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Innovative cancer therapy through Myc inhibition: taking OMO-103 to market

Periodic Reporting for period 1 - MYCure (Innovative cancer therapy through Myc inhibition: taking OMO-103 to market)

Reporting period: 2019-06-01 to 2020-05-31

Cancer is a global challenge with 9 millions (M) deaths annually and new cases projected to rise by 70% in the next 20 years, and there is a clear need for more effective therapies. In the EU, lung cancer is the most common cancer in men and the third in women, with 2 M new cases in 2018 accounting for ~20% of all cancer deaths. Despite considerable recent advances in treatments, current treatments are still 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 attack redundant proteins that can be compensated by tumours, which then evolve resistance. Drug resistance is responsible for most relapses of cancer and of 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 ready for use in the CT.
2. Perform all the non-clinical regulatory safety studies to confirm the preclinical safety of OMO-103 prior to the onset of the CT.
3. Achieve approval of the OMO-103 CT at national and European regulatory agencies.
4. Perform a first-in-human Phase I/II CT.
5. Reach a license or a co-development agreement with a pharmaceutical company.
During this reporting period, Peptomyc’s team have achieved important milestones that set the bases for accomplishing the overarching goal of the project. One of the most remarkable achievements during this period has been the successful production of a GMP batch of OMO-103 to be used in CTs, the Drug Substance (DS) has already been Quality Control (QC) tested and released by a Qualified Person (QP). The formulated Drug Product (DP) is currently under release. As planned, the stability studies of both the DS and the DP are currently being performed.

In order to get the approval of our CT, we are finishing the regulatory preclinical safety study for OMO-103 according to EMA’s and FDA’s guidelines. So far, we have already set up a method to detect the generation of anti-drug antibodies at the preclinical level. In addition, we have also performed studies to assess the potential immunogenicity of OMO-103 in a human context. Our results showed that the immunogenicity risk of OMO-103 can be considered very low. Moreover, we have successfully performed studies to find the maximum tolerated dose at the preclinical level. Results showed that OMO-103 has an excellent therapeutic window and that relatively high doses were well tolerated. The GLP-compliant 28-day toxicity study is currently being performed.

During this period Peptomyc’s team has started compiling all the documentation needed to support the OMO-103 CT in accordance to the regulatory guidelines. We are compiling all the information for the non-clinical regulatory studies section. We have already held Scientific Advice meetings with the Spanish and German authorities and with the EMA (European Medicines Agency), which outcomes were very positive.

Peptomyc’s team has written a comprehensive clinical protocol synopsis that serve as the basis of the whole CT execution. Our Chief Medical Officer (CMO) has already met with various Key Opinion Leaders (KOLs) and Principal Investigators (PI) of the different sites to ensure a good coordination and successful execution of the CT. In addition, the selection of a clinical CRO for the conduct of the CT has been thoroughly done and the final decision was executed at the end of June 2020. Meanwhile, we have already written up the clinical SOPs that will ensure the conduct of the study according to the GCP guidelines.

In parallel to all the above mentioned activities, we have performed plenty of communication activities linked to Peptomyc’s MYCure project, which include updating the project website, presence in social media, and participation in events that target a wide range of audiences. These events promoted networking as well as project and company’s visibility. In addition, this project has led to three scientific publications in peer-reviewed journals.
MYCure focuses on one of the most frequently diagnosed and deadliest neoplasms worldwide: lung cancer. Lung cancer has a major economic and societal impact, it is the most common cancer (2.09M cases) and by far the deadliest (1.76M deaths annually). Just 12.3% of lung cancer patients diagnosed today in the EU will be alive in 5 years. Therefore, a potent new therapy, like the one proposed in this project, would have a very notable effect. The MYCure project could change the paradigm of cancer treatment as it will unveil new interventional strategies for the treatment of this underserved cancer patients and will also 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 and non-redundant function conserved in the majority of lung cancer tumors. With MYCure, OMO-103 will provide a safer and more effective therapeutic option that will significantly increase life expectancy and quality of life of lung cancer patients. As Myc inhibition constitutes a novel mechanism to treat cancer, the oncologists are already aware of the strong potential such drug could have and are very interested in finally seeing it reaching the clinic.

The fact that OMO-103 displays an excellent therapeutic window will facilitate the approval of the CT by the regulatory agencies. The CTs will establish the safety of OMO-103 in solid tumour patients and efficacy in lung cancer patients, 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 lung cancer subtypes, and can be used as standalone therapy 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 treatment segment that will eventually expand to reach the majority of lung cancer patients. Moreover, it is also expected that OMO-103 could eventually treat many more cancer types, further expanding 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.

With MYCure, we will take to market our first-in-class Myc inhibitor to treat non-small cell lung cancer, for which the global market is expected to reach 14 bn € by 2023, a total addressable market of which OMO-103 is poised to gain considerable share of up to 15% by 2029 thanks to a sound business plan developed under the SME Instrument.
CEO Laura Soucek featured in special interview by El Mundo and IKEA
Peptomyc’s CEO Laura Soucek recognized as a Life Science Leader by Pharma Intelligence
Representative image of one of the publications written by Peptomyc’s team linked to MyCure project