ABM Therapeutics receives IND approval by FDA for MEK inhibitor ABM-168
Time: 2022-10-13
Source: Viva Biotech
[Abstract]:This is also the second approved self-developed drug from ABM Therapeutics after ABM-1310.

Shanghai, China / San Diego, USA, October 12, 2022 - ABM Therapeutics, invested and incubated by Viva BioInnovator, a biopharmaceutical company that focuses on small molecule research and development of novel drugs for the treatment of brain cancers, announced that the U.S. Food and Drug Administration (FDA) has granted IND approval of ABM-168, a self-developed MEK1/2 inhibitor. This is also the second approved self-developed drug from ABM Therapeutics after ABM-1310. With this approval, ABM Therapeutics’ upcoming Phase I clinical trial will recruit patients with advanced solid tumors, especially patients with concurrent brain metastases or primary brain tumors, aiming to explore the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of ABM-168 in such patients. 


ABM-168 is a highly potent allosteric MEK1/2 inhibitor, which can block the cancerous signaling pathway of cells caused by RAS and RAF mutation or signal amplification, thereby controlling the growth of cancer cells. The results of in vivo studies showed that when used alone, or in combination with other drugs in glioblastoma orthotopic models, human melanoma intracranial/intracardiac models, colon cancer subcutaneous transplantation models, colon cancer orthotopic tumors models and pancreatic cancer tumor models, ABM-168 shows great anti-tumor activity. It can effectively inhibit the proliferation of various RAS, RAF and NF1 mutated cancer cell lines. ABM-168 has an excellent ability to penetrate the blood-brain barrier and can effectively kill brain metastatic cancer cells or malignant brain tumor cells.


The blood-brain barrier (BBB) crossing has been a difficult drug delivery problem in the industry. It is foreseeable that if the efficiency of drug delivery to the brain can be improved, it will significantly promote the survival rate of patients and delay the development of tumors. Currently, 4 MEK1/2 inhibitors have been launched to market, but their ability to pass through the blood-brain barrier is relatively low. Based on preclinical studies, ABM-168 has demonstrated superior blood-brain barrier penetration.


"Thanks to the team's continuous efforts and innovation, the IND approval of ABM-168 in the United States is another milestone in the company's development. 2022 will be a fruitful year for ABM Therapeutics. The Phase I clinical trial of ABM-1310 in the United States, is progressing smoothly and has shown good safety and tolerability; ABM-1310 has also completed the first patient dosing in China… These achievements are further recognitions of our research and development capabilities." Dr. Chen Chen, Founder and CEO of ABM Therapeutics, said, "We will continue to work hard, stay true to our original aspiration, and continue to leverage the unique advantages of our platform to provide patients and clinicians with safer and more effective treatment options as soon as possible." 


In addition to ABM-1310 and ABM-168, ABM Therapeutics also has a wealth of independent research and development pipelines that are in progress. ABM Therapeutics completed Series B round financing earlier this year and is in the process of Series B+ round financing. ABM Therapeutics looks forward to cooperating with international pharmaceutical companies, domestic and foreign biopharmaceutical companies, and securities and funds. 



About ABM Therapeutics


ABM Therapeutics, a clinical-stage biopharmaceutical company with a mission to focus on the small molecule research and development of novel drugs for the treatment of cancer, and on brain cancer and cancer metastases. ABM has been building its broad and robust proprietary pipeline to construct a brain medicine R&D platform through collaboration with CROs. ABM’s pipeline includes several programs in various stages of discovery and development, most of which have improved brain permeability to address the unmet needs of treating cancers and metastases in the brain.

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