First-in-human Phase 1 study demonstrates early clinical proof of concept
Positive clinical biomarker data demonstrate evidence of immune system activation and the translation of the immunogenic response previously observed in preclinical studies
Data represent the first successful administration of intratumoral UNO therapy
Additional Phase 1 data for UNO expected in 2024
“The development of immunotherapy has pushed the frontier of cancer medicine further than ever expected,” stated Dr.
The Company’s abstract presented at SITC includes safety, tolerability, biomarker and initial antitumor activity results from 5 subjects dosed with 25,000 ppm UNO. The data show UNO at 25,000 ppm delivered over 5-minutes upregulates cytotoxic T-cells, T-central memory cells, M1 macrophages, and dendritic cells while downregulating T-regulatory cells and mononuclear-myeloid-derived suppressor cells (M-MDSC).
Specifically, by Day 21, a single UNO administration resulted in an immunostimulatory effect. Dendritic cells increased more than 250%, representing more than a 2-fold increase in the magnitude observed in a murine model utilizing 50,000 ppm UNO. In addition, more than a 150% increase in T-central memory cells was observed, consistent with previously reported murine data (Sela Y et al. AACR/NCI/EORTC 2023). Encouragingly, there was also a greater than 50% increase in M1 macrophages over the same time period.
UNO also had a favorable impact on the inhibitory cells of the immune system. T-regulatory cells decreased by 40% by Day 21 and myeloid derived suppressor cells (M-MDSC) decreased by greater than 30% by Day 7.
Dr.
Of the five heavily pre-treated patients treated as of this data cut, UNO was well tolerated with primarily Grade 1 related toxicities observed with an early clinical response (Day 7) in a highly refractory, salvage population.
The poster presentation detailing the emerging early clinical data titled, “Phase 1 study of ultra-high concentration nitric oxide (UNO) in relapsed or refractory, unresectable, primary, or metastatic cutaneous and subcutaneous malignancies,“ at the SITC 2023 Annual Meeting will be made available on the company's website (click here).
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Beyond
About Nitric Oxide
Nitric Oxide (NO) is a potent molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens.
About UNO Therapy for Solid Tumors
Cancer is the second leading cause of death globally, with tumor metastases responsible for approximately 90% of all cancer-related deaths. Current cancer treatment modalities generally include chemotherapy, immunotherapy, radiation, and/or surgery. Ultra-high concentration Nitric Oxide (UNO) therapy is a completely new approach to preventing relapse or metastatic disease. In vitro murine data show that local tumor ablation with UNO stimulates an anti-tumor immune response in solid tumor cancer models. Beyond
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Forward Looking Statements
This press release contains “forward-looking statements” concerning the potential safety and efficacy of inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate, as well as its therapeutic potential in a number of indications; and the potential impact on patients and anticipated benefits associated with inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate. Forward-looking statements include statements about expectations, beliefs, or intentions regarding product offerings, business, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “expects,” “plans,” “anticipates,” “believes” “expects,” “intends,” “looks,” “projects,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect views as of the date they are made with respect to future events and financial performance. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to: Beyond Cancer’s ability to raise additional capital; the timing and results of future preclinical studies and clinical trials concerning the ultra-high concentration nitric oxide product candidate; the potential that regulatory authorities, including the FDA and comparable non-
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