FDA grants breakthrough therapy designation to sacituzumab tirumotecan for advanced NSCLC
- The FDA has granted Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) for advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with EGFR mutations.
- This designation is based on data from Phase 2 studies showing promising results in patients with EGFR-mutated NSCLC.
- Sac-TMT is being developed by Merck in collaboration with Kelun-Biotech and is currently undergoing multiple Phase 3 trials.
- The designation aims to expedite the development and review process, potentially leading to Priority Review if criteria are met.
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Innovent and HUTCHMED announce NMPA conditional approval for sintilimab and fruquintinib combination
- The NMPA in China has conditionally approved the combination of sintilimab and fruquintinib for advanced endometrial cancer with pMMR tumors.
- Approval is based on data from the FRUSICA-1 Phase 2 study, showing an ORR of 35.6% and DCR of 88.5%.
- The combination treatment demonstrated a median PFS of 9.5 months and OS of 21.3 months.
- A Phase 3 confirmatory study is planned to further evaluate the combination therapy.
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Ipsen and Biomunex announce exclusive global licensing agreement for MAIT cell engager
- Ipsen secures global rights to develop and commercialize BMX-502, a pre-clinical bispecific antibody.
- BMX-502 targets MAIT cells and the GPC3 tumor antigen, offering a novel approach in immuno-oncology.
- Biomunex will complete the IND-enabling package, while Ipsen handles Phase I and further development.
- Biomunex is eligible for up to $610 million in milestones and royalties.
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FDA grants fast track designation to CRB-701 for metastatic cervical cancer
- The FDA has granted Fast Track designation to CRB-701 for relapsed or refractory metastatic cervical cancer.
- CRB-701 is an antibody drug conjugate targeting Nectin-4 with a cleavable linker and a drug antibody ratio of 2.
- Corbus completed enrollment for the dose escalation part of its Phase 1 trial in the U.S. and Europe.
- First data from the dose escalation study is expected in Q1 2025.
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Takeda strengthens oncology pipeline with elritercept through licensing agreement with Keros Therapeutics
- Takeda has entered an exclusive licensing agreement with Keros Therapeutics to develop, manufacture, and commercialize elritercept outside of mainland China, Hong Kong, and Macau.
- Elritercept is an investigational activin inhibitor for treating anemia in hematologic cancers like myelodysplastic syndromes (MDS) and myelofibrosis (MF).
- The FDA has granted Fast Track designation for elritercept in very low-, low-, and intermediate-risk MDS.
- Takeda will pay Keros $200 million upfront, with additional payments for regulatory, development, and sales milestones, plus royalties on net sales.
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Elevar and Relay announce global licensing agreement for lirafugratinib
- Elevar Therapeutics gains worldwide rights to develop and commercialize lirafugratinib, a selective FGFR2 inhibitor.
- Relay Therapeutics could receive up to $500 million in payments, including $75 million upfront and regulatory milestones.
- Lirafugratinib is being investigated in the ReFocus trial for FGFR2-altered tumors, with a pivotal cohort for FGFR2-fusion CCA.
- The FDA recommended filing an NDA for FGFR2-driven CCA, followed by a supplemental NDA for other FGFR2-altered tumors.
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Lantern Pharma's LP-184 receives second fast track designation from FDA for TNBC
- Lantern Pharma's investigational drug LP-184 has received its second Fast Track Designation from the FDA, this time for Triple Negative Breast Cancer (TNBC).
- LP-184 is currently in a Phase 1A clinical trial to assess its safety and tolerability in various solid tumors, including TNBC.
- Preclinical data shows LP-184's potential in TNBC, demonstrating complete tumor regression in patient-derived xenograft models.
- The drug's mechanism involves activation by PTGR1, making TNBC tumors particularly susceptible to treatment.
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Epsilogen initiates phase Ib trial of MOv18 IgE
- Epsilogen has started a Phase Ib trial for MOv18 IgE in patients with platinum-resistant ovarian cancer (PROC).
- The trial is open-label, dose escalation and expansion, enrolling 45 patients with PROC.
- MOv18 IgE targets the folate receptor alpha antigen, expressed in various cancers.
- The trial aims to assess safety, tolerability, and efficacy, building on positive Phase I results.
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SciTech Development announces promising preliminary results in phase 1a trial for T-cell non-Hodgkin lymphoma
- SciTech Development reports promising preliminary results from its Phase 1a trial of ST-001 nanoFenretinide for T-cell non-Hodgkin lymphoma.
- The trial shows early partial responses and a favorable safety profile, with minimal side effects observed.
- ST-001's nanoparticle delivery system achieves desired pharmacokinetics, enhancing targeted delivery and minimizing toxicity.
- The trial is nearing completion, with plans to enroll 45 additional patients and a future trial for small cell lung cancer anticipated in Q2 2025.
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Recursion doses first patient in phase 1/2 study of REC-1245 for solid tumors and lymphoma
- Recursion has initiated a Phase 1/2 clinical trial for REC-1245, targeting biomarker-enriched solid tumors and lymphoma.
- REC-1245 is a novel RBM39 degrader, developed using Recursion's AI-enabled drug discovery platform.
- The DAHLIA trial aims to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary activity of REC-1245.
- The trial will determine the maximum tolerated dose and recommended Phase 2 dose, with potential for combination therapy.
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Duality Biologics and GSK enter exclusive option agreement for a novel antibody-drug conjugate (DB-1324)
- Duality Biologics has entered an exclusive option agreement with GSK for the ADC candidate DB-1324.
- DB-1324 is in preclinical development, targeting gastrointestinal cancer using DualityBio's DITAC platform.
- GSK will pay $30 million upfront, with potential milestone payments up to $975 million upon option exercise.
- The agreement excludes rights in mainland China, Hong Kong, and Macau, with GSK paying royalties on global sales.
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Terns Pharmaceuticals announces positive early data from phase 1 CARDINAL trial of TERN-701 for chronic myeloid leukemia
- Phase 1 CARDINAL trial shows compelling molecular responses in heavily pre-treated CML patients.
- No dose limiting toxicities or adverse event-related discontinuations observed across three dose levels.
- High levels of target coverage achieved with once daily dosing; dose expansion to begin in 1H25.
- Additional efficacy data, including long-term MMR rates, expected in 4Q25.
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Gilead and Tubulis enter into exclusive option and license agreement to develop ADC candidate for select solid tumor target
- Gilead Sciences and Tubulis have partnered to develop an antibody-drug conjugate (ADC) for a solid tumor target.
- Gilead will access Tubulis' Tubutecan and Alco5 platforms, with Tubulis leading the discovery and development of a Topoisomerase I inhibitor-based ADC.
- Tubulis will receive a $20 million upfront payment, with potential additional payments totaling up to $415 million, plus royalties.
- If Gilead exercises its option, it will handle further development and commercialization of the ADC.
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Aptose collaborates with NCI to develop tuspetinib for AML and MDS
- Aptose Biosciences has entered a CRADA with the National Cancer Institute (NCI) to develop tuspetinib for AML and MDS.
- Tuspetinib will be tested in the myeloMATCH precision medicine trials, focusing on targeted drug combinations for newly diagnosed patients.
- The trials aim to expedite the development of tailored treatments for AML and MDS, leveraging tuspetinib's broad activity spectrum.
- Aptose is also developing tuspetinib in a triple drug combination for AML patients unfit for chemotherapy, with a Phase 1/2 study set to commence.
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Oncolytics Biotech completes initial safety phase enrollment for GOBLET trial's new pancreatic cancer cohort
- Oncolytics Biotech has completed the initial safety phase enrollment for Cohort 5 of the GOBLET trial, focusing on pancreatic cancer.
- The trial evaluates pelareorep combined with modified FOLFIRINOX, with or without atezolizumab, in newly diagnosed pancreatic ductal adenocarcinoma patients.
- The Data Safety Monitoring Board has recommended continued enrollment, pending final approval from Germany's Paul Ehrlich Institute.
- The study is funded by a US$5 million award from the Pancreatic Cancer Action Network, with updates expected in 2025.
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