Adaptimmune receives U.S. FDA accelerated approval of TECELRA (afamitresgene autoleucel)
- Adaptimmune Therapeutics received FDA accelerated approval for TECELRA (afamitresgene autoleucel) for adults with unresectable or metastatic synovial sarcoma.
- Approval is based on overall response rate and duration of response from the SPEARHEAD-1 trial, which showed a 43% overall response rate.
- TECELRA is the first engineered cell therapy for a solid tumor cancer approved in the U.S. and the first new therapy option for synovial sarcoma in over a decade.
- Adaptimmune plans to establish 6-10 authorized treatment centers this year and approximately 30 within the next two years.
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US FDA expands Jemperli plus chemotherapy approval for endometrial cancer
- The US FDA has approved Jemperli (dostarlimab-gxly) in combination with carboplatin and paclitaxel for adult patients with primary advanced or recurrent endometrial cancer.
- This approval includes patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors, representing 70-75% of endometrial cancer cases.
- The approval is based on the RUBY phase III trial, which showed a 31% reduction in risk of death and a 16.4-month improvement in median overall survival.
- The safety profile of Jemperli plus chemotherapy was consistent with known safety profiles of the individual agents.
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IDeate-Lung02 phase 3 trial of ifinatamab deruxtecan initiated in patients with relapsed small cell lung cancer
- Daiichi Sankyo and Merck have dosed the first patient in the IDeate-Lung02 phase 3 trial.
- The trial evaluates ifinatamab deruxtecan (I-DXd) versus physician’s choice of chemotherapy in relapsed SCLC patients.
- IDeate-Lung02 is a global, multicenter, randomized, open-label phase 3 trial with dual primary endpoints: objective response rate and overall survival.
- Approximately 460 patients will be enrolled across Asia, Europe, Oceania, North America, and South America.
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CStone announces European Commission approval for sugemalimab as first-line therapy for non-small cell lung cancer
- Sugemalimab is the first anti-PD-L1 monoclonal antibody approved in Europe for first-line treatment of non-small cell lung cancer (NSCLC).
- Approval is based on the Phase-3 GEMSTONE-302 study, which showed significant improvement in progression-free and overall survival.
- CStone has partnered with Ewopharma for marketing in Central and Eastern Europe and Switzerland, with further partnerships in progress.
- CStone is preparing additional regulatory submissions for other indications, including stage III NSCLC, first-line gastric cancer, and relapsed/refractory extranodal NK/T-cell lymphoma.
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PDS Biotech aligns with FDA on phase 3 trial in HPV16-positive first-line recurrent or metastatic head and neck cancer
- PDS Biotech to initiate Phase 3 VERSATILE-003 trial in Q4 2024.
- The trial will focus on Versamune® HPV + pembrolizumab for HPV16-positive HNSCC.
- FDA supports the strategy and development of both double and triple combinations.
- The Versamune® HPV + pembrolizumab combination has received Fast Track designation.
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Kiromic BioPharma reports 20% tumor size reduction at eight months in first patient enrolled in Deltacel-01
- Kiromic BioPharma reports favorable eight-month follow-up results from the first patient in its Deltacel-01 Phase 1 clinical trial.
- The trial evaluates Deltacel (KB-GDT-01), an allogeneic Gamma Delta T-cell therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC).
- Scans showed a 20% reduction in tumor size at eight months post-treatment, with no new tumor lesions detected.
- Kiromic expects to report additional follow-up results from the fourth and fifth patients in the study in August.
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Elevar Therapeutics granted orphan medicinal product designation by the European Medicines Agency for first-line systemic therapy for unresectable hepatocellular carcinoma
- Elevar Therapeutics received Orphan Medicinal Product Designation from the EMA for rivoceranib in combination with camrelizumab for first-line treatment of unresectable hepatocellular carcinoma (uHCC).
- The designation highlights the unmet need for new liver cancer therapies and supports Elevar's mission to provide novel treatment options.
- Orphan designation by the EMA offers incentives such as centralized authorization and 10 years of market protection from competition.
- Rivoceranib, a tyrosine kinase inhibitor, and camrelizumab, a PD-1 antibody, are being studied in various solid tumor indications, including uHCC.
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FDA grants orphan drug designation to Cellectis’ CLLS52 (alemtuzumab) for ALL treatment
- The FDA has granted Orphan Drug Designation (ODD) to Cellectis’ CLLS52 (alemtuzumab) for relapsed/refractory B-cell acute lymphoblastic leukemia (ALL).
- CLLS52 is used as part of the lymphodepletion regimen in the BALLI-01 clinical trial, showing sustained lymphodepletion and higher UCART22 cell expansion.
- Cellectis’ UCART22 product candidate has the CD52 gene inactivated by TALEN gene editing technology, making it resistant to alemtuzumab.
- ODD status may expedite and reduce the cost of development, approval, and commercialization of CLLS52.
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Corvus Pharmaceuticals granted FDA fast track designation for soquelitinib for treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL)
- FDA grants Fast Track Designation to soquelitinib for treating relapsed or refractory PTCL.
- Soquelitinib's Phase 3 clinical trial set to begin patient enrollment in Q3 2024.
- Fast Track Designation aims to expedite the development and review of drugs for serious conditions.
- Soquelitinib also holds FDA Orphan Drug Designation, offering additional development benefits.
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Moleculin announces plans for MIRACLE phase 3 pivotal trial
- Moleculin to proceed with a pivotal, adaptive Phase 3 clinical trial (MIRACLE) for Annamycin in combination with cytarabine for relapsed or refractory AML.
- The trial will be global, including sites in the US, and will allow dosing above the lifetime maximum allowable anthracycline dose.
- The primary endpoint will be complete remission (CR) at day 30, with secondary endpoints including durability of response (DoR) and overall survival (OS).
- Key milestones include starting site contracting in 2H 2024, first subject treatment in Q1 2025, and final data submission in 2H 2028.
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