NEWARK, Delaware, U.S.A. and NANJING, China, December 2, 2022——Biosion’s partner, Pyxis Oncology (NASDAQ:PYXS) announced that it has received clearance for its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate Phase 1 clinical trials. PYX-106 (BSI-060T), a fully human anti-Siglec-15 monoclonal antibody, will be investigated for the potential treatment of solid tumors, including bladder, cholangio-carcinoma, colorectal, and kidney cancer. The first-in-human trial will be a dose escalation trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with tumors in order to determine the recommended phase 2 dose.
BSI-060T is a humanized anti-Siglec-15 monoclonal antibody, discovered through Biosion’s H3 (high-throughput, high-content, high-efficiency) antibody discovery platform. Data from anti-Siglec-15 preclinical studies show that BSI-060T has high affinity, high cell binding and activity, dose-proportional activity on reducing immunosuppression of Siglec-15 on T cells and long half-life that will allow BSI-060T to become a best-in-class mAb in the treatment of solid tumors. It has been shown that Siglec-15, an immune suppressor and potential target, shares little overlap with the most prominent IO targets, the PD-1/PDL-1 pathway. The antibody's strong activity and its target's unique expression suggest that BSI-060T could be valuable in both mono and combination treatment settings for a broad range of tumors.
In March 2022, Biosion and Pyxis Oncology entered into an agreement under which Pyxis Oncology was granted an exclusive license to develop and commercialize Biosion’s anti-Siglec-15 monoclonal antibody, BSI-060T (PYX-106), world-wide, excluding Greater China. Under the terms of the agreement, Biosion received a $10 million up-front license fee from Pyxis Oncology. In addition to the up-front payment, Biosion has the potential to receive significant milestone payments for PYX-106, totaling up to $222.5 million and single to low double-digit royalties on commercial sales.
About Biosion, Inc. Biosion is a global, clinical-stage biotechnology company committed to developing antibody-based therapies to improve patient outcomes for the treatment of immune and oncologic diseases. Established in 2017, Biosion has built a pipeline of innovative biologics through its internally derived proprietary technologies including the H³ antibody discovery platform, SynTracer™ HT endocytosis platform, and Flexibody™ bispecific platform. Biosion’s lead asset, BSI-045B (anti-TSLP mAb), is currently in phase-II for severe asthma and phase-I for atopic dermatitis. Biosion and partners have plans to progress the immune-oncology and antibody drug conjugate-based portfolio into clinic trials for oncology indications over the next year. Biosion has operations in the US, Australia, and China. To learn more about Biosion, please go to www.biosion.com.
About Pyxis Oncology, Inc. Pyxis Oncology, Inc. is a clinical stage company focused on defeating difficult-to-treat cancers. The company is efficiently building next-generation therapeutics that hold the potential for mono and combination therapies. Pyxis Oncology’s therapeutic candidates are designed to directly kill tumor cells and to address the underlying pathologies created by cancer that enable its uncontrollable proliferation and immune evasion. Pyxis Oncology’s antibody-drug conjugates (ADCs) and immuno-oncology (IO) programs employ novel and emerging strategies to target a broad range of solid tumors resistant to current standards of care. To learn more, visit www.pyxisoncology.com or follow us on Twitter and LinkedIn.
BIOSION ALL RIGHTS RESERVED.
NEWARK, Delaware, U.S.A. and NANJING, China, December 2, 2022——Biosion’s partner, Pyxis Oncology (NASDAQ:PYXS) announced that it has received clearance for its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate Phase 1 clinical trials. PYX-106 (BSI-060T), a fully human anti-Siglec-15 monoclonal antibody, will be investigated for the potential treatment of solid tumors, including bladder, cholangio-carcinoma, colorectal, and kidney cancer. The first-in-human trial will be a dose escalation trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in patients with tumors in order to determine the recommended phase 2 dose.
BSI-060T is a humanized anti-Siglec-15 monoclonal antibody, discovered through Biosion’s H3 (high-throughput, high-content, high-efficiency) antibody discovery platform. Data from anti-Siglec-15 preclinical studies show that BSI-060T has high affinity, high cell binding and activity, dose-proportional activity on reducing immunosuppression of Siglec-15 on T cells and long half-life that will allow BSI-060T to become a best-in-class mAb in the treatment of solid tumors. It has been shown that Siglec-15, an immune suppressor and potential target, shares little overlap with the most prominent IO targets, the PD-1/PDL-1 pathway. The antibody's strong activity and its target's unique expression suggest that BSI-060T could be valuable in both mono and combination treatment settings for a broad range of tumors.
In March 2022, Biosion and Pyxis Oncology entered into an agreement under which Pyxis Oncology was granted an exclusive license to develop and commercialize Biosion’s anti-Siglec-15 monoclonal antibody, BSI-060T (PYX-106), world-wide, excluding Greater China. Under the terms of the agreement, Biosion received a $10 million up-front license fee from Pyxis Oncology. In addition to the up-front payment, Biosion has the potential to receive significant milestone payments for PYX-106, totaling up to $222.5 million and single to low double-digit royalties on commercial sales.
About Biosion, Inc. Biosion is a global, clinical-stage biotechnology company committed to developing antibody-based therapies to improve patient outcomes for the treatment of immune and oncologic diseases. Established in 2017, Biosion has built a pipeline of innovative biologics through its internally derived proprietary technologies including the H³ antibody discovery platform, SynTracer™ HT endocytosis platform, and Flexibody™ bispecific platform. Biosion’s lead asset, BSI-045B (anti-TSLP mAb), is currently in phase-II for severe asthma and phase-I for atopic dermatitis. Biosion and partners have plans to progress the immune-oncology and antibody drug conjugate-based portfolio into clinic trials for oncology indications over the next year. Biosion has operations in the US, Australia, and China. To learn more about Biosion, please go to www.biosion.com.
About Pyxis Oncology, Inc. Pyxis Oncology, Inc. is a clinical stage company focused on defeating difficult-to-treat cancers. The company is efficiently building next-generation therapeutics that hold the potential for mono and combination therapies. Pyxis Oncology’s therapeutic candidates are designed to directly kill tumor cells and to address the underlying pathologies created by cancer that enable its uncontrollable proliferation and immune evasion. Pyxis Oncology’s antibody-drug conjugates (ADCs) and immuno-oncology (IO) programs employ novel and emerging strategies to target a broad range of solid tumors resistant to current standards of care. To learn more, visit www.pyxisoncology.com or follow us on Twitter and LinkedIn.
BIOSION ALL RIGHTS RESERVED.