Open-Label, Single Dose, Parallel Group, Phase 1 Study in Healthy Volunteers Evaluating Safety, Tolerability, Pharmacokinetics, and Immunogenicity AIO-001 Administered by Injections

This goal of the open-label single dose study is to evaluate and compare the safety, tolerability, pharmacokinetic (PK), and immunogenicity of AIO-001 using two different formulations in 16 healthy volunteers.

Start Date01 Dec 2023

Sponsor / Collaborator

Syneos Health, Inc.

[+1]

CTR20231612 / Active, not recruitingPhase 2

评价SHR-1905注射液在慢性鼻窦炎伴鼻息肉患者中的有效性及安全性—多中心、随机、双盲、安慰剂对照、平行设计Ⅱ期临床研究

[Translation] Evaluation of the efficacy and safety of SHR-1905 injection in patients with chronic sinusitis and nasal polyps: a multicenter, randomized, double-blind, placebo-controlled, parallel-design phase II clinical study

评估不同给药方案SHR-1905注射液治疗慢性鼻窦炎伴鼻息肉的有效性指标。

[Translation]

To evaluate the effectiveness of SHR-1905 injection with different dosing regimens in the treatment of chronic sinusitis with nasal polyps.

Start Date04 Sep 2023

Sponsor / Collaborator

Guangdong Hengrui Pharmaceutical Co., Ltd.

NCT05891483 / Active, not recruitingPhase 2

A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase 2 Efficacy and Safety Study of SHR-1905 in Patiens With Chronic Rhinosinusitis With Nasal Polyps

The study is being conducted to evaluate the efficacy, and safety of SHR-1905 injection in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP), as well as to explore the reasonable dosage of SHR-1905 injection for CRSwNP.

Start Date04 Sep 2023

Sponsor / Collaborator

Guangdong Hengrui Pharmaceutical Co., Ltd.

100 Clinical Results associated with SHR-1905

100 Translational Medicine associated with SHR-1905

100 Patents (Medical) associated with SHR-1905

Literatures (Medical) associated with SHR-1905

Frontiers in Pharmacology

A phase 1, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-1905, a long-acting anti-thymic stromal lymphopoietin antibody, in healthy subjects

Article

Author: Qian, Weilin ; Shen, Yu ; McLendon, Kristi ; Fan, Yang ; Shen, Kai ; Fei, Yue ; Li, Na ; Wang, Quanren

Introduction:

Thymic stromal lymphopoietin (TSLP) is integral to inducing innate and T helper two cell inflammation that leads to clinical symptoms of asthma. SHR-1905 is a humanized immunoglobulin G1 kappa monoclonal antibody that inhibits TSLP bioactivity, developed for the treatment of severe uncontrolled asthma. This phase 1, randomized, double-blind, placebo-controlled single ascending dose study assessed the safety, tolerability, pharmacokinetics (PK), and immunogenicity of subcutaneous SHR-1905 in healthy subjects.

Methods:

Five dose cohorts were planned (50, 100, 200, 400, and 600 mg) and subjects were randomized (8:2) in each cohort to receive SHR-1905 or placebo with a follow-up period up to Day 253.

Results:

The majority of treatment-emergent adverse events (TEAEs) were mild and the incidence of TEAEs was comparable between the SHR-1905 and the placebo groups. The maximum serum concentration was reached 7.0–17.6 days after injection. The serum concentration of SHR-1905 increased with increasing dose level, and SHR-1905 exposure exhibited in a slightly greater-than-dose-proportional manner from 50 to 600 mg. SHR-1905 had a prolonged serum half-life around 80 days supporting every 6-month dosing. In SHR-1905 treated subjects, 15% tested positive for anti-drug antibodies post-dose with no apparent effect on corresponding PK profiles or safety.

Conclusion:

SHR-1905 demonstrated a good safety and tolerability profile with a long half-life in healthy subjects after a single administration in the dose range of 50–600 mg.

Clinical Trial Registration::

clinicaltrials.gov, identifier NCT04800263

News (Medical) associated with SHR-1905

06 Nov 2024

·www.prnewswire.com

Severe Asthma Clinical Trial Pipeline Appears Robust With 40+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

The severe asthma market is fueled by the rising prevalence of the condition, particularly in urban areas, alongside the emergence of innovative therapies like biologics targeting IgE and cytokine modulators. A growing demand for personalized medicine enhances treatment efficacy and patient compliance. Government initiatives and increased awareness improve access to care, while advancements in inhaler technology boost medication adherence. Collaborative efforts in R&D are also vital for driving innovation in asthma treatments. LAS VEGAS, Nov. 6, 2024 /PRNewswire/ -- DelveInsight's ' Severe Asthma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline severe asthma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the severe asthma pipeline domain. Key Takeaways from the Severe Asthma Pipeline Report DelveInsight's severe asthma pipeline report depicts a robust space with 40+ active players working to develop 50+ pipeline therapies for severe asthma treatment. Key severe asthma companies such as Kinaset Therapeutics, Bio-Thera Solutions, CSPC ZhongQi Pharmaceutical Technology, AB Science, GlaxoSmithKline, Oneness Biotech, Biosion, Lanier Biotherapeutics, Kymera Therapeutics, Suzhou Connect Biopharmaceuticals, Upstream Bio, Teva Branded Pharmaceutical Industries, Sanofi, Jiangsu Hengrui Medicine, AstraZeneca, Advagene Biopharma, Genrix (Shanghai) Biopharmaceuticals, and others are evaluating new severe asthma drugs to improve the treatment landscape. Promising severe asthma pipeline therapies such as KN-002, BAT2606, CM326, Masitinib, GSK3511294, FB 704A, BSI-045B, LNR 125.38, KT 621, CBP-201, Verekitug, TEV'248, Rilzabrutinib, SHR-1905, Atuliflapon, AD17002, GR1802, and others are under different phases of severe asthma clinical trials. In September 2024, Kinaset Therapeutics announced two oral presentations and a late-breaking poster presentation at the 2024 European Respiratory Society (ERS) Congress. The presentations demonstrate the potential of Kinaset's lead clinical candidate, frevecitinib ( KN-002), to treat all patients with moderate to severe asthma and patients with COPD. In May 2024, GSK announced positive headline results from the phase III clinical trials SWIFT-1 and SWIFT-2, which assessed the efficacy and safety of depemokimab versus placebo in adults and adolescents with severe asthma with type 2 inflammation characterized by blood eosinophil count. In April 2024, Twenty-five abstracts across approved and investigational medicines will be presented at this year's American Thoracic Society (ATS) International Conference. Notable data presentations for Sanofi's immunology pipeline include the first presentation of phase IIb moderate to severe asthma data for rilzabrutinib. In October 2023, Upstream Bio announced positive interim results in its Phase Ib clinical study of UPB-101, a thymic stromal lymphopoietin receptor (TSLPR) inhibitor. The Phase Ib study is a randomized, double-blinded, placebo-controlled multiple ascending dose (MAD) study with subcutaneous (SC) administration conducted in asthma patients. In October 2023, Aiolos Bio with an asthma drug in clinical trials, announced that it raised $245 million in Series A funding. Atlas Venture, Bain Capital Life Sciences, Forbion Capital Partners and Sofinnova Investments led the round, with additional investment from RA Capital Management Request a sample and discover the recent advances in severe asthma treatment drugs @ Severe Asthma Pipeline Report The severe asthma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage severe asthma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the severe asthma clinical trial landscape. Severe Asthma Overview Severe asthma is a chronic respiratory condition characterized by persistent symptoms that are difficult to control, even with high-dose medications. Unlike milder forms of asthma, severe asthma can significantly impair the quality of life and may result in frequent exacerbations requiring hospitalization. The exact cause of severe asthma is not entirely clear, but it often arises from a combination of genetic and environmental factors. These may include respiratory infections, allergens (pollen, mold, dust mites), pollutants (tobacco smoke, air pollution), occupational irritants, and lifestyle factors such as obesity and stress. Severe asthma can also develop in people whose milder asthma is not well-controlled over time. Diagnosis of severe asthma begins with a comprehensive medical history, physical examination, and pulmonary function tests like spirometry to assess lung function. Doctors may also order additional tests, such as chest X-rays, blood tests, and allergy tests to identify triggers. A key factor in diagnosing severe asthma is the persistence of symptoms despite the optimal use of standard asthma treatments. Managing severe asthma typically requires a multifaceted approach. Inhaled corticosteroids and long-acting bronchodilators are the mainstays of treatment. For those who do not respond to these medications, biologic therapies (such as omalizumab, mepolizumab, or dupilumab) may be prescribed to target specific pathways involved in the inflammatory response. In addition, patients with severe asthma may benefit from lifestyle modifications, including weight management, avoiding triggers, and pulmonary rehabilitation. In extreme cases, systemic corticosteroids may be necessary, although long-term use can have serious side effects. Find out more about severe asthma treatment drugs @ Drugs for Severe Asthma Treatment A snapshot of the severe asthma Pipeline Drugs mentioned in the report: Learn more about the emerging severe asthma pipeline therapies @ Severe Asthma Clinical Trials Severe Asthma Therapeutics Assessment The severe asthma pipeline report proffers an integral view of the severe asthma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Severe Asthma Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Interleukin 5 receptor antagonists, Thymic stromal lymphopoietin inhibitors, Thymic stromal lymphopoietin inhibitors, Thymic stromal lymphopoietin modulators, Interleukin 6 inhibitors, STAT6 transcription factor degraders, Interleukin 4 receptor alpha subunit antagonists Key Severe Asthma Companies: Kinaset Therapeutics, Bio-Thera Solutions, CSPC ZhongQi Pharmaceutical Technology, AB Science, GlaxoSmithKline, Oneness Biotech, Biosion, Lanier Biotherapeutics, Kymera Therapeutics, Suzhou Connect Biopharmaceuticals, Upstream Bio, Teva Branded Pharmaceutical Industries, Sanofi, Jiangsu Hengrui Medicine, AstraZeneca, Advagene Biopharma, Genrix (Shanghai) Biopharmaceuticals, and others. Key Severe Asthma Pipeline Therapies: KN-002, BAT2606, CM326, Masitinib, GSK3511294, FB 704A, BSI-045B, LNR 125.38, KT 621, CBP-201, Verekitug, TEV'248, Rilzabrutinib, SHR-1905, Atuliflapon, AD17002, GR1802, and others. Dive deep into rich insights for new drugs for severe asthma treatment, visit @ Severe Asthma Drugs Table of Contents For further information on the severe asthma pipeline therapeutics, reach out @ Severe Asthma Treatment Drugs Related Reports Severe Asthma Market Severe Asthma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key severe asthma companies including AstraZeneca plc, GlaxoSmithKline plc, Sanofi S.A., Novartis AG, Roche Holding AG, Teva Pharmaceutical Industries Ltd., Merck & Co., Inc., Boehringer Ingelheim International GmbH, Regeneron Pharmaceuticals, Inc., Johnson & Johnson, Pfizer Inc., Bristol Myers Squibb, Eli Lilly and Company, Vertex Pharmaceuticals Incorporated, Amgen Inc., AbbVie Inc., Genentech, Inc., Gilead Sciences, Inc., Biogen Inc., CSL Limited, among others. Asthma Market Asthma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key asthma companies including GlaxoSmithKline, 4D Pharma plc, AstraZeneca, Suzhou Connect Biopharmaceuticals, Avillion, Pearl Therapeutics, ARS Pharmaceuticals, Sinomab, Avalo Therapeutics, Kymab, Sanofi, Cumberland Pharmaceuticals, Genentech, Inc. , among others. Asthma Pipeline Asthma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key asthma companies, including Jiangsu Hengrui Medicine, GlaxoSmithKline, Immunotek SL, AB Science, EMS, Avalo Therapeutics, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., ARS Pharmaceuticals, Sanofi, Zura Bio Ltd., AstraZeneca, EURRUS Biotech GmbH, T-Balance Therapeutics GmbH, Gossamer Bio, Aldeyra Therapeutics, Inc., Trio Medicines, Janssen Research & Development, Arrowhead Pharmaceuticals, Hoffman-La-Roche, GlaxoSmithKline, Biohaven Pharmaceutical, TAK-Circulator Co., Shanghai Hengrui Pharmaceutical, among others. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ARDS companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, Windtree Therapeutics, Biomarck Pharmaceuticals, Athersys, Healios, Direct Biologics, Biohaven Pharmaceutical, Arch Biopartners, APEPTICO Forschung und Entwicklung GmbH, Staidson (Beijing) Biopharmaceuticals, Veru, Mesoblast Limited, Avalo Therapeutics, Pluristem Therapeutics, ILTOO Pharma, among others. 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 . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2Phase 3Phase 1

11 Sep 2024

·www.biospace.com

Bain Raises $3B for Fourth Fund to Back Promising Life Sciences Companies

Concept art showing a money icon and human hands iStock, cienpies Tuesday’s round brings Bain Capital Life Sciences’ fundraising total to around $6.7 billion since its founding in 2016. Many of its portfolio companies have resulted in high-value exits recently, including Cerevel Therapeutics, Aiolos Bio and Jnana Therapeutics. Bain Capital Life Sciences on Tuesday announced that it has raised approximately $3 billion for its fourth fund, which it will use to support promising companies working on addressing unmet medical needs and improving the lives of patients. The bulk of Bain’s raise—approximately $2.5 billion—comes from “outside commitments” from new and existing investors. Partners, employees and affiliates pitched in the remaining $500 million. Bain did not detail its investment priorities for its fourth fund, only noting that it will use this money to support biotech players developing “transformative medicines, medical devices, diagnostics, and life sciences tools that have the potential to improve the lives of patients with unmet medical needs.” Tuesday’s round brings Bain’s fundraising total to around $6.7 billion since its founding in 2016, according to its announcement. Bain’s third funding round, closed in August 2021 , brought in $1.9 billion, which the firm is using to back companies that it deems undervalued—and with an eye toward broadening its global presence, the company said at the time. Bain’s investment strategy is overseen by more than 25 investment professionals and advisors, who leverage their “extensive” investing experience in the private and public domains, as well as deep operating, consulting, medical and scientific expertise. This strategy appears to be working, with several of Bain’s portfolio firms enjoying high-value exits recently. In December 2023, Cerevel Therapeutics was bought by pharma giant AbbVie for $8.7 billion , a deal that formally closed in last month . Cerevel was working on psychiatric and neurological assets, including its late-stage next-generation antipsychotic emraclidine, being developed for schizophrenia. A month after the AbbVie deal was announced, GSK bought another Bain portfolio company , Aiolos Bio, for $1.4 billion. The agreement bolsters the pharma’s respiratory and inflammatory business with Aiolos’ long-acting monoclonal antibody AIO-001 for moderate-to-severe asthma. Joining Cerevel and Aiolos is Jnana Therapeutics, which was snapped up by Otsuka Pharmaceuticals last month for $800 million. Bain’s fourth fund is among this year’s biggest. In July 2024, fellow investment firm Flagship Pioneering raised $3.6 billion to pump into around 25 new breakthrough companies, especially those that leverage AI-enabled platforms to optimize drug discovery and accelerate the development process. Flagship has raised a total of $6.4 billion since 2021.

Acquisition

22 May 2024

·www.prnewswire.com

Perseus Therapeutics Announces Development of TSLP Antibody for Prevention of Hair Loss in Cancer Patients and Treatment of Inflammatory Diseases with well-known CRO partner

NEW YORK, May 22, 2024 /PRNewswire/ -- Perseus Therapeutics, a pioneering biopharmaceutical company based in New York City, is proud to announce the development of a novel thymic stromal lymphopoietin (TSLP) antibody aimed at preventing hair loss in cancer patients and treating a range of inflammatory diseases, including asthma. TSLP antibodies have recently gained significant attention in the medical and pharmaceutical communities. These antibodies have shown potential in addressing various inflammatory and allergic conditions, driven by their promising efficacy data and the unmet medical needs they aim to fulfill. Several companies and research groups are actively exploring TSLP antibodies, with notable developments including: AstraZeneca and Amgen have developed Tezepelumab, the first-in-class anti-TSLP monoclonal antibody approved for severe asthma treatment. Johnson & Johnson acquired Proteologix to access its bispecific antibody targeting TSLP and IL-13. Blackstone has launched Uniquity to advance Merck's Phase 2 high potency TSLP antibody. Innovent Biologics is conducting a Phase I study on IBI3002, a dual-function antibody targeting both IL-4Rα and TSLP. Sanofi and Regeneron are developing SAR443765, a novel biologic targeting both TSLP and IL-13 for asthma. Teva Pharmaceuticals and Biolojic Design have entered into an exclusive license agreement to develop bispecific antibodies targeting TSLP and IL-13. GSK recently acquired Aiolos Bio for $1 billion upfront to enhance its respiratory biologics portfolio with AIO-001, a Phase 2 long-acting anti-TSLP monoclonal antibody. These strategic moves underscore the growing interest in TSLP antibodies for treating a wide range of inflammatory and allergic conditions. Perseus Therapeutics is poised to contribute to this dynamic field with its innovative approach to preventing hair loss in cancer patients, a common and distressing side effect of cancer treatments, and addressing other inflammatory diseases. "Perseus Therapeutics is committed to advancing the science of TSLP antibodies to meet critical unmet medical needs," said Joseph Hernandez, Chairman and Founder of Perseus Therapeutics. "Our work aims not only to improve the quality of life for cancer patients by preventing hair loss but also to provide effective treatments for various inflammatory conditions." For more information about Perseus Therapeutics and its pipeline of innovative therapies, please visit or contact [email protected]. About Perseus Therapeutics, Inc. Perseus Therapeutics is a Duke University spinout biopharmaceutical company dedicated to developing innovative therapies for cancer patients and those suffering from inflammatory diseases. Based in New York City, Perseus Therapeutics is at the forefront of antibody research and development, striving to bring new hope and improved outcomes to patients worldwide. SOURCE Perseus Therapeutics, Inc.

License out/inPhase 1AcquisitionDrug ApprovalPhase 2

100 Deals associated with SHR-1905

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic rhinosinusitis with nasal polyps	Phase 2	CN	Guangdong Hengrui Pharmaceutical Co., Ltd.	04 Sep 2023
Asthma	Phase 2	CN	Shanghai Hengrui Pharmaceutical Co., Ltd.	17 Jan 2023
Respiratory Diseases	Phase 1	AU	Syneos Health, Inc.	01 Dec 2023
Mild asthma	Phase 1	CN	Shanghai Hengrui Pharmaceutical Co., Ltd.	15 Jun 2021
Pulmonary Disease, Chronic Obstructive	IND Approval	CN	Guangdong Hengrui Pharmaceutical Co., Ltd.	01 May 2024
Moderate asthma	Preclinical	US	Aiolos Bio, Inc.	24 Oct 2023
Severe asthma	Preclinical	US	Aiolos Bio, Inc.	24 Oct 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04800263 (SHR-1905, Pubmed)	Phase 1	TSLP	-	SHR-1905 50 mg	ewjcjxplds(bdublwonyd) = exhibited in a slightly greater-than-dose-proportional manner from 50 to 600 mg eqcftwlble (cuyxulrqny ) View more	Positive	15 Jul 2024
				SHR-1905 600 mg

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