#USA #Ningbo #TrueLab #Bionyra #TL-001

TrueLab Biopharmaceutical Partners with Bionyra Pharma

In a significant move in the field of biopharmaceuticals, TrueLab Biopharmaceutical has announced an exclusive licensing agreement with Bionyra Pharma. This partnership aims to develop TL-001, a monoclonal antibody targeting TL1A, and TL-003, a bispecific antibody designed to target both TL1A and IL-23p19. The financial implications of this deal are substantial, with the agreement valued at up to $985 million, highlighting the immense potential of these therapeutic interventions for immune-mediated inflammatory diseases.

The Licensing Agreement Details

Under the terms of the agreement, Bionyra Pharma secures worldwide exclusive rights, excluding Greater China, for the research, development, manufacturing, and commercialization of TL-001 and TL-003. TrueLab stands to gain nearly $1 billion in total consideration, which includes upfront payments as well as milestone payments related to development, regulatory, and commercial achievements. Additionally, TrueLab is set to receive tiered royalties based on future net sales. As part of this collaboration, TrueLab will also gain a single-digit equity stake in Bionyra post the completion of its Series A funding round.

Funding and Growth Opportunities

In connection with this collaboration, Bionyra Pharma has successfully raised $165 million in a Series A funding round. This funding was co-led by notable investors including Jeito Capital and Sofinnova Partners, alongside contributions from several other high-profile investment firms. This capital will not only aid in the development of TL-001 and TL-003 but also provide Bionyra with the opportunity to advance additional preclinical programs stemming from TrueLab’s innovative pipeline.

Dr. Francis Fan, the founder and CEO of TrueLab Biopharmaceutical, expressed enthusiasm about the partnership, emphasizing the transformative potential of TL-001 and TL-003 in treating conditions like inflammatory bowel disease (IBD) and other related immune-mediated diseases. He noted that this collaboration serves as a significant endorsement of TrueLab's proprietary TrueForge™ platform, which integrates advanced antibody engineering and translational science to systematically identify and develop cutting-edge biological products.

The Promise of TL-001 and TL-003

TL-001

TL-001 is a humanized IgG1 monoclonal antibody engineered for prolonged half-life. It specifically disrupts the signaling pathway mediated by TL1A, a cytokine associated with various immune-mediated inflammatory diseases, including IBD. TrueLab has completed patient recruitment for a Phase I clinical trial in Australia, which includes cohorts for both single and multiple ascending dose assessments. This promising therapy aims to deliver a new standard of care for patients suffering from IBD and similar conditions.

TL-003

On the other hand, TL-003 is a novel bispecific antibody designed to engage both TL1A and IL-23 simultaneously or independently. This dual-action approach positions TL-003 to potentially become a leading therapeutic option for IBD and other related inflammatory diseases. Currently, TL-003 is also under evaluation in a Phase I clinical trial with patient recruitment set to begin in 2026.

TrueForge™: A Gateway to Innovation

TrueLab's TrueForge™ platform plays a crucial role in the development of these innovative therapies. By utilizing a proprietary fusion of translational science and antibody engineering, coupled with advanced data-driven technologies such as machine learning, TrueForge™ enhances the drug discovery process. This integration aims to yield novel therapeutic targets while optimizing the pharmacokinetic properties of antibody modalities, thereby improving their efficacy and safety profiles.

About TrueLab Biopharmaceutical

TrueLab Biopharmaceutical is dedicated to the discovery and development of differentiated therapies for immune-mediated inflammatory diseases. The company has successfully raised a total of $53 million since its inception, reflecting strong investor confidence in its mission and capabilities. TrueLab’s focus on innovative therapeutic solutions, grounded in its robust R&D framework, positions it at the forefront of the biopharmaceutical landscape.

About Bionyra Pharma

Bionyra Pharma, a clinical-stage company, is committed to developing next-generation biological therapies targeted at severe immune-mediated diseases. With a keen focus on innovative treatment pathways, Bionyra delivers on the promise of tailored, effective therapies designed to meet the unmet medical needs of patients globally.

This strategic partnership between TrueLab and Bionyra not only marks a pivotal point for both companies but also sets the stage for advancements in treatments for complex inflammatory diseases, illustrating the power of collaboration in biopharmaceutical innovation.