Founded in 2003, the clinical-stage biopharmaceutical company Neumedicines Inc. is headquartered in Pasadena, California, USA, and has received $76 million in non-dilutive funding to date. Neumedicines has been exclusively engaged in the research and development of HemaMax™, recombinant human interleukin 12 (rHuIL-12), for the treatment of:

• Cancer, in combination with standard of care (SOC, radiotherapy, chemotherapy, or immunotherapy)
• Hematopoietic Syndrome of Acute Radiation Syndrome (HSARS), as a monotherapy

HemaMax has pleiotropic functions that can facilitate anti-tumor effects, against both solid tumors and hematologic malignancies, and is being evaluated for use in combination with the SOC. Exogenous HemaMax is able to activate the innate and adaptive immune systems, and hematopoiesis, to work in conjunction with the SOC to generate sustained and durable anti-tumor responses. HemaMax drives an extensive number of anti-tumor mechanisms:

• Activates cytotoxic cells (NK cells and CD8+ cells)
• Induces an IFN-γ signature, and a CD4+ Th1 response
• Migrates immune cells to the tumor microenvironment
• Demonstrates anti-angiogenic activity
• Facilitates tumor antigen processing
• Activates hematopoiesis and multi-cell replenishment

HemaMax also has significant radiomitigating functions, and enhances non-human primate (NHP) survival when administered after radiation exposure, in the complete absence of antibiotics, fluids and blood products. As a medical counter measure (MCM) HemaMax:

• Stimulates hematopoiesis and potent immune responses
• Mitigates bone marrow damage
• Reduces the incidence of severe neutropenia and thrombocytopenia
• Reduces systemic infection
• Reduces the need for mucositis treatment

Pre-clinical and Clinical results of HemaMax have been compelling.

• Efficacious in an extensive number of rodent disease models
• Complete responses demonstrated in canine cancer patients
• Significantly enhanced survival of irradiated NHP
• Safe and well tolerated in healthy subjects, and in patients, following single and repeat dosing regimens
• No generation of anti-HemaMax antibodies
• Favorable pharmacokinetic (PK) and pharmacodynamic (PD) properties
• Durable complete responses demonstrated in Cutaneous T cell Lymphoma (CTCL) patients

HemaMax through a novel dosing paradigm, eliminates the toxicity misconception of historical IL-12. Critically the infrequent and low concentration, subcutaneous dosing prevents tachyphylaxis (decreased immune response) . Additionally HemaMax has excellent stability, and its distinct glycosylation pattern results in an improved PK and PD profile.

The pleiotropic anti-tumor effector mechanisms of HemaMax are conserved across multiple tumor types. Thus the efficacy of HemaMax offers substantial market opportunities within the $43B immuno-oncology market (presently running at a 14.6% Compound Annual Growth Rate). The clinical status of HemaMax is:

• Phase 3-ready in Cutaneous T Cell Lymphoma (with radiotherapy)
• Phase 2-ready in Non-Small Cell Lung Carcinoma and Melanoma (with radiotherapy and immunotherapy, anti-PD-1 antibody)
• Phase 2-ready in Diffuse Large B cell Lymphoma (with chemotherapy, R-ICE or R-DHAP)