NIB103 / Noile-Immune Biotech - LARVOL DELTA

Notice regarding business alliance with Takara Bio Inc. for the development of NIB103 [Google translation] (Nikkei) - "Today, we are pleased to announce that we have entered into a business alliance agreement...with Takara Bio Inc...for the joint development of our pipeline NIB103...Under this agreement, we will work with Takara Bio to develop NIB103 in Japan. Takara Bio will be exclusively responsible for the manufacture of NIB103 clinical trial products and commercial products after launch, and will bear the costs associated with the manufacture of clinical trial products. We will be exclusively responsible for development work other than manufacturing of NIB103 in Japan and sales after launch, and will bear the costs associated with these. All rights related to the development, manufacture, and sales of NIB103 overseas will remain exclusively owned by us."

Licensing / partnership • Oncology • Solid Tumor

Regarding the return of NIB102 and NIB103 from Takeda Pharmaceutical [Google translation] (Noile-Immune Biotech Press Release) - "As announced on December 15, 2023, the Company has expanded its in-house drug discovery pipeline, NIB102 and Regarding NIB103 and NIB103, Takeda Pharmaceutical...which was the out-licensing partner, has provided support regarding the development and commercialization of NIB103 and NIB103. However, on June 22, discussions with the company regarding data transfer, etc., were completed...Due to the return of both pipelines, the Phase I study conducted by Takeda Pharmaceutical will be subject to future new patients. Patients will not be enrolled and will remain under Takeda's supervision until post-administration follow-up is completed and the clinical trial is completed. Therefore, there will be no financial burden on our company regarding the completion of this Phase I study....In addition, regarding NIB103, Takeda Pharmaceutical will We will pay Takeda a low-single-digit royalty after market launch for the use of Takeda's proprietary intellectual property."

Licensing / partnership • Oncology • Solid Tumor

Takeda drops cancer candidates, axing immunocytokine and CAR-Ts amid shifting treatment landscape (Fierce Pharma) - "Takeda’s vision of becoming a leader in oncology ran into more trouble Thursday when the drugmaker axed (PDF) a midphase immunocytokine and three early-stage CAR-T cell therapy prospects from its R&D pipeline...Takeda pushed modakafusp alfa out of the door as part of a pipeline clear-out that also hit three phase 1 autologous CAR-T candidates. Two of the prospects, GPC3-targeted TAK-102 and mesothelin-directed TAK-103, were in development in solid tumors. The third asset, TAK-940, was a CD19-directed, Memorial Sloan Kettering Cancer Center-partnered program that used the 1XX domain to try to enhance efficacy....While Takeda axed a clutch of cancer candidates, Plump said the company 'remains committed to oncology and will continue to develop therapies across hematologic and solid tumors.'"

Discontinued • Hematological Malignancies • Oncology • Solid Tumor

A Study of TAK-103 in Adult With Solid Tumors (clinicaltrials.gov) - P1 | N=2 | Active, not recruiting | Sponsor: Takeda | Recruiting ➔ Active, not recruiting | N=21 ➔ 2

Enrollment change • Enrollment closed • Metastases • Oncology • Solid Tumor • MSLN

Announcement on the Termination of License Agreement for NIB102 and NIB103 (Noile-Immune Biotech Press Release) - "Noile-Immune Biotech, Inc...hereby announces that Noile-Immune received the following notification today regarding the license agreements with Takeda: Takeda has decided to terminate the license agreement for NIB102 (TAK102) and NIB103 (TAK103), thereby returning the rights for the development and commercialization of NIB102 and NIB103 to Noile-Immune; The reason for the termination of the license agreement for NIB102 and NIB103 is due to a strategic shift in Takeda’s development portfolio towards allogeneic cell therapies, and is not related to any concerns about the safety or efficacy of NIB102 and NIB103....As a consequence of this termination, Noile-Immune will hold the rights of NIB102 and NIB103. Noile-Immune is going to discuss with Takeda regarding the transition of ongoing trials, transfer of the obtained data, handling of intellectual property rights, and settlement of termination fee paid by Takeda, so as to explore future options."

Licensing / partnership • Oncology • Solid Tumor

A Study of TAK-103 in Adult With Solid Tumors (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Takeda | Trial completion date: Oct 2026 ➔ Oct 2027 | Trial primary completion date: Oct 2026 ➔ Oct 2027

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • MSLN

A Study of TAK-103 in Adult With Solid Tumors (clinicaltrials.gov) - P1 | N=21 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • MSLN