On April 28, 2023 Hangzhou Sumgen Biotech Co., Ltd. (hereinafter referred to as "Sumgen Biotech"), an innovation-driven biopharmaceutical company, and Yantai MabPlex International Ltd. (hereinafter referred to as "MabPlex"), a global CDMO service provider, jointly reported a strategic collaboration agreement with regard to Sumgen’s SG301 in Yantai (Press release, Sumgen Biotech, APR 28, 2023, View Source;a=nav&id=347 [SID1234656266]). According to the agreement, MabPlex will integrate its internal resources to coordinate with the clinical and commercial developmentalignment of SG301, providing formulated solutions including manufacturing and process characterization & validation of batches during pivotal clinical studiesand mass production after NDA/BLA approval.

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Dr. Shiwei Miao, co-founder of Sumgen Biotech, and Dr. Xinfang Li, CEO of MabPlex, along with representatives from both parties, attended the signing ceremony.

Dr. Shiwei Miao, co-founder of Sumgen Biotech, stated: "MabPlex is an important partner for Sumgen Biotech. Over the past three years of collaboration, MabPlex has assisted Sumgen Biotech in completing IND applications and early-stageclinical sample production for five antibody/ADC candidates, including SG301, SG2501, SG1906, SG301SC, and SG2918. MabPlex’s professional and compliant technical capabilities, along with their efficient and customer-centric service philosophy, have left a profound impression on the Sumgen team. We appreciate the efforts of the MabPlex team! Sumgen Biotech has always adhered to a development strategy of win-win cooperation, actively exploring innovative treatment solutions to ensure that patients worldwide can access affordable biopharmaceuticals of international standards. This strategic collaboration marks another significant step forward in the commercial development process of the SG301 ."

Dr. Xinfang Li, CEO of MabPlex, stated: "We appreciate the trust from Sumgen Biotech! As a comprehensive CDMO service provider, MabPlex remains committed to contributing to the global biopharmaceutical development. We wish the projects of Sumgen Biotech smooth progress in clinical research and hope they can provide new treatment options for more cancer patients soon."

On April 28, 2023 Kirilys Therapeutics, Inc., a multi-asset biotechnology company founded by investment firm Catalys Pacific and supported by Lightspeed Venture Partners, reported the Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase 1 clinical study of KRLS-017, a potentially best in class reversible small molecule inhibitor of Cyclin Dependent Kinase 7 (CDK7) (Press release, Kirilys Therapeutics, APR 28, 2023, View Source [SID1234638426]).

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CDK7 plays a key role in control of both cell cycle and gene transcription, and dysregulation of CDK7 has been documented as a negative prognostic indicator across a broad spectrum of tumor types. The Phase 1 clinical trial of KRLS-017 is planned as a monotherapy, open-label, safety and PK/PD study for patients with treatment refractory solid tumors. The primary objective of the Phase 1a dose escalation portion of the trial is to evaluate safety and tolerability of KRS-017. Following establishment of a recommended Phase 2 dose and schedule from Phase 1a, Kirilys plans an indication-specific cohort expansion that will include breast, ovarian and potentially other transcriptionally active tumor types to evaluate anti-tumor activity.

On April 28, 2023 Imugene reported its Quarterly Activities and Cash Flow Report for Quarter ended 31 March 2023(Presentation, Imugene, APR 28, 2023, View Source [SID1234633364]).

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On April 28, 2023 Kazia Therapeutics, an oncologyf ocused drug development company, reported an update on the ongoing development of its product candidates for the quarter ending 31 March 2023 (Press release, Kazia Therapeutics, APR 28, 2023, View Source [SID1234633086]).

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On April 28, 2023 Starpharma reported its Quarterly Activities Report and Appendix 4C for the period ended 31 March 2023 (Q3 FY23) (Press release, Starpharma, APR 28, 2023, View Source [SID1234633039]). Starpharma’s net operating cash outflows for the quarter were $4.9 million, and the closing cash balance as at 31 March 2023 was $38.9 million.

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