A Randomised, Double-Blind, Phase 1b/2a, Placebo-Controlled, Single Dose Study to Evaluate Safety, Tolerability, and Efficacy of YQ23 in Adult Patients With Critical Limb Ischaemia

This is an early phase study to assess how safe and tolerable is the new study drug YQ23 and to compare the effectiveness of YQ23 against normal saline to treat critical limb ischaemia. The study also aims to understand how it affects the body and an optional substudy to assess how the human body takes up, breaks down, and clears the study drug.
Eligible patients will be randomised to have a 2:1 chance to receive a single, intravenous, fixed dose of YQ23 or normal saline. Neither the patient nor the study site will know which treatment has been given.
On the day of YQ23 administration, patients will be asked to stay in the study site for 3 days for safety observation. After discharge, they will be required to visit the study clinic for 3 times in a year to continue safety monitoring and assessment of treatment effect.
Each subject's participation will be about 13 months after signing the informed consent.

Start Date10 Mar 2021

Sponsor / Collaborator

New Beta Innovation Canada Ltd.

NCT04513067 / TerminatedPhase 1

A Phase Ib, Open-label, Dose-escalation Study of YQ23 as a Single Agent and in Combination With Pembrolizumab Administered to Patients With Advanced Solid Tumors

This is an early phase dose escalation study which is divided into two stages: (1) Single agent of the test drug YQ23, and (2) in combination with pembrolizumab administered to patients with advanced solid tumors.
The purpose of the study is find out the safety and tolerability profile, as well as maximum tolerated dose (MTD) of YQ23 as single agent (stage 1) and in combination with pembrolizumab (stage 2). Stage 2 will start only when the MTD of single agent YQ23 has been established in Stage 1.
The distribution of YQ23 in the blood, the tumor response to YQ23 (and pembrolizumab in stage 2), the change of some pre-defined biomarkers in the tumor tissues and blood, and the change of antibody response and its relationship with the disease response, safety and drug level in the blood will also be evaluated.
In stage 1, eligible patients will be given intravenous infusion of YQ23 weekly for 6 weeks. In stage 2, eligible patients will be also be given a fixed dose of pembrolizumab 200 mg on Day 1 and every 3 weeks thereafter in addition to the weekly dose of YQ23. Dose escalation decision will be made based on the safety data available for the 6 weeks study treatment(s).
Patients may continue study treatment(s) beyond 6 weeks if s/he tolerates the study drug(s) well, the disease does not get worse after first 6 doses and meet all treatment continuation criteria, as judged by the study doctor.

Start Date21 Aug 2020

Sponsor / Collaborator

New Beta Innovation Canada Ltd.

NCT03802292 / CompletedPhase 1

First-In-Man, Phase I, Single-Blind, Placebo-Controlled, Ascending Single Dose Study of Intravenous YQ23 in Healthy Male and Female Subjects to Assess Safety, Tolerability, and Pharmacokinetics

This study is to test the safety, tolerability, pharmacokinetics (PK-the amount of study drug in the blood), and immunogenicity (how the study drug affects the immune system) of single dose and dose levels of an investigational drug called YQ23.

Start Date16 Jan 2019

Sponsor / Collaborator

New Beta Innovation Canada Ltd.

100 Clinical Results associated with YQ23(New Beta Innovation Limited)

100 Translational Medicine associated with YQ23(New Beta Innovation Limited)

100 Patents (Medical) associated with YQ23(New Beta Innovation Limited)

Literatures (Medical) associated with YQ23(New Beta Innovation Limited)

01 Feb 2021·Translational cancer researchQ4 · MEDICINE

The anti-tumoral effects of the oxygen carrier YQ23 in a triple-negative breast cancer syngeneic model

Q4 · MEDICINE

Article

Author: Lam, Ian P Y ; Chow, Elysian ; Lau, Jonathan S H ; Wai, Terence

BACKGROUND:

Triple-negative breast cancer (TNBC), an aggressive breast cancer subtype, is associated with poor prognosis and high mortality rate. In the search for effective therapeutic options, preclinical studies have suggested using systemic oxygenation to inhibit tumor growth and metastasis in various cancer models, including TNBC, by weakening the hypoxia-A2A adenosine receptors (A2AR)-driven immunosuppression in the tumor microenvironment (TME). In our present study, a hemoglobin-based oxygen carrier (HBOC) "YQ23" was tested for its role in modulating the TME and tumor inhibition.

METHODS:

A syngeneic TNBC mouse model was established by inoculating 4T1 cells subcutaneously in BALB/c mice. Tumor (~100 mm³) bearing mice were treated either with saline or YQ23 (400 mg/kg) i.v. once weekly. To prove the immune-regulatory role of YQ23, CD4⁺ and CD8⁺ cells were depleted from a group of mice prior to treatment. Tumor growth was monitored for four weeks while xenografts were isolated at the end of the treatment for ex vivo immunohistological examination.

RESULTS:

YQ23 significantly inhibited the tumor growth, and this suppressive effect was abolished by depleting the host immune cells. Immunohistochemical staining of xenograft sections showed YQ23 reduced the level of hypoxia and adenosine producing ecto-enzyme CD73. Although there was no significant difference in the make up of the intra-tumoral immune populations, we observed a down-regulation of the immune checkpoint PD-1. In concordance with the weakened immunosuppression, the inflammatory cytokine interferon γ and cytolytic granzyme B were upregulated.

CONCLUSIONS:

YQ23 treatment may be a potential therapeutic strategy to modulate the TME in TNBC.

04 Dec 2019·Artificial cells, nanomedicine, and biotechnologyQ2 · ENGINEERING & TECHNOLOGY

A novel cross-linked haemoglobin-based oxygen carrier is beneficial to sepsis in rats

Q2 · ENGINEERING & TECHNOLOGY

ArticleOA

Author: Liu, Liangming ; Xue, Mingying ; Zhang, Jie ; Li, Tao ; Chen, Xiangyun ; Kuang, Lei ; Tian, Kunlun ; Wong, Bing Lou ; Wu, Yue ; Tzang, Fei Chuen ; Zhu, Yu ; Lau, Billi

Pathological hypoxia-induced organ dysfunction contributes to the high mortality of sepsis. Because of the microcirculation dysfunction following severe sepsis, it is difficult for erythrocytes to transport oxygen to hypoxic tissues. Haemoglobin-based oxygen carriers (HBOCs) are capable of delivering oxygen to hypoxic tissues. The aim of this study is to observe the potential benefits of a novel bovine-derived, non-polymerized, cell-free HBOC solution, YQ23, on sepsis in rats. Cecum ligation and puncture was performed to induce sepsis in Sprague-Dawley rats. Effects of Lactate Ringer's solution (LR), YQ23, and whole blood on oxygen delivery and consumption, mitochondrial function, organ protection and animal survival were observed. LR failed to restore oxygen delivery and the therapeutic effects were limited, whereas low dosage of YQ23 and whole blood significantly increased the tissue oxygen delivery and consumption, improved the mitochondrial function of heart, liver, kidney and intestine, prevented the vital organs injuries and improved the animal survival. The effects of 0.15 g·kg^-1 YQ23 resembled that of the whole blood. In addition, YQ23 did not induce renal toxicity, severe oxidative effect and acute vasoconstriction. Thus, YQ23 is a safe and effective resuscitation fluid for sepsis.

17 Oct 2017·Oncotarget

A hemoglobin-based oxygen carrier sensitized Cisplatin based chemotherapy in hepatocellular carcinoma

Article

Author: Geng, Wei ; Liu, Xiao Bing ; Ling, Chang Chun ; Li, Chang Xian ; Ma, Yuen Yuen ; Yeung, Wai Ho ; Kin-Wai Sun, Chris ; Shao, Yan ; Kwok, Sui Yi ; Liu, Hui ; Lo, Chung Mau ; Wong, Bing L. ; Lau, Sze Hang ; Man, Kwan ; Tak-Pan Ng, Kevin ; Liu, Jiang ; Qi, Xiang ; Tzang, Fei Chuen

Background and Objective:

Our previous study showed that liver graft injury not only promotes tumor recurrence, but also induces chemoresistance in recurrent HCC after liver transplantation. Recently, we found that the hemoglobin-based oxygen carrier"YQ23" significantly ameliorates hepatic IR injury and prevent tumor recurrence. Here, we intended to explore the novel therapeutic strategy using oxygen carrier "YQ23"to sensitize chemotherapy in HCC.

Methods:

To investigate the role of YQ23 combined with Cisplatin, the proliferation of HCC cells was examined under combined treatment by MTT and colony formation. To explore the effect of YQ23 on sensitization of Cisplatin based chemotherapy, the orthotopic liver cancer model was established. To characterize the delivery of YQ23 in tumor tissue, the intravital imaging system was applied for longitudinal observation in ectopic liver cancer model. The distribution of YQ23 was examined by IVIS spectrum.

Results:

YQ23 significantly suppressed the proliferation of HCC cells under Cisplatin treatment in a dose and time dependent manner. Moreover, YQ23 administration significantly sensitized Cisplatin based chemotherapy in orthotopic liver cancer model. Down-regulation of DHFR may be one of the reasons for YQ23 sensitizing Cisplatin based chemotherapy. Real-time intravital imaging showed that YQ23 accumulated in the tumor tissue and maintained as long as 3 days in ectopic liver cancer model. The IVIS spectrum examination showed that YQ23 distributed mainly at liver and bladder within the first 36 hours after administration in orthotopic liver cancer model.

Conclusion:

YQ23 treatment may be a potential therapeutic strategy to sensitize chemotherapy in HCC.

News (Medical) associated with YQ23(New Beta Innovation Limited)

07 Jun 2022

·www.prnewswire.com

Critical Limb Ischemia Market to Progress at a CAGR of 10.6% by 2030 | DelveInsight

The critical limb ischemia market is expected to expand with a rise in prevalence and the expected entry of emerging therapies into the 7MM markets. LAS VEGAS, June 7, 2022 /PRNewswire/ -- DelveInsight's critical limb ischemia market insights report includes a comprehensive understanding of current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted market size from 2018 to 2030, segmented into 7MM (the United States, the EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. Key Takeaways from the Critical Limb Ischemia Market According to DelveInsight estimates, the Critical Limb Ischemia market size in the 7MM was USD 1,519 million in 2020. As per analysis, the total critical limb ischemia diagnosed prevalent population in the 7MM was approximately 2 million in 2020. Key critical limb ischemia companies such as Boston Scientific Corporation, AnGes, Inc., Mitsubishi Tanabe Pharma, B. Braun Melsungen AG, Medtronic Endovascular, Ixaka Ltd (formerly Rexgenero), Mercator MedSystems, Inc, Hemostemix Inc., Caladrius Biosciences, Reven Pharmaceuticals, Inc., New Beta Innovation Limited, BioGenCell Ltd., Abbott Medical Devices, and others are developing novel drugs and technologies/devices, which can be available in the critical limb ischemia market in the upcoming years. The critical limb ischemia therapies/technologies/devices in the pipeline include REX-001, Temsirolimus Adventitial Delivery, Collategene, ACP-01, Honedra (CLBS12), RJX (Rejuveinix), YQ23, BGC101, Esprit BTK Device , and others. The increase in the critical limb ischemia market size directly impacts the increasing prevalent population of critical limb ischemia patients in the 7MM. Discover more about therapies that are set to grab major critical limb ischemia market share at critical limb ischemia market landscape Critical Limb Ischemia Critical limb ischemia is a clinical syndrome characterized by ischemic pain at rest and tissue loss, such as nonhealing ulcers or gangrene, caused by lower limb peripheral arterial disease (PAD). Critical limb ischemia is the final stage of PAD, and macrovascular lesions cause a decrease in distal perfusion. This disease drastically impairs nutrient blood flow to tissues and microcirculation exchange. Rutherford has traditionally characterized critical limb ischemia as rest pain (class 4), tissue loss (class 5), and gangrene (class 6). Rest discomfort is classified as class 3 in the Fontaine classification, and tissue loss or gangrene is classified as class 4 in the Fontaine classification. The threatened critical limb ischemia classification system was recently developed by the Society for Vascular Surgery Lower Extremity Guidelines Committee: Risk stratification based on wound, ischemia, and foot infection (WIfI). The critical limb ischemia life expectancy is around 1.23 years for men and 2.7 years for women. The most noticeable critical limb ischemia symptoms are ischemic rest pain — extreme pain in the legs and feet when a person is not moving or nonhealing sores on the feet or legs. Other critical limb ischemia symptoms include an absent or decreased pulse in the legs or feet, open sores, skin infections or nonhealing ulcers, toenail thickening, dry gangrene, shiny, smooth, dry skin of the legs or feet, and pain or numbness in the feet; other factors such as age, smoking, diabetes, high cholesterol, family history, etc. also contribute. Physical examination and noninvasive hemodynamic testing (ankle-brachial index [ABI]/ankle pressure [AP], toe-brachial index [TBI]/toe pressure [TP], imaging of vascular anatomy, duplex ultrasound imaging [DUS], computed tomography angiography [CTA], and others) can be used for critical limb ischemia diagnosis. Critical Limb Ischemia Epidemiology Segmentation In 2020, approximately 2 million critical limb ischemia diagnosed prevalent population was affected in the 7MM. Among EU5 countries, Germany had the highest critical limb ischemia diagnosed prevalence in 2020. The critical limb ischemia market report offers epidemiological analysis for the study period 2018–2030 in the 7MM segmented into: Total diagnosed prevalent cases of critical limb ischemia Age-specific diagnosed prevalent cases of critical limb ischemia Severity-specific diagnosed prevalent cases of critical limb ischemia Diagnosed prevalent cases of no-option critical limb ischemia Download the report to understand which factors are driving critical limb ischemia epidemiology trends at critical limb ischemia epidemiological insights Critical Limb Ischemia Treatment Market The basic aim of Critical Limb Ischemia treatment is pain relief, trophic lesion healing, avoiding high-level amputations, improving limb functionality and quality of life, and improving medium-term survival. These objectives call for an interdisciplinary approach. Revascularization is the most common and effective critical limb ischemia treatment option. Other approaches include the administration of analgesics, the treatment of infections, and the optimization of cardiac and pulmonary function. Patients with critical limb ischemia require monitoring and therapy for cardiovascular risk factors as much as any other patient with PAD. When revascularizing operations are not possible or have proven unsuccessful, prostanoids are utilized. Cell and gene therapies are gaining popularity as critical limb ischemia treatments for patients ineligible for endovascular or surgical revascularization. Several regeneration treatments, including angiogenic recombinant proteins, gene therapy, cell-based therapies (including stem or progenitor cells), and chemokines, have been studied in patients with PAD and nonrevascularizable critical limb ischemia. Collategene (HGF plasmid) is the only approved critical limb ischemia treatment in Japan. The company also intends to penetrate the US critical limb ischemia market. Furthermore, many cell therapies are being developed to target the population that is not appropriate for revascularization or has poor results following revascularization. To know about more Critical Limb Ischemia management, visit at critical limb ischemia guidelines Critical Limb Ischemia Pipeline Therapies/Technologies/Devices and Key Companies REX-001: Ixaka Ltd (formerly Rexgenero) Temsirolimus Adventitial Delivery: Mercator MedSystems, Inc. Collategene: Anges and Mitsubishi Tanabe Pharma ACP-01: Hemostemix Inc. Honedra (CLBS12): Caladrius Biosciences RJX (Rejuveinix): Reven Pharmaceuticals, Inc. YQ23: New Beta Innovation Limited BGC101: BioGenCell Ltd. Esprit BTK Device: Abbott Medical Devices Critical Limb Ischemia Market Dynamics The rising prevalence of diabetes due to an aging global population will boost the critical limb ischemia treatment options, resulting in critical limb ischemia market growth. Moreover, companies are actively developing critical limb ischemia drugs to address the disease's unmet requirements, despite the disease's low visibility and complexity. Except in Japan, there are no authorized pharmaceutical critical limb ischemia treatment alternatives, creating tremendous potential for investment and research for innovative drugs along with less competition. The present unmet need of the critical limb ischemia market is medications that are safer and more effective in providing an optimal cure. However, some factors restrain the critical limb ischemia market growth. The disease is being underdiagnosed and undertreated, resulting in greater morbidity, death, and costs. L ack of awareness and other similar diseases challenge the critical limb ischemia market's growth. Pricing and reimbursement rules that are strictly enforced also limit the growth of the critical limb ischemia market along with the failure of drugs in clinical development. Moreover, the availability of surgical procedures may make it difficult for innovative treatments to get a foothold. Scope of the Critical Limb Ischemia Market Report Study Period: 2018–2030 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Critical Limb Ischemia Companies: Boston Scientific Corporation , AnGes, Inc, Mitsubishi Tanabe Pharma, B. Braun Melsungen AG, Medtronic Endovascular, Ixaka Ltd (formerly Rexgenero), Mercator MedSystems, Inc, Hemostemix Inc., Caladrius Biosciences, Reven Pharmaceuticals, Inc., New Beta Innovation Limited, BioGenCell Ltd., Abbott Medical Devices, and others Key Critical Limb Ischemia Therapies/Technologies/Devices: REX-001, Temsirolimus Adventitial Delivery, Collategene, ACP-01, Honedra (CLBS12), RJX (Rejuveinix), YQ23, BGC101, Esprit BTK Device, and others Therapeutic Assessment: Critical Limb Ischemia current marketed and emerging therapies Critical Limb Ischemia Market Dynamics: Critical Limb Ischemia market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Critical Limb Ischemia Market Access and Reimbursement Discover more about the future critical limb ischemia market share of treatment therapies at critical limb ischemia treatment market Table of Contents Get in touch with our Business executive at Healthcare Due Diligence Services Related Reports Critical Limb Ischemia Epidemiology Critical Limb Ischemia Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical, and forecasted critical limb ischemia epidemiology in the 7MM. Critical Limb Ischemia Pipeline Critical Limb Ischemia Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key critical limb ischemia companies involved are Pluristem Therapeutics, Reven Pharmaceuticals, Inc., New Beta Innovation Limited, among others. Critical Limb Ischemia Market Critical Limb Ischemia Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key companies such as Boston Scientific Corporation, AnGes, Inc, Mitsubishi Tanabe Pharma, B. Braun Melsungen AG, among others. Peripheral Arterial Disease Epidemiology Peripheral Arterial Disease Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted peripheral arterial disease epidemiology in the 7MM. Peripheral Arterial Disease Pipeline Peripheral Arterial Disease Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products. The key companies are NovoNordisk, Takeda, Mercator MedSystems, Inc., among others. Peripheral Arterial Disease Market Peripheral Arterial Disease Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, and market barriers. The key companies are NovoNordisk, Takeda, Mercator MedSystems, Inc., among others. Other Trending Reports Degenerative Disc Disease (DDD) Market "Degenerative Disc Disease (DDD) Market" research report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the degenerative disc disease market size, share, and trends in the 7MM. Some of the key companies in the degenerative disc disease market are DiscGenics, Kuros Biosciences, Mesoblast, Ankasa Therapeutics, and others. Periodontal Disease Market "Periodontal Disease Market" research report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the periodontal disease market size, share, and trends in the 7MM. Some of the key companies in the periodontal disease market are D and D Pharmatech, Amyndas Pharmaceuticals, AngioLab, Denteric, Dexcel Pharma Technologies, Yuhan Corporation, and others. IgG4-related Disease Market "IgG4-Related Disease Market" research report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the IgG4-related disease market size, share, and trends in 7MM. Some of the key companies in the IgG4-related disease market are Bristol-Myers Squibb, Xencor, Principia Biopharma, Viela Bio, Horizon Therapeutics, and others. Nicotine Addiction Market "Nicotine Addiction Market" research report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the nicotine addiction market size, share, and trends in the 7MM. Some of the key companies in the nicotine addiction therapeutics market include Axsome Therapeutics, Achieve Life Sciences, Novo Nordisk, and others. Hairy Cell Leukemia (HCL) Market "Hairy Cell Leukemia (HCL) Market" report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the hairy cell leukemia (HCL) market size, share, and trends in the 7MM. Some of the key companies in the hairy cell leukemia (HCL) therapeutics market include AstraZeneca, Janssen, Merck, Pharmacyclics, Johnson and Johnson, Roche, Innate Pharma, and others. Hypereosinophilic Syndrome Market "Hypereosinophilic Syndrome Market" research report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the hypereosinophilic syndrome market size, share, and trends in 7MM. Some key companies in the hypereosinophilic syndrome market include AstraZeneca, GlaxoSmithKline, Knopp Biosciences, and others. Related Healthcare Blogs Heart Failure Market Upcoming Cardiovascular Diseases Drugs Key Companies in the Cardiology Segment About DelveInsight DelveInsight is a leading business consultant and market research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 SOURCE DelveInsight Business Research, LLP

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100 Deals associated with YQ23(New Beta Innovation Limited)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Peripheral ischaemia	Phase 2	HK	New Beta Innovation Canada Ltd.	31 Mar 2021
Chronic Limb-Threatening Ischemia	Phase 2	HK	New Beta Innovation Canada Ltd.	10 Mar 2021
Perioperative ischaemia	Phase 2	CN	New Beta Innovation Canada Ltd.	10 Mar 2021
Limb ischemia	Phase 1	CN	New Beta Innovation Canada Ltd.	30 Jan 2022
Advanced Malignant Solid Neoplasm	Phase 1	HK	New Beta Innovation Canada Ltd.	21 Aug 2020
Solid tumor	Phase 1	HK	New Beta Innovation Canada Ltd.	14 Aug 2020
Neoplasms	Phase 1	GB	New Beta Innovation Canada Ltd.	11 Jan 2019
Liver Cancer	Phase 1	-	New Beta Innovation Canada Ltd.	-

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