Posted: 24 January 2025
Recently, GeneCraft, a partner of ProBio, announced that its gene therapy for non-small cell lung cancer (NSCLC), RX001, has received IND clearance from the Ministry of Food and Drug Safety (MFDS) in South Korea. RX001 stands as the world’s first gene therapy leveraging AAV (Adeno-Associated Virus) technology specifically for lung cancer treatment. ProBio, the partner who provided plasmid and AAV research, manufacturing, and CTD documentation preparation services, extends warm congratulations to GeneCraft on reaching this remarkable milestone.
The RX001 program focuses on treating K-RAS mutant NSCLC, a condition that has historically been considered untreatable. Built on the tumor suppressor gene RUNX3, RX001 selectively targets and eliminates cancer cells while sparing normal cells. This innovative mechanism minimizes the side effects associated with traditional cancer treatments, offering new hope to patients with limited therapeutic options. The initiation of clinical trials for RX001 sets a new paradigm in the treatment of lung cancer and other K-RAS-related malignancies. It also underscores the vast potential of AAV-based therapies in addressing a broader range of complex diseases.
ProBio provided comprehensive support to GeneCraft through its independently developed PowerSTM-293 suspension cell line and professional AAV process platform. The company successfully tackled challenges related to the quality and stability of the AAV amplification process. This collaboration was further strengthened by GeneCraft’s proprietary AAV platform. Together, these combined efforts ensured the seamless manufacturing and delivery of the clinical batch for RX001 while optimizing efficiency and quality throughout the development process. ProBio’s contributions to the RX001 program not only highlight its industry-leading expertise in AAV drug development but also serve as a prime example of the synergy between the two companies.
ProBio CEO Dr. Allen Guo stated, “We congratulate GeneCraft on obtaining MFDS clearance for this IND application. We are proud that ProBio’s professional CDMO platform contributed significantly to this achievement. This collaboration reflects our shared commitment on advancing innovative therapies that meet critical medical needs.”
GeneCraft CEO Suk Chul Bae stated, “We are truly delighted to achieve such a historic milestone as a company. This IND approval signifies that we are one step closer to developing a treatment that can offer new hope to patients suffering from KRAS NSCLC.
In particular, the smooth CMC operations and prompt data provision by ProBio made it possible for us to prepare for clinical trials. ProBio has played a vital role as a key collaborative partner throughout the RX001 development process. I hope this joint achievement will serve as a foundation for the creation of many more innovative therapies in the future.”
