On September 17, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results for the six months ended June 30, 2025 (Press release, Innate Pharma, SEP 17, 2025, View Source [SID1234656012]). The consolidated financial statements are attached to this press release.

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"With key milestones anticipated over the next 12 months, our primary focus will be on progressing what we believe are our most promising and highest-value clinical assets and advancing our next ADCs toward development. In line with this strategic focus and in a challenging funding environment, we are taking necessary action to focus our resources on what we believe are the programs with the highest potential to deliver value for both patients and shareholders, and we therefore plan to streamline the size of the organization," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. "We made meaningful progress during the first half of the year in our pipeline and are determined to build on this momentum. At ASCO (Free ASCO Whitepaper), we presented a Trial In Progress for our Nectin-4 ADC, IPH4502, which is progressing rapidly through Phase 1 enrollment; and we shared long-term follow-up data for lacutamab, for which preparation of the confirmatory Phase 3 trial protocol is close to completion, following discussions with the FDA and EMA. Looking ahead, we have a number of important catalysts, including first patient data for IPH4502 in H1 2026, and high level read-out of AstraZeneca’s PACIFIC-9 Phase 3 trial with monalizumab in H2 2026."

Pipeline highlights:

Strategic focus

Innate Pharma plans to prioritize its investment on what it believes are its highest-value clinical assets, IPH4502, lacutamab, and monalizumab (partnered with AstraZeneca); its preclinical research and development (R&D) efforts will focus on advancing the next Antibody Drug Conjugates (ADCs) toward development, leveraging its pipeline of innovative targets.

IPH4502 (Nectin-4 ADC, proprietary):

IPH4502 is Innate’s novel and differentiated topoisomerase I inhibitor ADC targeting Nectin-4.

The first patient was dosed in a Phase 1 study in January 2025. The Phase 1 study will assess the safety, tolerability, and preliminary efficacy of IPH4502 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 study plans to enroll approximately 105 patients. A Trial in Progress Poster was shared at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2025. Enrollment is in progress and expected to be completed at the end of 2025 or in the first quarter of 2026.
New preclinical data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025. IPH4502 demonstrated superior preclinical anti-tumor activity compared to enfortumab vedotin (EV) in urothelial carcinoma (UC) models with low or heterogeneous Nectin-4 expression, as well as in models resistant to EV. Beyond UC, IPH4502 also exhibited anti-tumor activity in preclinical models of triple-negative breast cancer, head and neck squamous cell carcinoma, and esophageal cancer, suggesting broader potential clinical applicability.
Lacutamab (anti-KIR3DL2 antibody, proprietary):

Cutaneous T Cell Lymphoma

In February 2025, the FDA granted Breakthrough Therapy Designation to lacutamab for relapsed or refractory Sézary syndrome (SS) based on TELLOMAK Phase 2 results demonstrating efficacy and a favorable safety profile in patients with advanced SS, heavily pretreated, post-mogamulizumab. Breakthrough Therapy Designation is intended to accelerate the development and regulatory review in the U.S. of drugs that are intended to treat a serious condition.
At the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, updated long-term data from the Phase 2 TELLOMAK trial reinforced the clinical activity and durability of lacutamab in relapsed/refractory SS and mycosis fungoides (MF). In SS, lacutamab achieved a 42.9% ORR with a median duration of response of 25.6 months, while in MF, responses were observed regardless of KIR3DL2 expression, with a median PFS of 10.2 months. Across both cohorts, lacutamab was well tolerated, with no safety concerns and sustained improvements in quality of life.
Preparation of the confirmatory Phase 3 trial protocol is close to completion, following discussions with the FDA and EMA. Innate is evaluating potential paths forward to advance lacutamab toward Phase 3 initiation, including discussions with partners and investors.
Peripheral T Cell lymphoma (PTCL)

The Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial, an investigator-sponsored, randomized controlled trial, led by the Lymphoma Study Association, to evaluate lacutamab in combination with GEMOX (gemcitabine and oxaliplatin) chemotherapy versus GEMOX alone, in patients with KIR3DL2-expressing relapsed/refractory PTCL, is ongoing and continues to recruit patients.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

The Phase 3 PACIFIC-9 trial run by AstraZeneca evaluating durvalumab (anti-PD‑L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT) is ongoing. Enrollment in the trial is completed, and high level read-out is expected in H2 2026.
At the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2025, AstraZeneca presented updated results from the Phase 2 NeoCOAST-2 trial evaluating neoadjuvant and adjuvant durvalumab-based combinations in resectable NSCLC. The regimen including durvalumab, monalizumab, and chemotherapy (Arm 2, n=70) showed 25.7% pathological complete response (pCR) and 50.0% major pathologic response (mPR).
ANKET (Antibody-based NK cell Engager Therapeutics):

ANKET is Innate’s proprietary platform for developing next-generation, multi-specific NK cell engagers to treat certain types of cancer.

IPH6501 (ANKET anti-CD20 with IL-2V, proprietary)

The Phase 1/2 clinical trial is evaluating IPH6501 in B-cell Non-Hodgkin’s lymphoma (B-NHL). The study is planned to enroll up to 184 patients. Clinical sites are open in the US, Australia, and France. The dose escalation phase in the trial has been completed. Limited signals of activity were observed during the escalation phase, and maximum tolerated dose (MTD) is currently being explored to further assess clinical relevance. Clinical data are expected in late 2025 or beginning of 2026.
IPH6101 (ANKET anti-CD123, proprietary)

Innate regained the rights to SAR’579/IPH6101 in July 2025. The Company is in the process of receiving the product data from Sanofi relating to the Sanofi-led Phase 1/2 study and Phase 2 preliminary dose expansion of the trial.
SAR’514/IPH6401 (BCMA ANKET, Sanofi)

As previously disclosed, Sanofi has opted to pursue the development of SAR’514/IPH6401 (BCMA ANKET) in autoimmune indications under the terms of the 2016 License Agreement.
The Sanofi-led Phase 1/2 study (clinical study identifier: NCT05839626) for the treatment of patients with relapsed or refractory multiple myeloma has been terminated early, in line with the decision to focus SAR’514/IPH6401 development in autoimmune indications.
Preclinical ANKET

IPH62 (partnered with Sanofi): IPH62 is an NK-cell engager program targeting B7-H3 from Innate’s ANKET platform, which is under preclinical development. Following a research collaboration period and upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization.
Sanofi still retains an option on one additional ANKET target under the terms of the 2022 research collaboration and license agreement.
Other assets

IPH5201 (anti-CD39), partnered with AstraZeneca: The MATISSE Phase 2 clinical trial conducted by Innate in neoadjuvant lung cancer for IPH5201, an anti-CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, is ongoing, and recruitment is on track.
IPH5301 (anti-CD73): The investigator-sponsored CHANCES Phase 1 trial of IPH5301 with Institut Paoli-Calmettes is ongoing.
Corporate Update:

Innate Pharma plans to prioritize its investment on what it believes are its highest-value clinical assets, IPH4502, lacutamab, and monalizumab (partnered with AstraZeneca); its preclinical research and development (R&D) efforts will focus on advancing the next ADCs toward development, leveraging its pipeline of innovative targets. In line with such strategic focus and its objectives, the Company intends to streamline its organization. Staffing levels are expected to decrease overall by about 30% total, including through attrition. The planned layoffs will be implemented through a redundancy plan that is subject to consultation with the Workers’ Council and endorsement by the French authorities (Dreets). The implementation of the change is expected to be completed during the first half of 2026.
Eric Vivier, CSO, has decided to return to academic research full time, effective January 1, 2026, and he will continue to support the Company’s innovation as an advisor to the R&D Committee of the Board of Directors. Innate will continue accessing innovation through academic collaborations, including Eric Vivier’s lab at the Center for Immunology of Marseille-Luminy (CIML). As Chief Operating Officer (COO), Yannis Morel, will continue to be responsible for preclinical research and development, and effective January 1, 2026 will assume CSO responsibilities.
As announced on April 23, 2025, Sanofi and Innate agreed to terminate the 2016 Research Collaboration and Licence Agreement (the "2016 Agreement") as it relates to SAR’579/IPH6101 (CD123 ANKET). As part of their discussions with regards to the review of the 2016 Agreement, Sanofi and Innate announced the investment by Sanofi of up to €15 million in new shares of Innate. Sanofi then subscribed to 8,345,387 new ordinary shares of Innate, at a price of €1.7974 per share, representing a total capital increase of €14,999,998.59 (€417,269.35 in nominal amount and €14,582,729.24 of issue premium) representing 9.05% of Innate’s total outstanding shares as of the time of such capital increase.
On May 22, 2025, after approval at the Annual General Meeting, Innate Pharma changed its corporate governance from an executive board/supervisory board structure to a CEO/board of directors with Irina Staatz-Granzer as Chairwoman and Jonathan Dickinson as Chief Executive Officer. This transformation is part of the Company’s strategic plan to simplify and align its governance with international standards. As part of the change, two seasoned biotech executives, Marty J. Duvall and Christian Itin, joined the Board of Directors. In addition, a new R&D Committee has been established as a committee of the Board of Directors, the role of which is to analyze research and development opportunities for the Company’s products. Its members are Bpifrance Participations, represented by Olivier Martinez, also appointed Chairman of the Research and Development Committee, Véronique Chabernaud and Christian Itin.
As of June 30, 2025, the balance available under our April 2023 sales agreement under the At-The-Market program remains at $75 million.
Stéphanie Cornen was appointed Vice President, Investor Relations, Communications and Commercial Strategy after Henry Wheeler, VP Investor Relations and Communications resigned from his position in order to pursue another opportunity outside the Company. Stéphanie Cornen joined Innate in 2012. Between 2012 and 2022, she held several R&D positions, contributing to the advancement of programs across various development stages. Starting in 2022, she took on responsibilities in corporate development and portfolio strategy, while supporting investor relations. Stéphanie Cornen holds a PharmD and a PhD from Aix-Marseille University, as well as an Executive MBA from HEC Paris.
Financials highlights for the first half of 2025:

The key elements of Innate’s financial position and financial results as of and for the six-month period ended June 30, 2025 are as follows:

Cash, cash equivalents, short-term investments and financial assets amounting to €70.4 million (€m) as of June 30, 2025 (€91.1m as of December 31, 2024).
As of June 30, 2025, financial liabilities amount to €27.0m (€31.0m as of December 31, 2024). This change is mainly due to loan repayments.
Revenue and other income amounted to €4.9m in the first half of 2025 (€12.3m in the first half of 2024) and mainly comprised of:
Revenue from collaboration and licensing agreements, which mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi. They are recognized when the entity’s performance obligation is met. They are recognized at a point in time or spread over time according to the percentage of completion of the work that the Company is committed to carry out under these agreements:
(i) Revenue from collaboration and licensing agreements for monalizumab decreased by €2.9m to €0.1m in the first half of 2025 (€3.0m in the first half of 2024). This change is mainly due to the progress of Phase 1/2 trials close to termination.
(ii) Revenue related to the license and collaboration agreement signed with Sanofi in 2016 decreased by €4.0m. These revenues are nil for the first half of 2025 as compared to €4.0m for the first half of 2024. On April 15, 2024, the Company announced the treatment of the first patient in the Phase 2 dose expansion part of the Sanofi-sponsored clinical trial evaluating NK Cell Engager SAR443579/ IPH6101 in various blood cancers. Under the terms of the 2016 agreement, this trial progress triggered a milestone payment of €4.0 million fully recognized in revenue during the first quarter of 2024. This amount was received by the Company on May 17, 2024.
(iii) Revenue related to the research collaboration and licensing agreement signed with Sanofi in 2022 remained constant over the period, with revenue amounting to €0.2 million for the first half of 2025, as for the first half of 2024. As previously disclosed, on January 25, 2023, the Company announced the expiration of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 and the effectiveness of the licensing agreement as of January 24, 2023. Consequently, the Company received an upfront payment of €25.0 million in March 2023, including €18.5 million for the exclusive license, €1.5 million for the research activities and €5.0 million for the option on two additional targets. The €18.5 million upfront payment relating to the exclusive license was fully recognized in revenue as of June 30, 2023. The research work upfront payment is recognized on a straight-line basis over the duration of the research activities that the Company has agreed to carry out. On December 19, 2023, the Company announced that Sanofi had exercised one of the two license options for a new program based on the Company’s ANKET platform. This decision triggered a milestone payment of €15.0m, including €13.3m for the exclusive license, fully recognized in revenue as of December 31, 2023, and €1.7m for research work to be carried out by the Company as well as the recognition in revenue of an amount of €2.5m initially received in March 2023 in connection with this option. On October 9, 2024, the Company received a termination letter for the license agreement concerning this option. The termination ends the research work. The revenue of €1.7 million was therefore fully recognized as revenue on December 31, 2024. Revenue from research work on the first license amounted to €0.2 million for the first half of 2025. Amounts not recognized in revenue are classified as deferred revenue.
Government funding for research expenditures of €3.2m in the first half of 2025 (€4.1m in the first half of 2024), decreasing by €0.9 million, or 21.3% in connection with decrease in eligible subcontracting expenses following progress in studies and research programs.
Operating expenses are €30.3m in the first half of 2025 (€38.7m in the first half of 2024), of which 67.8% (€20.5m) are related to R&D.
R&D expenses decreased by €8.6m to €20.5m in the first half of 2025 (€29.1m in the first half of 2024). This change is mainly explained by direct R&D expenses, which slightly decreased by €7.3 million or 43% to reach €9.7 million for the first half of 2025. This decrease is related to the phasing of studies (maturity of clinical studies on lacutamab, discontinuation of preclinical studies, and start of phase 1 of our antibody-drug conjugate (ADC) program).
General and administrative (G&A) expenses increased by €0.2m to €9.8m in the first half of 2025 (€9.6m in the first half of 2024) mainly resulting from an increase in personnel expenses linked to provisions for risks and charges, bringing personnel expenses to €4.8 million in the first half of 2025, offset by a €0.5 million decrease in non-scientific and consulting fees, which amounts to €1.4 million in the first half of 2025, resulting mainly from greater use of recruitment agencies in 2024 (for the establishment of the clinical department), which was not renewed in 2025.
A net financial gain of €4.1m in the first half of 2025 (€1.5m in the first half of 2024). This change is mainly due to a favorable variation in net foreign exchange gain with its favorable impact on the collaboration liabilities recorded during the first half of 2025 in connection with the change in the dollar exchange rate despite an unfavorable variation in income resulting from financial assets and fair value revaluation due to an unfavorable effect of investment rates recorded on the financial markets.
A net loss of €21.3m for the first half of 2025 (net income of €24.8m for the first half of 2024).
The table below summarizes the IFRS consolidated financial statements as of and for the six months ended June 30, 2025, including 2024 comparative information.

In thousands of euros, except for data per share

June 30, 2025

June 30, 2024

Revenue and other income

4,860

12,345

Research and development expenses

(20,520)

(29,076)

General and administrative expenses

(9,767)

(9,582)

Operating expenses

(30,287)

(38,657)

Operating income (loss)

(25,427)

(26,313)

Net financial income (loss)

4,083

1,549

Income tax expense

—

—

Net income (loss)

(21,344)

(24,764)

Weighted average number of shares ( in thousands) :

86,937

80,872

– Basic income (loss) per share

(0.25)

(0.31)

– Diluted income (loss) per share

(0.25)

(0.31)

June 30, 2025

December 31, 2024

Cash, cash equivalents and financial assets

70,417

91,051

Total assets

92,937

111,059

Total shareholders’ equity

5,144

8,834

Total financial debt

27,029

30,995

On September 17, 2025 Amphista Therapeutics ("the Company" or "Amphista"), a leader in the discovery of next generation targeted protein degradation (TPD) medicines, reported first data on its SMARCA2 program including demonstrating exquisite selectivity of its sequentially bifunctional Targeted Glues for SMARCA2 over the closely related homolog, SMARCA4 (Press release, Amphista Therapeutics, SEP 17, 2025, View Source [SID1234656031]).

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Amphista has identified SMARCA2 Targeted Glues, which induce protein degradation via a novel mechanism and enable the development of smaller and more drug like molecules than conventional PROTAC binders. Amphista’s SMARCA2 Targeted Glues have demonstrated:

Novel mechanism of degradation: Amphista’s SMARCA2 Targeted Glue series induce degradation via induction of the E3 ligase DCAF16, a novel mechanism of degradation that goes beyond traditional TPD technologies.
Exquisite selectivity over SMARCA4: Through the generation of high-resolution cryo-EM, Amphista has learnt the structural basis for selectivity over SMARCA4 and has been able to design molecules with near complete selectivity for SMARCA2, with <5% SMARCA4 degradation observed.
Highly specific degradation of SMARCA2:Global proteomics profiling demonstrates statistically significant degradation of SMARCA2 vs >8000 other proteins, including SMARCA4.
Exceptional degradation kinetics: Amphista’s Targeted Glues are able to potently degrade >95% SMARCA2 within 4 hours.
CNS penetrance: Amphista has identified a series of SMARCA2 degraders that have demonstrated CNS penetration in vivo. This offers the potential to develop medicines which can treat CNS metastasis, which frequently occur in lung cancer.
Louise Modis, Chief Scientific Officer of Amphista Therapeutics, said: "We are excited by the quality of the profile we have been able to achieve with our selective SMARCA2 degraders. The bar for success is very high in this area and we believe achieving sufficient selectivity over SMARCA4 is absolutely critical to generate a best-in-class molecule. Through the extensive deployment of cutting-edge cryo-EM structures, we have been able to do just that – to generate Targeted Glues which degrade SMARCA2, and only SMARCA2, over sustained timepoints. In addition, we believe the impressive degradation kinetics we are able to achieve with our technology will give us a significant advantage clinically."

Amphista plans to present data from its SMARCA2 Targeted Glue program at a key forthcoming scientific conference.

On September 17, 2025 Arvinas, Inc. (Nasdaq: ARVN) reported an update on its collaboration with Pfizer Inc. (NYSE: PFE) for the co-development of vepdegestrant, an investigational oral PROTAC (PROteolysis TArgeting Chimera) estrogen receptor protein degrader, and announced additional corporate actions to support shareholder value creation (Press release, Arvinas, SEP 17, 2025, View Source [SID1234656032]).

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Update on Pfizer Collaboration
Arvinas and Pfizer have jointly agreed to out-license the commercialization rights to vepdegestrant to a third party. Together, the companies have begun seeking a partner with the capabilities and expertise to maximize the commercial potential of vepdegestrant, if approved, for patients with ESR1-mutant, ER+/HER2- advanced or metastatic breast cancer and potentially develop vepdegestrant in new settings. The companies are aligned in their belief that finding a third-party commercial partner is the best path forward to unlock the full value of vepdegestrant and ensure vepdegestrant is available promptly if approved for use by regulatory authorities.

"Today’s announcement further supports our goal to bring vepdegestrant to patients and we are confident that vepdegestrant’s differentiated profile will attract interest from potential partners seeking to strengthen their oncology portfolios," said John Houston, Ph.D., Arvinas Chairperson, Chief Executive Officer and President. "We and Pfizer remain committed to the metastatic breast cancer community and believe vepdegestrant has the potential to be a best-in-class therapeutic option in the second-line ESR1 mutant setting."

Vepdegestrant is currently under review by the U.S. Food and Drug Administration (FDA) as a monotherapy in the treatment of estrogen receptor–positive (ER+), human epidermal growth factor receptor 2–negative (HER2-), ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026.

Strategic Plan and Cost Optimization Measures
Following the decision to monetize the value of vepdegestrant and out-license its rights to a third party, Arvinas management and its Board of Directors conducted a thorough review of the Company’s business and strategic plan in consultation with its independent financial and legal advisors. Following this review, the Company continues to believe that its pipeline of differentiated PROTAC degraders has the potential to create important therapies for patients with debilitating and life-threatening diseases across oncology and neuroscience. Arvinas currently has three investigational PROTAC degraders in Phase 1 trials: ARV-102, a LRRK2 degrader for progressive supranuclear palsy and Parkinson’s disease; ARV-393, a BCL6 degrader for subsets of non-Hodgkin lymphoma; and ARV-806, a KRAS G12D degrader for solid tumor malignancies.

With the change to development plan for the vepdegestrant program and a refocus on its early development programs, Arvinas has determined it will take further action to optimize its organizational and cost structures and streamline operations in advance of multiple anticipated value inflection points in the coming months. These actions include:

Further limiting additional expenditures on the vepdegestrant program to support activities required for commercialization readiness and identification and out-licensing of vepdegestrant to a third party for commercialization, subject to alignment with Pfizer;
Reducing the Company’s workforce by an additional 15% to streamline operations, with the most significant reductions being roles related to vepdegestrant commercialization; and
Proactively managing pipeline cost by seeking strategic business development opportunities and by identifying further efficiencies across the business.
These steps build on prior actions by the Arvinas Board and management team to strengthen the Company’s financial profile and drive additional operational efficiencies. The planned out-licensing of vepdegestrant and the resulting cost optimization actions, when combined with the approximately $80 million in annual cost savings from the measures announced on May 1, 2025, are expected to result in overall annual cost savings of more than $100 million compared to FY 2024.

Share Repurchase Program
The Arvinas Board of Directors has authorized the repurchase of up to $100 million of the Company’s common stock. The timing and amount of any share repurchases under the share repurchase program will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of Arvinas’ common stock and general market conditions, and will be at the Company’s discretion. Share repurchases under the share repurchase program may be made from time to time through a variety of methods, which may include open market purchases, privately negotiated block trades, accelerated share repurchases, other privately negotiated transactions or any combination of these methods. Repurchases may also be made under a Rule 10b5-1 plan, which would permit shares to be repurchased when the Company might otherwise be precluded from doing so under insider trading laws. The share repurchase program will be funded using the Company’s working capital. The share repurchase program does not obligate Arvinas to acquire any particular amount of its common stock. The share repurchase program has no time limit and can be modified, suspended or discontinued at any time without prior notice.

The priority of the Arvinas Board of Directors and management is to drive value from the portfolio by deliberately and responsibly deploying capital to advance Arvinas’ programs, which, if successful, will deliver benefits for patients and value for shareholders.

"Arvinas’ decision to repurchase shares is a testament to our conviction in the strength of our business and our long-term growth prospects and demonstrates our commitment to maximizing value for shareholders," said Briggs Morrison, M.D., Arvinas Board Member and Lead Independent Director. "We believe our disciplined management of costs will enable us to continue advancing our PROTAC technology to create transformational therapies for patients with severe diseases, while preserving maximum value creation for shareholders as the Board continues its CEO search."

Cash Runway Guidance
Following the actions announced today, Arvinas is reaffirming its cash runway guidance into the second half of 2028. The Company currently expects that this runway will support multiple opportunities to deliver value from clinical-stage programs derived from the Company’s de-risked and clinically validated platform technology. These opportunities include clinical data readouts from its PROTAC degraders ARV-102, ARV-393, and ARV-806.

About Vepdegestrant
Vepdegestrant is an investigational, orally bioavailable PROteolysis TArgeting Chimera (PROTAC) estrogen receptor degrader. Vepdegestrant is being developed as a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting.

In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; pursuant to the original agreement, Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits, including any costs, expenses and profits that arise due to the parties’ agreement to out-license commercialization rights.

Vepdegestrant was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026.

On September 17, 2025 Microbiotica, a clinical-stage biopharma company developing a pipeline of oral precision microbiome medicines called live biotherapeutic products (LBPs), reported that patient recruitment is complete in its advanced melanoma (MELODY-1) trial (Press release, Microbiotica, SEP 17, 2025, View Source [SID1234656033]).

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This international trial has recruited 41 patients at clinical centres in the UK, France, Italy, and Spain. Initial results are expected in the first half of 2026.

MELODY-1 is a Phase 1b study to evaluate the safety and tolerability of MB097 given in combination with pembrolizumab in patients with melanoma who demonstrate primary resistance to anti-PD-1 therapy. It is a first-in-human, randomised open-label clinical trial with all patients receiving MB097 and pembrolizumab for up to six months. Half of the participants also receive vancomycin before starting the co-therapy to determine whether it helps the bacterial strains in MB097 embed and grow in the gut more efficiently. Participants benefiting from the treatment at the end of the initial six-month period may continue to receive pembrolizumab for up to an additional 18 months (approximately 24 months total).

Melanoma is a life-threatening skin cancer that can spread to other parts of the body in its advanced stages. PD-1 inhibitor immunotherapies have revolutionised cancer treatment and are now commonly used to treat melanoma. However, new treatment options are still needed to extend the benefit to patients for whom immunotherapies do not work (treatment-resistant patients). This can be up to 50% of all advanced melanoma patients. There is a growing body of evidence demonstrating that the make-up of the gut microbiome can significantly influence a patient’s ability to respond to immunotherapy.

MB097 is a once daily, orally administered LBP consisting of a defined consortium of nine strains of commensal bacteria designed to enhance the efficacy of immune checkpoint inhibitors (ICIs). The MELODY-1 study is designed to investigate the safety, tolerability, and initial signals of efficacy of MB097 in advanced (metastatic) melanoma, in combination with KEYTRUDA (pembrolizumab), MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, in patients with cutaneous melanoma who have failed to respond to immunotherapies. MSD has supplied KEYTRUDA (study identifiers NCT06540391; MSD KEYNOTE-E75; 023-507377-17) to Microbiotica.

The bacterial strains in MB097 were identified by analysing the microbiome of patients in multiple studies of ICIs in melanoma, including the MELRESIST study carried out with the company’s collaborators at Cambridge University Hospitals, UK. Collectively, the MB097 bacterial consortium provides microbiome signalling that appears to be needed for ICI response. Pre-clinical studies demonstrate that MB097 activates core pathways of the immune system including Cytotoxic T Lymphocytes and Natural Killer cells to enable them to kill tumour cells. Research to understand the mechanism of action of the nine bacterial strains has indicated that in addition to this immune-activating effect, the bacteria in MB097 produce metabolites that act directly at the site of the tumour.

Dr Robert Tansley, Microbiotica’s Chief Medical Officer, said, "It is another significant milestone that this clinical study is fully recruited. In cancer patients, the bacteria in MB097 appear to be associated with better response rates to immune checkpoint inhibitor therapies, such as anti-PD-1 drugs. MB097, with its precisely selected microbes based on data from responsive patients, in combination with ICIs, could therefore activate a therapeutic benefit for non-responding patients with advanced melanoma. Moreover, as the MB097 bacteria are found in healthy subjects as well as in patients who responded to ICIs, we anticipate a favourable safety profile. We thank the investigators and patients for participating in the study and look forward to the results."

On September 17, 2025 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported new results focused on patients with primary cutaneous melanoma from the ongoing Phase 1 Study 1100 evaluating JNJ-1900 (NBTXR3) in combination with immune checkpoint inhibitors (pembrolizumab or nivolumab) for patients with advanced cancers (Press release, Nanobiotix, SEP 17, 2025, View Source [SID1234656034]). These findings were presented at the 2025 ImmunoRad conference in Paris, France on September 17.

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Patients with anti-PD-1 resistant primary cutaneous melanoma in the study had advanced disease that progressed despite multiple prior lines of therapy, including anti–PD-1, ipilimumab, T-VEC, TIL, and radiotherapy ("RT"), among others. All patients received a one-time intratumoral injection of JNJ-1900 (NBTXR3) followed by RT and sequential anti–PD-1 therapy. As of the August 21, 2025, data cutoff, 21 patients had been injected with JNJ-1900 and 19 were evaluable for tumor response (2 patients were not evaluable due to lack of post-treatment imaging).

"The patients in this analysis represent one of the more difficult clinical challenges we face as many have exhausted standard therapies, including checkpoint inhibitors," said Study 1100 Coordinating Investigator Colette Shen, MD, PhD, Assistant Professor of Radiation Oncology, University of North Carolina Lineberger Comprehensive Cancer Center. "While these data are preliminary, the responses we’re seeing provide a strong signal that this treatment approach could potentially offer a new possibility for patients who need more options."

Safety and Feasibility

All 21 patients with primary cutaneous melanoma had shown prior resistance to anti-PD-1 and treatment with RT-activated JNJ-1900 (NBTXR3) followed by anti-PD-1 showed a favorable safety profile:

Injection feasibility was confirmed at the recommended Phase 2 dose (33% GTV)
In total, 16 patients experienced grade 1, grade 2, or grade 3+ TEAEs related to the overall therapeutic regimen (RT, anti-PD-1, JNJ-1900 (NBTXR3), and injection procedure)
Of which 5 patients experienced grade 1, grade 2, or grade 3+ treatment-emergent adverse events (TEAEs) related to JNJ-1900 (NBTXR3) and/or the injection procedure
Of these patients, 1 patient experienced grade 3+ TEAEs (hypotension and pleuritic pain)
Early Signs of Efficacy

JNJ-1900 (NBTXR3) demonstrated preliminary signals of efficacy in 19 patients who were evaluable for tumor response:

A best observed objective response rate ("ORR") in all lesions of 47.4% (9/19) per RECIST 1.1, including 4 complete responses and 5 partial responses
A best observed disease control rate ("DCR") in all lesions of 78.9% (15/19) per RECIST 1.1
In JNJ-1900 injected & irradiated tumors, a DCR of 100% (19/19) was observed
A median Overall Survival (mOS) of 14.6 months [95% CI: 10.7 months; 16.7 months] in all patients treated (n=21)
Notably, a relationship was observed between the depth of local response and systemic tumor regression, suggesting a possible priming or re-activation of immune response.

"We are encouraged by these new findings and the potential signals of activity in this difficult-to-treat population," said Louis Kayitalire, MD, Chief Medical Officer of Nanobiotix. "Notably, the relationship we observed between the depth of local response and systemic tumor regression further supports our hypothesis regarding the potentially broad applicability of JNJ-1900 (NBTXR3) for patients with cancer. We look forward to further clinical evaluation of JNJ-1900 (NBTXR3) to better understand its capacity to drive both local and systemic responses in primary cutaneous melanoma."

Nanobiotix Conference Call

Nanobiotix will host a conference call and webcast featuring Nanobiotix chief executive officer, Laurent Levy, to discuss the new data on Thursday, September 18th, 2025, at 8:00 AM EDT / 2:00 PM CET.

Details for the call are as follows:

Webcast link: View Source

Audio-only dial-in link: View Source

Participants can use the audio-only link above to register and obtain dial-in instructions to listen to the presentation via phone and ask questions during the Q&A session, or participants can use the webcast link to register and listen and watch the slide presentation online; the replay version will be available under the same webcast link shortly after the presentation and will be archived on the Company’s website at www.nanobiotix.com. It is recommended to join 10 minutes prior to the event start. Participants are invited to email their questions in advance to [email protected].

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.