Periodic Reporting for period 2 - MYCure (Innovative cancer therapy through Myc inhibition: taking OMO-103 to market)
Reporting period: 2020-06-01 to 2021-05-31
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 against it. We have expanded the scope of the MYCure project, now focusing on the major contributors to these numbers: Non-Small Cell Lung Cancer (NSCLC), Triple Negative breast Cancer (TNBC) and Colorectal cancer (CRC). Lung cancer is the most widespread and lethal cancer, with increasing incidence (~2M new cases/year, of which 80% are NSCLC) and mortality; Breast Cancer is the most common cancer in women with 2M new cases in 2018 and 626,000 deaths. TNBC accounts for ~15% of breast cancer cases and it’s the most aggressive subtype. Finally, CRC is the 3rd most common cancer worldwide (with 1.8M annual cases, of which ~45-50% are RAS mutant) and the 2nd by number of deaths (800,000). 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 attack are directed to redundant proteins that can be compensated for by tumours, which then evolve resistance. In fact, 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 Spanish and other national 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.
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 are directed to redundant proteins that can be compensated for by tumours, which then evolve resistance. In fact, 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 Spanish and other national 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.
Peptomyc’s team has 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 three GMP batches of OMO-103 to be used in CTs. Then, both the Drug Substance (DS) and Drug Product (DP) have been Quality Control (QC) tested and released by a Qualified Person (QP). The long term stability studies have revealed an outstanding stability of the DP and thus an excellent shelf life.
We have successfully finished all the preclinical safety-toxicology studies for OMO-103 according to EMA’s and FDA’s guidelines. Methods to determine the levels of OMO-103 and anti-drug antibodies in serum have been set up and validated. In addition, we have also performed an additional study to assess the potential risk that OMO-103 could trigger a first infusion reaction and a cytokine release syndrome when infused for the first time to patients. Our results show that OMO-103 has a very low risk of causing an unwanted first infusion reaction. Moreover, we have completed the regulatory preclinical safety studies and we have been able to select the NOAEL (No Observed Adverse Events Effect Level) dose and this has allowed us to determine the starting dose of our Phase I clinical trial.
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, that serve as the basis of the whole clinical trial execution. These documents were submitted in the Clinical Trial Application (CTA) to the Spanish regulatory agency (AEMPS) and to the independent Ethics Committee to request authorization to conduct a first-in-man Phase I/II clinical trial with OMO-103. Official approval for the OMO-103-01 clinical trial was received on the 15th of March 2021. The Phase I of the OMO-103 clinical trial officially started in April 2021 in three different sites in Spain. The first patients have already been treated. So far, no adverse events related to the drug have been observed and thus the clinical trial is progressing swiftly as planned. The start of the Phase II in Spain is forecasted for Q1 2022. We are currently in the selection process of the other sites that will participate in the Phase II in the additional countries.
In parallel to all the above mentioned activities, we have performed patent maintenance activities and plenty of communication events linked to Peptomyc’s MYCure project. These events promoted networking as well as project and company’s visibility. In addition, this project has led to several scientific publications in peer-reviewed journals.
We have successfully finished all the preclinical safety-toxicology studies for OMO-103 according to EMA’s and FDA’s guidelines. Methods to determine the levels of OMO-103 and anti-drug antibodies in serum have been set up and validated. In addition, we have also performed an additional study to assess the potential risk that OMO-103 could trigger a first infusion reaction and a cytokine release syndrome when infused for the first time to patients. Our results show that OMO-103 has a very low risk of causing an unwanted first infusion reaction. Moreover, we have completed the regulatory preclinical safety studies and we have been able to select the NOAEL (No Observed Adverse Events Effect Level) dose and this has allowed us to determine the starting dose of our Phase I clinical trial.
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, that serve as the basis of the whole clinical trial execution. These documents were submitted in the Clinical Trial Application (CTA) to the Spanish regulatory agency (AEMPS) and to the independent Ethics Committee to request authorization to conduct a first-in-man Phase I/II clinical trial with OMO-103. Official approval for the OMO-103-01 clinical trial was received on the 15th of March 2021. The Phase I of the OMO-103 clinical trial officially started in April 2021 in three different sites in Spain. The first patients have already been treated. So far, no adverse events related to the drug have been observed and thus the clinical trial is progressing swiftly as planned. The start of the Phase II in Spain is forecasted for Q1 2022. We are currently in the selection process of the other sites that will participate in the Phase II in the additional countries.
In parallel to all the above mentioned activities, we have performed patent maintenance activities and plenty of communication events linked to Peptomyc’s MYCure project. These events promoted networking as well as project and company’s visibility. In addition, this project has led to several scientific publications in peer-reviewed journals.
MYCure focuses on the most frequently diagnosed and deadliest neoplasms worldwide: lung cancer, breast cancer and colorectal cancer. A potent new therapy against all three 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, validating new interventional strategies for the treatment of these underserved cancer patients and will also addressing one of the main goals in oncology: to achieve durable responses to treatment. In this context, Peptomyc proposes a revolutionary approach: to attacking Myc, an essential and non-redundant function conserved in the majority of tumours. With MYCure, OMO-103 will provide a safer and more effective therapeutic option that will significantly increase life expectancy and quality of life of NSCLC, TNBC and CRC 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 OMO-103 CT consisting of a combined Phase I/II study has been approved in March 2021. The CTs will establish the safety of OMO-103 in solid tumour patients and efficacy in lung cancer, breast cancer and colorectal 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 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 lung, breast and colorectal cancer patients. For these indications, the global market is expected to reach 23.3 B€ by 2025, 3.14B$ in 2028, and 8.1B$ in 2028, respectively. In this context, OMO-103 is poised to penetrate this market and from 1% to 13% between 2027 and 2034, thanks to a sound business plan developed under this SME Instrument.
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 has been approved in March 2021. The CTs will establish the safety of OMO-103 in solid tumour patients and efficacy in lung cancer, breast cancer and colorectal 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 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 lung, breast and colorectal cancer patients. For these indications, the global market is expected to reach 23.3 B€ by 2025, 3.14B$ in 2028, and 8.1B$ in 2028, respectively. In this context, OMO-103 is poised to penetrate this market and from 1% to 13% between 2027 and 2034, thanks to a sound business plan developed under this SME Instrument.
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.