Biosyngen's BRG01 enters Phase II clinical trial for nasopharyngeal carcinoma
- Biosyngen's BRG01, an autologous EBV-specific CAR-T therapy, has entered a pivotal Phase II clinical trial for recurrent/metastatic nasopharyngeal carcinoma.
- The trial was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China.
- Initial Phase I trials showed promising results, with 75% of high-dose patients experiencing tumor shrinkage and some achieving complete remission.
- BRG01 has received orphan drug designation and fast track designation from the FDA, highlighting its potential in treating EBV-positive tumors.
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Mabwell receives NMPA approval for clinical trial of novel Nectin-4 targeting ADC in TNBC
- Mabwell's novel Nectin-4 targeting ADC (9MW2821) approved by NMPA for Phase II clinical trial in TNBC.
- The trial will evaluate 9MW2821 as monotherapy or in combination with a PD-1 inhibitor in locally advanced or metastatic TNBC.
- Cohort A: Patients with prior taxane/anthracycline-based chemotherapy will receive 9MW2821 monotherapy.
- Cohort B: Patients without prior systemic therapy will receive 9MW2821 combined with a PD-1 inhibitor.
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Oncternal completes enrollment and initiates dosing for sixth dose cohort in phase 1/2 study of ONCT-534
- Oncternal Therapeutics has completed enrollment and initiated dosing for the sixth dose cohort in its Phase 1/2 study of ONCT-534.
- Patients in this cohort are receiving 1200 mg of ONCT-534 daily, following a review by the Safety Review Committee.
- An initial update on safety and efficacy, based on PSA levels, is expected in Q3 2024.
- The study aims to evaluate the safety, tolerability, and preliminary anti-tumor activity of ONCT-534 in patients with metastatic castration-resistant prostate cancer.
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GRAIL advances the Galleri registrational clinical trial program
- GRAIL has completed enrollment of over 35,000 participants in the PATHFINDER 2 study.
- Results from the first 25,000 participants in PATHFINDER 2 are expected in the second half of 2025.
- The NHS-Galleri trial has completed final study visits with over 140,000 participants; final results expected in 2026.
- Data from these studies will support GRAIL's premarket approval application for Galleri to the FDA.
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Artelo Biosciences receives FDA clearance of its IND application for ART26.12
- FDA has issued a 'Study May Proceed' letter for ART26.12, a selective FABP5 inhibitor.
- ART26.12 aims to treat chemotherapy-induced peripheral neuropathy (CIPN), a condition with no current FDA-approved treatments.
- The Phase 1 single ascending dose study will be initiated in collaboration with Worldwide Clinical Trials.
- Phase 1 trial results are expected in the first half of 2025.
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Sumitomo Pharma's DSP-5336 receives FDA fast track designation for relapsed or refractory AML
- DSP-5336 is an investigational menin and mixed-lineage leukemia (MLL) inhibitor.
- FDA granted Fast Track designation for treatment of relapsed or refractory acute myeloid leukemia (AML) with MLLr or NPM1m.
- Phase 1/2 study shows 57% objective response rate, with 24% achieving complete remission or partial hematologic recovery.
- DSP-5336 is well-tolerated with no dose-limiting toxicity and manageable differentiation syndrome cases.
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Camurus announces positive Phase 3 results from the ACROINNOVA 2 study of octreotide SC depot (CAM2029) in acromegaly patients
- The 52-week Phase 3 ACROINNOVA 2 study evaluated the safety and efficacy of CAM2029 in 135 acromegaly patients.
- CAM2029 was well tolerated with a safety profile consistent with standard-of-care treatments.
- Significant increases in biochemical response rates and continuous improvement in symptom and quality of life scores were observed.
- Regulatory reviews are ongoing in the US and EU, with a first approval decision expected from the US FDA by October 21, 2024.
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Orum Therapeutics announces global license agreement with Vertex
- Orum Therapeutics has entered a global, multi-target license and option agreement with Vertex Pharmaceuticals.
- Vertex will use Orum’s TPD² technology to develop novel degrader-antibody conjugates (DACs).
- Orum will receive an upfront payment of $15 million and potential additional payments up to $310 million per target.
- Vertex is responsible for all research, development, and commercialization of the DACs.
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Lowcountry Oncology Associates partners with OneOncology
- Lowcountry Oncology Associates partners with OneOncology to enhance cancer services in Charleston, SC.
- The partnership includes four new clinics in North Charleston, West Ashley, Mt. Pleasant, and Summerville.
- Lowcountry Oncology will add services like in-office drug dispensing, lab services, and medical imaging.
- This is the third South Carolina oncology practice and 24th nationally to join the OneOncology platform.
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GC Cell and Checkpoint Therapeutics advance collaborative cancer research
- GC Cell and Checkpoint Therapeutics are collaborating to explore the combined therapeutic potential of cosibelimab and Immuncell-LC.
- The initial focus will be on in vitro combination studies to evaluate the synergistic effects on cancer cell destruction.
- Positive preliminary data could lead to future in vivo research and clinical studies.
- The collaboration aims to leverage immune system components more effectively in targeting and eliminating cancer cells.
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