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Innate Pharma Presents at AACR 2024 Preclinical Efficacy of Its Pre-IND Drug Candidate IPH45, a Novel Nectin-4 Antibody Drug Conjugate

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Innate Pharma SA announces promising preclinical data for IPH45, a novel exatecan-Antibody Drug Conjugate targeting Nectin-4, showing stronger activity than EV in urothelial tumors. IPH45 demonstrates anti-tumor efficacy in various solid tumors and EV-refractory models, with plans for IND in 2024.
Positive
  • Promising preclinical data for IPH45 presented at AACR Annual Meeting 2024
  • IPH45 inhibits Nectin-4 expressing tumor growth effectively in vitro and in vivo
  • Shows stronger activity than EV in multiple urothelial carcinoma PDX models
  • Additive anti-tumor effect to anti-PD1 treatment demonstrated in vivo
  • Favorable safety profile in relevant animal toxicology models
  • Potential for new solutions in various Nectin-4 expressing cancers
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The introduction of IPH45, an exatecan-antibody drug conjugate (ADC), represents a significant advancement in targeted cancer therapy, particularly for urothelial tumors. The preclinical data suggesting superior efficacy over the current Nectin-4 targeting therapy, Enfortumab Vedotin (EV), indicates a potential shift in treatment paradigms. The ability of IPH45 to function in EV-refractory models is particularly noteworthy, as it addresses a critical need for therapies that can overcome resistance mechanisms.

Furthermore, the combination of IPH45 with anti-PD1 treatments suggests a synergistic approach that could enhance patient outcomes. The favorable safety profile in animal models also suggests a potentially lower risk of adverse events, which is a significant consideration in oncology drug development. However, it's important to remain cautious as these findings are preclinical and the true test of IPH45's efficacy and safety will come with human clinical trials.

From an investment perspective, these developments could have a positive impact on Innate Pharma's valuation, provided that the clinical trials, which are planned to proceed with an Investigational New Drug (IND) application in 2024, confirm the preclinical results. The ability to target a broader range of Nectin-4 expressing tumors could expand the addressable market for IPH45, potentially leading to increased revenue streams for Innate Pharma.

The pharmaceutical market for cancer treatments is highly competitive, with a constant demand for innovative therapies that offer improved efficacy and safety profiles. The preclinical success of IPH45 could position Innate Pharma as a notable player in the ADC space, a sector that has been gaining traction due to the specificity and potency of these types of drugs. ADCs have the advantage of targeting tumor cells while sparing healthy ones, leading to fewer side effects compared to traditional chemotherapy.

The potential for IPH45 to treat various solid tumors and to be effective in tumors with low Nectin-4 expression levels could differentiate it from other therapies, offering a competitive edge. It's important to monitor the progress of IPH45 through the regulatory pathway, as delays or setbacks could impact investor sentiment. Conversely, a smooth transition to clinical trials and positive results could lead to partnerships or acquisition interest, further influencing Innate Pharma's stock performance.

Investors should also consider the broader implications of a successful ADC like IPH45 on the market dynamics, including potential pricing strategies, market penetration rates and the impact on existing treatments. The additive effect with anti-PD1 treatments opens up collaborative opportunities which could be strategically beneficial.

In the biotech industry, intellectual property (IP) and regulatory compliance play important roles in a company's ability to capitalize on new discoveries. For Innate Pharma, the development of IPH45 could involve securing patents that protect the novel aspects of their ADC, such as the exatecan payload and its application in Nectin-4 targeting. Strong IP protection is essential for maintaining a competitive advantage and justifying the investments made in R&D.

As IPH45 progresses towards an IND application, the company will need to navigate complex regulatory requirements to demonstrate safety and efficacy. The preclinical data's alignment with regulatory expectations will be key in determining the speed at which IPH45 can enter clinical trials. Any deviations could result in additional data requirements or even rejections, impacting the company's timeline and financial projections.

For stakeholders, understanding the legal and regulatory landscape is important for assessing the risks associated with the development of IPH45. Positive regulatory milestones can serve as catalysts for stock appreciation, while any legal challenges or compliance issues could have a detrimental effect on investor confidence.

  • IPH45 is a novel and differentiated exatecan-Antibody Drug Conjugate targeting Nectin-4
  • In PDX models of urothelial tumors, IPH45 has stronger activity than approved Nectin-4 targeting EV. IPH45 shows anti-tumor efficacy in various solid tumor and EV-refractory models
  • Preclinical efficacy and toxicology data support further development of IPH45 which is progressing towards the clinic with IND planned in 2024

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

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that first preclinical data for its asset IPH45, a novel and differentiated exatecan-Antibody Drug Conjugate (ADC) targeting Nectin-4, were presented in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2024.

In preclinical studies, data demonstrated that IPH45 effectively inhibits Nectin-4 expressing tumor growth both in vitro and in vivo, including in Enfortumab Vedotin (EV) refractory models. Importantly, IPH45 shows stronger activity than EV, in multiple urothelial carcinoma PDX (patient-derived xenografted) mice models, across Nectin-4high and Nectin-4low expression levels. In addition, IPH45 has an additive anti-tumor effect to anti-PD1 treatment in vivo and has a favorable safety profile in relevant animal toxicology models.

IPH45 is a novel and differentiated Nectin-4 ADC with preclinical efficacy in tumor types with various expression levels of Nectin-4. Its exatecan payload allow for higher bystander-effect and a broader therapeutic index than MMAE-ADCs," commented Prof. Eric Vivier, DVM, PhD, Chief Scientific Officer at Innate Pharma. "These promising results underscore the potential of IPH45 to provide new solutions for patients in a variety of Nectin-4 expressing cancers, beyond Nectin-4high expressing bladder. Based on these encouraging data, we are eagerly advancing IPH45 towards clinical trials."

The presentation is available on Innate Pharma’s website.

About IPH45

Nectin-4 is a cell membrane adhesion protein overexpressed in several solid tumors, including urothelial, breast, lung, ovarian, and pancreatic cancers, with limited expression in normal tissues. IPH45 is a novel exatecan-Antibody Drug Conjugate (ADC) targeting Nectin-4. In non-clinical models, IPH45 is well tolerated and shows anti-tumor efficacy in vitro and in vivo. IPH45 is progressing towards First in Human study.

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 X and LinkedIn.

Information about Innate Pharma shares

ISIN code
Ticker code
LEI

FR0010331421

Euronext: IPH Nasdaq: IPHA

9695002Y8420ZB8HJE29

Disclaimer on forward-looking information and risk factors

This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “believe,” “potential,” “expect” and “will” 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 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.

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.

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

IPH45, a novel exatecan-Antibody Drug Conjugate targeting Nectin-4

At the American Association for Cancer Research (AACR) Annual Meeting 2024

IPH45 effectively inhibits Nectin-4 expressing tumor growth in vitro and in vivo, showing stronger activity than EV in urothelial carcinoma PDX models

Prof. Eric Vivier, DVM, PhD, Chief Scientific Officer at Innate Pharma

Advancing towards clinical trials with an IND planned in 2024
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About IPHA

innate pharma s.a. is a clinical-stage biotechnology company dedicated to improving cancer treatment and clinical outcomes for patients through first-in-class therapeutic antibodies that harness the innate immune system. innate pharma specializes in immuno-oncology, a new therapeutic field that is changing cancer treatment by mobilizing the power of the body’s immune system to recognize and kill cancer cells. the company's broad pipeline includes four first-in-class clinical stage antibodies as well as preclinical candidates and technologies that have the potential to address a broad range of cancer indications with high unmet medical needs. innate pharma has pioneered the discovery and development of checkpoint inhibitors, with a unique expertise and understanding of natural killer cell biology. this innovative approach has resulted in major alliances with leaders in the biopharmaceutical industry including astrazeneca, bristol-myers squibb, novo nordisk a/s and sanofi. innate pharma