Mabwell (688062.SH), an innovation-focused biopharmaceutical company with an integrated value chain, has announced that the National Medical Products Administration (NMPA) has accepted the Investigational New Drug (IND) application for its novel LILRB4/CD3 T cell engager (TCE) bispecific antibody, 6MW5311. This candidate is being developed to treat hematologic cancers, including Acute Myeloid Leukemia (AML), Chronic Myelomonocytic Leukemia (CMML), and Multiple Myeloma (MM).

6MW5311 is the first LILRB4/CD3 TCE bispecific antibody worldwide to reach the clinical trial application stage, highlighting its strong development potential and promising commercial outlook. In the United States, the IND process is currently at the pre-IND stage, with a formal submission to the FDA planned for the second quarter of 2026.

Built on a T cell engager platform, 6MW5311 features a “2+1” asymmetric design that enables it to bind simultaneously to LILRB4 on tumor cells and CD3 on T cells. This dual targeting facilitates the formation of an immune synapse, activating T cells to effectively attack cancer cells.

The molecule also incorporates a distinctive steric hindrance mechanism that limits CD3 binding in the absence of tumor cells. As a result, T cells are primarily activated only when tumor cells are present, which enhances safety while maintaining strong anti-tumor activity.

Preclinical in vitro studies have shown that 6MW5311 demonstrates robust cytotoxic effects across various tumor cell lines and patient-derived samples. In vivo studies further indicate significant tumor suppression in both high and low LILRB4-expressing AML models, with complete tumor elimination observed in high-expression cases. Additionally, safety evaluations in cynomolgus monkeys suggest a favorable safety profile.

T cell engager therapies represent an important strategy for directing immune cells to target cancer, and they have already shown meaningful clinical success in several lymphoma indications, with multiple approved products. However, treatment options for AML and CMML are still largely limited to chemotherapy, stem cell transplantation, and mutation-specific targeted therapies. To date, no TCE therapies have been approved for these diseases.

Pelotonia is just around the corner, and Team ScottsMiracle-Gro is gearing up to cycle between 20 and 190 miles across central Ohio. This initiative focuses on teamwork among associates to support cancer research. Our involvement with Pelotonia dates back to 2010, and we often receive a few common questions over the years:
 

Question: Are bike seats comfortable? 

Answer: Not really!
 
Training
Preparing for the Ride Weekend requires significant training, which includes getting accustomed to the bike seat. However, Pelotonia is not a race; it’s a community event where participants set their own pace. For many, this will be the longest distance they have ever cycled. We aim to raise awareness for cancer research, with each participant committing to raise at least $1,250.
 
Question: Is that a lot of money for one person to raise? 
Answer: Yes, it is!
 
Commitment
The commitment to raise this amount can be daunting, but it’s important to remember that the funds don’t go to us. They support cancer research, and we have experienced riders who participate year after year. One of our team members has raised over $50,000 for Pelotonia in the last 12 years. Since we joined in 2010, we have collectively raised over $3 million, and we are grateful for the support from our company and colleagues.
 
Every dollar raised goes directly to cancer research at The Ohio State University Comprehensive Cancer Center (OSUCCC), also known as The James.
 
Question: Do other states benefit from cancer research in Ohio? 
Answer: Yes, they do!
 
Impact
The cancer research conducted at OSUCCC has a broad impact. In July 2023, Pelotonia announced five new studies supported by their funding, focusing on topics such as immunotherapy for breast cancer, targeted therapies for aggressive brain tumors, and addressing depression in lung cancer survivors.
 
If you’d like to contribute to saving more lives, remember our fundraising deadline is in October, giving you plenty of time to help out!
 
Click here if you would like to visit our team fundraising page and make a donation to the general fund. Thank you for supporting our cause.