Datopotamab deruxtecan new BLA submitted for accelerated approval in the U.S. for patients with previously treated advanced EGFR-mutated non-small cell lung cancer
- Daiichi Sankyo and AstraZeneca have submitted a new Biologics License Application (BLA) for datopotamab deruxtecan for EGFR-mutated NSCLC.
- The submission follows the withdrawal of a previous BLA for nonsquamous NSCLC based on FDA feedback.
- The new BLA is supported by data from the TROPION-Lung05 phase 2 trial and other trials.
- Upcoming presentations at ESMO Asia 2024 Congress will feature new pooled analysis results.
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Antelope Surgical Solutions receives IND approval for PSMA-fluorescent drug AS1986NS
- Antelope Surgical Solutions has secured commercial IND approval from the FDA for AS1986NS, a novel prostate cancer drug.
- AS1986NS is a radiofluorescent drug combining therapeutic and imaging radioisotopes with a fluorescent linker.
- The drug targets prostate-specific membrane antigen (PSMA) to enhance surgical precision by illuminating cancer margins.
- Phase I/II clinical trials are set to begin in Q1 2025, focusing on safety and efficacy in human volunteers.
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Pimicotinib significantly improved outcomes for patients with tenosynovial giant cell tumor in a global phase III trial
- The Phase III MANEUVER trial showed pimicotinib improved objective response rate (ORR) to 54.0% compared to 3.2% for placebo in TGCT patients.
- Significant improvements were also observed in secondary endpoints like stiffness and pain reduction.
- Pimicotinib was well-tolerated with a low rate of treatment-emergent adverse events leading to discontinuation.
- The trial included patients from China, Europe, the US, and Canada, and results will be shared with regulators in China.
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Wugen to initiate pivotal trial for CD7-targeted CAR-T therapy
- Wugen will start a pivotal Phase 2 trial for WU-CART-007 in Q1 2025.
- The trial targets relapsed or refractory T cell acute lymphoblastic leukemia and lymphoblastic lymphoma.
- The study will enroll pediatric and adult patients across the US, Europe, Asia, and Australia.
- WU-CART-007 has received RMAT and PRIME designations to expedite development.
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FDA grants rare pediatric disease designation to elraglusib for Ewing sarcoma
- Elraglusib, a GSK-3β inhibitor, receives FDA rare pediatric disease designation for Ewing sarcoma.
- The designation allows eligibility for a Priority Review Voucher upon marketing approval.
- Ongoing Phase 1/2 trial shows promising anti-tumor activity with durable complete responses.
- Topline Phase 1 data expected in the second half of 2025.
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Tempest receives FDA approval to proceed with phase 3 trial of amezalpat for liver cancer
- Tempest Therapeutics received a 'Study May Proceed' letter from the FDA for a pivotal Phase 3 trial.
- The trial will evaluate amezalpat in combination with atezolizumab and bevacizumab versus the standard of care for first-line treatment of unresectable or metastatic hepatocellular carcinoma.
- The Phase 3 study is a global, blinded, 1:1 randomized trial with a pre-specified efficacy analysis.
- The company plans to start the Phase 3 study in the first quarter of 2025.
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Syndax announces positive pivotal topline results from relapsed or refractory mNPM1 AML cohort in AUGMENT-101 trial of revumenib
- The AUGMENT-101 trial met its primary endpoint with a CR/CRh rate of 23% in the pivotal Phase 2 cohort of R/R mNPM1 AML patients.
- The overall response rate (ORR) was 47% in a heavily pre-treated population, with 75% having prior venetoclax exposure.
- Revumenib showed a favorable safety profile, with only 5% of patients discontinuing due to treatment-related adverse events.
- Syndax plans to file a supplemental NDA for R/R mNPM1 AML in the first half of 2025, following anticipated FDA approval for R/R KMT2Ar acute leukemia in Q4 2024.
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Moleculin receives IRB approval for MIRACLE Phase 3 trial of Annamycin in AML
- Moleculin Biotech has received IRB approval for its Phase 3 MIRACLE trial evaluating Annamycin with Cytarabine for relapsed or refractory AML.
- The trial aims for potential accelerated approval and will be conducted globally, including sites in the US.
- The adaptive trial design will initially randomize 75-90 subjects to determine the optimal Annamycin dose.
- Annamycin has Fast Track and Orphan Drug Designations from the FDA and EMA for AML treatment.
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Syros announces topline data from SELECT-MDS-1 phase 3 trial of tamibarotene in higher-risk myelodysplastic syndrome with RARA gene overexpression
- The SELECT-MDS-1 Phase 3 trial evaluated tamibarotene with azacitidine in HR-MDS patients with RARA gene overexpression.
- The trial did not meet its primary endpoint of complete response rate, with 23.8% in the treatment arm vs. 18.8% in the control arm.
- Tamibarotene was generally well-tolerated, with a safety profile similar to earlier studies.
- Syros plans to stop the study, review the clinical data, and evaluate next steps.
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Zetagen Therapeutics enrolls first patients in phase 2a study of ZetaMet for metastatic breast cancer
- Zetagen Therapeutics has enrolled the first two patients in a phase 2a study of ZetaMet (Zeta-BC-003) for spinal metastatic lytic breast cancer lesions.
- The 26-week study at the University of British Columbia will assess safety and efficacy, focusing on skeletal related events, pain, vertebral defect size, and opioid use.
- ZetaMet is a synthetic small-molecule therapy designed to resolve bone lesions, reduce pain, and potentially increase survival rates.
- The FDA has granted multiple Breakthrough Designations for ZetaMet, and previous studies have shown promising results in lesion resolution and pain reduction.
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Natera completes Signatera analysis from CALGB/SWOG 80702 trial in colorectal cancer
- Natera completed a study using Signatera in the CALGB/SWOG 80702 phase III trial for stage III colorectal cancer.
- The trial evaluated the addition of celecoxib to FOLFOX in a biomarker unselected population.
- Signatera aims to identify patients who may benefit from celecoxib, despite no significant improvement in disease-free survival.
- Results will be presented at the ASCO GI Symposium in January 2024.
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GlycoNex partners with Sterling for GNX102-ADC clinical trial production
- GlycoNex has signed a manufacturing agreement with Sterling Pharma Solutions for GNX102-ADC production.
- GNX102-ADC is set for a Phase 1 clinical program, combining GlycoNex's monoclonal antibody with cytotoxic drugs.
- Preclinical trials showed GNX102-ADC's safety and potential to treat various solid tumors.
- GlycoNex retains full development rights and has secured patents in key global markets.
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Cellworks enhances TRI with personalized tumor microenvironment modeling to predict overall survival in NSCLC patients receiving immunotherapy
- Cellworks Group Inc. has developed a Therapy Response Index (TRI) combined with personalized tumor microenvironment (TME) modeling to predict overall survival in NSCLC patients receiving immunotherapy.
- The study involved an algorithm using RNA-seq data from 63 NSCLC patients, generating a personalized Computational Biosimulation Model (CBM) for each patient.
- Results showed that combining TRI scores with tumor microenvironment cell proportions significantly improved the prediction of overall survival.
- Specific immune markers, such as the ratio of CXCL9+ M1-like macrophages to SPP1+ CD163+ M2-like macrophages, were correlated with improved patient outcomes.
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Mainz Biomed and Thermo Fisher Scientific collaborate on colorectal cancer screening product
- Mainz Biomed and Thermo Fisher Scientific have signed a collaboration agreement to develop a next-generation colorectal cancer screening product.
- The partnership will utilize Thermo Fisher's technologies to enhance Mainz Biomed's mRNA-based screening tests.
- The focus is on early detection of colorectal cancer and precancerous lesions, with significant clinical success in US and European trials.
- The collaboration aims to accelerate the availability of innovative colorectal cancer screening tests globally.
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Repare Therapeutics partners with US National Cancer Institute for camonsertib development
- Repare Therapeutics has entered a Cooperative Research and Development Agreement with the US National Cancer Institute.
- The collaboration aims to advance camonsertib, an ATR inhibitor, for cancer treatment.
- Camonsertib is being tested in clinical trials for metastatic solid tumors, both as monotherapy and in combination with other treatments.
- The partnership will explore combination studies with radiation therapy and identify predictive biomarkers.
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