Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 103

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 103
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/s00432-009-0589-1                            |

Clinical Background and Unmet Need

The global anticancer therapeutics market is
undergoing rapid growth, driven by the rising incidence of cancer and advancements in treatment technologies. According to The Brainy
Insights, the market was valued at approximately $222.71 billion in 2023 and is projected to reach around $885.44 billion by 2033, reflecting
a compound annual growth rate (CAGR) of 14.80% from 2024 to 2033.

The Nano-Candesartan platform has broad potential
applicability across multiple cancer indications. Although preclinical studies have demonstrated activity in various tumor models, our
initial clinical development will focus on Pancreatic Ductal Adenocarcinoma (PDAC) as the first indication in which efficacy will be
evaluated in humans.

PDAC is a highly aggressive malignancy with extremely
limited treatment options and a very poor prognosis. Current standard therapies offer only modest survival benefits, and there remains
a significant unmet need for more effective and better-tolerated treatments. PDAC remains one of the deadliest malignancies with a 5-year
survival rate under 11% [1]. The current standard of care for advanced PDAC includes combination chemotherapy with Gemcitabine (Gemzar®)
and Nab-Paclitaxel (Abraxane®), and provides only a limited survival benefit. Angiotensin receptor blockers (ARBs), including generic
candesartan, have shown preliminary promise as modulators of the tumor microenvironment. Based on these findings, it is hypothesized
that ARBs may have the potential to enhance the clinical outcomes of anti-cancer therapies, especially such deadly cancer as pancreatic.

Our novel formulation of liposomal ARB, Nano-Candesartan,
is being developed as a potential combination therapy with standard-of-care agents such as Gemcitabine (Gemzar®) and Nab-Paclitaxel
(Abraxane®). The objective of this approach is to explore whether modulation of the tumor microenvironment could improve tumor penetration
and potentially reduce systemic risks such as blood pressure lowering. Preclinical data suggest Nano-ARB may also influence cancer-associated
fibroblasts (CAFs) and vascular permeability, which could support enhanced delivery and retention of therapeutic agents within the tumor
(EPR effect). However, these observations are based solely on preclinical findings. There can be no assurance that such