NK Cell Therapy
AP44: Our lead clinical stage natural killer (NK) Cell Therapy, called AP44, is an autologous platform technology that activates NK cells to kill cancer. We have entered into an exclusive worldwide license with Multimmune GmbH of Munich, Germany for its autologous clinical stage NK Cell therapy that targets cells expressing Heat Shock Protein 70.
Heat shock protein 70 (HSP70) is a protein produced by cells in response to exposure to stressful conditions. Hsp70 has been discovered to be highly expressed on a variety of different cancer types, but not on normal tissues. AP44 NK Cell therapy redirects NK Cells to recognize cells highly expressing HSP70, and attack those cells. AP44 NK-Cell therapy starts with blood extracted from the patient by a series of leukopoiesis draws, and the lymphocyte white blood cells incubated with a patented synthetic peptide form of HSP70 and activating agents to “educate” the patient’s NK cells to recognize cells expressing mHSP70. The activated NK cells are administered back to the patient by intravenous administration.
Completed Trials
Phase I Clinical Trial -Completed: A Phase I Clinical trial with AP44 NK Cell Therapy after radio-chemotherapy in patients with metastatic colorectal and Non-Cell Small Lung Cancer (NSCLC) was completed in Germany, and met safety and tolerability endpoints.
CDx: Companion Diagnostic: Identifying patients having disease-specific therapeutic targets with a Companion Diagnostic (CDx) dramatically improves outcomes, even in difficult-to-treat disease indications. Tumors expressing membrane Hsp70 cells actively release Hsp70 in exosome-like lipid vesicles.
Phase IIa Clinical (Randomized, Controlled) Trial- Completed: A Phase IIa (randomized controlled) multi-centre clinical trial with AP44 NK Cell Therapy radio-chemotherapy in patients with Stage IIIb inoperable squamous NSCLC, was completed and showed promising signs of efficacy.
Planned Trials
Phase IIa Clinical Trial: We are planning a Phase II Clinical Trial in Metastatic Colorectal Cancer. Colorectal cancer is the 3rd leading cause of cancer deaths.
Phase IIb/III Pivotal Combination Trial: We plan to initiate a Phase IIb/III ‘ ‘Pivotal’ Clinical Trial in NSCLC, in combination with a PD-1 Checkpoint inhibitor. Lung cancer is the leading cause of cancer deaths, with 85% of lung cancer Non-Small Cell Lung Cancer.