On September 18, 2020 LamKap Bio Group and Lonza reported that it Collaborate to Manufacture Bispecific Antibodies for Cancer Treatment (Press release, LamKap Bio Group, SEP 18, 2020, View Source [SID1234565465]).

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LamKap Bio Group develops fully human bispecific κλ antibodies targeting malignant cells in solid cancers
Lonza to provide cell line development, drug substance and drug product services and cGMP manufacturing for two programs
Lonza’s LightPath cell line development program was optimized to ensure improved process yield and throughput
Quote from Shiva Khalafpour, VP, Head of Commercial Mammalian and Microbial Development and Manufacturing, Lonza:
"Lonza’s subject matter experts enjoyed working with LamKap’s technical team to identify specific molecule needs and design a tailored work package suitable to achieve their goals. This included a customized cell line development program based on Lonza’s GS Gene Expression System and LightPath CLC methodology and optimization of the customer downstream purification approach in order to facilitate manufacturing. "

Quote from Klaus Strein, Chairman of the LamKap Bio Group:
The LamKap Bio Group together with its strategic partner Light Chain Biosciences/NovImmune have considerable experience in the R&D of T-cell bispecific antibodies and tumor targeted anti-CD47 bispecific antibodies. Technical development and GMP manufacturing of both types of bispecific antibodies were already successfully performed by Lonza in the recent years. The new collaboration with Lonza is an important pillar in the development of two Clinical Leads.

Basel and Pfäffikon, Switzerland, 17 September 2020 – LamKap Bio Group, a biotechnology group focused on the research, development and manufacturing of tumor-targeted antibody-based therapies, and Lonza announced today that the companies have a development and manufacturing collaboration in place to support their current and future product pipeline. Lonza will provide cell line and process development, drug substance manufacturing and drug product services of LamKap’s two fully human bispecific antibody products, NILK-2301 and NILK-2401.

LamKap’s therapeutic bispecific antibodies are engineered to bind to two different antigens simultaneously. The two antigens can be either located on one cell type, e.g., a tumor cell, or two different cell types, e.g., on a tumor cell and an immune effector cell. Both NILK-2301 and NILK-2401 can be used as monotherapy and/or in combination. NILK-2301 binds to a tumor-associated antigen (TAA) and CD3 on T-cells, re-targeting T cells to kill tumor cells. NILK-2401 is also targeted to a TAA and in addition to CD47 on tumor cells, thus causing increased antibody-dependent cellular phagocytosis (ADCP) and antibody-dependent cell-mediated cytotoxicity (ADCC).

Using LamKap’s fully human bispecific Kappa Lambda antibodies (κλ), consisting of two identical heavy chains, a kappa (κ) and a lambda (λ) light chain and an IgG1 Fc, helps the human body to fight cancer. This structure is nearly identical to the structure of a standard IgG antibody and lowers the risk of inducing immunogenicity while minimizing the loss of exposure. Antibodies in this format are ideally suited for therapeutic application in both benign and malignant diseases. The κλ format facilitates production/purification.

Building upon Lonza’s previous experience with the κλ body program, as well as several other bispecific antibody platforms and the extensive upstream and downstream processing know-how, Lonza will carry out cell line construction and cGMP drug substance manufacturing at its Slough, UK and Hayward, US sites. The LightPath cell line development program will start in Q3 2020, providing LamKap with material to enter phase I clinical studies. The early-stage drug product formulation and stability studies will be performed at Lonza’s Drug Product Services facility in Basel, Switzerland.

The scope of the package was tailored to ensure the program could meet the requirements of large-scale manufacturing of unique κλ body products.