BioCina Pty Ltd., a global biologics Contract Development and Manufacturing Organization (CDMO), has announced a new partnership with clinical-stage biopharmaceutical company EnGeneIC Pty Ltd. to advance the manufacturing of EnGeneIC's innovative cancer treatment technology. The collaboration will focus on technology transfer, process scale-up, and GMP batch manufacture of EnGeneIC's proprietary 'EnGeneIC Dream Vector' (EDV™) nanocells.
The partnership represents a significant step forward for EnGeneIC's targeted cancer therapy platform, which has shown promise in addressing difficult-to-treat cancers while minimizing side effects commonly associated with traditional chemotherapy.
Revolutionary Nanocell Technology
EnGeneIC's platform centers on Antibody-Nanocell Drug Conjugates (ANDCs), which utilize antibody-targeted, non-living nanocells to deliver cytotoxic payloads directly to tumor cells. This approach enables the use of highly potent chemotherapeutic drugs encapsulated within nanocells, significantly reducing systemic toxicity while effectively targeting cancer cells.
The EDV™ technology offers a dual mechanism of action: it delivers potent anti-cancer agents directly to tumors, while simultaneously stimulating the patient's immune system to mount an anti-cancer response. This combination approach is particularly valuable for addressing drug-resistant cancers and providing options for patients with limited treatment alternatives.
Mark W. Womack, Chief Executive Officer of BioCina, expressed enthusiasm about the collaboration: "I'm so very proud for BioCina to be entrusted to advance EnGeneIC's transformative therapeutic, which has the potential to make a profound impact on previously untreatable cancers."
Addressing Manufacturing Challenges
For EnGeneIC, finding a suitable contract manufacturer capable of producing their complex nanocell technology to regulatory standards has been a significant hurdle. Dr. Himanshu Brahmbhatt, Co-Founder and CEO of EnGeneIC, highlighted this challenge: "For several years, EnGeneIC has been searching for a contract cGMP manufacturer for its EDV cancer therapeutics. It has been a difficult road."
The partnership with BioCina appears to resolve this manufacturing bottleneck. "We couldn't be more pleased to be able to entrust our technology to the professional team at BioCina," Dr. Brahmbhatt added. "Mark Womack and his colleagues are remarkable in that they are genuinely concerned about the plight of cancer patients. This gives great confidence to EnGeneIC that the partnership will succeed in getting cGMP quality EDV therapeutics to cancer patients in a timely manner."
BioCina will provide an end-to-end package of services to prepare for both clinical and commercial manufacture of the EDV™ nanocells, leveraging their expertise in biologics manufacturing.
Clinical Progress and Future Directions
EnGeneIC is currently advancing its technology into Phase IIa clinical trials in both Australia and the United States. These trials will focus on patients with intractable, low-survival cancers, including metastatic pancreatic cancer – an indication with particularly poor outcomes and limited effective treatment options.
The EDV™ nanocell platform has broader potential beyond oncology, with possible applications in infectious disease. The technology can deliver various therapeutic payloads, including drugs, siRNAs, miRNAs, and adjuvants, via antibody-targeting to specific cell surfaces with minimal toxicity.
Manufacturing Capabilities
BioCina brings significant manufacturing expertise to the partnership. Based in Adelaide, South Australia, the company offers high-quality, cost-effective cell line, process, analytical, and formulation development services, along with cGMP clinical and commercial manufacturing capabilities for microbial, pDNA, and mRNA modalities.
The company's facility has a strong track record in developing and manufacturing both clinical and commercial drug substances, supported by a team with extensive experience in the field. BioCina has successfully passed regulatory inspections by major health authorities, including the US FDA, EMA, TGA, and Health Canada, demonstrating their commitment to quality and regulatory compliance.
Through a partnership with NovaCina, BioCina also offers fill-and-finish solutions, providing comprehensive manufacturing support for clients globally, including those in the U.S., Europe, and Asia Pacific regions.
The collaboration between BioCina and EnGeneIC represents a significant advancement in the development of novel cancer therapeutics, potentially offering new hope for patients with limited treatment options. As the partnership progresses toward clinical and commercial manufacturing, it may help accelerate the availability of this innovative treatment approach for cancer patients worldwide.
