HUTCHMED receives full NMPA approval for Orpathys in China for MET exon 14 NSCLC
- HUTCHMED's Orpathys (savolitinib) gains full approval from China's NMPA for treating locally advanced or metastatic NSCLC with MET exon 14 skipping alteration.
- The approval expands the indication to include both treatment-naĂŻve and previously treated patients.
- Approval was based on Phase IIIb trial data showing a 62.1% objective response rate in treatment-naĂŻve patients.
- Orpathys is the first selective MET inhibitor approved in China, developed in collaboration with AstraZeneca.
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FDA clears Ariceum Therapeutics' 225Ac-Satoreotide Phase I/II clinical study in patients with small cell lung cancer or Merkel cell carcinoma
- The FDA has approved Ariceum Therapeutics' IND application for a Phase I/II trial of 225Ac-SSO110 (satoreotide) in patients with SCLC or MCC.
- The SANTANA-225 trial is a global, open-label study to evaluate safety, tolerability, and preliminary efficacy of 225Ac-SSO110.
- Patient recruitment is set to begin in Q1 2025, focusing on those receiving first-line maintenance therapy with checkpoint inhibitors.
- 225Ac-SSO110 is part of a 'theranostic pair' with 68Ga-SSO120, targeting SSTR2-expressing aggressive cancers.
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Umoja Biopharma secures $100 million in Series C financing
- Umoja Biopharma closed a $100 million Series C financing round co-led by Double Point Ventures and DCVC Bio.
- Funds will support the development of in vivo CAR T cell therapies, including the lead CD22 UB-VV400 program.
- New board member Campbell Murray, M.D., joins from Double Point Ventures.
- The financing aims to advance Umoja's oncology and autoimmune clinical studies.
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World’s first drug candidate developed by organoid and AI doses first patient in phase 1 study for first diffusive gastric cancer targeted therapy
- Signet Therapeutics has dosed the first patient in a Phase I trial for SIGX1094, targeting diffuse gastric cancer (DGC) and other solid tumors.
- The trial, conducted at Beijing Cancer Hospital, aims to assess the safety, tolerability, and optimal dosing of SIGX1094.
- SIGX1094, discovered using AI and organoid models, has shown promise in preclinical studies for various cancers, including ovarian and pancreatic.
- The drug received Orphan Drug Designation from the FDA, highlighting its potential for rare cancer treatments.
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Verastem Oncology licenses VS-7375, a KRAS G12D inhibitor, from GenFleet
- Verastem Oncology has exercised an early option to license VS-7375, a KRAS G12D inhibitor, from GenFleet Therapeutics.
- Preliminary data from a Phase 1 study in China shows partial responses in patients with pancreatic and non-small cell lung cancer.
- No dose-limiting toxicities observed in six dose cohorts; ongoing enrollment in the Phase 1 study.
- Verastem plans to file a U.S. IND application in Q1 2025 and initiate a Phase 1/2a study by mid-2025.
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TransCode Therapeutics doses first patient in third cohort of phase 1 trial
- TransCode Therapeutics has dosed the first patient in Cohort 3 of its Phase 1 trial for TTX-MC138.
- The Safety Review Committee approved the third cohort after reviewing safety data from Cohorts 1 and 2.
- No significant safety issues or dose-limiting toxicities were reported in the earlier cohorts.
- The trial is a multicenter, open-label study focusing on safety and tolerability of TTX-MC138 in metastatic cancers.
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Context therapeutics doses first patient in phase 1 trial of CTIM-76
- Context Therapeutics has initiated a Phase 1 trial for CTIM-76, targeting CLDN6-positive gynecologic and testicular cancers.
- The trial is an open-label, dose escalation and expansion study to assess safety, tolerability, and anti-tumor activity.
- Up to 70 patients will be enrolled, with initial data expected in the first half of 2026.
- CTIM-76 is a CLDN6 x CD3 T cell engaging bispecific antibody, showing potential for treating various solid tumors.
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C4 Therapeutics announces 2025 milestones for degrader medicines in oncology
- Cemsidomide data supports best-in-class profile; advancing to next phase for multiple myeloma and non-Hodgkin’s lymphoma.
- CFT1946 Phase 1 trial in BRAF V600X solid tumors progressing; data expected in melanoma and colorectal cancer in 2025.
- CFT8919 Phase 1 dose escalation in Greater China to inform future development for non-small cell lung cancer.
- Cash runway expected to fund operations into 2027.
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Taiho Oncology's decitabine and cedazuridine included in NIH precision medicine trials
- Taiho Oncology's oral decitabine and cedazuridine are part of the NIH's myeloMATCH precision medicine trials.
- The trials target genetic mutations in myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).
- Two Phase 2 trials will assess the efficacy and safety of these drugs in combination with others like enasidenib and venetoclax.
- The trials aim to match patients with specific genetic profiles to appropriate treatment regimens.
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Instil Bio announces clinical progress in China for IMM2510/SYN-2510
- ImmuneOnco has dosed the first patient in a Phase 1b/2 trial of IMM2510/SYN-2510 combined with chemotherapy for advanced NSCLC in China.
- Initial clinical data from the trial is expected in the second half of 2025.
- Instil plans to initiate a similar trial in the U.S. for first-line NSCLC patients in the second half of 2025, pending regulatory approvals.
- The trial aims to explore the potential of IMM2510/SYN-2510, a PD-L1xVEGF bispecific antibody, in treating multiple solid tumors.
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OS Therapies announces phase 2b clinical trial of OST-HER2 achieves primary endpoint
- OS Therapies reported positive results from a Phase 2b trial of OST-HER2 for preventing recurrent lung metastatic osteosarcoma.
- The trial met its primary endpoint with a statistically significant 12-month event-free survival (EFS) rate of 33% compared to 20% in historical controls.
- Interim analysis showed a trend towards improved overall survival (OS) at 1-year (91% vs. 80%) and 2-year (61% vs. 40%) timepoints.
- OS Therapies plans to engage with the FDA for accelerated approval, leveraging the trial's success and existing regulatory designations.
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Zai Lab announces positive results for TIVDAK in China subpopulation of innovaTV 301 trial
- Zai Lab reported positive topline results from the China subpopulation of the global Phase 3 innovaTV 301 trial for TIVDAK in recurrent or metastatic cervical cancer.
- TIVDAK showed a 45% reduction in the risk of death compared to chemotherapy in the China subpopulation.
- The safety profile of TIVDAK was consistent with the global profile, with manageable side effects.
- Zai Lab plans to submit a New Drug Application (NDA) to China's NMPA in Q1 2025.
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Innovent receives NMPA breakthrough therapy designation for IBI343 as monotherapy for advanced pancreatic cancer
- Innovent Biologics has been granted Breakthrough Therapy Designation (BTD) by China's NMPA for IBI343, an anti-CLDN18.2 ADC, as monotherapy for advanced pancreatic cancer.
- The designation is based on Phase 1 study data showing favorable safety and promising antitumor activity in patients with CLDN18.2-positive advanced pancreatic ductal adenocarcinoma (PDAC).
- The study involved 43 patients, with a confirmed overall objective response rate of 23.3% and a median progression-free survival of 5.3 months.
- Innovent plans to initiate pivotal multi-regional clinical trials to further confirm the efficacy and safety of IBI343 in this indication.
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Evaxion completes dosing in phase 2 trial with personalized cancer vaccine EVX-01
- Evaxion Biotech has completed dosing all 16 patients in its phase 2 trial for the personalized cancer vaccine EVX-01.
- The trial, targeting advanced melanoma, is on track for completion and data readout in the second half of 2025.
- EVX-01 is designed using Evaxion’s AI-Immunology platform and is tested in combination with KEYTRUDA (pembrolizumab).
- Interim data showed a 69% overall response rate and a strong correlation between AI predictions and immune responses.
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New drug application initiated with U.S. FDA for TAR-200
- Johnson & Johnson has submitted a New Drug Application to the U.S. FDA for TAR-200, targeting BCG-unresponsive high-risk non-muscle-invasive bladder cancer.
- The application is under the FDA's Real-Time Oncology Review program, based on Phase 2b SunRISe-1 study results showing an 83.5% complete response rate.
- TAR-200 is an intravesical drug releasing system delivering gemcitabine locally in the bladder, designed for outpatient use without anesthesia.
- The FDA granted Breakthrough Therapy Designation to TAR-200 in December 2023, and the company anticipates further regulatory actions.
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