Announcement of identification of the highly potent small molecule drug candidates targeting a novel kinase and decision of pursuing clinical development

On July 31, 2013 OncoTherapy Science reported that OncoTherapy has identified novel highly potent small molecule drug candidates for a novel kinase target and has decided to pursue clinical development (Press release OncoTherapy Science, JUL 31, 2013, View Source [SID:1234500750]). OncoTherapy has been developing small molecule inhibitors for several novel targets that had been discovered with the genome-wide expression profile analysis. Recently, OncoTherapy has identified novel small molecule compounds including OTS964 that specifically inhibit a novel kinase target and decided to pursue clinical development of them. This novel kinase is totally different from MELK (maternal embryonic leucine zipper kinase) for which US Food and Drug Administration (FDA) has already accepted Phase I clinical trial with the MELK inhibitor OTS167. This novel kinase is not expressed in the important vital organs at all, but highly up-regulated in various types of cancers such as the lung cancer, and plays an important role in tumor growth. These highly potent small molecule drug candidates including OTS964 which specifically inhibit the novel kinase showed striking anti-tumor effects against human lung and bladder cancers in animal studies, and are therefore expected to show potent anti-tumor effects in human. This drug candidate is our second small molecule drug candidate, following OTS167. OncoTherapy does make every effort to develop this candidate, based on our mission "To develop anti-cancer medicine and cancer therapy with high efficacy and minimum risk of adverse events, and to win the war against cancer". The impact of this identification on our consolidated business performance is immaterial.

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Bristol-Myers Squibb and Samsung BioLogics Announce Biopharmaceutical Manufacturing Relationship

On July 29, 2023 Bristol-Myers Squibb Company (NYSE:BMY) and Samsung BioLogics reported the companies have entered into a 10-year agreement under which Samsung BioLogics will manufacture a commercial antibody cancer drug for Bristol-Myers Squibb at its recently completed plant in Songdo Incheon, South Korea (Press release, Bristol-Myers Squibb, JUL 29, 2013, View Source [SID1234635229]).

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Financial terms were not disclosed. Technology transfer and trial production will commence in July 2013 and commercial production will immediately begin following regulatory approvals.

"We are pleased to announce this strategic manufacturing relationship with Bristol-Myers Squibb and look forward to delivering best-in-class manufacturing services with the highest global quality standards," said Tae-Han Kim, president and CEO of Samsung BioLogics. "The relationship with Bristol-Myers Squibb represents the validation of our long-term commitment to the biopharmaceutical manufacturing industry."

"Our agreement with Samsung is an important part of our company’s overall manufacturing and supply strategy focused on creating long-term relationships with high quality manufacturing partners around the world," said Louis Schmukler, president, Global Manufacturing & Supply, Bristol-Myers Squibb. "This agreement increases our biologic manufacturing capacity to help ensure sufficient long-term supply of our commercial products."

Immunocore and Genentech enter strategic alliance

On 27 June 2013 Immunocore reported that it has entered into a research collaboration and licensing agreement with Genentech, a member of the Roche Group for the discovery and development of multiple novel cancer targets using Immunocore’s ImmTAC technology (Press release, Immunocore, JUL 27, 2013, View Source [SID1234518787]).

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Under the terms of the agreement, Immunocore will receive an initiation fee of between $10 and $20 million per programme and is eligible to receive in excess of $300 million in development and commercial milestone payments for each target programme and significant tiered royalties.

(Press release, TNI BioTech, JUL 24, 2013, View Source [SID:1234507316])

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Application Seeking Approval for Additional Indication for ATL, PTCL and CTCL of Mogamulizumab

On July 19, 2013 Kyowa Hakko Kirin reported that it has been filed an application to Japan’s Ministry of Health, Labour and Welfare (MHLW) seeking approval for additional indication for untreated CCR4-positive adult T-cell leukemia-lymphoma (ATL), relapsed CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) of Mogamulizumab (brand name: POTELIGEO Injection 20 mg) (Press release , JUL 19, 2013, View Source [SID:1234500288]).

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Mogamulizumab is a novel, humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4), which is over-expressed on various malignant T cells, including ATL, PTCL and CTCL cells. Engineered by Kyowa Hakko Kirin’s unique POTELLIGENT Technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity (ADCC). Clinical studies of Mogamulizumab in patients with untreated CCR4-positive ATL, relapsed CCR4-positive PTCL and CTCL in Japan met their primary endpoint, which allowed Kyowa Hakko Kirin to file an application. Mogamulizumab was also granted orphan drug designations for the treatment of CCR4-positive ATL in August 2010, PTCL and CTCL in March 2013 by the MHLW.
Mogamulizumab was launched in Japan with the brand name "POTELIGIO Injection 20 mg" on May 29, 2012 for the treatment of patients with relapsed or refractory CCR4-positive ATL and is being investigated world-wide in a number of clinical studies for other potential indications.