Designation is driven by compelling Phase 2 clinical data in patients with complicated Staphylococcus aureus bacteremia showing AP-SA02 may offer substantial improvement over available therapies Potentially accelerating the path to market for this innovative antibacterial treatment AP-SA02 now holds Breakthrough Therapy, Fast Track and QIDP designations, providing strong regulatory validation Armata Pharmaceuticals, Inc., a late clinical-stage biotechnology company focused on the development of high-purity and potency, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections, announced that the U.S. Food and Drug Administration (the “FDA”) has granted Breakthrough Therapy designation to AP-SA02, the Company’s intravenously administered Staphylococcus aureus (“S. aureus”) multi-phage product candidate, for adjunct treatment of complicated bacteremia caused by methicillin-sensitive S. aureus (“MSSA”) or methicillinresistant S. aureus (“MRSA”). Breakthrough Therapy designation is intended to expedite the review of medicines that treat a serious or life-threatening condition and have shown preliminary clinical evidence indicating the potential for substantial improvement over available therapies. “The decision by the FDA to grant Breakthrough Therapy designation to APSA02, in addition to Qualified Infectious Disease Product (“QIDP”) and Fast Track designations, recognizes the urgent need for new treatment options for patients with complicated S. aureus bacteremia (“SAB”), including MRSA, where many outcomes remain poor despite current standard-of-care,” said Dr. Deborah Birx, Chief Executive Officer of Armata. “Based on the Phase 2 clinical trial data, we believe AP-SA02 has the potential to represent an important advancement in the treatment of complicated SAB, a serious bloodstream infection that continues to be associated with significant relapse rate, morbidity and mortality. If ultimately confirmed in Phase 3 and approved, AP-SA02 has the potential to become the first antibacterial therapy approved based on superiority to current standard-ofcare treatment in this patient population. We are grateful for the FDA’s enhanced engagement and are committed to working closely with the Agency to efficiently advance the development and review of AP-SA02, with the goal of bringing this potential new treatment option to patients as quickly as possible.” Critically, the Breakthrough Therapy designation is supported by data from the successful Phase 1b/2a diSArm study in adults with complicated SAB. Armata’s proprietary purification process yielded the production of a high-purity, hightiter AP-SA02 drug product formulation enabling repetitive dose intravenous administration every six hours for five days. This dosing regimen was well tolerated with no serious adverse events attributed to AP-SA02, and, when added to best available antibiotic therapy (“BAT”) demonstrated higher and earlier clinical cure rates than placebo plus BAT. At the end-of-study assessment, 28 days after completion of BAT, 100% of patients treated with AP-SA02 maintained clinical response without relapse, compared with 75% of patients receiving placebo. Patients treated with AP-SA02 also demonstrated favorable trends across multiple measures of disease resolution, including more rapid normalization of C-reactive protein (CRP) and Interleukin-10 (IL-10), biomarkers associated with mortality risk and complications in SAB. Armata Pharmaceuticals Receives U.S. FDA Breakthrough Therapy Designation for AP-SA02 Prominent among these recruited immune cells are TAMs, which are abundant in nearly all solid tumours. There are two primary types of macrophages, M1 and M2. M1 macrophages are pro-inflammatory – the “soldiers” that eliminate threats like bacteria and viruses. M2 macrophages are anti-inflammatory – the “medics” that orchestrate wound healing and tissue repair once threats are cleared. Cancer cells corrupt most TAMs into adopting the M2 “medic” state, suppressing immune attacks against the tumour while facilitating tumour growth and metastasis. The key to this macrophage reprogramming lies in a protein called TRPC1 (Transient Receptor Potential Canonical 1), which regulates the M1 state. Crucially, TRPC1 also allows cells to sense and respond to magnetic fields. In their experiments, the NUS team confirmed that a brief 10-minute exposure to PEMFs activated TRPC1 channels on M2-like TAMs, setting off a signalling cascade that converted them to the M1 state – essentially turning TAMs from helpful “medics” to aggressive cancerkilling “soldiers”. These activated TAMs then selectively target cancer cells while sparing healthy tissue. Furthermore, the same magnetic signature disrupts cancer’s ability to hijack TAMs, altering the TAM-cancer communication loop in both directions. “We have identified a molecular “switch”, the specific cell signalling pathway that allows us to reprogram TAMs. Once reprogrammed, these immune cells actively hunt and devour cancer cells, obliterating the tumour,” said Assoc Prof Franco-Obregón. “With the non-invasive and targeted nature of PEMF therapy, we hope to provide patients an effective and safe alternative treatment, with fewer undesirable side effects.” Pulses of hope for cancer patients Assoc Prof Franco-Obregón shared that the same PEMF device used in this study has just successfully completed Phase 1 clinical trials, demonstrating its safety in humans. The team is now seeking partners to conduct Phase 2 efficacy trials to evaluate how well the PEMF treatment works in patients and to further advance its development towards clinical use. “Since we previously showed that PEMFs selectively increased the uptake of DOX in breast cancer cells, we will be evaluating if our PEMF immunotherapy can work synergistically with chemotherapy for better results,” added Assoc Prof Franco-Obregón. “As the immune cells we reprogram are commonly found in most solid tumours, we are optimistic that our PEMF therapy could potentially be a complementary treatment for other cancers beyond breast cancer.” Read more: https://news.nus.edu.sg/ magnetic-pulses-reprogram-immune-cellsto-fight-breast-cancer
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