Reed Biologics announces a Phase II clinical collaboration with Bristol-Myers Squibb to evaluate LVGN7409 in combination with nivolumab injection for the treatment of non-small cell lung cancer

Lijin Biologics, an innovative biotechnology company focused on the development and commercialization of first-in-class and best-in-class oncology biologics, today announced the opening of an open-label, multicenter, randomized Phase II clinical trial to evaluate the efficacy and safety
of LVGN7409 in combination with docetaxel or nivolumab in combination with Bristol-Myers Squibb in advanced/metastatic non-small cell lung cancer (NSCLC).

"The clinical collaboration between Lijin Biologics and Bristol-Myers Squibb reflects our commitment to exploring the combination of other therapeutic modalities that complement the company's pipeline and biological mechanisms, with a view to achieving new breakthroughs
in oncology treatment.
" Dr.
Jieyi Wang, Founder and CEO of Lijin Biologics, said, "We are excited to soon begin a U.
S.
-China clinical collaboration with Bristol-Myers Squibb to address clinical needs
that cannot be met by existing treatments.
"

The recombinant monoclonal antibody LVGN7409 selectively activates CD40
efficiently in the tumor microenvironment.
CD40 is a member of the Tumor Necrosis Factor (TNF) receptor family, also known as TNFRSF5
.
The activation of CD40 will promote tumor antigen presentation, reverse the immunosuppression of the tumor microenvironment, and restore the tumor suppressor function
of the immune system.

Bristol-Myers Squibb's nivolumab is a humanized monoclonal antibody against programmed death receptor-1 (PD-1), blocking its interaction with PD-L1 and PD-L2 and releasing immune responses
including anti-tumor functions inhibited by the PD-1 pathway.

Docetaxel is an antitubulin chemotherapy drug used to treat a variety of cancers, including non-small cell lung, breast, head and neck, gastric, and prostate cancers
.

"Lijin Biologics believes that the combination therapy that directly activates CD40 and relieves PD-1 inhibition has the potential to enhance the efficacy of tumor immunotherapy, that is, the combination of LVGN7409 and immune checkpoint inhibitors shows excellent synergy in resistant and relapsed patients, further validating our preclinical research results," emphasized Dr.
Zhan Zonghuang, Chief Medical Officer
.
"We also believe that LVGN7409 may play a role
in combination regimens with immunomodulatory chemotherapy drugs such as docetaxel.
" With this phase II study, we hope to demonstrate that CD40 activation can reverse the immunosuppressive tumor microenvironment that leads to drug resistance, improving efficacy
by combining with existing standard treatments.
" Refractory non-small cell lung cancer has a large unmet clinical need, and we hope to provide effective treatment for such patients
.
Dr.
Zhan added
.

The development of innovative drugs must prove that patients benefit through rigorous clinical studies, and there are no shortcuts
.
The immune agonist antibodies developed by Lijin Biologics are theoretically suitable for most types of cancer
.
Compared with other agonist antibodies, antibodies developed based on the xlinkAb platform find a new balance between safety and efficacy and have higher druggability, which has been verified
by preclinical and clinical studies.
At present, the field of agonist antibodies is still in its infancy, but it is developing rapidly and has great potential to become the next hot track
in cancer immunotherapy.
Our long-term dedication to agonist antibodies has initially achieved gratifying clinical progress
.
In addition, the layout of Lijin's biopipeline insists on balancing benefits and costs, and expects to benefit a variety of cancer patient populations
.

Under the terms of the agreement, Lijin Biologics is the sponsor of the study, and Bristol-Myers Squibb will provide nivolumab injection for the joint trial
.
Lijin Biologics owns the worldwide development and commercial rights
to LVGN7409.

About LVGN7409

LVGN7409 is a new generation of CD40 agonist monoclonal antibody developed based on the xlinkAb platform of Lijin Biologics, which promotes tumor antigen presentation and induces anti-tumor T cell activation by activating CD40, so that the immune "cold" tumor microenvironment "warms up"
.
The unique structure and function of LVGN7409 makes it more tolerant and more widely used in clinical applications
.