FDA grants orphan drug and rare pediatric disease designation status to Cellectis’ UCART22 product candidate for acute lymphoblastic leukemia treatment
- The FDA has granted Orphan Drug (ODD) and Rare Pediatric Disease Designation (RPDD) status to Cellectis' UCART22 for treating acute lymphoblastic leukemia (ALL).
- ALL accounts for about 10% of all leukemia cases in the US and is typically fatal within weeks or months if untreated.
- UCART22 is an allogeneic CAR T-cell product targeting CD22, currently in a Phase 1/2 study (BALLI-01) to evaluate its safety and efficacy.
- Cellectis plans to provide updates on the BALLI-01 trial by the end of 2024.
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Summit Therapeutics and MD Anderson announce strategic collaboration to accelerate development of ivonescimab
- Summit Therapeutics and MD Anderson Cancer Center have entered a five-year collaboration to accelerate the development of ivonescimab.
- MD Anderson will lead multiple clinical trials to evaluate ivonescimab's safety and potential clinical benefits across various tumor types.
- Early research will focus on renal cell carcinoma, colorectal cancer, skin cancer, breast cancer, and glioblastoma.
- The collaboration aims to expand the development program of ivonescimab, leveraging its unique PD-1/VEGF bispecific antibody mechanism.
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Presage Biosciences announces first patient dosing of Pure Biologics' ROR1 targeting antibody for treatment of cancer
- Presage Biosciences has dosed the first cancer patient in a Phase 0 study with Pure Biologics' PBA-0405, an antibody targeting ROR1.
- PBA-0405 is designed to induce tumor cell killing by cytotoxic immune cells and is being tested using Presage's Comparative In Vivo Oncology (CIVO) platform.
- The study aims to evaluate the biological effects of PBA-0405 within the human tumor microenvironment.
- The U.S. FDA issued a Study May Proceed notification for this Phase 0 testing, which involves microdosing directly in a human tumor planned for surgical removal.
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Actinium announces FDA clearance of Iomab-ACT targeted conditioning IND application for sickle cell disease patients undergoing bone marrow transplant
- FDA has cleared Actinium's IND application to study Iomab-ACT for targeted conditioning before bone marrow transplant in sickle cell disease patients.
- The study, in collaboration with Columbia University, will evaluate the safety of Iomab-ACT in patients receiving allogeneic BMT.
- If successful, the trial will inform a subsequent study on Iomab-ACT as a conditioning agent before gene therapy for sickle cell disease.
- Iomab-ACT aims to replace non-targeted chemotherapy and total body irradiation, potentially reducing severe side effects and improving access to curative therapies.
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California Institute for Regenerative Medicine awards funding for CAR-T NXC-201 U.S. AL amyloidosis clinical trial (NEXICART-2)
- Immix Biopharma's cell therapy division, Nexcella, received an $8 million CLIN2 grant from CIRM.
- The funding supports the NEXICART-2 U.S. study, evaluating the safety and efficacy of NXC-201 in relapsed/refractory AL amyloidosis patients.
- NEXICART-2 builds on positive data from the NEXICART-1 study, which showed a 92% overall response rate.
- NXC-201 is the only CAR-T therapy currently in development for AL amyloidosis.
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BioAtla highlighted clinical program and pipeline updates at virtual R&D day
- Phase 2 trial of mecbotamab vedotin (CAB-AXL-ADC) in NSCLC shows clinical benefit in patients with KRAS mutations.
- AXL expression ≥1% correlated with clinical benefit in heavily pretreated patients.
- Phase 1/2 trial of evalstotug (CAB-CTLA-4) shows promising anti-tumor activity with low incidence of immune-related adverse events.
- Phase 2 study exploring 700mg evalstotug + pembrolizumab in 1st line melanoma is currently enrolling.
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Nectin Therapeutics licenses novel antibodies to Immunome
- Nectin Therapeutics has entered a global, exclusive license agreement with Immunome Inc. for a panel of antibodies targeting an undisclosed target.
- Immunome will handle the research, development, manufacturing, and commercialization of products incorporating these antibodies.
- Nectin will receive an upfront payment and is eligible for milestone payments and royalties.
- This agreement allows Nectin to focus on its anti-PVR program (NTX1088) and advance its novel ADCs into clinical development.
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Glycocalyx Research Institute announces breakthrough study linking microvascular health to reduced cancer radiation therapy side effects
- The study links healthier microvascularization to reduced side effects from radiation therapy in breast, prostate, and head and neck cancer patients.
- Conducted in collaboration with Fondazione IRCCS Istituto Nazionale dei Tumori and the University of Verona Hospital Trust.
- Utilized the GlycoCheck™ imaging device to assess patients' microvascular health before radiation therapy.
- Findings suggest that improving microvascular health can be a key strategy in reducing treatment-related side effects.
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Immunome provides update on recent business development activity expected to expand ADC capabilities
- Immunome acquired exclusive rights to antibodies from Nectin Therapeutics, Bluefin Biomedicine, and OncoResponse.
- Previously, Immunome purchased 28 antibodies from Atreca and licensed IM-1021 and ADC platform technology from Zentalis.
- The acquisitions aim to enhance Immunome's antibody-drug conjugate (ADC) capabilities.
- Next steps include advancing their pipeline with IND submissions for IM-1021 and IM-3050 expected in Q1 2025.
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Inovio receives advanced therapy medicinal product certificate from European Medicines Agency for quality and non-clinical data for lead candidate INO-3107
- INOVIO's INO-3107 has received certification from the European Medicines Agency's Committee for Advanced Therapies (CAT) for its quality and non-clinical data.
- The certification confirms compliance with standards for evaluating a European Marketing Authorization Application.
- INO-3107 is designed to elicit an antigen-specific T cell response against HPV-6 and HPV-11 proteins, aiming to prevent or slow the growth of new papillomas.
- In a Phase 1/2 clinical trial, 81.3% of patients had a decrease in surgical interventions, with 28.1% requiring no surgical intervention during or after the dosing window.
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