Lotte Biologics has won a contract for contract manufacturing organization (CMO) for a dual antibody new drug candidate being developed by OTTIMO Pharma in the United Kingdom. This is the second contract win in about two months, following the agreement in April with an Asia-based corporation for the production of a candidate for clinical trials of an antibody-drug conjugate (ADC).
Lotte Biologics announced on the 18th (local time) that it has signed a contract for the contract manufacturing of the anti-cancer drug candidate jankistomig with OTTIMO Pharma at the 'Bio International Convention (BioUSA)' held in Boston, USA. The signing ceremony took place at the Lotte Biologics exhibition booth at BioUSA. The size of the contract was not disclosed in accordance with the agreement between the two companies.
Jankistomig is a dual antibody that targets the protein PD-L1, which cancer cells use to disguise themselves as normal cells, and the vascular endothelial growth factor (VEGF) that promotes tumor growth. Under this contract, Lotte Biologics will produce the active pharmaceutical ingredient for jankistomig at its Syracuse plant in New York, USA.
Park James, CEO of Lotte Biologics, said at a press conference held in Boston on the same day that “jankistomig has great potential to become a blockbuster drug if developed successfully”, adding that “it is significant that this contract win presents the opportunity for future contract manufacturing success for new drugs.”
Joseph Shultz, vice president of OTTIMO, noted, “This production partnership will be a crucial milestone in advancing the development of jankistomig in a swift and precise manner,” adding, “Based on Lotte Biologics’ excellent biopharmaceutical production capabilities, we have strengthened preparations for the submission of the Investigational New Drug (IND) and the start of clinical trials, enabling us to move forward to the next stage more quickly.”
◇“Aim for 5 to 6 contracts for ADC contract manufacturing within the year”
Lotte Group established Lotte Biologics, a contract development and manufacturing organization (CDMO) corporation, in June 2022 and acquired the manufacturing facility of Bristol-Myers Squibb (BMS), a U.S. pharmaceutical company, the same year. CEO Park took office as head of Lotte Biologics in December of last year. He has worked at Samsung Biologics, GC Cell, BMS, and Merck (MSD).
Lotte Biologics is focusing on expanding its contracts for ADC contract manufacturing centered on its Syracuse facility in New York, USA. ADC is a next-generation cancer treatment technology known as a guided missile that targets cancer cells by delivering drugs exclusively to them, leading to higher therapeutic effects than existing cancer drugs and preventing damage to normal cells.
CEO Park stated, “Many global clients are visiting our Syracuse facility,” adding, “I expect we will be able to announce 1 to 2 additional contracts for ADC contract manufacturing within a month.” He further mentioned, “As the demand for ADC development is increasing, our goal is to secure 5 to 6 contracts for ADC contract manufacturing by the end of the year.”
Following the expansion of ADC production facilities at its Syracuse plant, Lotte Biologics is in the process of constructing a large-scale commercial production plant in Songdo, Incheon. The goal is to operate the first plant in Songdo by 2027. The ADC production facility at the Syracuse plant has received cGMP (current Good Manufacturing Practice) certification.
CEO Park stated, “We are focusing on expanding contract acquisitions with our strategy of 'Dual Engine and Dual Site', emphasizing production infrastructure such as antibody drug and ADC production technologies and the Syracuse and Songdo plants.”
Lotte Biologics has announced that it is pursuing a ‘coexistence strategy’ by collaborating with various corporations to leap toward becoming a global bio CDMO. CEO Park noted, “Last month we signed a memorandum of understanding for CDMO business cooperation with ASIMOV in the U.S., and this company introduced us to OTTIMO Pharma, leading to this contract manufacturing win.” He mentioned, “We are also in discussions with several corporations that possess excellent technology in the ADC field,” adding, “We will enhance our competitiveness in the ADC CDMO sector by collaborating with various companies and increasing our acquisition results.”