ApopLogic is focused on the development and commercialization of B201-acetate (Breceptin) and AP-300 (Fasaret), a unique pluripotent synthetic peptide and a biologic respectively for the treatment of a wide range of solid tumors. Both products are targeted and biomarkers have been identified. The IND for a phase 1 clinical trial of B201-acetate is open. Clinical studies of AP-300 in dogs with oral melanomas and osteosarcoma were recently completed and have generated data that could be used to apply for conditional approval from the USDA. The company is seeking partners to support clinical development for both products in humans as well as a partner in the animal health care space for AP-300. In lieu of establishing a partnership, ApopLogic will seek additional grant, philanthropic and/or investment funding to carry out comprehensive product development plans.
B201 is a rationally-designed synthetic peptide dimer of a potent decapeptide bradykinin B1 & B2 receptor antagonist that directly induces apoptosis of cancer cells that overexpress these receptors. Cancer targets for B201 include small cell cancers (lung, carcinoid, Merkel, extrapulmonary); HRPC, NSCLC, CRC, and melanoma. B201 is closely related to Shire's angioedema drug Firazyr, but has anti-cancer activity in addition to being anti-angiogenic and anti-inflammatory. AP-300 is an immunotherapeutic comprised of recombinant viral or DNA vectors encoding Fas ligand that targets activated tumor infiltrating cells including T-regulatory cells that express functional Fas receptors. AP-300 is used in the neo-adjuvant or adjuvant setting with standard-of-care agents to improve survival outcomes in humans and companion animals with any accessible solid tumor including carcinomas, sarcomas and lymphomas, especially those that are Fas-resistant.
The Value Proposition:
ApopLogic is seeking a partner and/or up to $6-10 million in series A financing to develop B201-acetate through phase 2 proof-of-concept studies (in SCLC and HRPC). We anticipate that funding will occur in two tranches. The first tranche will require $1.5 to 2 million and will be used to carry out a phase 1b/2a clinical trial to establish phase 2 dosing. While we would prefer to raise the full $10 million from venture capital investors, we recognize that the initial phase 1b trial may require angel investors, grants, philanthropy, or a combination of all three in order to have first-in-human data that will attract venture capital investment and/or a corporate partner. Investors will have the opportunity to achieve efficacy data in two cancer indications with high unmet need for a minimal investment leading to the possibility of an attractive and early exit. An additional $2 million is required to bring Fasaret to market as a veterinary oncology product. We are planning on meeting with the USDA to discuss our data and to seek their guidance in applying for conditional approval to initiate sales. The Company is open to considering the option of spinning out the veterinary opportunity and raising capital independently while retaining rights to the related but novel human product and indications.
FOR ADDITIONAL INFORMATION, PLEASE CONTACT:
Richard C. Duke, Ph.D., President and CEO
ApopLogic Pharmaceuticals, Inc.
12635 East Montview Blvd. Suite 100
Aurora, CO 80045