LaNova Medicines Announces Initiation of Phase 1 Clinical Trial of Anti-PD-1/VEGF Bispecific Antibody LM-299 and Completion of $42 Million Series C1 Financing

• Phase 1 trial of LM-299, an anti-PD-1/VEGF BsAb, initiated in China for advanced solid tumors following promising preclinical results demonstrating strong inhibition of tumor growth and well-tolerated safety profile
• IND for LM-299 in the US expected to be submitted in the second half of 2024
• Proceeds from the completed Series C1 financing will be primarily used to advance the clinical development of the Company's pipeline, including lead candidates LM-299 (anti-PD-1/VEGF BsAb), LM-302 (anti-CLDN 18.2 ADC) and LM-108 (anti-CCR8 mAb)
• Financing led by Sino Biopharmaceuticals, with participation of new and current investors

SHANGHAI, Oct. 18, 2024 /PRNewswire/ -- LaNova Medicines Limited ("LaNova" or "The Company"), a privately-held clinical-stage innovation-driven biotech specializing in ADCs and immuno-oncology, announced the initiation of its Phase 1 clinical trial of LM-299, an anti-PD-1/VEGF BsAb, in China for advanced solid tumors and the successful completion of its $42 million Series C1 financing.

Founded in September 2019, LaNova's R&D engine is based on three proprietary platforms adept at tackling challenging targets and versatile modality development, which has so far enabled the in-house development of more than ten innovative programs, including monoclonal antibodies, ADCs and bispecific antibodies.

Following promising preclinical results demonstrating LM-299's strong inhibition of tumor growth in hPBMCs-humanized mice and well tolerated safety profile in NHP GLP tox study, LaNova has initiated its first-in-human clinical trial in China for advanced solid tumors. LaNova is planning to initiate an additional Phase 1 clinical trial in the US and expects to submit an IND in the second half of 2024.

The completed Series C1 financing was led by Sino Biopharmaceuticals and included participation from new investors Pudong Innovation Investment and Zhangjiang Haoheng, and existing investors, Qiming Venture Partners and Shanghai Healthcare Capital. Zhong Lun Law Firm acted as the legal advisor for this round of financing.

LaNova has recently initiated its Series C2 financing round.

Proceeds will be primarily used to advance the clinical development of the Company's pipeline, including lead candidates:

• LM-302 (anti-CLDN 18.2 ADC): ongoing Phase III registrational clinical trial in China for gastric cancers, making it one of the top three candidates globally in terms of development progress for this target; US Phase II trial expected to start in H2 2025
• LM-108 (anti-CCR8 mAb): ongoing Phase II clinical trials in China for multiple solid tumors, making it one of the top three most advanced projects worldwide targeting CCR8; US Phase II trial expected to start in H2 2024
• LM-299 (anti-PD-1/VEGF BsAb): Phase I clinical trial in China is currently enrolling patients for advanced solid tumors

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. We have established a robust pipeline of differentiated innovative drugs, with independent intellectual property rights and profiles that are competitive on a global scale. We are thrilled to have initiated our Phase 1 trial for LM-299 and completed our series C1 financing round. We are especially grateful for the continued support and confidence of our new and long-standing investors during this challenging period for pharmaceutical investments. 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. We look forward to strengthening our partnerships across the industry and enhancing our self-sustainability through business development collaborations. Together, we aspire to bring China's innovative drugs to a global stage, ultimately providing high-quality treatment solutions to more patients and promoting healthier lives worldwide."

About LaNova Medicines Ltd.

Founded in September 2019, LaNova Medicines Ltd. is a privately held biotech company headquartered in Shanghai. With the mission of "Care for life, Dedicate to innovation", the Company focuses on discovering novel biologic therapies in the fields of ADC and Immuno-Oncology, with a commitment to developing best-in-class or first-in-class therapies that address significant unmet medical needs.

LaNova's robust portfolio is made possible by an industry-leading R&D engine, which includes three distinct platform: a proprietary antibody platform capable of generating antibodies against a range of targets, including multi-transmembrane proteins and GPCRs; a next-generation ADC platform that utilizes proprietary payload and linker technologies to produce highly differentiated ADCs; and a modular 4-1BB-based T-cell engager (TCE) platform for developing bispecific antibodies targeting distinct tumor-associated antigens (TAAs).

Currently, LaNova's pipeline includes 6 clinical-stage assets and over 10 innovative preclinical programs. Its leading clinical-stage candidates include LM-302, a differentiated anti-Claudin 18.2 ADC in Phase 3 development in China; LM-108, a potential best-in-class CCR8-targeting monoclonal antibody in Phase 2 in China; and several Phase 1 programs including LM-299 (anti-PD-1/VEGF bispecific antibody), LM-101 (anti-SIPRα monoclonal antibody), LM-305 (anti-GPRC5D ADC with global rights licensed to AstraZeneca), and LM-24C5 (anti-CEACAM5 bispecific antibody). Through internal R&D innovation and strategic external partnerships, LaNova is committed to advancing its pipeline to benefit patients worldwide.

LaNova's key clinical stage pipeline programs and expected upcoming milestones

LM-299 (Anti-PD-1/VEGF bispecific antibody)

LM-299 is a bispecific antibody developed by LaNova that targets both PD-1 and VEGF. This innovative therapy can simultaneously block the PD-1/PD-L1 and VEGF/VEGFR signaling pathways, achieving a synergistic anti-tumor effect that combines tumor immunity with anti-angiogenesis. LM-299 features a differentiated molecular design, comprising an anti-VEGF antibody linked to a C-terminal anti-PD-1 antibody, which ensures high expression, optimal druggability, and best-in-class potential. Preliminary studies have demonstrated that LM-299 effectively inhibits the PD-1 and VEGF signaling pathways, enhancing anti-tumor efficacy. Additionally, toxicological and pharmacokinetic evaluations indicated that LM-299 possesses a superior safety profile. As a promising cornerstone therapy for the next generation of tumor immunotherapy, LM-299 can be combined with various treatment modalities, including immuno-oncology drugs, small molecule targeted therapies, antibody-drug conjugates and T cell activators, thereby significantly broadening the market potential for LM-299-based combination therapies. The Phase I clinical trial for LM-299 is currently enrolling patients.

LM-302 (Anti-Claudin 18.2 ADC)

LM-302 is an innovative antibody-drug conjugate (ADC) developed by LaNova, targeting Claudin 18.2, using the company's proprietary multi-transmembrane protein antibody discovery platform. The drug consists of a Claudin 18.2-specific antibody linked to the cytotoxic agent monomethyl auristatin E (MMAE) via a cleavable VC-PAB linker. Claudin 18.2 is a transmembrane protein highly expressed in gastrointestinal cancers, including gastric, gastroesophageal junction, pancreatic, and biliary tract cancers. Treatments targeting Claudin 18.2 have shown significant anti-cancer potential in clinical settings. In the first quarter of 2024, LM-302 entered a Phase III registrational clinical trial in China, making it one of the top three candidates globally in terms of development progress for this target. Additionally, Phase II clinical trials exploring LM-302 in combination with PD-1 monoclonal antibodies are actively underway.

• Phase III GC/GEJ monotherapy: interim data readout expected in H2 2025
• Phase II 1L GC/GEJ combination study in US to be initiated in H2 2025

LM-108 (Anti-CCR8 monoclonal antibody)

LM-108 is a monoclonal antibody targeting CCR8, independently developed by LaNova using its proprietary multi-transmembrane protein antibody discovery platform. LM-108 effectively eliminates tumor-infiltrating regulatory T cells (Tregs) via antibody-dependent cell-mediated cytotoxicity (ADCC), while sparing peripheral Tregs. This enhances the immune system's ability to attack tumor cells. Due to the specificity of CCR8, many global pharmaceutical companies are pursuing this target. LaNova has advanced LM-108 to Phase II clinical trials, making it one of the top three most advanced projects worldwide targeting CCR8. Preliminary clinical data show that LM-108 has demonstrated excellent safety and efficacy across multiple solid tumor types with significant unmet clinical needs. LM-108 holds promise as a new immunotherapy option, particularly for patients with advanced tumors who have become resistant to PD-1 treatments.

• Phase III registrational trial to be initiated in China in H2 2024
• Phase II combination trial to be initiated in US in H2 2024