Carsgen initiates trial for allogeneic CD19/CD20 CAR-T therapy
- CARsgen has started an investigator-initiated trial in China for KJ-C2219, an allogeneic CAR T-cell therapy.
- The trial targets relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL).
- KJ-C2219 is developed using the THANK-u Plus platform, which enhances therapeutic efficacy.
- THANK-u Plus shows superior antitumor activity and potential for diverse CAR-T therapies.
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Galera Therapeutics completes acquisition of Nova Pharmaceuticals
- Galera Therapeutics has acquired Nova Pharmaceuticals, focusing on anti-cancer therapeutics for resistant breast cancer.
- The lead program is a Phase 1/2 trial of a pan-NOS inhibitor combined with nab-paclitaxel and alpelisib for metaplastic breast cancer.
- The acquisition is supported by a $3 million investment, funding operations through 2026.
- Galera plans additional trials, including one for TNBC with the I-SPY 2 consortium and another for HR+ advanced breast cancer.
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Innovent enters into exclusive global license agreement with Roche for novel DLL3 antibody drug conjugate
- Innovent Biologics has partnered with Roche to develop IBI3009, a DLL3-targeted antibody drug conjugate (ADC) for small cell lung cancer.
- IBI3009 has received IND approvals in Australia, China, and the U.S., with Phase 1 trials starting in December 2024.
- Innovent will receive an upfront payment of $80 million and up to $1 billion in milestone payments, plus royalties on sales.
- Roche will take over full development after early-stage collaboration, focusing on global manufacturing and commercialization.
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HUTCHMED announces NDA acceptance in China for ORPATHYS and TAGRISSO combination
- The NDA for ORPATHYS (savolitinib) and TAGRISSO (osimertinib) combination has been accepted by China's NMPA with priority review status.
- This combination targets NSCLC patients with MET amplification after progression on first-line EGFR inhibitor therapy.
- The NDA is supported by the SACHI Phase III trial, which met its primary endpoint of progression-free survival.
- The acceptance triggers a milestone payment from AstraZeneca, and results will be presented at an upcoming scientific conference.
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Innovent's Dovbleron approved by China's NMPA for ROS1-positive NSCLC
- China's NMPA approved Dovbleron (taletrectinib adipate capsule) for adult patients with locally advanced or metastatic ROS1-positive NSCLC.
- Approval based on positive results from the Phase 2 TRUST-I trial, showing high overall response rates and activity against intracranial lesions.
- Dovbleron is part of Innovent's precision therapy portfolio, offering a new first-line treatment option for ROS1-positive NSCLC.
- Taletrectinib has received Orphan Drug and Breakthrough Therapy Designations from the U.S. FDA and China's NMPA.
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Hanx biopharmaceuticals begins phase 1 trial of HX044
- Hanx Biopharmaceuticals has dosed the first patient in a Phase 1 trial of HX044 in Australia.
- HX044 is a bispecific antibody targeting advanced solid tumors, including PD-1-resistant types.
- The trial will assess safety, tolerability, pharmacokinetics, and initial efficacy.
- HX044 aims to enhance antitumor immune responses and optimize safety.
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New tool developed to advance precision medicine for cancer
- Researchers at Children's Hospital of Philadelphia and the University of Pennsylvania developed ATLAS-seq, a new screening technology.
- ATLAS-seq efficiently identifies antigen-reactive T cell receptors (TCRs) that enhance immune responses against cancer cells.
- The technology uses a single-cell approach with an aptamer-based fluorescent sensor to isolate and sequence TCRs.
- ATLAS-seq aims to drive the development of novel T cell immunotherapies for hard-to-treat cancers.
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China's NMPA approves VYLOY (zolbetuximab) for advanced gastric cancer
- Zolbetuximab is the first therapy in China targeting claudin 18.2, a biomarker in 35% of advanced gastric cancer patients.
- Approved for first-line treatment in combination with chemotherapy for HER2-negative gastric or GEJ adenocarcinoma.
- Phase 3 GLOW and SPOTLIGHT trials showed significant improvements in progression-free and overall survival.
- Approval based on trials with 145 and 36 Chinese patients, showing consistent survival benefits.
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Amgen’s tarlatamab receives conditional marketing authorisation in the UK for small cell lung cancer
- The UK’s MHRA has granted conditional marketing authorisation to tarlatamab for ES-SCLC patients who have progressed after at least two prior therapies.
- The authorisation is based on Phase 2 DeLLphi-301 study results showing a 41% objective response rate and a median duration of response of 9.7 months.
- Tarlatamab is a bispecific T-cell engager targeting DLL3 on tumour cells and CD3 on T cells, leading to tumour cell lysis.
- Common side effects include cytokine release syndrome, pyrexia, and dysgeusia. Further evidence is awaited as the product is under additional monitoring.
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Cytomed collaborates with SunAct for phase 2 trial in India
- CytoMed Therapeutics partners with SunAct Cancer Institute to explore gamma delta T cells for solid cancer treatment.
- The collaboration includes a Phase 2 clinical trial in India, focusing on safety, efficacy, and optimal dosing.
- CytoMed will provide scientific and technical support, while SunAct leverages local expertise and facilities.
- The agreement spans five years, aiming to offer affordable cancer treatments in India.
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I-Mab prioritizes givastomig as lead clinical program
- Givastomig, a CLDN18.2 x 4-1BB bispecific antibody, is now I-Mab's lead clinical program.
- Phase 1 trials showed a 16.3% overall response rate with a favorable safety profile.
- A Phase 1b dose escalation study in combination with nivolumab plus chemotherapy is fully enrolled.
- Data from the dose expansion study is expected in early 2026.
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