“We are excited to start clinical trials,” said Dr Yan Han, CEO of TianLi Biotech. “Our team has worked hard to advance the development of this new drug aimed at improving the treatment of lung fibrosis.”
On Thursday, August 8th, the first healthy volunteers received our anti-fibrotic drug, TLB001, via inhalation in our Phase I study. This milestone marks the beginning of our investigation into the safety, tolerability and pharmacokinetics of TLB001, a crucial step toward making this innovative treatment available to patients with idiopathic pulmonary fibrosis (IPF).
IPF is a progressive and debilitating lung disease characterised by the gradual scarring of lung tissue, which leads to severe breathing difficulties and reduced quality of life. Current treatment options are limited, highlighting the need for novel therapeutic approaches.
“This milestone of reaching a Phase I human trial marks the transition of Tianli Bioetch to a clinical stage biotech company and would not have been possible without the outstanding efforts of our R&D team and networks of consultants and CROs,” said Prof. Alastair Stewart, CSO. “We are eager to further explore the potential of our novel inhalational treatment for pulmonary fibrosis and other chronic respiratory diseases.”
“TLB001 is a proprietary small molecule drug targeting casein kinase δ/ε that provides a potentially groundbreaking advancement in the treatment of fibrosis, including IPF.” said Dr Bowen Zhang, Board Chair of Tianli Bioetch. Our innovative approach involves administering this aerosol drug directly to lung tissue, which is anticipated to minimise the adverse effects often associated with oral anti-fibrotic medications.
We are enthusiastic about continuing this journey and will keep you updated with more news and progress as the study advances.
We are excited to announce the successful completion of the site initiation visit at Melbourne Nucleus Network site for our upcoming Phase I clinical trial. This milestone marks the beginning of an important journey in advancing the development of TLB001, our novel inhalational treatment for idiopathic pulmonary fibrosis (IPF).
IPF affects approximately 9,000 Australians and typically results in death within 3-5 years of diagnosis. This condition causes the lung tissue, normally soft and easily expandable, to become scarred and stiff, progressively impairing breathing. Currently approved drug treatments only slow disease progression and often have significant side effects. There is an urgent need for more effective and better tolerated therapies for IPF patients.
Our approach involves administering TLB001 aerosol to healthy volunteers, allowing the drug to directly target lung tissue. This method is expected to reduce the adverse effects that frequently limit the tolerability of oral anti-fibrotic drugs.
During the visit on July 10th, we confirmed that the Nucleus Network site has secured all regulatory approvals, implemented study procedures, and established site infrastructure. Everything proceeded smoothly, and we are now on track to commence the next phase of this innovative study.
TianLi Biotech will continue to provide updates on the clinical progress of TLB001.
TianLi Biotech is pleased to announce the approval from The Alfred Hospital Ethics Committee to initiate a Phase I clinical trial in Australia with our novel anti-fibrotic drug, TLB001. This approval marks a significant milestone as TianLi Biotech can now enrol healthy volunteers at each site listed with The Alfred Hospital.
TLB001 is designed to selectively inhibit key pathways associated with inflammation and fibrogenesis in idiopathic pulmonary fibrosis, a debilitating and currently incurable condition. While presently approved treatments slow down lung scaring, TLB001 has a broadly based suppression of fibrogenesis.
"The Ethics approval represents a pivotal step towards delivering this groundbreaking treatment to patients in urgent need.” said Dr. Yan Han, CEO of TianLi Biotech. "We are excited to move forward with this trial as the first step towards offering new treatment options for IPF patients. I extend my heartfelt gratitude to the team for their exceptional dedication and hard work."
The First-in-Human study for TLB001 is set to commence in July in Australia. The purpose of the study is to assess the safety, tolerability, and pharmacokinetics of single and repeat doses of TLB001 administered via inhalation to healthy volunteers.
Stay tuned as TianLi Biotech continues to provide updates on the progress of TLB001 as we embark on this critical phase of clinical trials.
Recently, the TianLi Biotech team came together for a pivotal moment: our biannual review meeting. It was an inspiring gathering where our CEO, Dr. Yan Han discussed our company's plans for the upcoming year, with a particular focus on our transition towards becoming a clinical-stage biopharmaceutical company.
The highlight of the meeting was the remarkable progress we’ve made towards regulatory approval and our imminent leap into First in Human trial in Australia, scheduled for July 2024. This significant step represents the culmination of years of dedication and innovation from our team, bringing us closer to realising our vision of transforming the wellbeing of patients with chronic respiratory diseases.
We were privileged to have the Chair of the board, Dr. Bowen Zhang, join us in person. His words of encouragement, and recognition of the significant milestones achieved by TianLi Biotech on our journey towards clinical trials were truly inspiring. Dr. Zhang unwavering support serves as a testament to the collective commitment and expertise driving TianLi Biotech forward.
Watch this space as we continue to drive innovation in the field of chronic respiratory disease!
We're thrilled to share some exciting news with our community! TianLi Biotech has been selected to present at the upcoming ATS 2024 Respiratory Innovation Summit, a prestigious event that brings together leaders and innovators in pulmonary medicine. This is a significant recognition of our commitment to excellence and innovation in the treatment of inflammatory and fibrotic lung disease.
At ATS RIS 2024, we'll have the opportunity to showcase our latest results and share insights into how the novel class of anti-inflammatory anti-remodelling agents we develop addresses challenges in the treatment of fibrotic lung disease. We're proud of the hard work and dedication our team has put into this project, and we're eager to highlight the impact it can make.
We're grateful for the opportunity to present at ATS RIS 2024 and extend our sincere thanks to the organisers for recognising our work. We're looking forward to connecting with fellow professionals, exchanging ideas, and exploring new opportunities for collaboration.
Stay tuned for updates from the conference and thank you for your ongoing support!
We are pleased to announce a significant milestone in our journey at TianLi Biotech – the recent grant of 5 patents across China, Japan, and the US, for our groundbreaking biotech innovations. These patents not only reflect the dedication and expertise of our team but also mark a substantial step forward in solidifying our position at the forefront of respiratory disease research.
Key Highlights
Cutting-Edge Technology: The granted patents highlight our commitment to pioneering advancements in the treatment of respiratory diseases.
Intellectual Property Portfolio: With these new patents added to our intellectual property portfolio, we have strengthened our position in the competitive landscape, providing a solid foundation for future growth.
Validation of Innovation: The approval of these patents signals the uniqueness and impact of our discoveries.
What This Means for TianLi Biotech
Market Leadership: The granted patents position us as a leader in innovation in the treatment of respiratory diseases, setting the stage for strategic collaborations and partnerships.
Advancing Patient Impact: Ultimately, these patents represent a step closer to translating our scientific discoveries into tangible solutions that can positively impact patient outcomes.
We thank our dedicated team and partners who have contributed to this achievement. As we celebrate this milestone, we look forward to the transformative impact our technology can bring to the landscape of respiratory disease treatment.
We are thrilled to share the latest developments in our commitment to advancing anti-fibrotic strategies for idiopathic pulmonary fibrosis (IPF). In his recent manuscript published in Advances in Pharmacology, our Chief Scientific Officer, Prof. Alastair Stewart and his team delved into the challenges and breakthroughs in developing new anti-fibrotic drugs, highlighting the crucial need for improved models emulating IPF progression.
At TianLi Biotech, we remain dedicated to rigorous validation and benchmarking of our drug candidates against approved treatments in clinically relevant IPF models. This strategic approach aims to enhance the successful translation of our promising drug candidates from the lab to the clinic.
Stay tuned for more updates as we continue our journey towards transformative solutions for IPF patients.
Five years after the signature of the Memorandum of Understanding, it was a great pleasure to welcome Dr. Bowen Zhang, president of Beijing No.1 Biochemical Pharmaceutical Co., Ltd and Mr. Guowei Jin, chief consultant, who were joined by the rest of the management team here in Melbourne.
We were also delighted to have them attending the TianLi Biotech biannual review meeting. The board and the executives said that they were impressed by the quality of the research and the momentum has built even further since our previous review.
Great achievement everyone!
While under a tight the schedule, we took some time to enjoy delicious Chinese pastries (“Dao xiang cun 稻香村”) provided by TianLi Biotech CEO, Dr. Yan Han. Thanks for sharing, Yan!
We are excited to participate in the upcoming 19th World Congress of Basic & Clinical Pharmacology in Glasgow (Scotland) (2-7 July 2023). TianLi Biotech will be well-represented at WCP2023 with our CSO, Prof. Alastair Stewart chairing the Mechanopharmacology session and two researchers presenting their latest research featuring our lead CK1δ/ε inhibitor.
Dr. Bryan Gao will give a biologist’s perspective on the design of pharmacology on-a-chip systems and Ms. Jana Zielinski will present her work on the essential role of CK1δ in breast cancer tumourigenesis.
We hope to see many of you at the Congress!
For information on TianLi Biotech and the company development program please contact us via:
info@tlbiotech.com.au
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