Biologic Drugs in Development

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.

Voyager Therapeutics presented six-month GLP toxicology data showing its tau-silencing AAV gene therapy VY1706 was well tolerated and reduced tau protein by up to 75% in key brain regions of non-human primates, with a clinical trial in Alzheimer's disease expected to begin in the second half of 2026.

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.

Innovent Biologics and Spero Therapeutics have signed a $1.1 billion licensing deal for IBI355, a phase 2-ready Fc-silent anti-CD40L antibody planned for testing in IgG4-related disease and Sjögren's disease.

The FDA has approved Padcev, a Nectin-4-directed antibody-drug conjugate, plus Keytruda as neoadjuvant and adjuvant treatment for muscle-invasive bladder cancer regardless of cisplatin eligibility, based on Phase III EV-304 data showing a 47% reduction in recurrence risk.

GSK reports that dostarlimab (Jemperli) monotherapy achieved sustained clinical complete responses in the phase 2 AZUR-1 trial for dMMR/MSI-H locally advanced rectal cancer, with data to be submitted for regulatory review.

Opamtistomig, a PD-L1/4-1BB bispecific antibody from Nanjing Leads Biolabs, has been granted priority review by China's NMPA for advanced extrapulmonary neuroendocrine carcinoma, a rare and aggressive cancer with no globally approved therapy.

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.

FT839, Fate Therapeutics' off-the-shelf, iPSC-derived CAR T-cell candidate co-targeting CD19 and CD38, has received FDA IND clearance and will advance into a phase 1/2 basket trial designed to treat multiple autoimmune diseases without conditioning chemotherapy.

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.

The FDA has approved an expanded indication for Wilate (von Willebrand Factor/Coagulation Factor VIII Complex, Human) to include routine prophylaxis in children younger than 6 years with von Willebrand disease — the first FDA-approved option for this age group — based on phase 3 WIL-33 trial data showing significantly reduced bleeding episodes in young pediatric patients.

The FDA has granted accelerated approval to Trutakna, a recombinant fusion protein that simultaneously inhibits BAFF and APRIL, for adults with primary IgA nephropathy at risk for disease progression — marking the first approval of a dual BAFF/APRIL inhibitor in the US and a significant advance in the growing wave of targeted biologics for this immune-mediated kidney disease.

Kenai Therapeutics has completed enrollment in the Phase 1b/2a REPLACE trial of RNDP-001, an allogeneic iPSC-derived dopaminergic neuron replacement therapy for idiopathic Parkinson's disease, with safety and preliminary efficacy data expected in 2027 — representing a significant step toward a potential disease-modifying cell therapy for a condition affecting more than 10 million people worldwide.

LTZ Therapeutics has received FDA IND clearance for LTZ-232, a first-in-class bispecific antibody designed to activate tumor-associated macrophages to phagocytose EpCAM-positive colorectal cancer cells — a novel myeloid-engaging approach aimed at overcoming the immunologically cold tumor microenvironment that has historically limited immunotherapy in this setting.

Biocytogen and Whitehawk Therapeutics have announced a global collaboration combining Biocytogen's RenLite bispecific antibody discovery platform with Whitehawk's CPT113-based ADC linker-payload technology to generate bispecific ADC candidates with differentiated tumor-targeting profiles — with Whitehawk targeting new ADC INDs within 12 to 24 months.

The European Commission has approved Tepkinly in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma after at least two prior systemic therapies, based on Phase 3 EPCORE FL-1 data showing a 79% reduction in risk of disease progression or death — marking the first bispecific antibody-based combination regimen approved in Europe for this indication.

Three-year follow-up data from Agenus' Phase 2 trial of botensilimab plus balstilimab in refractory microsatellite-stable metastatic colorectal cancer show a 33% overall survival rate at three years — with evidence of a plateau on the Kaplan-Meier curve beyond two years — representing an unprecedented durability signal in a tumor type historically resistant to immune checkpoint therapy.

CNS monoclonal antibody therapies demand rigorous screening and monitoring to ensure patient safety in MS, NMOSD, and Alzheimer disease.

92Bio, Inc. has dosed the first patient in a Phase 1 trial of NTB-928, a fully human bispecific T-cell engager targeting FOLR1 and CD3, designed to selectively kill FOLR1-overexpressing ovarian cancer cells while sparing normal tissue — addressing a key limitation of prior FOLR1-directed therapies in platinum-resistant ovarian cancer.

FDA reported that the PRECISION-T trial showed 78% chronic GVHD-free survival at 1 year versus 38.4% with standard transplant and granted the approval to Orca Biosystems, making the therapy the first Treg cell–based therapy in blood cancers.

The European Investment Bank-backed investment establishes a new single-use GMP facility with which Icosagen can support complex protein therapeutics from early discovery through phase 1/2 clinical manufacturing.

The FDA has accepted Sarepta's supplemental New Drug Applications seeking to convert casimersen (Amondys 45) and golodirsen (Vyondys 53) from accelerated to traditional approval in Duchenne muscular dystrophy, with a PDUFA target action date of February 28, 2027, backed by ESSENCE confirmatory trial data and years of real-world evidence.

The FDA has granted priority review to Genentech's sBLA for Enspryng (satralizumab), an IL-6 receptor-targeting monoclonal antibody, as a potential first at-home subcutaneous treatment for thyroid eye disease, based on Phase III SatraGO data showing significant proptosis reduction, with an FDA decision expected by October 15, 2026.