Harbour BioMed Gains FDA Clearance for First-in-Human Study of B7H4xCD3 Bispecific Antibody HBM7004
Harbour BioMed announced FDA IND clearance to launch a Phase I first‑in‑human study of its bispecific antibody HBM7004, which targets B7H4 and CD3 in advanced solid tumors. The trial will assess safety, tolerability, pharmacokinetics and early anti‑tumor activity across multiple cancer types. HBM7004 is built on the company’s HBICE® platform, designed to focus T‑cell activation within the tumor microenvironment while minimizing systemic exposure. Preclinical data showed strong tumor‑specific killing and synergistic potential when combined with a B7H4×4‑1BB bispecific.
Merck Advances Scalable Manufacturing for Oral PCSK9 Therapy
Merck has published a landmark study in Science describing a scalable biocatalytic synthesis platform for its investigational oral PCSK9 inhibitor, enlicitide decanoate. The enzyme‑driven process enables selective peptide fragment formation, coupling, macrocyclization and uses crystallization‑based purification, aiming to reduce reliance...
The BioPharm Brief: Breakthrough Signals in Cancer, Duchenne, and RNA Medicine
Aptevo Therapeutics reported an 87% clinical benefit rate and 81% remission in its Phase 1b AML RAINIER study, combining mipletamig with venetoclax and azacitidine. Entrada Therapeutics disclosed positive Phase 1/2 data for ENTR‑601‑44, showing functional gains and increased dystrophin in Duchenne patients...
Stem Cell-Derived Islet Therapies Target Type 1 Diabetes Challenges
Sana Biotechnology is leveraging hypoimmune cell engineering to create allogeneic, stem‑cell‑derived pancreatic islet‑like cells that can evade both adaptive and innate immune attacks. The company aims to deliver a single intramuscular injection that restores normal blood‑sugar control for type 1 diabetes...
Aptevo Reports Strong Remission Data in Frontline AML Trial as RAINIER Study Advances Toward Phase 2
Aptevo Therapeutics disclosed Phase 1b data from its RAINIER trial, showing mipletamig combined with venetoclax and azacitidine achieved an 87% clinical benefit rate and an 81% composite remission rate in 31 frontline AML patients. The regimen produced a 65% complete remission...
Funding Roundup: Kanvas Biosciences, LTZ Therapeutics Draw Investor Interest for Next-Generation Cancer Immunotherapies
Kanvas Biosciences and LTZ Therapeutics announced a combined $86 million financing round to accelerate next‑generation cancer immunotherapies. Kanvas closed a $48 million Series A to push its microbiome‑based platform and the lead candidate KAN‑001 toward clinical trials. LTZ secured $38 million to expand its...
The BioPharm Brief: Precision, Immunotherapy, Expansion
Madrigal Pharmaceuticals is licensing Arrowhead’s RNA‑interference candidate ARO‑PNPLA3 to broaden its precision‑medicine pipeline for metabolic dysfunction‑associated steatohepatitis (MASH). LTZ Therapeutics secured $38 million to push forward myeloid‑engager immunotherapies that activate innate immune cells against cancer. Amgen and Eli Lilly announced major U.S....
LTZ Therapeutics Secures $38M to Advance Myeloid Engager Immunotherapy Pipeline
LTZ Therapeutics announced an oversubscribed $38 million financing round led by GL Ventures, bringing its total capital to roughly $130 million since 2022. The funds will propel the Universal Myeloid Cell Engager (U‑MCE) platform, supporting the Phase 1 trial of lead bispecific antibody...
The BioPharm Brief: Breakthrough Biologics and Long-Term Wins in IBD and Beyond
Viridian Therapeutics reported positive Phase III REVEAL‑2 data for veligrotug (VRDN‑001) in chronic thyroid eye disease, showing statistically significant reductions in proptosis and higher overall response rates. Eli Lilly presented four‑year long‑term results for mirikizumab (Omvoh) in ulcerative colitis, with a substantial...
Viridian Reports Positive Phase III REVEAL-2 Data for Elegrobart in Chronic Thyroid Eye Disease
Viridian Therapeutics announced that its subcutaneous IGF‑1R antibody elegrobart met the primary endpoint in the phase 3 REVEAL‑2 trial for chronic thyroid eye disease (TED). Patients receiving the drug every four or eight weeks showed 50‑54% proptosis responder rates and 55‑61%...
Phase 3 FUZION Data Show Guselkumab Benefit in Perianal Fistulizing Crohn Disease
Late‑breaking Phase 3 FUZION data presented at DDW 2026 show that guselkumab significantly improves combined fistula remission in adults with perianal fistulizing Crohn disease. At 24 weeks, remission rates were 28.3% with 100 mg every eight weeks and 27.0% with 200 mg every four weeks,...
AAPS NBC 2026 To Highlight Predictive Tools in Drug Discovery with Opening Plenary
The AAPS National Biotechnology Conference 2026 will open with a plenary by Johns Hopkins professor Thomas Hartung, focusing on artificial intelligence and new‑approach methods (NAMs) that enhance predictive toxicology and human‑relevant models. Hartung will detail how AI‑driven in‑vitro systems, organoids...
Choosing the Right CDMO for Long-Term Stability
Biotech firms must scrutinize contract development and manufacturing organizations (CDMOs) before committing to multi‑year projects. Dr. Patrick Meyer of Rentschler Biopharma outlines criteria such as transparent communication, accurate timelines, and a proven commercialization record. Technical expertise and a resilient supply chain...
The Biopharm Brief: Microbiome Fast Track, Leo Pharma Gene Therapy Deal, AAV Automation Advances
The FDA has awarded Fast Track designation to a live biotherapeutic aimed at restoring gut microbiota in moderate‑to‑severe ulcerative colitis, accelerating its development path. Leo Pharma is buying Replay’s gene‑therapy program to broaden its rare‑dermatology portfolio, marking a shift toward...
Ensorcell Debuts VersaWeld Platform, Wins Best New Product at INTERPHEX 2026
Ensorcell introduced the VersaWeld sterile tube welding platform at INTERPHEX 2026, marking its entry into cell and gene therapy (CGT) manufacturing equipment. The system automates thermoplastic tubing welding in closed‑system environments, delivering consistent weld integrity across multiple tube sizes and materials...