LAM Therapeutics Announces Progress of its Clinical Portfolio With FDA Clearance

LAM Therapeutics, a 4Catalyzer company, advanced its clinical portfolio with the US FDA clearance of LAM’s Investigational New Drug (IND) application for LAM-003 in leukemia patients. LAM-002 has transitioned into Phase 2 as a single agent and in combination with other therapies for treatment of B-cell non-Hodgkin lymphoma (B-NHL).

Identified by LAM’s technology platform in 2016, LAM-003 is a first-in-class immune-modulating drug for treating a genetically-defined population of acute myeloid leukemia (AML) patients. “The short time from discovery to Phase 1 initiation highlights the power of LAM’s strategy for leveraging high-throughput screening and patient-derived data to develop precision medicines faster and at a lower cost than conventional approaches,” said Dr. Lieping Chen (co-discoverer of the PD-1/PD-L1 pathway, Co-Director Cancer Immunology Program, Yale Cancer Center, and Advisor to LAM). “We are excited about LAM’s new therapeutic approach that is designed to overcome resistance observed with existing drugs used to treat AML, and we look forward to offering AML patients a new option for their disease,” said Dr. Steven Gore (Director of Hematologic Malignancies, Yale University).

LAM further announced that clinical trial results for LAM-002, a first-in-class PIKfyve kinase inhibitor for B-cell malignancies, was presented on December 11, 2017, by Dr. Jeremy Abramson (Clinical Director, Center for Lymphoma, Massachusetts General Hospital) and Dr. Sarah Rutherford (Assistant Professor of Medicine, Weill Cornell Medical College) at the American Society of Hematology conference. LAM-002 was found to be safe and well-tolerated in the dose escalation portion of the trial, and anti-tumor activity was observed in patients who had failed multiple prior lines of therapy.

LAM has selected the recommended Phase 2 dose for LAM-002 and has initiated patient accrual; anti-tumor activity is being assessed in specific subtypes of B-NHL. “By taking advantage of artificial intelligence and Next Gen sequencing approaches, we are matching LAM-002 to patients who can most benefit from its novel mechanism of action,” said Tian Xu (co-founder of LAM, CNH LONG Professor, Vice Chair of Genetics at Yale Medical School, Investigator at Howard Hughes Medical Institute).

LAM has partnered with Genentech, a member of the Roche group, who will provide the checkpoint inhibitor, atezolizumab (TECENTRIQ), to be used in combination with LAM-002 in B-NHL patients. “LAM is eager to collaborate with Genentech to test the novel mechanistic approach of treating patients with refractory lymphomas through the inhibition of both PIKfyve kinase and PD-L1. As published earlier this year in the journal Blood, we observed excellent synergy in animal models with both LAM-002 and anti-PD-L1, and LAM-002 with rituximab, and our Investigators are very enthusiastic about testing these innovative combinations in our trial,” said Henri Lichenstein, President and CEO of LAM Therapeutics.

LAM leverages the inflection point between biological understanding and computer science, incorporating data from Next Gen sequencing, artificial intelligence, genome editing, chemical genomics, and combinational drug screening, to develop precision therapeutics and companion diagnostics for cancer and rare diseases. LAM’s “virtuous circle” approach to drug development results in active learning from big data analyses of patient treatments and corresponding clinical responses, thus driving the rapid optimization of patient selection. LAM has already advanced three drugs into the clinic: LAM-001 for lymphangioleiomyomatosis, LAM-002 for B-cell non-Hodgkin lymphoma and LAM-003 for acute myeloid leukemia.

4Catalyzer is a start-up incubator dedicated to transforming 21^st century medicine by developing therapeutics and pairing devices with artificial intelligence. 4Catalyzer is driven by the desire to develop products that will improve the lives of people we love.