Neumedicines signed a contract worth up to $273 million for the development of its HemaMax™ (recombinant human interleukin 12; rhuIL-12) for the treatment of hematopoietic syndrome of acute radiation syndrome (HSARS). The contract was awarded on September 15 by the Biomedical Advanced Research & Development Authority (BARDA) and is expected to support the firm’s clinical and commercial strategy including scaling up manufacturing, expanded human safety trials, and pivotal, nonclinical efficacy studies in animals, through FDA licensure.
Neumedicines will initially receive about $17 million over 18 months to speed up development activities. Additional financing over the next 3.5 years will be made based on achievement of certain milestones.
“We have been working with BARDA to further the development of HemaMax as a radiation countermeasure since 2008 and are now extremely pleased to extend this partnership under this current contract to fund the advanced development of HemaMax,” notes Lena A. Basile, Ph.D., president and CEO of Neumedicines. To date, Neumedicines has reportedly received $33 million in government funding for the advanced development of HemaMax, including money from HHS, BARDA, and NCI.
“HemaMax is to be utilized after a catastrophic event where U.S. citizens and/or military personnel are exposed to lethal levels of radiation,” Dr. Basile continues. “With this funding, Neumedicines is positioned to accelerate the nonclinical efficacy and human safety development of HemaMax towards FDA approval under the Animal Rule.”
Scientists from Neumedicines discovered the previously unexplored hematological properties of IL-12 by demonstrating the potent survival effects of single, low-dose IL-12 on hematopoietic recovery following lethal radiation. HemaMax is being designed as a therapeutic that will be administered to potential victims of a radiation disaster in very low, microgram doses to achieve potent radiomitigation effects.
To date Neumedicines has shown that HemaMax can increase survival in mice and nonhuman primates who receive the therapeutic in single, low doses 24 hours after lethal radiation exposure. To get an FDA go-ahead the company will have to demonstrate efficacy in representative animal models as well as safety, pharmacokinetic, pharmacodynamic, and biomarker testing in healthy human volunteers.
In June healthy volunteers were dosed with HemaMax in a first-in-human Phase I study in HSARS. This initial safety study involves single injections of HemaMax in ascending dose groups of six healthy volunteers in four cohorts. Participants in the study will be assessed for adverse side effects over a four-week period, and blood samples will be obtained to evaluate the effects of HemaMax on various biomarkers.
The study has reportedly advanced to the third cohort with no safety issues and is scheduled to be completed by the first quarter of next year. This safety study is to be followed by several larger safety studies in healthy human volunteers, prior to submission of a BLA, which is expected by 2016.
HemaMax is also being developed for use in cancer patients to alleviate the side effect of radiation or chemotherapy. A Phase I trial for the prevention of chemotherapy-induced thrombocytopenia in patients with solid tumors is targeted to begin in the second quarter of next year.