Innate Pharma Announces FDA Clearance of the IND for IPH4502, a Nectin-4 ADC to Be Developed in Solid Tumors

Rhea-AI Summary

Innate Pharma announced FDA clearance of its IND application for IPH4502, a novel topoisomerase I inhibitor antibody drug conjugate (ADC) targeting Nectin-4 in solid tumors. The company plans to initiate a Phase 1 clinical study in the coming months. The study will be an open-label, multi-center trial assessing the safety, tolerability, and preliminary efficacy of IPH4502 as a single agent in advanced solid tumors known to express Nectin-4, including urothelial carcinoma, non-small cell lung, breast, ovarian, gastric and colorectal cancers.

The study will include a Part 1 Dose Escalation and a Part 2 Dose Optimization. This marks Innate's first ADC program to enter clinical trials, representing a significant milestone for the company.

Positive

• FDA clearance of IND application for IPH4502
• Advancement of first ADC program to clinical trials
• Potential new therapeutic option for multiple solid tumor types

Negative

• None.

Insights

Oncology Doctor

The FDA clearance of the IND for IPH4502 is a significant milestone for Innate Pharma. This novel antibody-drug conjugate (ADC) targeting Nectin-4 with a topoisomerase I inhibitor payload represents a promising approach in oncology. The planned Phase 1 study will evaluate IPH4502 in various solid tumors, including urothelial carcinoma, non-small cell lung, breast, ovarian, gastric and colorectal cancers. This broad spectrum of target cancers suggests the potential for wide applicability if successful. The study's design, with dose escalation and optimization phases, is standard for early-phase oncology trials and should provide important safety and preliminary efficacy data. However, it's important to note that this is just the beginning of clinical development and many hurdles remain before potential approval.

Biotech Analyst

Innate Pharma's advancement of IPH4502 into clinical trials marks a significant step in their ADC pipeline development. The Nectin-4 target is particularly interesting, as it's already validated by the success of enfortumab vedotin in urothelial cancer. However, IPH4502's differentiated payload (topoisomerase I inhibitor) could potentially offer improved efficacy or safety profiles. For investors, this progress demonstrates Innate's ability to bring novel candidates to the clinic, potentially diversifying their portfolio beyond NK cell engagers. The broad range of targeted solid tumors also presents multiple shots on goal for future development. While it's early days, positive Phase 1 results could significantly impact Innate's valuation, especially given the current high interest in ADC technologies in the biotech sector.

Market Research Analyst

The ADC market is experiencing rapid growth, with projections suggesting it could reach $20 billion by 2028. Innate Pharma's entry into this space with IPH4502 is timely and strategic. The Nectin-4 target has already shown commercial success with Seagen's Padcev, which achieved $451 million in sales in 2022. This validates the market potential for Nectin-4 targeted therapies. However, Innate will face competition from established players and other emerging ADCs. The company's $182 million market cap suggests significant upside potential if IPH4502 shows promise in early clinical trials. Investors should monitor the upcoming Phase 1 results closely, as positive data could lead to partnership opportunities or increased valuations, while setbacks could significantly impact the company's prospects given its relatively small size.

• IPH4502 is Innate’s novel and differentiated topoisomerase I inhibitor antibody drug conjugate (ADC) targeting Nectin-4

MARSEILLE, France--(BUSINESS WIRE)-- Regulatory News:

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the U.S Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to initiate a Phase 1 clinical study of IPH4502, its novel and differentiated topoisomerase I inhibitor antibody drug conjugate (ADC) targeting Nectin-4 in solid tumors. Innate expects to initiate the Phase 1 study in the coming months.

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 and colorectal cancers.

“We are thrilled to advance the IPH4502 program, and the IND application acceptance is an important milestone for Innate, as this is our first ADC program to enter the clinic,” said Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma. “IPH4502 is a novel and differentiated Nectin-4 ADC that has the potential to provide a new therapeutic option for patients with a cancer expressing a wide range of Nectin-4. Through this Phase 1 study we aim to advance the research on our ADC technology for the benefit of patients.”

About IPH4502

IPH4502 is a novel topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4.

Nectin-4 is a cell membrane adhesion protein overexpressed in several solid tumors, including urothelial, breast, esophageal, lung, ovarian, and pancreatic cancers, with limited expression in normal tissues.

In non-clinical models, IPH45 was well tolerated and shows anti-tumor efficacy in vitro and in vivo.

About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET^® (Antibody-based NK cell Engager Therapeutics) proprietary platform.

Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET^® multi-specific NK cell engagers to address multiple tumor types.

Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients.

Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com and follow us on Twitter and LinkedIn.

Information about Innate Pharma shares

ISIN code									FR0010331421
Ticker code									Euronext: IPH Nasdaq: IPHA
LEI									9695002Y8420ZB8HJE29

Disclaimer on forward-looking information and risk factors

This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “expect” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release.

In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240922158244/en/

For additional information, please contact:

Investors

Innate Pharma

Henry Wheeler

Tel.: +33 (0)4 84 90 32 88

Henry.wheeler@innate-pharma.fr

Media Relations

NewCap

Arthur Rouillé

Tel.: +33 (0)1 44 71 00 15

innate@newcap.eu

Source: Innate Pharma SA

FAQ

What is IPH4502 and what cancers does it target?

IPH4502 is a novel topoisomerase I inhibitor antibody drug conjugate (ADC) targeting Nectin-4. It is being developed for solid tumors including urothelial carcinoma, non-small cell lung, breast, ovarian, gastric and colorectal cancers that express Nectin-4.

What phase of clinical trials is IPH4502 (IPHA) entering?

IPH4502 is entering Phase 1 clinical trials. Innate Pharma plans to initiate the study in the coming months following FDA clearance of the IND application.

What will the Phase 1 study of IPH4502 (IPHA) evaluate?

The Phase 1 study will assess the safety, tolerability, and preliminary efficacy of IPH4502 as a single agent in advanced solid tumors known to express Nectin-4. It will include a Part 1 Dose Escalation and a Part 2 Dose Optimization.

Is IPH4502 Innate Pharma's (IPHA) first ADC program in clinical trials?

Yes, IPH4502 is Innate Pharma's first antibody drug conjugate (ADC) program to enter clinical trials, marking a significant milestone for the company.