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Innate Pharma: First Patient dosed in Phase 1/2 study of IPH6501 in relapsed /refractory B-Cell non-Hodgkin’s Lymphoma

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Innate Pharma SA initiates Phase 1/2 trial for IPH6501, a CD20-targeting tetraspecific NK cell engager for B-cell Non-Hodgkin's Lymphomas. The study aims to enroll up to 184 patients, with the first patient already dosed. IPH6501 co-engages CD20 on malignant B cells and three NK cell receptors, enhancing cytotoxic activity. The IL-2 variant in IPH6501 provides proliferation signals to NK cells, offering a promising alternative to T cell therapies. Dr. Sonia Quaratino and Dr. Lorenzo Falchi express optimism about IPH6501's potential in treating refractory B-cell NHL.
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The initiation of a Phase 1/2 trial for IPH6501, a novel CD20-targeting tetraspecific natural killer cell engager, marks a significant advancement in the therapeutic landscape for B-cell Non-Hodgkin's Lymphomas (NHL). This therapy introduces a new mechanism of action by not only targeting the malignant B cells but also engaging multiple receptors on natural killer (NK) cells, which are a critical component of the innate immune system. By co-engaging CD20 on B cells and activating NK cells, IPH6501 could potentially overcome resistance mechanisms that have limited the efficacy of existing treatments.

Furthermore, the addition of an interleukin-2 (IL-2) variant to this therapy is a strategic move to enhance NK cell proliferation and cytotoxic activity without the adverse effects associated with the alpha subunit of the IL-2 receptor. This could mean a more favorable safety profile and improved tolerability for patients. As an oncologist, the potential for IPH6501 to provide a more targeted and potent immune response is promising, particularly for patients who have relapsed or are refractory to current therapies.

The clinical development of IPH6501 from Innate Pharma's ANKET® platform is a noteworthy event for investors monitoring the biotechnology sector. As a first-in-class therapy, IPH6501's success or failure in clinical trials could significantly influence Innate Pharma's market valuation and the stock's performance. The planned enrollment of up to 184 patients will provide a substantial data set to assess the drug's safety and efficacy.

From a research perspective, the innovative tetraspecific approach, which allows for simultaneous targeting and activation of multiple immune pathways, is a differentiator that could set IPH6501 apart from monospecific and bispecific antibodies currently in use or development. If trial results are positive, IPH6501 could capture a significant portion of the NHL treatment market, addressing an unmet need for patients with relapsed or refractory disease. This would likely have a positive impact on Innate Pharma's revenue streams and strategic positioning within the industry.

Non-Hodgkin's Lymphoma represents a market with a continuous need for innovative treatments, particularly for patients who do not respond to existing therapies. The introduction of IPH6501 into clinical trials is a strategic move by Innate Pharma to tap into this demand. As a market research analyst, it is important to note that the success of such a novel therapeutic could disrupt the current market dynamics by providing an alternative to T cell therapies, which have been the focus of much recent investment.

Given the high cost of cancer treatments and the potential for improved outcomes with IPH6501, healthcare providers and payers will be closely watching the clinical progress of this drug. A successful trial could lead to rapid adoption and significant market share gains, provided the cost-benefit ratio is favorable. Conversely, any setbacks in the trial could have a negative impact on the perceived value of Innate Pharma's pipeline and its attractiveness to potential partners or acquirers.

  • Phase 1/2 study is evaluating IPH6501, a first-in-class CD20-targeting tetraspecific natural killer cell engager, from ANKET® platform, for the treatment of CD20-expressing B-cell Non-Hodgkin's Lymphomas.

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

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced the first patient was dosed in its Phase 1/2 multicenter trial (NCT06088654), investigating the safety and tolerability of IPH6501 in patients with Relapsed and/or Refractory CD20-expressing B-cell Non-Hodgkin’s Lymphoma (NHL).

IPH6501 is Innate’s first-in-class CD20-targeting tetraspecific ANKET® (Antibody-based NK cell Engager Therapeutics) that co-engages CD20 as a target antigen on malignant B cells and three receptors on NK cells: two activating receptors (NKp46 and CD16) and the interleukin-2 receptor (but not its alpha subunit), with a human IL‑2 variant, hence providing proliferation and activation signals targeted to NK cells and promoting their cytotoxic activity against CD20 expressing malignant cells. The study is planned to enroll up to 184 patients.

“We are pleased to announce the dosing of a first patient in this Phase 1/2 study evaluating IPH6501, our proprietary ANKET® asset and the first tetraspecific NK Cell Engager to enter the clinic.” commented Dr Sonia Quaratino, Chief Medical Officer at Innate Pharma. With the addition of the IL-2 variant, our second generation ANKET® molecules can deliver proliferation signals to NK cells, and thus enhance their effector functions against cancer cells. Thanks to this novel format, IPH6501 represents a promising alternative strategy to T cell therapies for patients with B-cell non-Hodgkin’s lymphomas.”

“The discovery and implementation of novel chemotherapies, T-cell based immunotherapies and targeted therapies have improved outcomes for patients with B-cell non-Hodgkin’s lymphomas compared with traditional chemotherapy.” added Dr Lorenzo Falchi, Lymphoma Specialist at the Memorial Sloan Kettering Cancer Center, New-York, and principal investigator of the study. “However, many patients fail to achieve a response to or develop disease relapse after treatment. In this context, IPH6501 represents an innovative option for the treatment of patients with R/R B-cell non-Hodgkin’s lymphomas and has the potential to fulfil a large unmet need.”

More information about the trial can be found on clinicaltrials.gov.

About B-Cell Non-Hodgkin’s Lymphoma

B-cell lymphomas are clonal tumors of mature and immature B cells that constitute the majority (80-85%) of NHLs. NHLs are a heterogeneous group of lymphoproliferative malignancies. NHL usually originates in the lymphoid tissues and can spread to other organs. NHL is the most common hematological malignancy worldwide, accounting for nearly 3% of cancer diagnoses and deaths.

According to the latest World Health Organization (WHO) classification, the most common B-NHL in Western countries is Diffuse large B cell lymphoma (DLBCL), accounting for around 31% of adult cases. Other common aggressive B-cell subtypes include Mantle Cell Lymphoma (MCL) (6% of cases) and Burkitt lymphoma (BL) (2% of cases). Among indolent B-cell NHL, Follicular Lymphoma (FL) accounts for 22% of cases in the Western world, followed by marginal zone lymphoma (MZL) (8% of cases).

About IPH6501

IPH6501 is the first Antibody-based NK cell Engager Therapeutic to co-engage activating receptors on NK cells (NKp46 and CD16), IL-2R (but not α subunit) through a variant of human IL-2, and a tumor antigen (CD20) via a single molecule, hence providing proliferation and activation signals targeted to NK cells and promoting their cytotoxic activity against CD20 expressing malignant cells. IPH6501 has shown better anti-tumor efficacy than approved benchmark antibodies in preclinical tumor models (Demaria, EHA 2023).

About ANKET®

ANKET® (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multispecific natural killer (NK) cell engagers to treat certain types of cancer. This fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

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® 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, 2022, 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.

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 the purpose of the Phase 1/2 trial for IPH6501?

The trial aims to evaluate the safety and tolerability of IPH6501 in patients with Relapsed and/or Refractory CD20-expressing B-cell Non-Hodgkin's Lymphoma.

How many patients are expected to be enrolled in the study?

The study is planned to enroll up to 184 patients.

What is unique about IPH6501 in terms of NK cell engagement?

IPH6501 is a tetraspecific NK cell engager that co-engages CD20 on malignant B cells and three NK cell receptors, enhancing cytotoxic activity.

How does the IL-2 variant in IPH6501 contribute to its effectiveness?

The IL-2 variant in IPH6501 provides proliferation signals to NK cells, enhancing their effector functions against cancer cells.

Who is leading the Phase 1/2 trial for IPH6501?

Dr. Sonia Quaratino, Chief Medical Officer at Innate Pharma, is overseeing the trial.

What potential does IPH6501 hold for the treatment of B-cell NHL?

IPH6501 represents an innovative option for patients with Relapsed and/or Refractory B-cell Non-Hodgkin's Lymphomas, addressing a large unmet need.

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