Early Phase Development

The company is targeting the $3 billion pancreatic cancer market with its lead proenzyme therapy candidate, PRP, which is supported by strong preclinical tumor inhibition data and for which a PK assay will be developed and validated.

Under the collaboration, Merck and Mayo Clinic will integrate multimodal clinical and genomic datasets with AI models to enhance target biology insights and translational decision-making.

Under an exclusive license, the joint venture aims to advance HCW11-006 into Phase I for solid tumors, validating TRBC-derived immunotherapy in a global development strategy.

Stoke has initiated a Phase I trial of STK-002, advancing antisense protein restoration as a potential strategy for genetic optic neuropathies.

Operational missteps, not flawed science, remain a leading cause of drug development delays, as fragmented systems, uneven technology adoption, and transactional sponsor–CRO relationships widen the “clinical execution gap.”

VectorY Therapeutics advances ALS R&D with a vectorized antibody strategy that targets TDP-43 pathology to enable sustained CNS exposure and biomarker-driven evaluation.

The biological reagents provider is moving to a 5000-square-foot site in Cambridge Technopark to accommodate the company’s growth.

Scientists at MIT and other institutions have discovered compounds that activate a defense pathway inside host cells that could be used as antiviral drugs.

Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.

CAR T-cell therapies, TILs, and other advanced therapies are pushing progress in the treatment of cancers.

Hurdles exist across all aspects and phases of drug development and manufacturing.

Treatment for cancer continues to drive immense innovation in the drug development pipeline, with advanced cell therapies, vaccines, and ADCs taking center stage.

Platform processes and effective risk assessments help overcome time and cost challenges.

The authors have reviewed applications of novel technologies in the major stages of biosimilars development: process development, pharmacology, toxicology, and clinical trials, with an emphasis on recent regulatory requirements.

With the Proteologix acquisition, Johnson & Johnson gains two bispecific antibody early phase assets for immune-mediated diseases.

Broken String Biosciences and the Francis Crick Institute will collaborate on research into how genome stability impacts ALS.

Under a global license and collaboration agreement, AbbVie and OSE Immunotherapeutics will aim to develop OSE-230, a mAb for treating chronic inflammation.

With the formation of the new R&D unit, Regeneron will assume full development and commercialization rights to 2seventy bio’s preclinical- and clinical-stage cell therapy pipeline.

The company is currently developing EVX-101 as an adjunctive treatment for MDD due to patients experiencing an inadequate response to first-line antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors SNRIs.

Stable producer cell lines show real promise despite continued development challenges.

Chime Biologics, Leads Biolabs, and BeiGene have formed a three-way collaboration to advance the development and global manufacturing of Leads Biolabs’ lead mAb candidate, LBL-007.

Despite many development challenges, stable producer cell lines show real promise.

Lives are saved when time from vein to vein decreases.

Key challenges posed to autologous and allogeneic treatments could be resolved by in-vivo CAR-T gene therapies.

Decreasing vein to vein time saves lives.