Ivonescimab beats PD-1 plus chemo in first-line squamous NSCLC
Akeso’s ivonescimab, a first-in-class PD-1/VEGF bispecific antibody, has improved overall survival versus PD-1 plus chemotherapy in patients with advanced squamous non-small cell lung cancer.
In the phase 3 HARMONi-6 trial, ivonescimab plus chemotherapy reduced the risk of death by 34 percent compared with tislelizumab plus chemotherapy. Median overall survival was 27.9 months in the ivonescimab arm versus 23.7 months in the control arm, with 24-month survival rates of 64.7 percent and 48.6 percent, respectively.
The regimen also improved progression-free survival, with median PFS of 11.1 months versus 6.9 months. Grade 3 or higher treatment-related adverse events occurred in 69.2 percent of patients receiving ivonescimab plus chemotherapy and 58.9 percent of those in the control arm. Source
EC approves Amgen’s T-cell engager for small cell lung cancer
The European Commission has approved Amgen’s Imdylltra (tarlatamab) as a monotherapy for adults with extensive-stage small cell lung cancer who need systemic therapy after progressing on or after first-line platinum-based chemotherapy.
The approval was based on the phase 3 DeLLphi-304 trial, in which the DLL3-targeted T-cell engager reduced the risk of death by 40 percent compared with standard chemotherapy. Median overall survival was 13.6 months with Imdylltra versus 8.3 months with chemotherapy.
“Small cell lung cancer is one of the most aggressive solid tumors, with high rates of relapse following first-line treatment and limited treatment options,” said Jean-Charles Soria, senior vice president of Oncology at Amgen. “The European Commission's approval of Imdylltra, the first and only T-cell engager therapy approved to treat small cell lung cancer, marks an important step forward for patients in Europe.” Source
Aragen manufactures Renaissance’s Fast Track anti-GD2 mAb
Aragen has tech-transferred and manufactured the first commercial-scale GMP batches of Renaissance Pharma’s Daretabart, a humanized anti-GD2 monoclonal antibody, as part of an ongoing strategic collaboration.
The antibody, which targets GD2 for the treatment of high-risk neuroblastoma, received FDA Fast Track Designation in April 2026. Aragen developed the cell line and initial process at its Morgan Hill site in California before transitioning GMP manufacturing to its commercial biologics facility in Bengaluru, India, where production was scaled to 2KL single-use bioreactors.
Renaissance has previously reported phase 2 data showing 73.7 percent event-free survival and 86 percent overall survival at three years in pediatric patients with high-risk neuroblastoma. The companies said the Morgan Hill-to-Bengaluru transfer was completed in nine months and supports clinical supply, BLA readiness, and eventual launch. Source
Dark Horse and Altruist team up on China biologics manufacturing
Dark Horse Consulting Group and Altruist Biologics have signed an MOU to help biopharma companies accelerate biologics development and global commercialization in China.
The collaboration combines Dark Horse’s regulatory, CMC, nonclinical, clinical, quality, supply chain, and launch consulting expertise with Altruist’s end-to-end cGMP manufacturing capabilities. The partnership will support biologic modalities including monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other biologic therapies.
Altruist, a wholly owned subsidiary of Innovent Biologics, operates cGMP facilities in Suzhou and Hangzhou with 232,000 liters of total production capacity. The companies said the partnership is designed to help sponsors navigate NMPA requirements, local quality systems, and global CMC expectations while accessing China’s biomanufacturing infrastructure. Source
Pfizer and Innovent strike oncology deal worth up to $10.5 billion
Pfizer and Innovent Biologics have entered a global licensing and collaboration agreement to develop 12 early-stage and de novo oncology programs.
The pipeline includes antibody-drug conjugates with differentiated payloads and multispecific immune-engaging antibodies. Under the deal, Innovent will advance the programs through phase 1, after which Pfizer will lead future global development.
Innovent will receive $650 million upfront and is eligible for up to $9.85 billion in development, regulatory, and commercial milestone payments. The companies will co-develop selected programs and co-commercialize some assets in the US and Europe, while Innovent will retain Greater China rights for those programs. Source
NewLimit raises $435 million to move longevity medicine into human trials
NewLimit has raised $435 million in a Series C round led by Founders Fund to advance its first aging reprogramming medicine into human trials next year.
The company is developing epigenetic reprogramming medicines designed to restore youthful function in old cells. NewLimit says it has discovered a prototype therapy that reverses cellular age in old human liver cells, accelerating its timeline to the clinic.
The lead liver reprogramming therapy is designed to help the liver heal faster after injury, resist damage from dietary challenges, and recover more quickly from alcohol exposure. NewLimit said the planned trial will test how liver age reprogramming translates into humans for the first time. Source
Servier to buy Edgewise muscular dystrophy business
Servier has agreed to acquire Edgewise Therapeutics’ muscular dystrophy business in a deal worth up to $2.65 billion, including $1.55 billion upfront and up to $1.1 billion in regulatory and commercial milestones.
The acquisition includes sevasemten, an investigational orally administered fast skeletal myosin inhibitor designed to protect unstable muscle from contraction-induced damage in rare muscular dystrophies. The therapy is currently being evaluated in a pivotal cohort for Becker muscular dystrophy and in phase 2 for Duchenne muscular dystrophy.
Servier said the deal supports its rare neurology strategy and could help establish the company as a global player in neuromuscular disorders. The transaction is expected to close in the third quarter of 2026, subject to regulatory clearance and customary conditions. Source
For this week’s cell and gene therapy news – including promising in vivo phase 1 data from Legend and Kelonia, dual CAR T for kidney transplant patients, and iPDSC therapy for heart failure – click here.
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