Lakewood-Amedex, Batu Biologics File Separate INDs With FD

Batu Biologics has filed for approval of a Phase 1/2 clinical trial for non-small cell lung cancer (NSCLC) while Lakewood-Amedex is planning to conduct a Phase 1/2a trial for diabetic foot infections. Both companies have submitted an Investigational Drug Application (IND) with the Food and Drug Administration (FDA). The federal agency has 30 days to respond with questions or revisions. Upon approval, the companies may proceed with enrollment and clinical activities.

Batu Biologics

Batu Biologics filed an application for ValloVax to treat NSCLC. The company announced the Phase 1/2 clinical trial in a press release, stating that ValloVax is a polyvalent cancer vaccine. Samuel Wagner, CEO of Batu Biologics, said, “Given the recent success of checkpoint inhibitors and other immunotherapies, we are excited to present this novel approach to a non-toxic approach to cancer. In our opinion, targeting tumor angiogenesis utilizing an active immunological approach will provide patients with the best tools to fight this devastating disease.”

ValloVax inhibits new blood vessel formation by stimulating an immune response in melanoma, breast, and lung cancer patients, though Batu Biologics states that the agent may be viable against other tumor types. The proposed trial will assess safety and efficacy in NSCLC patient who have not responded to chemotherapy. Upon FDA approval, investigators will administer three ascending doses of ValloVax to patients at the University of Utah in early 2015.

Lakewood-Amedex

Lakewood-Amedex announced in a press release that it submitted an IND to the FDA for a Phase 1/2a study of Nu-3 to treat diabetic foot infections. The company intends to test the synthetic broad-spectrum antimicrobial in foot ulcers because that indication is well suited to test the agent against both gram-positive and gram-negative bacteria. Upon FDA approval, the trial will evaluate safety and efficacy of the topical treatment in increasing doses. Additionally, the company will collect data on the ulcer’s change in microbiology.

Lakewood-Amedex is working on anti-infective products to treat MRSA, VRE, NDM-1, and biofilm strains. The company has an extensive patent portfolio of 74 patents and 13 patents-pending. Nu-3 is an antimicrobial developed from the company’s Bisphosphocin program. The company states that its agents are bactericidal agents, as opposed to the more common bacteriostatic agents. Lakewood-Amedex is focusing on bactericidal agents that directly kill bacteria instead of bacteriostatic agents that rely on a properly functioning immune system to work.