drug
SN Bioscience’s pioneering nanoparticle anticancer drug, SNB-101, has sparked hope for patients battling various forms of cancer. Developed from the highly insoluble SN-38 into polymer nanoparticles, SNB-101 has exhibited significant improvements in efficacy and safety compared to existing irinotecan products. Animal studies suggest its potential effectiveness against lung, pancreatic, and stomach cancers, expanding treatment options for these conditions.

The drug’s journey towards clinical validation has seen significant progress, with approval for Phase I clinical trials in both the US and Korea. SN Bioscience is now poised to submit investigational new drug (IND) applications for Phase II trials in the US and Europe, following encouraging results in pancreatic cancer animal models.

Furthermore, SNB-101’s designation as an orphan drug by the US FDA underscores its potential as a therapeutic breakthrough. This designation provides exclusive marketing rights, tax credits, trial design assistance, and exemption from review application fees, offering significant incentives for its accelerated clinical development.

Despite these advancements, the pharmaceutical landscape faces legislative debates surrounding drug pricing and innovation. US lawmakers in the House of Representatives are deliberating changes to the Inflation Reduction Act (IRA), particularly focusing on the bipartisan Optimizing Research Progress Hope And New (ORPHAN) Cures Act and Maintaining Investments in New Innovation (MINI) Act.

The ORPHAN Cures Act proposes exemptions for orphan drugs exclusively approved for rare diseases, aiming to streamline negotiations. Conversely, the MINI Act seeks to delay negotiations for certain “advanced drug products.” However, concerns have been raised regarding the potential impact of these amendments on innovation within the pharmaceutical industry.

While some argue that the IRA may stifle innovation, others contend that the legislation will ensure access to affordable cures while preserving innovation. The ongoing debate highlights the complexities surrounding drug pricing and regulatory frameworks, with stakeholders advocating for policies that balance access, affordability, and innovation.

As SN Bioscience advances the clinical development of SNB-101, its potential to revolutionize cancer treatment underscores the importance of fostering an environment conducive to innovation within the pharmaceutical industry. Amidst legislative discussions, the pursuit of groundbreaking therapies like SNB-101 remains pivotal in addressing unmet medical needs and improving patient outcomes.

Source:
https://www.pharmaceutical-business-review.com/news/sn-bioscience-fda-orphan-drug/
https://endpts.com/house-committee-debates-ira-changes-that-would-impact-orphan-drugs-and-other-areas/
GMP mRNA
Check out our AAV CDMO service to expedite your gene therapy research
About PackGene

PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.

Related News

Scientists develop potential stealth cancer therapy

Credit: ACS Central Science (2024). DOI: 10.1021/acscentsci.4c00559Sneaking by cancer's defenses, by disguising tumor-fighting antibodies inside the molecules cancer uses to nourish tumor growth, is the basis of a novel therapy from Yale Cancer Center researchers at...

read more

Related Services

Plasmids GMP Services

Multiple scales & grade of solutions of various kind of plasmids suitable for multiple treatments in a fast and cost effective way.
READ MORE

AAV GMP Services

Ranging from small-scale AAV production, to large-scale AAV cGMP manufacturing for animal studies.
READ MORE
aav icon

Technology Platforms

PackGene’s proprietary π-Alpha™ 293 AAV High-yield Platform increases AAV production by 3 to 8 times that of traditional platforms.
READ MORE