Manufacturing, Monoclonal Antibodies

Solstice Oncology launched with a $225 million Series A financing to advance porustobart, a second-generation, Fc-enhanced CTLA-4 antibody licensed from Harbour BioMed, into neoadjuvant Phase 2 testing for microsatellite-stable colon cancer.

Amgen and AstraZeneca announced that the Phase 3 DeLLphi-305 trial met its primary endpoint, with Imdelltra (tarlatamab) plus Imfinzi (durvalumab) significantly improving overall survival versus durvalumab alone as first-line maintenance therapy for extensive-stage small cell lung cancer — the first phase 3 study of a bispecific T-cell engager to show a survival benefit in this earlier-line setting.

Sanofi has suspended a phase 2 trial of SAR445399, an anti-IL-1R3 monoclonal antibody, in non-cystic fibrosis bronchiectasis, part of new ceo Belén Garijo's ongoing portfolio review rather than a safety concern.

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 new peer-reviewed publication in Clinical Cancer Research details preclinical data for Pheast Therapeutics' PHST001, an anti-CD24 monoclonal antibody, showing anti-tumor activity across six solid tumor types and enhanced effects when combined with chemotherapy, radiotherapy, and antibody-drug conjugates.

Keytruda improved progression-free survival versus chemotherapy in first-line dMMR advanced or recurrent endometrial cancer.

ImmunoBrain has published phase 1b data in Nature Medicine and presented late-breaking results at AAIC 2026 for IBC-Ab002, an investigational anti-PD-L1 monoclonal antibody that met its primary safety endpoint and showed encouraging trends in biomarkers of neuronal and synaptic damage in patients with early Alzheimer's disease.

The FDA has approved lecanemab-irmb (Leqembi Iqlik) a once-weekly subcutaneous autoinjector formulation, as an initiation dose for early Alzheimer's disease, making it the first anti-amyloid antibody offering at-home dosing across the entire treatment course, from initiation through maintenance.

The FDA has approved subcutaneous Sarclisa Escena, administered via on-body injector, across all existing multiple myeloma indications for the IV formulation, making isatuximab the first anticancer monoclonal antibody available through both wearable injector and manual subcutaneous administration in the US.

Teva Pharmaceuticals has entered a global licensing agreement with Polpharma Biologics for exclusive commercialization rights to a proposed biosimilar of Ocrevus (ocrelizumab), the CD20-targeted monoclonal antibody used to treat relapsing and primary progressive multiple sclerosis.

Chemomab Therapeutics and Scipher Medicine will merge to advance nebokitug, a first-in-class anti-CCL24 monoclonal antibody, into a precision medicine Phase 2 trial in rheumatoid arthritis guided by Scipher's PrismRA test and AI Network Medicine platform.

Vaccinex will present new biomarker data from the Phase 1b/2 SIGNAL-AD trial of pepinemab — a humanized IgG4 monoclonal antibody targeting Semaphorin 4D — at AAIC 2026 in London on July 13, showing that SEMA4D blockade regulates glial biomarkers associated with disease progression in early Alzheimer's disease, while outlining plans for an enlarged Phase 2b SIGNAL-AD2 study.

Newly launched Bionyra Pharma has raised $165 million in Series A financing and secured exclusive global rights to two TL1A-targeting biologics from China's TrueLab Biopharmaceutical — an anti-TL1A monoclonal antibody and a TL1A×IL-23p19 bispecific antibody — in a deal worth up to $985 million, positioning the company to compete in an IBD drug class already drawing attention from Merck, Roche, and the Sanofi/Teva partnership.

During an interview with BioPharm International, Cencora experts Andrea Zobel, senior manager of dangerous goods, and Marco Hogenboom, senior director of specialty logistics, highlighted the unique regulatory, logistical, and educational challenges associated with delivering radiopharmaceutical therapies to patients worldwide.

Andrea Zobel and Marco Hogenboom of Cencora World Courier discuss how advances in radiopharmaceutical manufacturing, cancer biology, and specialty logistics are enabling the expansion of targeted radiopharmaceutical therapies into larger patient populations and broader oncology indications.

According to Eli Lilly and Company, the extended dosing interval reduces maintenance injections to as few as 6 per year without required topical corticosteroids.

As the ADC market races toward a projected $32 billion valuation, manufacturers face a precision imperative, as integrated CDMO partnerships, advanced analytics, and emerging technologies like AI and continuous manufacturing may hold the key to unlocking the next wave of oncology breakthroughs.

Risk-based ADC cleaning validation must integrate degradation profiling, HBEL-aligned analytical methods, and dual large/small molecule strategies for facility safety, according to STERIS technical services director, Paul Lopolito.

The SK bioscience–Gates MRI agreement highlights how scalable mAbs could broaden infant RSV prevention beyond high-income markets.

Next-gen antibody R&D is shifting to multifunctional modalities driven by manufacturing scale and regulatory acceleration.

Samsung Biologics’ Maryland acquisition signals a major push into US biologics manufacturing, reshaping the company’s capacity strategy and supply chain resilience.

Abzena’s antibody platform enables Orion to streamline biologics development, showcasing trends in scalable, risk-reduced manufacturing for the industry.

The next-generation monoclonal antibody could potentially be used to prevent and treat active COVID-19 infections, according to its developer, providing a non-vaccine option.

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

EMA’s CHMP recommended conditional marketing authorization for linvoseltamab to treat adults with relapsed and refractory multiple myeloma.