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1. Phase 1 dose escalation study of the MDM2 inhibitor milademetan as monotherapy and in combination with azacitidine in patients with myeloid malignancies.

Author

DiNardo, Courtney D., Olin, Rebecca, Wang, Eunice S., Skikne, Barry, Rosenthal, Joseph, Kumar, Prasanna, Sumi, Hiroyuki, Hizukuri, Yoshiyuki, Hong, Ying, Patel, Parul, Seki, Takahiko, Duan, Tao, Lesegretain, Arnaud, and Andreeff, Michael

Subjects
MYELODYSPLASTIC syndromes, ACUTE myeloid leukemia, HEMATOLOGIC malignancies, MOUSE leukemia, POLYMERASE chain reaction
Abstract

Background: Mouse double minute‐2 homolog (MDM2) plays a key role in downregulating p53 activity in hematologic malignancies, and its overexpression is associated with poor outcomes. Methods: This phase 1 study assessed the safety and efficacy of different dosing regimens of the MDM2 inhibitor milademetan as monotherapy and in combination with azacitidine (AZA) in patients with relapsed or refractory acute myeloid leukemia or high‐risk myelodysplastic syndromes. Results: Seventy‐four patients (monotherapy, n = 57; milademetan‐AZA combination, n = 17) were treated. The maximum tolerated dose of milademetan was 160 mg once daily given for the first 14–21 days of 28‐day cycles as monotherapy and on Days 5–14 in combination with AZA. Dose‐limiting toxicities were gastrointestinal, fatigue, or renal/electrolyte abnormalities. Treatment‐emergent adverse events related to milademetan occurred in 82.5% and 64.7% of participants in the monotherapy and AZA combination arms, respectively. Two participants (4.2%) in the monotherapy arm achieved complete remission (CR), and 1 (2.1%) achieved CR with incomplete blood count recovery (CRi). Two participants (13.3%) achieved CRi in the combination arm. New TP53 mutations, detected only during milademetan monotherapy, were found pre‐existing below standard detection frequency by droplet digital polymerase chain reaction. Interpretation: Milademetan was relatively well tolerated in this population; however, despite signals of activity, clinical efficacy was minimal. [ABSTRACT FROM AUTHOR]

Published
2024
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2. Enhanced TP53 reactivation disrupts MYC transcriptional program and overcomes venetoclax resistance in acute myeloid leukemias

Author

Nishida, Yuki, primary, Ishizawa, Jo, additional, Ayoub, Edward, additional, Montoya, Rafael Heinz, additional, Ostermann, Lauren B., additional, Muftuoglu, Muharrem, additional, Ruvolo, Vivian R, additional, Patsilevas, Tallie, additional, Scruggs, Darah A., additional, Khazaei, Shayaun, additional, Mak, Po Yee, additional, Tao, Wenjing, additional, Carter, Bing Z., additional, Boettcher, Steffen, additional, Ebert, Benjamin L., additional, Daver, Naval G., additional, Konopleva, Marina, additional, Seki, Takahiko, additional, Kojima, Kensuke, additional, and Andreeff, Michael, additional

Published
2023
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3. Selective inhibition of mutant IDH1 by DS-1001b ameliorates aberrant histone modifications and impairs tumor activity in chondrosarcoma

Author

Nakagawa, Makoto, Nakatani, Fumihiko, Matsunaga, Hironori, Seki, Takahiko, Endo, Makoto, Ogawara, Yoko, Machida, Yukino, Katsumoto, Takuo, Yamagata, Kazutsune, Hattori, Ayuna, Fujita, Shuhei, Aikawa, Yukiko, Ishikawa, Takamasa, Soga, Tomoyoshi, Kawai, Akira, Chuman, Hirokazu, Yokoyama, Nobuhiko, Fukushima, Suguru, Yahiro, Kenichiro, Kimura, Atsushi, Shimada, Eijiro, Hirose, Takeshi, Fujiwara, Toshifumi, Setsu, Nokitaka, Matsumoto, Yoshihiro, Iwamoto, Yukihide, Nakashima, Yasuharu, and Kitabayashi, Issay

Published
2019
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4. Table S1 from A Potent Blood–Brain Barrier-Permeable Mutant IDH1 Inhibitor Suppresses the Growth of Glioblastoma with IDH1 Mutation in a Patient-Derived Orthotopic Xenograft Model

Author

Machida, Yukino, primary, Nakagawa, Makoto, primary, Matsunaga, Hironori, primary, Yamaguchi, Masayuki, primary, Ogawara, Yoko, primary, Shima, Yutaka, primary, Yamagata, Kazutsune, primary, Katsumoto, Takuo, primary, Hattori, Ayuna, primary, Itoh, Masato, primary, Seki, Takahiko, primary, Nishiya, Yumi, primary, Nakamura, Koichi, primary, Suzuki, Kanae, primary, Imaoka, Tomoki, primary, Baba, Daichi, primary, Suzuki, Makoto, primary, Sampetrean, Oltea, primary, Saya, Hideyuki, primary, Ichimura, Koichi, primary, and Kitabayashi, Issay, primary

Published
2023
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5. Figure S2 from A Potent Blood–Brain Barrier-Permeable Mutant IDH1 Inhibitor Suppresses the Growth of Glioblastoma with IDH1 Mutation in a Patient-Derived Orthotopic Xenograft Model

Author

Machida, Yukino, primary, Nakagawa, Makoto, primary, Matsunaga, Hironori, primary, Yamaguchi, Masayuki, primary, Ogawara, Yoko, primary, Shima, Yutaka, primary, Yamagata, Kazutsune, primary, Katsumoto, Takuo, primary, Hattori, Ayuna, primary, Itoh, Masato, primary, Seki, Takahiko, primary, Nishiya, Yumi, primary, Nakamura, Koichi, primary, Suzuki, Kanae, primary, Imaoka, Tomoki, primary, Baba, Daichi, primary, Suzuki, Makoto, primary, Sampetrean, Oltea, primary, Saya, Hideyuki, primary, Ichimura, Koichi, primary, and Kitabayashi, Issay, primary

Published
2023
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6. Supplementary Tables from Discovery of a Novel ATP-Competitive MEK Inhibitor DS03090629 that Overcomes Resistance Conferred by BRAF Overexpression in BRAF-Mutated Melanoma

Author

Takano, Kohei, primary, Munehira, Yoichi, primary, Hatanaka, Mana, primary, Murakami, Ryo, primary, Shibata, Yoshihiro, primary, Shida, Takeshi, primary, Takeuchi, Kosuke, primary, Takechi, Sho, primary, Tabata, Toshiki, primary, Shimada, Takashi, primary, Kishikawa, Shuhei, primary, Matsui, Yumi, primary, Ubukata, Osamu, primary, Seki, Takahiko, primary, and Kaneta, Yasuyuki, primary

Published
2023
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7. Supplementary Figures from Discovery of a Novel ATP-Competitive MEK Inhibitor DS03090629 that Overcomes Resistance Conferred by BRAF Overexpression in BRAF-Mutated Melanoma

Author

Takano, Kohei, primary, Munehira, Yoichi, primary, Hatanaka, Mana, primary, Murakami, Ryo, primary, Shibata, Yoshihiro, primary, Shida, Takeshi, primary, Takeuchi, Kosuke, primary, Takechi, Sho, primary, Tabata, Toshiki, primary, Shimada, Takashi, primary, Kishikawa, Shuhei, primary, Matsui, Yumi, primary, Ubukata, Osamu, primary, Seki, Takahiko, primary, and Kaneta, Yasuyuki, primary

Published
2023
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8. Supplementary Methods from Discovery of a Novel ATP-Competitive MEK Inhibitor DS03090629 that Overcomes Resistance Conferred by BRAF Overexpression in BRAF-Mutated Melanoma

Author

Takano, Kohei, primary, Munehira, Yoichi, primary, Hatanaka, Mana, primary, Murakami, Ryo, primary, Shibata, Yoshihiro, primary, Shida, Takeshi, primary, Takeuchi, Kosuke, primary, Takechi, Sho, primary, Tabata, Toshiki, primary, Shimada, Takashi, primary, Kishikawa, Shuhei, primary, Matsui, Yumi, primary, Ubukata, Osamu, primary, Seki, Takahiko, primary, and Kaneta, Yasuyuki, primary

Published
2023
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9. Data from A Potent Blood–Brain Barrier-Permeable Mutant IDH1 Inhibitor Suppresses the Growth of Glioblastoma with IDH1 Mutation in a Patient-Derived Orthotopic Xenograft Model

Author

Machida, Yukino, primary, Nakagawa, Makoto, primary, Matsunaga, Hironori, primary, Yamaguchi, Masayuki, primary, Ogawara, Yoko, primary, Shima, Yutaka, primary, Yamagata, Kazutsune, primary, Katsumoto, Takuo, primary, Hattori, Ayuna, primary, Itoh, Masato, primary, Seki, Takahiko, primary, Nishiya, Yumi, primary, Nakamura, Koichi, primary, Suzuki, Kanae, primary, Imaoka, Tomoki, primary, Baba, Daichi, primary, Suzuki, Makoto, primary, Sampetrean, Oltea, primary, Saya, Hideyuki, primary, Ichimura, Koichi, primary, and Kitabayashi, Issay, primary

Published
2023
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10. Data from Discovery of a Novel ATP-Competitive MEK Inhibitor DS03090629 that Overcomes Resistance Conferred by BRAF Overexpression in BRAF-Mutated Melanoma

Author

Takano, Kohei, primary, Munehira, Yoichi, primary, Hatanaka, Mana, primary, Murakami, Ryo, primary, Shibata, Yoshihiro, primary, Shida, Takeshi, primary, Takeuchi, Kosuke, primary, Takechi, Sho, primary, Tabata, Toshiki, primary, Shimada, Takashi, primary, Kishikawa, Shuhei, primary, Matsui, Yumi, primary, Ubukata, Osamu, primary, Seki, Takahiko, primary, and Kaneta, Yasuyuki, primary

Published
2023
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11. Supplementary Materials and Methods from A Potent Blood–Brain Barrier-Permeable Mutant IDH1 Inhibitor Suppresses the Growth of Glioblastoma with IDH1 Mutation in a Patient-Derived Orthotopic Xenograft Model

Author

Machida, Yukino, primary, Nakagawa, Makoto, primary, Matsunaga, Hironori, primary, Yamaguchi, Masayuki, primary, Ogawara, Yoko, primary, Shima, Yutaka, primary, Yamagata, Kazutsune, primary, Katsumoto, Takuo, primary, Hattori, Ayuna, primary, Itoh, Masato, primary, Seki, Takahiko, primary, Nishiya, Yumi, primary, Nakamura, Koichi, primary, Suzuki, Kanae, primary, Imaoka, Tomoki, primary, Baba, Daichi, primary, Suzuki, Makoto, primary, Sampetrean, Oltea, primary, Saya, Hideyuki, primary, Ichimura, Koichi, primary, and Kitabayashi, Issay, primary

Published
2023
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12. Supplemental File 3 from Predictive Gene Signatures Determine Tumor Sensitivity to MDM2 Inhibition

Author

Ishizawa, Jo, primary, Nakamaru, Kenji, primary, Seki, Takahiko, primary, Tazaki, Koichi, primary, Kojima, Kensuke, primary, Chachad, Dhruv, primary, Zhao, Ran, primary, Heese, Lauren, primary, Ma, Wencai, primary, Ma, Man Chun John, primary, DiNardo, Courtney, primary, Pierce, Sherry, primary, Patel, Keyur P., primary, Tse, Archie, primary, Davis, R. Eric, primary, Rao, Arvind, primary, and Andreeff, Michael, primary

Published
2023
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13. Supplemental File 1 from Predictive Gene Signatures Determine Tumor Sensitivity to MDM2 Inhibition

Author

Ishizawa, Jo, primary, Nakamaru, Kenji, primary, Seki, Takahiko, primary, Tazaki, Koichi, primary, Kojima, Kensuke, primary, Chachad, Dhruv, primary, Zhao, Ran, primary, Heese, Lauren, primary, Ma, Wencai, primary, Ma, Man Chun John, primary, DiNardo, Courtney, primary, Pierce, Sherry, primary, Patel, Keyur P., primary, Tse, Archie, primary, Davis, R. Eric, primary, Rao, Arvind, primary, and Andreeff, Michael, primary

Published
2023
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14. Supplemental File 2 from Predictive Gene Signatures Determine Tumor Sensitivity to MDM2 Inhibition

Author

Ishizawa, Jo, primary, Nakamaru, Kenji, primary, Seki, Takahiko, primary, Tazaki, Koichi, primary, Kojima, Kensuke, primary, Chachad, Dhruv, primary, Zhao, Ran, primary, Heese, Lauren, primary, Ma, Wencai, primary, Ma, Man Chun John, primary, DiNardo, Courtney, primary, Pierce, Sherry, primary, Patel, Keyur P., primary, Tse, Archie, primary, Davis, R. Eric, primary, Rao, Arvind, primary, and Andreeff, Michael, primary

Published
2023
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15. Supplemental Information from Predictive Gene Signatures Determine Tumor Sensitivity to MDM2 Inhibition

Author

Ishizawa, Jo, primary, Nakamaru, Kenji, primary, Seki, Takahiko, primary, Tazaki, Koichi, primary, Kojima, Kensuke, primary, Chachad, Dhruv, primary, Zhao, Ran, primary, Heese, Lauren, primary, Ma, Wencai, primary, Ma, Man Chun John, primary, DiNardo, Courtney, primary, Pierce, Sherry, primary, Patel, Keyur P., primary, Tse, Archie, primary, Davis, R. Eric, primary, Rao, Arvind, primary, and Andreeff, Michael, primary

Published
2023
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16. Data from Predictive Gene Signatures Determine Tumor Sensitivity to MDM2 Inhibition

Author

Ishizawa, Jo, primary, Nakamaru, Kenji, primary, Seki, Takahiko, primary, Tazaki, Koichi, primary, Kojima, Kensuke, primary, Chachad, Dhruv, primary, Zhao, Ran, primary, Heese, Lauren, primary, Ma, Wencai, primary, Ma, Man Chun John, primary, DiNardo, Courtney, primary, Pierce, Sherry, primary, Patel, Keyur P., primary, Tse, Archie, primary, Davis, R. Eric, primary, Rao, Arvind, primary, and Andreeff, Michael, primary

Published
2023
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20. Discovery of a Novel ATP-Competitive MEK Inhibitor DS03090629 that Overcomes Resistance Conferred by BRAF Overexpression in BRAF-Mutated Melanoma

Author

Takano, Kohei, primary, Munehira, Yoichi, additional, Hatanaka, Mana, additional, Murakami, Ryo, additional, Shibata, Yoshihiro, additional, Shida, Takeshi, additional, Takeuchi, Kosuke, additional, Takechi, Sho, additional, Tabata, Toshiki, additional, Shimada, Takashi, additional, Kishikawa, Shuhei, additional, Matsui, Yumi, additional, Ubukata, Osamu, additional, Seki, Takahiko, additional, and Kaneta, Yasuyuki, additional

Published
2023
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24. Enhanced TP53 Reactivation Disrupts MYC Transcriptional Program and Overcomes Venetoclax Resistance in Acute Myeloid Leukemias

Author

Nishida, Yuki, primary, Ishizawa, Jo, additional, Ayoub, Edward, additional, Patsilevas, Tallie, additional, Ostermann, Lauren, additional, Heinz Montoya, Rafael, additional, Muftuoglu, Muharrum, additional, Ruvolo, Vivian R., additional, Mak, Po Yee, additional, Tao, Wenjing, additional, Carter, Bing Z., additional, Scruggs, Darah A., additional, Kojima, Kensuke, additional, Daver, Naval, additional, Seki, Takahiko, additional, Shacham, Sharon, additional, Konopleva, Marina, additional, and Andreeff, Michael, additional

Published
2022
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25. Enhanced p53 Activation By Dual Inhibition of MDM2 and XPO1 Disrupts MYC Transcriptional Program and Restores Sensitivity to BCL-2 Inhibition in Ven/HMA Resistant AML

Author

Nishida, Yuki, primary, Ishizawa, Jo, additional, Ayoub, Edward, additional, Patsilevas, Tallie, additional, Ostermann, Lauren, additional, Montoya, Rafael Heinz, additional, Muftuoglu, Muharrem, additional, Ruvolo, Vivian, additional, Mak, Po Yee, additional, Tao, Wenjing, additional, Carter, Bing Z, additional, Kojima, Kensuke, additional, Daver, Naval, additional, Lesegretain, Arnaud, additional, Seki, Takahiko, additional, Shacham, Sharon, additional, Konopleva, Marina, additional, and Andreeff, Michael, additional

Published
2021
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27. A Potent Blood–Brain Barrier-Permeable Mutant IDH1 Inhibitor Suppresses the Growth of Glioblastoma with IDH1 Mutation in a Patient-Derived Orthotopic Xenograft Model

Author

Machida, Yukino, primary, Nakagawa, Makoto, additional, Matsunaga, Hironori, additional, Yamaguchi, Masayuki, additional, Ogawara, Yoko, additional, Shima, Yutaka, additional, Yamagata, Kazutsune, additional, Katsumoto, Takuo, additional, Hattori, Ayuna, additional, Itoh, Masato, additional, Seki, Takahiko, additional, Nishiya, Yumi, additional, Nakamura, Koichi, additional, Suzuki, Kanae, additional, Imaoka, Tomoki, additional, Baba, Daichi, additional, Suzuki, Makoto, additional, Sampetrean, Oltea, additional, Saya, Hideyuki, additional, Ichimura, Koichi, additional, and Kitabayashi, Issay, additional

Published
2020
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29. A high fill factor and progressive scan PtSi Schottky-barrier IR-CCD image sensor using new wiring technology

Author

Tohyama, Shigeru, Masubuchi, Kouichi, Konuma, Kazuo, Azuma, Hiromi, Tanabe, Akihito, Utsumi, Hiroaki, Teranishi, Nobukazu, Takano, Eiji, Yamagata, Shigeki, Hijikawa, Minoru, Sahara, Hirokazu, Muramatsu, Toshio, Seki, Takahiko, Ono, Takeshi, and Goto, Hideki

Subjects
Image processing -- Equipment and supplies, Sensors -- Research, Business, Electronics, Electronics and electrical industries
Abstract

New wiring technology, known as CLOSE Wiring, is used to make high fill factor and a progressive scan PtSi Schottky-barrier IR-CCD image sensor. A 64.4% fill factor is obtained, in a 30 by 30 micro m pixel, a 3.9 by 3.9 mm image area and a 5.5 by 5.5 mm chip size, using this image sensor. A charge of 9.8 multiplied by 10 to 5th power can be managed by a 3.3 micro m wide vertical CCD. With a 50 mm f/1.3 lens and operating at 120 frames/sec the noise equivalent temperature difference is 0.099 K.

Published
1995

32. Predictive Gene Signatures Determine Tumor Sensitivity to MDM2 Inhibition

Author

Ishizawa, Jo, primary, Nakamaru, Kenji, additional, Seki, Takahiko, additional, Tazaki, Koichi, additional, Kojima, Kensuke, additional, Chachad, Dhruv, additional, Zhao, Ran, additional, Heese, Lauren, additional, Ma, Wencai, additional, Ma, Man Chun John, additional, DiNardo, Courtney, additional, Pierce, Sherry, additional, Patel, Keyur P., additional, Tse, Archie, additional, Davis, R. Eric, additional, Rao, Arvind, additional, and Andreeff, Michael, additional

Published
2018
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33. Discovery of Predictive Gene Signatures for Tumor Sensitivity to MDM2 Inhibition in Development of a Novel MDM2 Inhibitor DS-3032b

Author

Ishizawa, Jo, primary, Nakamaru, Kenji, additional, Seki, Takahiko, additional, Tazaki, Koichi, additional, Kojima, Kensuke, additional, Chachad, Dhruv, additional, DiNardo, Courtney D, additional, Pierce, Sherry, additional, Patel, Keyur P., additional, Tse, Archie, additional, Davis, R Eric, additional, Rao, Arvind, additional, and Andreeff, Michael, additional

Published
2016
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39. Abstract 3101: The mutant IDH1 inhibitor prevents growth of glioblastoma with IDH1 mutation in patient-derived xenograft (PDX) model

Author

Yukino Machida, Yoko Ogawara, Hironori Matsunaga, Kazushi Araki, Seki Takahiko, Koichi Ichimura, and Issay Kitabayashi

Subjects
Cancer Research, IDH1, business.industry, Mutant, medicine.disease, 03 medical and health sciences, 0302 clinical medicine, Oncology, 030220 oncology & carcinogenesis, IDH1 Mutation, Cancer research, Medicine, In patient, business, 030217 neurology & neurosurgery, Glioblastoma
Abstract

Mutations in isocitrate dehydrogenase (IDH) 1 and 2 are frequently observed in acute myeloid leukemia (AML), glioma, and many other cancers. While wild-type IDHs convert isocitrate to α-ketoglutarate (α-KG), mutant IDHs convert α-KG to oncometabolite 2-hydroxyglutarate (2-HG), which dysregulates a set of α-KG-dependent dioxygenases, such as TETs, histone demethylases, EGLNs, and other enzymes. Because the role of mutant IDH is not necessary for normal cells, inhibitors directed against mutant IDH are expected to have minimum side effects as those of anti-cancer agents. We established a mouse AML model harboring IDH mutations by co-transducing four mutant genes that frequently occur simultaneously in human AML patients. Conditional deletion of the IDH mutant blocked 2HG production and maintenance of leukemia stem cells, resulting in survival of the AML mice. These results indicate that the IDH mutations are critical for the development and maintenance of AML stem cells. Based on these findings, we developed potent and specific inhibitors of mutant IDH1 and tested their effects on the mutant IDH1-dependent AML mouse model, created by introducing four mutant genes including mutant IDH1. The 2HG level was promptly and dramatically decreased in AML cells soon after treatment with the mutant IDH1 inhibitors, and the number of leukemia cells was reduced after a 4-week treatment. To test the effect of the mutant IDH1 inhibitor on glioblastoma, we have established a patient-derived xenograft (PDX) model of glioblastoma carrying IDH1 mutation, and tested the effect of the mutant IDH1 inhibitor on this model. The inhibitor reduced 2HG levels in tumors as well as in plasma. The inhibitor prevented the growth of the tumors with IDH1 mutation. On the other hand, the inhibitor did not affect the growth of the glioblastoma with wild type IDH1. Gene expression analysis identified a set of genes, of which expressions is changed by the IDH1 inhibitor. The most strongly upregulated gene is Glial fibrillary acidic protein (GFAP), which is a differentiation marker for astrocytes. Up-regulation of GFAP is confirmed by immune-staining and quantitative RT-PCR analyses. These results suggest that IDH inhibitor induces differentiation of the glioblastoma with IDH1 mutation. We have found that the glioblastoma is transplantable in mouse brain. We are now looking at effects of the inhibitor on this model. Taken together, the results indicate that IDH1 mutant inhibitors are effective for the treatment for AML as well as glioblastoma with IDH1 mutations. Citation Format: Yukino Machida, Yoko Ogawara, Koichi Ichimura, Hironori Matsunaga, Seki Takahiko, Kazushi Araki, Issay Kitabayashi. The mutant IDH1 inhibitor prevents growth of glioblastoma with IDH1 mutation in patient-derived xenograft (PDX) model. [abstract]. In: Proceedings of the 107th Annual Meeting of the American Association for Cancer Research; 2016 Apr 16-20; New Orleans, LA. Philadelphia (PA): AACR; Cancer Res 2016;76(14 Suppl):Abstract nr 3101.

Published
2016

45. Bloom Helicase and DNA Topoisomerase IIIα Are Involved in the Dissolution of Sister Chromatids

Author

Seki, Masayuki, primary, Nakagawa, Takayuki, additional, Seki, Takahiko, additional, Kato, Genta, additional, Tada, Shusuke, additional, Takahashi, Yuriko, additional, Yoshimura, Akari, additional, Kobayashi, Takayuki, additional, Aoki, Ayako, additional, Otsuki, Makoto, additional, Habermann, Felix A., additional, Tanabe, Hideyuki, additional, Ishii, Yutaka, additional, and Enomoto, Takemi, additional

Published
2006
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46. Ubc9 Is Essential for Viability of Higher Eukaryotic Cells

Author

Hayashi, Tomoko, primary, Seki, Masayuki, additional, Maeda, Daisuke, additional, Wang, Wensheng, additional, Kawabe, Yoh-ichi, additional, Seki, Takahiko, additional, Saitoh, Hisato, additional, Fukagawa, Tatsuo, additional, Yagi, Hideki, additional, and Enomoto, Takemi, additional

Published
2002
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