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LaNova Medicines Initiates Phase 1 Trial of LM-299, Anti-PD-1/VEGF Bispecific Antibody, for Advanced Solid Tumors

  • LaNova Medicines has begun a Phase 1 clinical trial in China for LM-299, a bispecific antibody targeting PD-1 and VEGF, in patients with advanced solid tumors.
  • Preclinical studies of LM-299 demonstrated strong inhibition of tumor growth and a favorable safety profile, supporting its advancement into human trials.
  • LaNova anticipates submitting an Investigational New Drug (IND) application to the FDA for LM-299 in the United States in the second half of 2024.
  • The company's recent $42 million Series C1 financing will support the clinical development of LM-299, along with other pipeline candidates like LM-302 and LM-108.
LaNova Medicines has announced the initiation of a Phase 1 clinical trial in China for LM-299, a bispecific antibody (BsAb) targeting both PD-1 and VEGF, in patients with advanced solid tumors. This first-in-human trial follows promising preclinical results that demonstrated significant tumor growth inhibition and a well-tolerated safety profile in preclinical models.
LM-299 is designed to simultaneously block the PD-1/PD-L1 and VEGF/VEGFR signaling pathways, aiming to achieve a synergistic anti-tumor effect by combining tumor immunity with anti-angiogenesis. The bispecific antibody features a molecular design that links an anti-VEGF antibody to a C-terminal anti-PD-1 antibody, which LaNova believes ensures high expression, optimal druggability, and best-in-class potential.

Clinical Development and Financing

In addition to the Phase 1 trial in China, LaNova Medicines plans to initiate another Phase 1 clinical trial in the United States, with an Investigational New Drug (IND) application expected to be submitted in the second half of 2024. The company has also completed a $42 million Series C1 financing round, led by Sino Biopharmaceuticals, with participation from new and current investors. The proceeds from this financing will primarily support the clinical development of LaNova's pipeline, including LM-299, LM-302 (anti-CLDN 18.2 ADC), and LM-108 (anti-CCR8 mAb).

LaNova's Pipeline

LaNova Medicines has a diverse pipeline of drug candidates, including:
  • LM-302 (anti-CLDN 18.2 ADC): Currently in a Phase III registrational clinical trial in China for gastric cancers. A US Phase II trial is expected to start in H2 2025.
  • LM-108 (anti-CCR8 mAb): Ongoing Phase II clinical trials in China for multiple solid tumors. A US Phase II trial is expected to start in H2 2024.

Executive Commentary

Dr. Crystal Qin, LaNova's founder, chairwoman, and CEO, stated, "Since its establishment, LaNova has been dedicated to original innovation, with a focus on the tumor microenvironment and the development of tumor-specific targeted ADCs and immune-modulating biologics... Proceeds from this financing will allow us to expedite the development of our late-stage clinical programs, LM-302 and LM-108, moving us closer to market approval. We will also accelerate the clinical development of LM-299, which is currently in Phase 1 clinical trials with best-in-class potential."
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Reference News

[1]
LaNova Medicines Announces Initiation of Phase 1 Clinical Trial of Anti-PD-1/VEGF ... - BioSpace
biospace.com · Oct 18, 2024

LaNova Medicines initiates Phase 1 trial of LM-299 (anti-PD-1/VEGF BsAb) in China for advanced solid tumors, plans US IN...

[2]
LaNova Medicines Announces Initiation of Phase 1 Clinical Trial of Anti-PD-1/VEGF ...
cnhinews.com · Oct 18, 2024

LaNova Medicines initiates Phase 1 trial of LM-299, an anti-PD-1/VEGF BsAb, in China for advanced solid tumors after pro...

[3]
LaNova Medicines Announces Initiation of Phase 1 Clinical Trial of Anti-PD-1/VEGF ...
finance.yahoo.com · Oct 18, 2024

LaNova Medicines initiates Phase 1 trial of LM-299, an anti-PD-1/VEGF BsAb, in China for advanced solid tumors, followin...

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