used either as standalone therapy or/and as combination with other current drugs, it will open new market opportunities and significantly expand the market share. This means that the pharmaceutical company commercializing OMO-103 will position itself in a new market, generating a treatment segment that will eventually expand to reach the majority of such cancer patients. Moreover, it is also expected that OMO-103 could eventually treat many more cancer types, further expanding its market opportunities. As such, OMO-103 is poised to generate a real new market in oncology and lends itself to empowering pharma companies in market leadership.
The OMO-103 CT consisting of a combined Phase I/II study was approved in March 2021. The Phase I CT has demonstrated the excellent safety of OMO-103 in solid tumour patients and positive signs of efficacy, thus reaching a major de-risking milestone and making OMO-103 really attractive to large pharmaceutical companies. As OMO-103 is expected to treat previously untreatable cancer subtypes, and can be used either as standalone therapy or/and as combination with other current drugs, it will open new market opportunities and significantly expand the market share. This means that the pharmaceutical company commercializing OMO-103 will position itself in a new market, generating a treatment segment that will eventually expand to reach the majority of such cancer patients. Moreover, it is also expected that OMO-103 could eventually treat many more cancer types, further expanding its market opportunities. As such, OMO-103 is poised to generate a real new market in oncology and lends itself to empowering pharma companies in market leadership.