Bionyra Pharma Launches with $165M and Two TL1A Biologics Licensed From TrueLab, Entering Crowded IBD Race

TrueLab Biopharmaceutical announced on June 22, 2026, that it has entered into an exclusive license agreement with Bionyra Pharma, a newly launched Paris- and Boston-based clinical-stage biopharmaceutical company, granting Bionyra exclusive worldwide rights, excluding Greater China, to develop and commercialize two TL1A-targeting assets: TL-001 (BYN-002), an extended half-life anti-TL1A monoclonal antibody, and TL-003 (BYN-003), a TL1A×IL-23p19 bispecific antibody.¹ TrueLab is eligible to receive up to $985 million in total consideration, including an undisclosed upfront payment and milestone payments across development, regulatory, and commercial stages, as well as a single-digit equity stake in Bionyra following the Series A close.²

Simultaneously with the deal announcement, Bionyra revealed a $165 million oversubscribed Series A financing led by Sofinnova Partners and Jeito Capital, which will support the advancement of both licensed assets alongside a third program, BYN-001 (NBL-023), an anti-IL-25 monoclonal antibody licensed from NovaRock Biotherapeutics for atopic dermatitis and other type 2 inflammatory conditions.³

What makes TL1A a target worth pursuing?

Tumor necrosis factor-like ligand 1A (TL1A) is a cytokine encoded by the TNFSF15 gene, acting through its receptor death domain receptor 3 (DR3) to drive mucosal inflammation by amplifying T-cell activation and promoting pro-inflammatory cytokine secretion.⁴ Critically, TL1A also activates intestinal fibroblasts and promotes collagen deposition, giving it a dual role in both the inflammatory and fibrotic components of IBD — a mechanistic profile that differentiates it from earlier targets such as TNF-alpha and IL-23, which address inflammation but not fibrosis directly.⁴

Genome-wide association studies have identified variants in TNFSF15 and its receptor TNFRSF25 as risk loci for IBD susceptibility and severity, providing genetic validation for the target.⁴ Phase 2 clinical trial data from anti-TL1A monoclonal antibodies, including Merck's tulisokibart and the Sanofi/Teva co-developed duvakitug, have shown encouraging efficacy in ulcerative colitis and Crohn's disease, generating considerable commercial and scientific interest in the class.

What are the two assets Bionyra licensed?

TL-001 (BYN-002) is an extended half-life, humanized IgG1 monoclonal antibody targeting TL1A, designed to block TL1A-mediated signaling by inhibiting the interaction between TL1A and its receptor DR3. TrueLab has completed enrollment for a phase 1 clinical trial in healthy volunteers in Australia, including both single ascending dose and multiple ascending dose cohorts.¹ The half-life extension (HLE) technology is intended to enable less frequent dosing, potentially as infrequently as quarterly or twice yearly — a pharmacokinetic profile that Bionyra's CEO, Frédéric Marrache, has described as setting up opportunities for combination therapy with approved agents.²

TL-003 (BYN-003) is a novel bispecific antibody designed to bind both TL1A and IL-23p19 simultaneously with high affinity, incorporating the same HLE backbone as TL-001.¹ IL-23 inhibition is already validated in IBD through approved agents including risankizumab and guselkumab, but no approved bispecific antibody has yet paired TL1A with IL-23 blockade in this indication. TL-003 entered a phase 1 clinical trial in patients with ulcerative colitis in April 2026.¹

"It builds, as a backbone, on BYN-002," Marrache told BioPharma Dive. "BYN-003 is the only bispecific molecule for these kinds of diseases that already has some level of clinical validation for one of its building blocks."²

The push toward more patient-centric biologic delivery in IBD is also shaping how these next-generation programs are being designed. Speaking with BioPharm International about subcutaneous infliximab at Digestive Disease Week 2026, Juby Jacob-Nara, MD, senior vice president and chief medical officer at Celltrion, described the shift in IBD care as fundamental. "Technically, it is a game changer for patients with IBD," Jacob-Nara said, pointing to the potential for self-administered biologics to reduce infusion-center burden, improve flexibility, and alleviate the psychological stress of hospital-based care. While her comments were specific to subcutaneous infliximab, they speak to the broader patient-experience rationale that underpins the HLE technology in both BYN-002 and BYN-003 — biologics designed from the outset for infrequent, potentially self-administered dosing.

How does this deal fit the TL1A competitive field?

The TL1A class has attracted substantial investment from large and mid-sized pharmaceutical companies. Merck and Roche have late-stage programs in IBD, while Sanofi and Teva are co-developing duvakitug and Earendil Labs recently secured a worldwide exclusive license with Sanofi for next-generation bispecific antibodies targeting IBD and autoimmune indications — a deal BioPharm International previously reported.⁵ Bionyra's entry with two early-clinical TL1A assets, including a first-in-class TL1A×IL-23p19 bispecific, positions it at the leading edge of the next wave within the class rather than in direct head-to-head competition with phase 3-stage assets.

Whether the half-life extension technology and bispecific mechanism can translate into a clinical differentiation advantage will depend on data from planned phase 2 studies, anticipated to deliver proof-of-concept signals in 2028.³ For TrueLab, the deal represents meaningful validation of its TrueForge AI-powered antibody engineering platform and an entry into the global immunology market via a well-capitalized partner with expertise in the European and North American commercial environments.

References

1. TrueLab Biopharmaceutical announces license agreement with Bionyra Pharma for two next-generation monoclonal and bispecific antibodies for immune-mediated inflammatory diseases valued up to $985 million. (2026 Jun 22). TrueLab Biopharmaceutical. https://www.prnewswire.com/news-releases/truelab-biopharmaceutical-announces-license-agreement-with-bionyra-pharma-for-two-next-generation-monoclonal-and-bispecific-antibodies-for-immune-mediated-inflammatory-diseases-valued-up-to-985-million-302804996.html
2. Beasley D. (2026 Jun 22). Bionyra brings in $165M for next-generation immune drugs. BioPharma Dive. https://www.biopharmadive.com/news/bionyra-immune-drug-startup-sofinnova-jeito/823296/
3. Bionyra Pharma launches with $165 million oversubscribed Series A to advance clinical stage pipeline of next generation biologics for immune-mediated inflammatory diseases. (2026 Jun 22). Bionyra Pharma. https://www.businesswire.com/news/home/20260622319137/en/Bionyra-Pharma-Launches-with-$165-million-Oversubscribed-Series-A-to-Advance-Clinical-Stage-Pipeline-of-Next-Generation-Biologics-for-Immune-Mediated-Inflammatory-Diseases
4. Tettoni E, Gabbiadini R, Dal Buono A, et al. (2025 May 23). TL1A as a target in inflammatory bowel disease: exploring mechanisms and therapeutic potential. Int J Mol Sci. https://pubmed.ncbi.nlm.nih.gov/40507829/
5. Schoenthaler E. (2026 Mar 20). Earendil Labs to scale AI-driven biologics platform with $787 million funding. BioPharm International. https://www.biopharminternational.com/view/earendil-labs-to-scale-ai-driven-biologics-platform-with-787-million-funding