LAWRENCEVILLE, N.J.--(BUSINESS WIRE)--Asana BioSciences, LLC, a clinical stage biopharmaceutical company, today announced that the first patient has been dosed in a Phase 1 trial for ASN004, an antibody drug conjugate (ADC) targeting the 5T4 oncofetal antigen (trophoblast glycoprotein), that is expressed in a wide range of malignant tumors but shows very limited expression in normal tissues. Higher 5T4 expression is associated with worse clinical outcome in non-small cell lung, head and neck, gastric, pancreatic, colorectal, and ovarian cancers.
ASN004 incorporates a novel single-chain Fv-Fc antibody linked to a clinically validated Auristatin F hydroxypropylamide cytotoxic payload, and drug to antibody ratio (DAR) of approximately 10-12. In preclinical cancer models, a single dose of ASN004 achieved complete and durable tumor regression leading to tumor-free survivors.
“5T4 is an ideal antigen target for payload delivery to tumor with high internalization rate dynamics combined with the high DAR and represents a clear opportunity for precision guided therapy as needed” said Dr. Anthony Tolcher, Director of Clinical Research, Next Oncology, San Antonio, Texas and the Principal Investigator of the Phase 1, multicenter, dose-finding study, designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of ASN004, in patients with advanced solid tumors in the US (NCT04410224).
“We are delighted to initiate the clinical development of ASN004. The broad tumor expression profile of 5T4 qualifies it as a promising target for cancer therapies, with potential to be the best-in-class ADC,” said Sandeep Gupta, PhD, Founder, President and Chief Executive Officer at Asana BioSciences. “ASN004 is the 6th novel program that Asana has successfully brought into the clinic, affirming our mission to provide new and better treatment options to patients,” added Dr. Gupta.
About Asana BioSciences, LLC
Asana BioSciences is a clinical stage biopharmaceutical company based in Lawrenceville, NJ. Asana is focused on discovery and development of novel targeted investigational medicines in immunology/inflammation and oncology.
Gusacitinib (ASN002) is an oral potent inhibitor of the Janus Kinase (JAK) family (JAK1, JAK2, JAK3 and TYK2) and Spleen Tyrosine Kinase (SYK). This potential best-in-class JAK/SYK inhibitor has been studied in ~350 patients with moderate-to-severe atopic dermatitis (NCT03531957) and chronic hand eczema (NCT03728504) and has demonstrated efficacy and good safety/tolerability.
ASN003 is a potent and highly selective inhibitor of B-RAF and PI3 Kinases. It has been evaluated in a Phase 1 trial in metastatic melanoma, colorectal and advanced non-small cell lung cancer, and other advanced solid tumors patients harboring BRAFV600 and PI3K pathway mutations (NCT02961283).
ASN008 is a novel, topical Na+-channel blocker with high functional selectivity for itch and pain sensing neurons without affecting motor neurons. In a Phase 1b study in atopic dermatitis patients, topical application of ASN008 showed rapid onset of pruritus relief (NCT03798561). ASN008 also has potential for the treatment of pain, urologic and other chronic conditions.
ASN009 is a selective antagonist of the purinergic P2X3 ion channel that is activated by extracellular ATP and involved in various pain, urological and respiratory disease conditions. ASN009 shows robust efficacy in a preclinical model of cough and is currently in preclinical development.