With strong pharma business and drug development expertise, CRD Pharma initiated focused research projects and carried them out successfully. In almost three years, CRD Pharma successfully developed a unique antibody 29Z6 that kill cancer cells by selectively target HER3. The intellectual property (PCT/CA2019/050869) was filed to protect the invention. The currently available treatments are failing due to the HER3 receptor since it is playing an important role in tumor growth and escaping targeted therapy. 29Z6 an innovative monoclonal antibody designed to bind to HER3 receptor in cancer cells and block the signaling communication and therefore stop the growth of the tumor. With the combination of available treatments, 29Z6 may increase the successful treatment of pancreatic cancer patients by reversing tumor growth and regression to cancer. We plan also to test 29Z6 in patients with EGFR and HER2 resistant therapies.

29Z6 has a novel HER3-dependent mechanism of action. It demonstrated strong in vitro and in vivo activity and effective against many common cancers with HER3 overexpression such as pancreatic cancer, lung cancer, head and neck cancer, and breast cancer. The drug showed no toxicity in preclinical development. 29Z6 has strong Intellectual IP protection in place. The International Patent Office has granted all of the 29Z6 claims. The antibody has first-and best-in-class potential with opportunity for single-agent and combination therapy.FUTURE OF 29Z6

29Z6 preclinical evaluations, including in vitro and in vivo pharmacology (including initial evidence of efficacy in an appropriate animal model of the disease) has been completed successfully. The next steps are optimizing the manufacturing process, and scaling up production to support clinical evaluations (i.e., chemistry, manufacturing, and controls; CMC).

Additionally, GLP toxicology studies and safety pharmacology studies, as well as pharmacokinetics, will also be conducted. These studies will provide critical information about the safety of the antibody for the FDA to allow clinical studies to proceed. This Investigational New Drug (IND)-enabling studies necessary to obtain the permission of Regulatory Authorities (FDA and Health Canada) to begin human clinical investigations. Although our IP for 29Z6 covers a broad range of cancers, including breast cancer, head & neck cancer, and lung cancer, pancreatic cancer became a priority to the company.

Pancreatic cancer is a major disease burden that is essentially incurable at present. Estimates show in 2020; pancreatic cancer will be the 2nd leading cause of cancer-related death. Pancreatic cancer drug development is considered an orphan drug designation. The 29Z6 project, therefore, will enjoy a significant reduction in the translational risk of the project through animal to human clinical trials. The FDA’s Orphan Drug program provides orphan status to drugs and biologics that are intended for the treatment of diseases that affect fewer than 200,000 people in the United States. This designation will provide CRD Pharma eligibility for seven years of market exclusivity in the United States after product approval, FDA assistance in clinical trial design, and an exemption from FDA user fees.

Although our IP for 29Z6 covers a broad range of cancers, including breast cancer, head & neck cancer, and lung cancer, pancreatic cancer became a priority to the company. Pancreatic cancer is a major disease burden that is essentially incurable at present. Estimates show in 2020; pancreatic cancer will be the 2nd leading cause of cancer-related death. Pancreatic cancer drug development is considered an orphan drug designation. The 29Z6 project, therefore, will enjoy a significant reduction in the translational risk of the project through animal to human clinical trials. The FDA’s Orphan Drug program provides orphan status to drugs and biologics that are intended for the treatment of diseases that affect fewer than 200,000 people in the United States. This designation will provide CRD Pharma eligibility for seven years of market exclusivity in the United States after product approval, FDA assistance in clinical trial design, and an exemption from FDA user fees.