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KDDF-201904-30 Establishment of a Master Cell Bank (MCB) and ADC manufacturing process optimization for an ADC candidate for triple-negative breast cancer (TNBC) treatment(Oncology, Protein) [2019-10-25]

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Ongoing Project
Section Lead
Generation
Lead
Optimization
Preclinical Phase I Phase II Phase III

Development and Market Objectives

Through the generation of a Master Cell Bank for a cognate human mAb and the development of the scale-up ADC production processes for an ADC candidate for the treatment of TNBC using LegoChem Bioscience’s ADC platform including next-generation site specific conjugation, proprietary plasma-stable cancer-specifically cleavable linker and a novel DNA toxin and ABL Bio’s human mAb, we aim to increase the chances of licensing-out as well as the value of the final ADC product.

Unmet Medical Need & Target Patients

- Target Patients : Triple Negative Breast Cancer (TNBC) patients


- Unmet Medical Needs
TNBC is one of the most aggressive, relapsing breast cancers, with no specified target for the treatment. TNBC patients account for 15-20% of breast cancer patients. TNBC is a term derived from tumors that are characterized by the absence of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor (HER2). Therefore, this type of cancer cannot be treated with an anti-hormone therapies such as aromatase inhibitors and does not respond to targeted therapies such as Herceptin, Perjeta, and Tykerb. It has been reported that recurrence rate of TNBC is more frequent and its prognosis is worse than other types of breast cancers.
TNBC is predominantly diagnosed in younger patients (before the age of 40). Since the TNBC patients who do not respond to chemotherapy are more likely to develop metastasis / recurrence, there is a great need to identify additional treatment options for TNBC.
 

Status

1) Validation of superb anticancer efficacy in TNBC cell lines and xenograft animal models

2) Excellent toxicity profiles in non-GLP rat and non-human primate toxicity studies

3) Completion of generation of research cell bank (RCB) of the mAb used in ADC

4) MCB (Master Cell Bank) generation and culture condition/ antibody production process optimization under development

5) Linker-payload production process development for final ADC manufacturing in progress

Intellectual Property

Patents for LegoChem Bio's proprietary site-specific conjugation covering its material, method and formulation as well as the one for the proprietary beta-glucuronide linker have been granted in major countries including US. More recently, a patent for LegoChem Bio's unique DNA toxin technology (PBD prodrug enabling cancer-selective activation of the payload) also has been issued in Korea, and is under review in other countries.

 

Therefore, a strong patent portfolio for the three main components of ADC technology called conjugation, linker, and payload has been established for LegoChem Bio’s ADC platform. In addition, ABL Bio's cognate human antibody which also is an important constituent of the final ADC has unique novel amino acid sequence and its patent is pending.

Competitive Advantages

Many of the investigational drugs in the competition for TNBC treatment are conventional NCE-based drugs which target a variety of proteins / signaling pathways that are thought to be associated with triple-negative breast cancer while several immuno-oncology related drugs and ADCs are also being identified. However, with regard to the targets related to signaling mechanisms, other adverse events other than tumor cell death are likely to occur since those target proteins may have normal physiological functions in the normal cells and organs.

 

The ADC drug candidate as new TNBC therapy currently developed by LegoChem Bio is believed to have significant competitiveness of high efficacy and low toxicity by virtue of the novel antibody recognizing the cancer-specific target antigen, the efficiently payload-releasing linker, and a new DNA-cross linking prodrug payload. The advantage of the monoclonal antibody used for the ADC has been confirmed by comparing the efficacy of the ADCs made of an antibody from a competing company and the one developed by ABL Bio.

 

If anti-cancer efficacy recognized in TNBC animal models is further reconfirmed as survival prolongation in the future clinical trials, the likelihood of obtaining approval-related benefits from regulatory authorities such as fast track and orphan drug designations will be higher, as seen with Immunomedics’ anti-TROP2 ADC.

Contact & Company Overview

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