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Asana BioSciences Announces Acceptance of IND Application for Its Oral ERK1/2 InhibitorAsana BioSciences, an oncology-focused, clinical stage biopharmaceutical company, today announced that the U.S. FDA has accepted the IND application for ASN007, a potent and selective ERK1/2 inhibitor. "We are extremely pleased with the acceptance of this IND for evaluation of our potential Best-in-Class, oral ERK1/2 inhibitor that shows potent anti-proliferative activity in cancer models driven by MAP Kinase pathway mutations, as well as those resistant to BRAF and MEK inhibitors," said Sandeep Gupta, PhD, Founder, President and Chief Executive Officer at Asana BioSciences. "We continue to execute on our strategy of developing novel drugs that work on clinically validated targets, are clearly differentiated from the competition, and expected to offer significant benefit over the existing standards of care. This represents the 5th successful IND of our proprietary portfolio in the past 3 years, and is a testament to the capabilities, dedication and high efficiency of Asana's R&D team," said Dr. Gupta. The RAS/RAF/MEK/ERK (MAP Kinase) signaling pathway is frequently hyperactivated in a wide range of cancers through mutations in upstream targets such as BRAF, RAS and receptor tyrosine kinases. Inhibition of ERK1/2 offers a promising therapeutic strategy for these cancers, particularly those driven by RAS mutations. Enrollment in this Phase 1, open-label, dose-finding study of ASN007 in patients with advanced solid tumors is expected to start soon. The study will evaluate the safety, tolerability and preliminary efficacy of ASN007 in patients with BRAFV600, KRAS, HRAS or NRAS mutations. About Asana BioSciences, LLC Asana BioSciences is a research and development company based near Princeton, NJ, specializing in the discovery and development of new chemical and biological entities. Multiple assets from Asana's portfolio are currently in clinical development in a variety of therapeutic areas, including oncology, dermatology and autoimmune diseases. Asana is an independent member of the AE Companies, Bridgewater, NJ. Asana's lead compound ASN002 is a potent inhibitor of Janus kinases (JAK) including TYK2 and spleen tyrosine kinase (SYK). These kinases are involved in both cytokine production and signaling and have been implicated in the pathogenesis of various types of lymphomas, solid tumors, myeloproliferative and inflammatory/autoimmune disorders such as atopic dermatitis, psoriasis, rheumatoid arthritis, etc. ASN002 is currently being evaluated in a Phase I/II clinical study in patients with non-Hodgkin lymphomas (NHL), peripheral T-cell lymphoma (PTCL), chronic lymphocytic leukemia (CLL) and myelofibrosis (MF), with early evidence of clinical activity and good tolerability (NCT02440685). ASN002 is also being investigated in patients with moderate to severe atopic dermatitis (NCT03139981). ASN003, a selective inhibitor of BRAF and PI3 Kinase, is currently in Phase I development in patients with advanced solid tumors (NCT02961283). The RAS-RAF-MEK and PI3K pathways are frequently mutated in melanoma and other cancers, such as colon and lung cancer. Dual targeting of RAF and PI3K pathways with ASN003 has the potential to overcome and/or delay acquired resistance to selective RAF inhibitors and improved efficacy against cancers driven by both pathways. To date, the drug is well tolerated in patients and shows pharmacodynamic activity. Enrollment is ongoing in patients with BRAFV600 mutated metastatic melanoma, metastatic colorectal cancer (CRC), or advanced non-small cell lung cancer (NSCLC), and advanced solid tumors with documented PIK3CA mutation. ASN004 is an Antibody Drug Conjugate (ADC (News - Alert)) that targets the 5T4 oncofetal antigen that is expressed in a wide range of malignant tumors, while very limited expression is found in normal tissues. ASN004 demonstrates robust antitumor activity leading to complete tumor regressions in multiple human tumor xenograft models, with no development of resistance to ASN004 treatment. The IND-enabling program for ASN004 has been completed and a First-in-Human Phase 1 trial is being planned in 2018.
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