EnGeneIC Chooses BioCina as CDMO for Cancer Treatment

ADELAIDE, South Australia, Sept. 24, 2024 – BioCina Pty Ltd., an international biologics Contract Development and Manufacturing Organization (CDMO), has announced a collaboration with drug developer EnGeneIC Pty Ltd. The partnership will involve technology transfer, process scaling, and GMP batch production of EnGeneIC's innovative 'EnGeneIC Dream Vector' (EDV™) nanocells.

EnGeneIC's goal is to revolutionize cancer therapy through its targeted cyto-immunotherapy approach. They are developing Antibody-Nanocell Drug Conjugates (ANDCs) via their EDV™ platform, which uses antibody-targeted nanocells to deliver cytotoxic substances directly to cancerous cells. This method allows for the use of highly potent chemotherapeutic drugs encapsulated within the nanocells, minimizing systemic toxicity. Additionally, it provides a novel way to treat drug-resistant cancers and triggers a robust anti-cancer immune response. This dual strategy aims to offer more precise and safer treatments, particularly for patients with limited options. BioCina will provide comprehensive services to prepare for the clinical and commercial production of these EDVs.

Mark W. Womack, CEO of BioCina, expressed his pride in being chosen to advance EnGeneIC's groundbreaking treatment, which has significant potential to impact previously untreatable cancers.

EnGeneIC's Co-Founder and CEO, Dr. Himanshu Brahmbhatt, shared that the search for a contract cGMP manufacturer for their EDV cancer therapeutics had been challenging. He expressed great satisfaction in partnering with BioCina, whose dedication to cancer patients instills confidence that the collaboration will successfully deliver cGMP quality EDV therapeutics to patients efficiently.

BioCina is a global biologics CDMO that provides cost-effective and high-quality cell line, process, analytical, and formulation development. They also offer cGMP clinical and commercial manufacturing for microbial, pDNA, and mRNA modalities. Their primary facility in Adelaide, South Australia, has a long history of developing and manufacturing drug substances for both clinical and commercial use. BioCina prides itself on a strong quality record, having passed regulatory inspections by authorities such as the US FDA, EMA, TGA, and Health Canada. In partnership with NovaCina, BioCina offers top-notch fill-and-finish solutions. Their clients span across the U.S., Europe, and the Asia Pacific. Australia is an attractive location for biologics companies due to its significant tax incentives and premier trial networks, making it ideal for scaling up and manufacturing products.

EnGeneIC is a clinical-stage biopharmaceutical company focused on its proprietary EDV™ nanocell technology, intended for oncology and infectious disease treatments. The EDV™ nanocell is a unique platform for delivering various therapeutic payloads—including drugs, siRNAs, miRNAs, and adjuvants—targeting cancer cells with minimal toxicity. For cancer applications, this technology enables the delivery of highly potent chemotherapeutic agents, effectively addressing drug resistance and killing tumor cells while simultaneously stimulating the patient’s immune system to elicit a strong anti-tumor response. EnGeneIC is currently entering Phase IIa clinical trials in Australia and the USA for treating aggressive, low-survival cancers, including metastatic pancreatic cancer.

This collaboration between BioCina and EnGeneIC holds promise for advancing cancer treatment technologies and providing new hope for patients with difficult-to-treat cancers.