Company: IPHYF
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001598599-25-000042
Chunk: 123

Company: Innate Pharma SA
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 123
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-4 and conjugated to exatecan, were presented at the 2024 AACR and SITC conferences.

- Strong bystander effect in vivo and high internalization efficiency in vitro compared to other Nectin-4-targeting ADCs. These characteristics contribute to enhanced anti-tumor activity compared to EV across a broad range of Nectin-4 expression levels, from low to high, in PDX models.

- Superior efficacy to EV in bladder cancer models with low Nectin-4 expression.

- Potential beyond bladder cancer in tumors with low and heterogeneous Nectin-4 expression: Leveraging its bystander activity, IPH4502 is active in tumor models with low and heterogeneous Nectin-4 expression beyond UC.

- Activity in models with primary or acquired resistance to EV: IPH4502 demonstrates efficacy in an in vivo model with primary resistance to MMAE due to MDR1 transporter expression and shows anti-tumor activity in a PDX model of UC with acquired resistance to EV.

- Strong combination potential with PD-1-targeting agents: In syngeneic mouse models, the combination of IPH4502 with an anti-PD-1 antibody induces synergistic anti-tumor activity in both EV-sensitive and EV-resistant models.

- Hydrophilic and stable linker enables high ADC exposure and minimal free exatecan release in cynomolgus monkey plasma.

The activity of IPH45 in various indications and its enhanced anti-tumor activity in combination with anti-PD-1 therapies in preclinical models support its development beyond UC.

3. Clinical development

The Phase 1, open-label, multi-center study, includes a Part 1 Dose Escalation and a Part 2 Dose Optimization, and will assess the safety, tolerability, and preliminary efficacy of IPH4502 as a single agent in advanced solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal cancers.

The U. S Food and Drug Administration (FDA) cleared its investigational new drug (IND) application to initiate a Phase 1 clinical study of IPH4502 in September 2024 and the first patient was dosed in its Phase 1 study (NCT06781983) in January 2025.

The study is recruiting and plans to enroll approximately 105 patients.

c. Former Partner

Innate announced in April 2023