Sirusho BIOS initiates phase 1 study of KB004 in EphA3 expressions hematologic malignancies

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Sirusho BIOS pharmaceuticals, Inc., a biopharmaceutical company, treatment of first patients in a phase 1 study of KB004, the first-in-class Humaneered ™ announced monoclonal antibodies in EphA3 expressions hematologic malignancies.

EphA3 is a Haemato fetal protein that is expressed in a number of cancers such as hematologic malignancies and possibly on Leukemic cells. A team of Australian employees, including Dr. Martin Lackmann of at Monash University in Melbourne; Dr. Andrew Boyd Queensland Institute of medical research and the University of Queensland, Brisbane, which originally the KB004 precursor monoclonal antibody, IIIA4 isolated; and Dr. Andrew Scott Ludwig Institute for cancer research, Melbourne, as the cancer target and in a number of animal studies, recognized the potential of the EphA3 the IIIA4 antibodies as anti cancer agent evaluated.

"We are curious to see progression of the KB004 in the clinic, we believe that these antibodies given its potential to tumors by several different mechanisms, kill significant benefit for patients with a wide range of types of cancer, could provide", said Dr. Lackmann.

"KB004's unique ability to target and select EphA3 and its similarity with the human germ line sequences in measurable effectiveness and low immunogenicity could lead", Dr. Boyd said. "As a hematologist, I am particularly pleased that the first trial in patients with leukemia is."

"KB004 is that results, which we hopefully be reflected in the clinical setting for leukemia, has shown, a patient specific, potentially disease-modifying antibodies, the promotion of the preclinical proof-of-concept," said Jeffrey E. Lancet, MD of Moffitt Cancer Center Tampa, Florida, the first patient treated. MD Anderson Cancer Center in Houston, Texas is also the study take part.

The open-label, multi-center phase 1, the study in patient populations with EphA3 positive hematologic malignancies, including chronic myelogenous leukemia, acute myeloid leukemia, Acute Lymphocytic Leukemia and myelodysplastic syndromes, which on are carried out will have failed or not standard-of-care have received treatment. Patients older than 65 years who are not medically suitable for standard-of-care. In the escalation of the dose up to 24 patients, which showed one of the four dosage levels, once a week for three weeks for maximum 17 cycles to prospective on the presence of EphA3 get the study, phase. Once the escalation phase is complete, an advanced phase of the study is be initiated with up to an additional 15 patients. The primary endpoint of the study the determination is the maximum tolerated dose. Secondary endpoints include safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and clinical efficacy.

About KB004

KB004 is a first-in-class IgG1? engineered antibodies for the EphA3 receptor tyrosine kinase. Sirusho BIOS has allowed this goal from the Australian team, the EphA3 discovered, and has used to develop a Afucosylated activity its proprietary Humaneering ™ technology platform antibody recombinant of human antibody with extended antibody dependent cytotoxic (ADCC). KB004 to be enabled also variable regions, which much like human germline klich sequences, an attribute of Sirusho BIOS' Humaneering ™ technology platform, and offers the potential for low immunogenicity in patients.

Of antibody Humaneering ™ technology

Sirusho BIOS' Humaneering ™ technology is a proprietary method to convert non-human antibodies in Humaneered ™ antibody. Humaneered ™ are high affinity antibodies, but closer to human germline sequence as is possible with other available antibody engineering methods, it is potentially suitable for the treatment of chronic or repeated other therapies.

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Sirusho BIOS pharmaceuticals, Inc.