Neumedicines Receives Award of $14 Million from BARDA for Continued Development of HemaMax™ as a Medical Countermeasure to Acute Radiation Exposure

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Neumedicines Receives BARDA Award of $14 Million to Support Advanced Development of HemaMax(TM), Including Advanced GMP Manufacturing Activities and a Phase 2 Clinical Safety Study in 200 Healthy Human Volunteers

Neumedicines Inc., a privately held biotechnology company focused on developing and commercializing innovative products and approaches for the treatment of various clinical indications in the areas of oncology, hematology, and immunology, announces the award of $14 million from the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Office of the Secretary, Department of Health and Human Services (DHHS), under Contract No. HHSO100201100037C.

The award is intended to support the advanced development of HemaMax™ (recombinant human interleukin-12 or rHuIL-12) for hematopoietic syndrome of acute radiation sickness (HSARS). Specifically, the award will support a phase 2 clinical safety study of HemaMax™ in 200 healthy human volunteers, GMP manufacturing of drug product, and various other advanced development activities related to chemistry, manufacturing, and controls (CMC).

Under the U.S. FDA’s Animal Rule (21 CFR 601.90-95), Neumedicines is advancing HemaMax™ for the treatment of HSARS toward submission of applications for Emergency Use Authorization or EUA (21 U.S.C. 360bbb-3) and FDA licensure in 2015 and 2016, respectively.

“We are grateful to have now received more than $64 million from BARDA to support the development of HemaMax™ for HSARS,” said Neumedicines President & CEO Lena A. Basile, Ph.D., J.D. “Our efficacy studies have shown that a single, low-dose, subcutaneous injection of HemaMax™ at 24 hours after exposure to lethal radiation (LD70-LD90) increases survival by an average of more than 2-fold without any supportive care or antibiotics (PMIDs: 24708888 and 18489769). To our knowledge, these results are unmatched by any intervention available to the CDC’s Strategic National Stockpile or in development by industry or academia. In clinical studies, we have also shown that HemaMax™ is safe in healthy volunteers.”

“With BARDA’s continued funding, we are advancing HemaMax™ toward consideration for EUA, which, if granted, would allow for its use in the event of a radiological/nuclear emergency,” she added. “We believe HemaMax™ could have a significant impact in saving lives in such an event, and our team is committed to advancing HemaMax™ so that it may soon be a component of the United States’ arsenal in countering radiological/nuclear emergencies.”

Research and development of HemaMax™ for HSARS has been funded entirely with federal funds from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract Nos. HHSO1002000800060C and HHSO100201100037C.

“We are also focused on developing rHuIL-12 as an immunotherapy for cancer patients to be used in combination with various cancer treatments, including radiation, chemotherapies, and other immunotherapies. The promise of IL-12 as an immunotherapy is substantiated by the fact that the National Cancer Institute (NCI) and the Cancer Immunotherapy Trials Network (CITN) consider IL-12 a Priority Agent and rank it the top priority vaccine adjuvant and the third overall immunotherapy agent, only behind IL-15 and anti-PD-1,” Dr. Basile stated.

About HemaMax™:

HemaMax™ (rHuIL-12) holds considerable value and promise playing a central role in linking and regulating both innate (early nonspecific) and adaptive (late specific) immunity, while also playing a critical role in hematopoietic cell-to-cell signaling. In addition to HSARS, HemaMax™ is also being developed for various indications in oncology, including cutaneous T cell lymphoma (CTCL), acute myeloid leukemia (AML), melanoma, solid tumors, various immunotherapy applications, and hematopoietic support.

About Neumedicines Inc.:

Neumedicines Inc., a California corporation, is an emerging therapeutic biotechnology company focused on developing and commercializing innovative and proprietary products and approaches for the treatment of various clinical indications that address unmet clinical and societal needs in the fields of oncology, hematology, and immunology. The company operates from its headquarters and laboratories in Pasadena, California.

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About Biomedical Advanced Research & Development Authority (BARDA):

The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. BARDA manages Project BioShield, which includes the procurement and advanced development of medical countermeasures for chemical, biological, radiological, and nuclear agents, as well as the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases that fall outside the auspices of Project BioShield. In addition, BARDA manages the Public Health Emergency Countermeasures Enterprise (PHEMCE).

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About Hematopoietic Subsyndrome of Acute Radiation Syndrome:

Acute Radiation Syndrome (ARS) (sometimes known as radiation toxicity or radiation sickness) is an acute illness caused by irradiation of the entire body (or most of the body) by a high dose of ionizing radiation in a very short period of time (usually a matter of minutes). The major cause of this syndrome is depletion of progenitor stem cells in specific tissues. Examples of people who suffered from ARS are the survivors of the Hiroshima and Nagasaki atomic bombs, the firefighters that first responded after the Chernobyl Nuclear Power Plant event in 1986, and some unintentional occupational exposures from irradiators.

There are three classic ARS sub-syndromes: 1) Hematopoietic (H), 2) Gastrointestinal (GI), and 3) Cardiovascular (CV) / Central Nervous System (CNS). The hematopoietic syndrome (sometimes referred to as bone marrow syndrome) will usually occur with a dose between 0.7 and 10 Gy (70 – 1000 rads), though mild symptoms may occur as low as 0.3 Gy or 30 rads. The survival rate of patients with this syndrome decreases with increasing dose. The primary cause of death is either infection or bleeding caused by the destruction of the bone marrow, resulting in deficiencies of white blood cells (WBCs), lymphocytes, and platelets, with immunodeficiency, increased infectious complications, bleeding and hemorrhage, anemia, and impaired wound healing.

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