Discovery Pipeline

The FDA has granted Fast Track designation to C-1101, Consano Bio's investigational platelet-derived multi-protein biologic for chronic, painful lumbosacral radiculopathy, following the drug's recent IND clearance and as the company advances a Phase 1 trial evaluating the epidural injection.

Evaxion has added EVX-05, an AI-designed, off-the-shelf therapeutic vaccine targeting glioblastoma, to its pipeline, discontinuing the EVX-03 program as part of a broader R&D refocus while maintaining its cash runway into the second half of 2027.

OncoC4 has dosed the first patient in a phase 1 trial of ONC-783, a T-cell engager targeting neoCD24, a cancer-specific glycoform of CD24, positioning the subcutaneously administered candidate as a potential treatment across multiple solid tumor types.

Fate Therapeutics has initiated RECLAIM-LN, a Phase 2 potentially registrational trial of its off-the-shelf, iPSC-derived CD19-targeting CAR T-cell candidate FT819, in patients with refractory lupus nephritis, following favorable Phase 1 safety and efficacy data.

Infinimmune has closed a $75 million Series A financing co-led by Regeneron Ventures and Playground Global to advance its lead atopic dermatitis programs, IFX-101 (targeting IL-22) and IFX-201 (targeting IL-13), both derived from its Anthrobody platform for discovering fully human antibodies.

Boulevard Bio has emerged from stealth with $65 million in financing from Deerfield Management and early Phase 1 data for BLVD101, a bispecific BAFF/APRIL antibody for IgA nephropathy supporting once-quarterly dosing, alongside two additional multi-specific antibody candidates for B cell-driven autoimmune disease.

Nucleai has announced an ongoing translational research collaboration with Gilead Sciences applying AI-powered tissue analytics to support Gilead's global antibody-drug conjugate clinical development programs, generating candidate spatial biomarkers across multiple oncology indications.

Stand Up To Cancer has awarded its Nina Nicolai Pancreatic Cancer Innovation in Collaboration Award to a research team developing a combination approach that pairs an engineered mRNA vaccine with KRAS G12D-directed TCR-T cell therapy, aiming to sustain antigen production and improve T-cell responses against pancreatic cancer.

Ascletis has initiated two Phase I studies for its obesity pipeline: ASC36, a once-monthly amylin receptor peptide agonist, and ASC36_35FDC, a once-monthly fixed-dose co-formulation of ASC36 with its GLP-1R/GIPR dual agonist ASC35, following recent FDA IND clearances for both candidates.

Neurocrine Biosciences has dosed the first participants in a Phase 1 study of NBIP-'1968, an investigational GLP-1/GIP/glucagon receptor triple agonist for obesity, marking the company's entry into the increasingly competitive multi-agonist incretin therapeutics space.

Mediar Therapeutics has signed a collaboration and option agreement with Ono Pharmaceutical to co-develop novel antibody therapeutics targeting myofibroblast biology in fibro-inflammatory diseases, building on Mediar's existing three-program antifibrotic antibody pipeline.

The FDA has cleared Satellite Bio's IND application for SB-101, an off-the-shelf hepatocyte cell therapy for urea cycle disorders, marking the company's transition to clinical-stage status ahead of a planned Phase 1/2 trial in infants later this year.

Opus Genetics has enrolled the last patient in its registrational Phase 3 trial of OPGx-LCA5, an AAV8 gene therapy for LCA5-associated inherited retinal disease, keeping the program on track for a potential first-in-disease approval.

China's NMPA has approved an IND for a Phase Ib/II trial combining Leads Biolabs' PD-L1/4-1BB bispecific antibody opamtistomig with standard regimens in metastatic colorectal cancer, extending the drug's reach into one of oncology's most immunotherapy-resistant tumor types.

Iksuda Therapeutics has received FDA clearance of its IND application for IKS04, a CA242-directed antibody-drug conjugate paired with a novel dosing approach designed to improve solid tumor penetration, enabling a Phase 1 trial in gastrointestinal cancers.

Johnson & Johnson has entered a collaboration and equity investment agreement with Sail Biomedicines to advance in vivo CAR-T therapies for immune-mediated diseases, securing an exclusive option to acquire the company for $2.58 billion.

The FDA has granted Regenerative Medicine Advanced Therapy designation to Ocugen's OCU410, a one-time AAV gene therapy for geographic atrophy secondary to dry age-related macular degeneration, based on Phase 2 data showing a statistically significant reduction in lesion growth.

Paul Romness, chair, chief executive officer, and president of OS Therapies, discusses how advances in linker chemistry, payload design, and evolving regulatory approaches could shape the next generation of antibody–drug conjugates for oncology.

A preclinical study links a DR5-Lig3 feedback loop to immune recognition and checkpoint inhibitor response in dMMR colorectal cancer.

The deal, announced at BIO 2026, carries total potential value exceeding $2.5 billion and will use Insilico's Pharma.AI platform to drive target-to-candidate discovery across neuroinflammatory, neurodegenerative, and rare neurological indications.

Takeda will use Boltz biomolecular AI models to support structure prediction, affinity estimation, and molecular design in preclinical research.

Biohub has released an open-source AI protein design model aimed at early drug discovery, with initial testing in cancer and immune targets.

Artificial intelligence delivers meaningful value in drug development only when it is grounded in real-world constraints and tightly integrated into expert-led workflows, rather than treated as a standalone, model-first solution.

Isomorphic Labs’ $2.1 billion financing will support expansion of its AI-driven drug discovery platform and advancement of therapeutic candidates toward clinical development.

The opening plenary session at this year’s AAPS National Biotechnology Conference will spotlight AI and NAMs as tools that advance predictive toxicology and human-relevant models to improve drug safety and translational research.