PRISM: PRecIsion in SCLC Via a Multicohort Study: Randomized Phase II Studies Evaluating Maintenance Durvalumab With or Without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC)

This phase II trial tests how well biomarker tests on patients tumor tissue works in selecting personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). Biomarker tests look for certain features in cancer cells that may give doctors more information about what is driving cancer and how to treat it. Based on the biomarker test results, study doctors can determine the subtype of ES-SCLC that study treatments can target. This study also tests different types of maintenance treatment for ES-SCLC with drugs durvalumab, saruparib, ceralasertib or monalizumab. Maintenance treatment is given after initial treatment and is given to help keep the cancer under control and prevent it from getting worse. Immunotherapy with monoclonal antibodies, such as durvalumab and monalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Saruparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Ceralasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for tumor cell growth. Giving biomarker selected personalized maintenance treatment with durvalumab, saruparib, ceralasertib or monalizumab may work better in treating patients with ES-SCLC.

Start Date08 Sep 2025

Sponsor / Collaborator

SWOG

[+1]

NCT06503614

/ RecruitingPhase 2IIT

ENHANCE (Elevated NKG2A and HLA-E Amplify NK/CD8 Checkpoint Engagers): A Phase 2 Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer

This is a phase 2 open-label two cohort study of durvalumab plus monalizumab in patients with BCG-unresponsive or BCG-exposed CIS NMIBC. Arm A will enroll 43 participants who have cancer in situ (CIS) with or without high grade papillary urothelial cancer. Arm B will enroll 17 participants who do not have cancer in situ (CIS) but do have high grade papillary urothelial cancer. Eligible patients will be enrolled to receive up to 13 cycles of monthly combination of monalizumab and durvalumab. Both monalizumab and durvalumab will be administered intravenously (IV) every 28 days.

Start Date24 Feb 2025

Sponsor / Collaborator

Hoosier Cancer Research Network

[+3]

NCT06152523

/ Not yet recruitingPhase 2IIT

Monalizumab and MEDI5752 in Patients With MSI and/or dMMR Metastatic Cancer

MSI is a molecular indicator of defective DNA mismatch repair (dMMR). The MSI/dMMR status is observed in all tumor types, representing notably 5% of metastatic colorectal cancers (mCRC), 25% of advanced endometrial cancer and 8% of metastatic gastric cancer.
MSI/dMMR cancers are highly immunogenic. MSI/dMMR tumors are characterized by a high tumor mutational burden with highly immunogenic neoantigens. These tumors are associated with an upregulation of immune checkpoints (PD1, PDL1, CTLA4, etc.) that protects MSI cancer cells from their hostile immune micro-environment, characterized by a high infiltration of activated cytotoxic T CD8+ and NK lymphocytes. Consequently, MSI/dMMR cancers are highly sensitive to ICIs, whatever the tumor location. MSI/dMMR status is a predictive biomarker for the efficacy of immunotherapy, regardless of the tumor type. Then, by several phase II and III studies The efficacy of immunotherapy has been demonstrated as front-line treatment for patients with chemotherapy-naive MSI/dMMR mCRC and gastric cancer. The phase III KEYNOTE-177 trial evaluating first-line treatment of pembrolizumab in patients with MSI/dMMR mCRC demonstrated its superiority over first-line chemotherapy, with a significant improvement of health-related quality of life. At final analysis, the median follow-up was 44.5 months. Median PFS was 16.5 versus 8.2 months (HR = 0.59; 95%CI 0.45-0.79). The hazard ratio favored pembrolizumab versus chemotherapy with a trend toward reduction in the risk of death (HR 0.74; 95% CI, 0.53-1.03; P=0.0359), despite a 60% effective crossover rate. Pembrolizumab has been approved by the FDA and the EMA for patients with newly diagnosed MSI/dMMR mCRC and is now the standard of care for this population. Also, the phase III CHECKMATE-649 trial reveal that the Combination of immunotherapy and cytotoxic chemotherapy is the new standard of care for patients with newly diagnosed metastatic oesogastric cancer. Importantly, results of the CHECKMATE-649 are outstanding for the subgroup population of MSI/dMMR gastric cancer patients (N = 44). Indeed, the unstratified hazard ratio for OS with nivolumab plus chemotherapy versus chemotherapy alone was 0.33 (95% CI 0.12-0.87) for patients with MSI/dMMR tumors. All in all, ICIs are the standard of care in first-line setting for patients with mCRC or metastatic oesogastric cancer. Besides, several phase II studies suggest that ICI combinations might overcome primary resistance to anti-PD1 monotherapy These data justify the development of bispecific monoclonal antibodies targeting both PD1 and CTLA4 such as MEDI5752. MEDI5752 has been developed based on the observation that there is a higher expression of PD-1/CTLA-4 on tumor resident versus peripheral T cells. Preclinical data show MEDI5752 fully suppresses PD-1 and preferentially inhibits CTLA-4 in the tumor versus the periphery, which is meant to uncouple CTLA-4 dependant peripheral toxicity from antitumor activity Natural killer cells are integral to the functioning of the innate immune system and play an important role in innate antitumor immunity. There is a growing body of evidence for targeting the NKG2A/HLA-E axis in combination with other ICIs to sensitize tumors to ICI therapy. NKG2A recognizes the non-classical HLA class I molecule HLA-E. The NKG2A receptor is found on peripheral NK cells and subsets of T cells in cancer patients. It is also present in tumor-infiltrating NK and cytotoxic T cells. Importantly, NK cells and the NKG2A/HLA-E axis play a crucial role in MSI/dMMR tumors. Therefore, a combined blockade of non-redundant checkpoint pathways to unleash NK and T cells seems particularly promising for MSI/dMMR neoplasms. Monalizumab specifically binds and blocks the inhibitory receptor NKG2A. Monalizumab has been investigated in combination with ibrutinib (in chronic lymphoid leukemia), cetuximab +/- durvalumab (in squamous cell carcinoma of the head and neck, and in solid tumors), durvalumab +/- FOLFOX (in solid tumors). In the first-in-human dose escalation of monalizumab plus durvalumab, a manageable toxicity profile was shown.
Taken together, these data provide a strong rational to combine an inhibitor of the NKG2A/HLA-E axis with a bispecific monoclonal antibody targeting both PD1 and CTLA4 for patients with metastatic MSI/dMMR cancers.

Start Date01 Dec 2023

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

100 Clinical Results associated with Monalizumab

100 Translational Medicine associated with Monalizumab

100 Patents (Medical) associated with Monalizumab

Literatures (Medical) associated with Monalizumab

01 Jul 2025·CLINICAL CANCER RESEARCH

INTERLINK-1: A Phase III, Randomized, Placebo-Controlled Study of Monalizumab plus Cetuximab in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Article

Abstract:

Purpose::

Treatment options for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) after failure of immune checkpoint inhibitor treatment and platinum-based chemotherapy are limited. Preliminary data suggested that monalizumab plus cetuximab had clinical activity in R/M HNSCC.

Patients and Methods::

INTERLINK-1 (NCT04590963) was a double-blind, phase III study. Participants with R/M HNSCC who had received immune checkpoint inhibitor therapy and progressed despite platinum-based chemotherapy were randomized 2:1 to monalizumab (750 mg, every 2 weeks) or placebo, plus cetuximab (400 mg/m2 loading dose, then 250 mg/m2, weekly). The primary endpoint was overall survival (OS) in participants with non-oropharyngeal cancer or human papillomavirus (HPV)-negative oropharyngeal cancer (HPV-unrelated analysis set). Secondary endpoints included progression-free survival and objective response rate.

Results::

At data cutoff, 216 participants were randomized in the HPV-unrelated analysis set: 145 to monalizumab plus cetuximab and 71 to placebo plus cetuximab. Median OS was 8.8 months for monalizumab plus cetuximab versus 8.6 months for placebo plus cetuximab (HR, 1.00; 95% confidence interval, 0.66–1.54); median progression-free survival was 3.6 versus 3.8 months, respectively (HR, 1.11; 95% confidence interval, 0.79–1.57); and the objective response rate was 15.2% versus 23.9%, respectively. INTERLINK-1 was terminated after a preplanned interim analysis showed that futility criteria were met (predetermined futility HR >0.874). Grade 3/4 treatment–related adverse events were reported in 18.3% and 17.2% of participants treated in the monalizumab and placebo arms, respectively.

Conclusions::

Monalizumab plus cetuximab did not improve OS compared with placebo plus cetuximab. The safety profile of the combination was consistent with safety observations for cetuximab monotherapy.

01 May 2025·ESMO Open

A phase II study of monalizumab and durvalumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck: results of the I2 cohort of the EORTC-HNCG-1559 trial (UPSTREAM)

Article

Author: Kong, A ; Rutten, A ; Licitra, L ; Seront, E ; Prevost, J B ; Tsechilidou, K ; Even, C ; Tinhofer, I ; Olungu, C ; Fortpied, C ; Rolland, F ; Borel, C ; Govaerts, A S ; Guigay, J ; Galot, R ; Le Tourneau, C ; Dirix, L ; Daste, A ; Abdeddaim, C ; Joaquim, A ; Machiels, J P ; Bonomo, P ; Saada-Bouzid, E ; Henry, S ; Rasschaert, M

BACKGROUND:

Monalizumab (M), targeting the natural killer group 2A (NKG2A) receptor, has limited activity as monotherapy in recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). Preliminary data of M and durvalumab (D) have shown encouraging activity in other tumor types.

PATIENTS AND METHODS:

The UPSTREAM trial was an umbrella trial of targeted therapies and immunotherapy for R/M SCCHN. The immunotherapy 2 (I2) cohort was a phase II, randomized, open-label substudy evaluating the efficacy of D + M versus physician's choice (control). Patients non-eligible for the biomarker-driven cohorts and pretreated with PD(L)1, were included in the I2 cohort. The primary endpoint was the objective response rate (RECIST version 1.1) during the first 16 weeks.

RESULTS:

Sixty-six patients with R/M SCCHN were included in the I2 cohort, of whom 60 were assessable (D + M: n = 42, control: n = 18): median age 62 years; 87% with two or three previous lines of treatment. In the D + M arm, one partial response (PR) was recorded, and stable disease (SD) was observed in 11 (26%). One PR was reported in the control arm and SD in 8 (44%). The median progression-free survival (PFS) was 2.0 and 3.1 months in the D + M arm and control arm, respectively. The median overall survival (OS) was 4.3 months (95% confidence interval 3.3-8.9 months) and 8.0 months (95% confidence interval 3.1-14.9 months) in the D + M and control arms, respectively. In the D + M arm, 4 (9%) patients reported grade ≥3 treatment-related adverse events.

CONCLUSION:

The I2 substudy failed to demonstrate an activity of D + M in heavily pretreated patients with SCCHN previously exposed to anti-PD(L)1. No benefit was seen in PFS and OS.

13 Sep 2024·Future Oncology

PACIFIC-9: Phase III trial of durvalumab + oleclumab or monalizumab in unresectable stage III non-small-cell lung cancer

Article

Author: Mann, Helen ; Yoh, Kiyotaka ; Gopinathan, Aarthi ; Bielecka, Zofia Felicja ; Barlesi, Fabrice ; Cho, Byoung Chul ; Aggarwal, Charu ; Newton, Michael ; Goldberg, Sarah B ; Zimmer Gelatti, Ana Caroline

Evidence from the Phase III PACIFIC trial established durvalumab, a monoclonal antibody (mAb) targeting PD-L1, following concurrent chemoradiotherapy (cCRT) as a global standard of care for patients with unresectable, stage III non-small-cell lung cancer (NSCLC). There remains an unmet need to improve upon the outcomes achieved with the PACIFIC regimen. Combining durvalumab with other immunotherapies may improve outcomes further. Two such immunotherapies include oleclumab, an mAb targeting CD73, and monalizumab, an mAb targeting NKG2A. Both agents demonstrated antitumor activity in early-phase trials. PACIFIC-9 (NCT05221840) is an international, double-blind, randomized, placebo-controlled, Phase III trial comparing durvalumab plus either oleclumab or monalizumab with durvalumab plus placebo in patients with unresectable, stage III NSCLC and no disease progression following cCRT.Clinical Trial Registration: NCT05221840 (ClinicalTrials.gov).

107

News (Medical) associated with Monalizumab

04 Aug 2025

·www.businesswire.com

Number of Shares and Voting Rights of Innate Pharma as of August 1, 2025

MARSEILLE, France--(BUSINESS WIRE)--Regulatory news: Pursuant to the article L. 233-8 II of the French “Code de Commerce” and the article 223-16 of the French stock-market authorities (Autorité des Marchés Financiers, or “AMF”) General Regulation, Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) releases its total number of shares outstanding as well as its voting rights as of August 1, 2025: Total number of shares outstanding: 92,184,823 ordinary shares 6,424 Preferred Shares 2016 7,581 Preferred Shares 2017 Total number of theoretical voting rights (1): Total number of exercisable voting rights (2): 92,962,943 92,944,368 (1) The total number of theoretical voting rights (or “gross” voting rights) is used as the basis for calculating the crossing of shareholding thresholds. In accordance with Article 223-11 of the AMF General Regulation, this number is calculated on the basis of all shares to which voting rights are attached, including shares whose voting rights have been suspended. The total number of theoretical voting rights includes voting rights attached to AGAP 2016, i.e. 130 voting rights for the AGAP 2016-1 and 111 voting rights for the AGAP 2016-2. No voting rights attached to AGAP 2017. (2) The total number of exercisable voting rights (or “net” voting rights) is calculated without taking into account the shares held in treasury by the Company, with suspended voting rights. It is released so as to ensure that the market is adequately informed, in accordance with the recommendation made by the AMF on July 17, 2007. 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 three therapeutic approaches: multi-specific NK Cell Engagers via its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC) and monoclonal antibodies (mAbs). Innate’s portfolio includes several ANKET® drug candidates to address multiple tumor types as well as IPH4502, a differentiated ADC in development in solid tumors. In addition, anti-KIR3DL2 mAb lacutamab is developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, and anti-NKG2A mAb monalizumab is developed with AstraZeneca in non-small cell lung cancer. 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 LinkedIn and X. 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 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,” “intend,” “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, 2024, 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.

ImmunotherapyClinical Study

29 Jul 2025

·www.businesswire.com

Innate Pharma Announces Its Participation in the BTIG Virtual Biotechnology Conference

MARSEILLE, France--(BUSINESS WIRE)--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the company’s CEO Jonathan Dickinson and COO Yannis Morel will participate in the BTIG Virtual Biotechnology Conference being held on July 29-30, 2025. BTIG, a global financial services firm specializing in investment banking, institutional trading, research and related brokerage services, recently initiated analyst coverage of Innate Pharma. The Fireside chat will be held on Wednesday July 30 at 2pm EST, with 1x1 meetings hosted the same day. About BTIG BTIG is a global financial services firm specializing in institutional trading, investment banking, research and related brokerage services. With an extensive global footprint and more than 700 employees, BTIG, LLC and its affiliates operate out of 20 cities throughout the U.S., and in Europe, Asia and Australia. BTIG offers execution, expertise and insights for equities, equity derivatives, ETFs and fixed income, currency and commodities. 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 three therapeutic approaches: multi-specific NK Cell Engagers via its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC) and monoclonal antibodies (mAbs). Innate’s portfolio includes several ANKET® drug candidates to address multiple tumor types as well as IPH4502, a differentiated ADC in development in solid tumors. In addition, anti-KIR3DL2 mAb lacutamab is developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, and anti-NKG2A mAb monalizumab is developed with AstraZeneca in non-small cell lung cancer. 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 LinkedIn and X. 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 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,” “intend,” “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, 2024, 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.

ImmunotherapyClinical Study

17 Jun 2025

·www.businesswire.com

Innate Pharma Announces Its Participation in H.C. Wainwright and Wolfe Research Healthcare Conferences

MARSEILLE, France--(BUSINESS WIRE)--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that members of its executive team will participate in the upcoming investor conferences, detailed below. H.C. Wainwright 3 rd Annual Immune Cell Engager Virtual Conference Dates: June 24, 2025 | Virtual Wolfe Research Virtual Biotech Day Dates: June 26, 2025 | Virtual 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 three therapeutic approaches: multi-specific NK Cell Engagers via its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC) and monoclonal antibodies (mAbs). Innate’s portfolio includes several ANKET® drug candidates to address multiple tumor types as well as IPH4502, a differentiated ADC in development in solid tumors. In addition, anti-KIR3DL2 mAb lacutamab is developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, and anti-NKG2A mAb monalizumab is developed with AstraZeneca in non-small cell lung cancer. 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 LinkedIn and X. 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 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,” “intend,” “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, 2024, 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.

ImmunotherapyClinical Study

100 Deals associated with Monalizumab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Monalizumab	-	DB12824

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	United States	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	China	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Japan	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Australia	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Brazil	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Canada	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Colombia	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	France	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Germany	AstraZeneca PLC	07 Feb 2022
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	Italy	AstraZeneca PLC	07 Feb 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WCLC2024	Phase 2	Extensive stage Small Cell Lung Cancer First line NKG2A/CD94 \| HLA-E	6	Platinum-based chemotherapy + Durvalumab + Monalizumab	pucmgwyihh(snpyulghft) = tjhrrlstqc ikbdfysrtr (rzxebwnqkw )	Positive	08 Sep 2024
NCT03822351 (COAST, ASCO2024) Manual	Phase 2	Unresectable Lung Non-Small Cell Carcinoma	189	durvalumab	dckclcwtse(wbsilgupln) = bcvomopjfu ogfsuymams (jaulbfoswe, 14.3 - 35.9) View more	Positive	24 May 2024
				durvalumab+oleclumab	dckclcwtse(wbsilgupln) = ewthdjnueg ogfsuymams (jaulbfoswe, 23.1 - 48.4) View more
NCT03794544 (NeoCOAST, AACR2024) Manual	Phase 2	Resectable Lung Non-Small Cell Carcinoma Neoadjuvant	47	durvalumab	oeeorqbdti(olctekrjzo) = Percent CD73+ TC and B cell abundance was higher in patients with MPR vs those without MPR in the durva + ole arm, but not in the durva monotherapy or durva + mona arms. Increased CD8 T cell and NK cell abundance was not associated with MPR in any arm. qubvzkzrgk (igpizzhijk ) View more	Positive	22 Mar 2024
				durvalumab+oleclumab
NCT03088059 (EORTC-HNCG-1559, ESMO2023)	Phase 2	Squamous Cell Carcinoma of Head and Neck PD(L)1	66	Durvalumab + Monalizumab	ivkuuwyrzo(cvaisvwsfm) = lfvlzpkblx xwhhrfjjhp (plmcqfzido ) View more	Negative	22 Oct 2023
				monalizumab (Physician's choice)	ivkuuwyrzo(cvaisvwsfm) = okxckjqwpp xwhhrfjjhp (plmcqfzido ) View more
NCT04590963 (INTERLINK-1, Corporate Publications) Manual	Phase 3	Recurrent Squamous Cell Carcinoma of the Head and Neck	600	Cetuximab+Monalizumab	kaqocsapfi(pfqmivykjk) = not reach tbyfgaqcnn (cuczawjkah )	Negative	01 Aug 2022
				Cetuximab+Placebo
NCT03794544 (AACR2022) Manual	Phase 2	Non-Small Cell Lung Cancer Neoadjuvant	84	Durvalumab	tqxkdujxlt(ixillddcvj) = ovzxxgxtlh bdibufhkvh (aftenwttxa, 2.4 - 29.2) View more	Positive	15 Jun 2022
				Durvalumab+Oleclumab	tqxkdujxlt(ixillddcvj) = xwhtkvwzxe bdibufhkvh (aftenwttxa, 5.4 - 41.9) View more
NCT03822351 (COAST, Pubmed \| J Urol)	Phase 2	Non-small cell lung cancer stage III Consolidation	189	Durvalumab	zilbqghaxy(chqlokbiqb) = pcvqnifses ktogjoulri (atflhchmfl, 9.6 - 29.2)	Positive	22 Apr 2022
				Durvalumab+Oleclumab	zilbqghaxy(chqlokbiqb) = spzygydosc ktogjoulri (atflhchmfl, 18.8 - 43.2)
NCT02643550 (ESMO_IO 12021 \| ESMO_IO 22021) Manual	Phase 2	Recurrent Squamous Cell Carcinoma of the Head and Neck First line	40	durvalumab+Monalizumab+cetuximab	eucshfnzdk(wusxlvsuzf) = mmlljdqomg kxmiwkjdrg (uicploaedd, 20 - 48) View more	Positive	09 Dec 2021
NCT03088059 (UPSTREAM, Pubmed \| Eur J Cancer Care (Engl)) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck	26	Monalizumab	jgtdgfkbre(ljpnkjbezg) = byclysleas gvhurgglky (axxngcekeh ) View more	Negative	09 Oct 2021
NCT04307329 (MIMOSA-trial, ESMO_BC2021)	Phase 2	HER2 Positive Breast Cancer sTILs	-	Monalizumab + Trastuzumab	zxjomronqo(qxqdsnhfsp) = lgghdokwsm xugtwyjoba (eivqpttovt )	-	05 May 2021

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