Biologic Drugs in Development

At AAIC 2025, Roche presented new data from its Alzheimer’s disease research efforts across its diagnostics and pharmaceutical portfolios.

The company’s technology was used to create CAR-T cells that demonstrated the expression of complex CARs in a single DNA donor.

The biopharmaceutical landscape is undergoing a huge shift from traditional therapies to more specialty-driven modalities.

Avidicure is a new biotechnology company that has been launched on the back of a $50 million seed financing round for developing a new multifunctional antibody modality for treating cancer.

The proposed business combination would create a publicly traded, clinical-stage biopharmaceutical company that will focus on developing a pipeline of next-generation cancer therapies.

Using cholesterol-modified oligonucleotides, the research team aims to improve the delivery of antisense nucleotide-based therapies for treating neurodegenerative diseases and brain cancers.

This collaboration aims to advance a first-in-human clinical study by using autologous iPSC technology.

Through this collaboration, Circio will combine its circVec DNA vectors with Entos’ Fusogenix PLV delivery technology, which is expected to enhance delivery efficiency and reduce toxicity.

The £10 million (US$13 million) investment is part of a larger £58 million (US$75 million) Series A financing round to be used for the development of Maxion Therapeutics’ preclinical lead program for treating inflammatory diseases.

The commission’s approval makes durvalumab the first and only immunotherapy for LS-SCLC in the EU.

With the investment, AstraZeneca will establish a second global strategic R&D center in Beijing as well as support major research and manufacturing agreements to further advance life sciences in the country.

Under the agreement, Shilpa will undertake development and commercial supply for a novel checkpoint inhibitor for immuno-oncology indications.

The value of outsourcing partnerships for next-gen biotherapeutics rests in the expertise and technologies that service providers bring to the table.

Co-led by Andera Partners and Bpifrance, the Series B financing will go toward an ongoing Phase Ib/IIa clinical study for EG 427’s lead candidate and to advance the company’s genetic medicines platform.

The company plans to assess alternate payloads for its gene therapy program, which will shift its timeline.

Development of new modalities of biotherapeutic molecules will rely on manufacturing, regulatory, and collaborative support.

Under this early stage R&D collaboration, the companies aim to engineer recombinant biologics for blocking Fc receptors, which play a key role in autoimmune diseases.

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

The UK MHRA has granted approval for garadacimab for use in preventing angioedema attacks in patients 12 years old and older who have hereditary angioedema.

The approval makes Enhertu (fam-trastuzumab deruxtecan-nxki) the first HER2-directed therapy in the United States for treating HER2-low or HER2-ultralow metastatic breast cancer.

Lonza will develop spray-dried formulations for an intranasally delivered biologic using a reformulated biologic drug candidate for obesity in Iconovo’s pipeline.

This latest fast track designation marks the second such designation by FDA for J&J’s tau-directed investigational therapies for treating Alzheimer’s disease.

The new company will harness splicing technology to innovate safer and more effective RNA therapies for severe genetic diseases.

The companies will advance the development of Innovent’s ADC candidate, IBI3009, which has received IND approvals in the US, China, and Australia.

Advancements in bioprocessing and analytics are crucial to the future development of bispecific antibodies and beyond.