Periodic Reporting for period 1 - HbMP-700 (The World's First Safe and Efficacious Human Blood Substitute: HbMP-700, a Haemoglobin based oxygen carrier, based on bovine blood.)
Reporting period: 2017-01-01 to 2017-04-30
About 100 Mio. blood transfusions are performed worldwide p.a. Today, no substitute for human blood as an oxygen carrier exists. CC-Ery develops HbMP-700, the first safe and effective human blood substitute for the use in Red Blood Cell (RBC) concentrates, from an abundant, low cost source: bovine blood.
In Germany alone, every 5 seconds someone needs a RBC transfusion - to compensate for blood loss during surgery, to save lives of accident victims or to treat patients with anaemia. 12.000 lives per day saved in the U.S. by RBC transfusions. Worldwide, global blood supply does not match demand, due to dependency on voluntary donations, short shelf life, difficult storage, risks of disease transmission, and blood type mismatching. This is a recognized problem even in the developed countries:
HbMP-700 can address those problems both in the developed world as well as developing countries. HbMP 700 is the first substitute for human blood as a source for RBC transfusions. Thanks to a sophisticated safety concept aligned with EU guidelines and regulators, no viral agents are transferred to humans3. HbMP- 700 is as effective as human blood, while having superior safety and storage characteristics.
The overall objective is to develop HbMP-700 until market launch to address the above named problems. The objective of the SME I action is to lay the foundation for clinical development, namely a) business case, b) GMP manufacturing concept for the medicinal product to be investigated in clinical trials and c) the synopsis development for the first study in humans (Ph I).
In Germany alone, every 5 seconds someone needs a RBC transfusion - to compensate for blood loss during surgery, to save lives of accident victims or to treat patients with anaemia. 12.000 lives per day saved in the U.S. by RBC transfusions. Worldwide, global blood supply does not match demand, due to dependency on voluntary donations, short shelf life, difficult storage, risks of disease transmission, and blood type mismatching. This is a recognized problem even in the developed countries:
HbMP-700 can address those problems both in the developed world as well as developing countries. HbMP 700 is the first substitute for human blood as a source for RBC transfusions. Thanks to a sophisticated safety concept aligned with EU guidelines and regulators, no viral agents are transferred to humans3. HbMP- 700 is as effective as human blood, while having superior safety and storage characteristics.
The overall objective is to develop HbMP-700 until market launch to address the above named problems. The objective of the SME I action is to lay the foundation for clinical development, namely a) business case, b) GMP manufacturing concept for the medicinal product to be investigated in clinical trials and c) the synopsis development for the first study in humans (Ph I).
The first part of the action – Business Plan – has helped to deepen the understanding of the various indications and target market segments. It is essential in justifying the investment going forward vs. current and future private investors, strategic partners, as well as public funding sources. In addition, it has helped to prioritize possible applications from a market potential perspective, which is an important input for the further clinical development plan.
The second part of the action – detailing of the GMP manufacturing concept – has brought the company a significant step closer to GMP production and such to the start of clinical development with a GMP IMP (Investigational Medicinal Product). The partners for this step have been identified, evaluated and selected, including a back-up option. The concept was validated with regulatory authorities.
The third part of the action – clinical development plan –had as the main output the synopsis for the first clinical study (Ph I) of HbMP-700. It is important for discussions with regulatory authorities (pre-submission meeting), as well as for budgeting and planning of the next private and public funding rounds.
The second part of the action – detailing of the GMP manufacturing concept – has brought the company a significant step closer to GMP production and such to the start of clinical development with a GMP IMP (Investigational Medicinal Product). The partners for this step have been identified, evaluated and selected, including a back-up option. The concept was validated with regulatory authorities.
The third part of the action – clinical development plan –had as the main output the synopsis for the first clinical study (Ph I) of HbMP-700. It is important for discussions with regulatory authorities (pre-submission meeting), as well as for budgeting and planning of the next private and public funding rounds.
As a conclusion, the SME I project has brought CC-Ery close to market, reduced the risk of the upcoming development steps, and improved the economic justification of the HbMP-700 project. The manufacturing concept that was developed is unique regarding the performance parameter of HbMP-700 that are achieved. CC-Ery believes it is able to reach clinical stage over the next 12-18 months.