RxMP Therapeutics Advances Hemostatic Agent RMP-402 with DoD Partnership and FDA Manufacturing Approval
核心洞察
RxMP Therapeutics (搜索) secured a Cooperative Research and Development Agreement with the Department of Defense (搜索)'s Institute of Surgical Research (搜索) to validate RMP-402 (搜索) in large animal models of polytrauma (搜索) hemorrhage (搜索) and shock (搜索).
The company reached consensus with the FDA on its GMP allogeneic manufacturing process for RMP-402 (搜索), enabling large-scale production of the red cell-derived hemostatic agent.
RxMP appointed Shawna Khouri as Chief Operating Officer to oversee operational strategy for its injectable drug platform focused on hemostasis and bleeding management.
RxMP Therapeutics (搜索) has achieved significant regulatory and partnership milestones for its lead hemostatic agent RMP-402 (搜索), including a research collaboration with the U.S. Department of Defense (搜索) and FDA approval of its manufacturing process. The Seattle-based company announced these developments alongside the appointment of a new Chief Operating Officer to advance its bleeding management platform.
DoD Partnership for Trauma Research
In March 2025, RxMP entered into a Cooperative Research and Development Agreement (CRADA) with the Institute of Surgical Research (搜索), a subordinate federal laboratory of the Defense Health Agency within the Department of Defense (搜索). Under the agreement, RxMP will provide RMP-402 (搜索), described as red cell-derived lyophilized microparticles, along with related research materials to the Institute.
The Institute of Surgical Research (搜索) will validate the effects of RMP-402 (搜索) alone or as a component in promoting coagulation (搜索) function using large animal preclinical models of polytrauma (搜索) hemorrhage (搜索) and shock (搜索). This collaboration aims to develop transformative products that could benefit both civilian public health and military personnel.
FDA Manufacturing Consensus
Earlier in 2025, RxMP achieved consensus with the FDA on its GMP manufacturing process for allogeneic RMP-402 (搜索) following a Type C meeting. The FDA had requested the company present its finalized GMP manufacturing process prior to further IND-enabling studies. The meeting outcome allows RxMP to proceed with its proposed manufacturing approach, which has important implications for large-scale production capabilities.
"I could not be more excited about our achievements in the last few months especially achieving concurrence with FDA on our allogenic GMP manufacturing process that permits large scale manufacturing in the future, which has important implications for our lead product," commented Dr. Rifat Pamukcu, President and Chief Executive Officer of RxMP Therapeutics (搜索).
Leadership Expansion
In May 2025, RxMP appointed Shawna Khouri as Chief Operating Officer to spearhead the company's operational strategy for its injectable drug platform focused on hemostasis. Prior to joining RxMP, Khouri served as Director for Health and Innovation Initiatives at Tulsa Innovation Labs (搜索), the technology and innovation ecosystem arm of the George Kaiser Family Foundation (搜索).
At Tulsa Innovation Labs (搜索), Khouri established the operational framework for managing more than $100 million in federal and philanthropic initiatives, including the EDA Build Back Better and Tech Hubs programs. Her background combines financial expertise with biomedical engineering experience.
RMP-402 Mechanism and Development
RMP-402 (搜索) is a hemostatic agent derived from red blood cells, designed to prevent and treat excessive bleeding (搜索) by enhancing platelet function (搜索) and coagulation (搜索) without causing off-target clotting. The company's broader platform includes RMP-HPE, red cell-derived microparticles produced by high-pressure extrusion, as a hemostatic agent for treating or preventing excessive bleeding.
Dr. Pamukcu emphasized the strategic value of the new partnerships and leadership: "The CRADA will allow us to benefit from the additional outside expertise that the ISR brings in this cooperative agreement to further collaborative research and development, with a goal of producing transformative and marketable products that potentially benefit both civilian public health and our military personnel."
The company expects Khouri's appointment to strengthen its leadership team through her complementary expertise in scaling up the unique GMP manufacturing process and managing business operations growth.