Rgenta Therapeutics announces FDA clearance of IND application for RGT-61159
- FDA has cleared the IND application for RGT-61159, an oral small molecule RNA modulator.
- RGT-61159 targets MYB RNA to inhibit oncogenic MYB protein production in ACC and CRC.
- The first-in-human Phase 1a/1b clinical trial will evaluate RGT-61159 in adults with ACC and CRC.
- Preclinical data showed significant inhibition of tumor growth at tolerated doses.
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Kazia Therapeutics announces phase II/III clinical trial results for paxalisib in glioblastoma
- GBM AGILE trial shows a 3.8-month improvement in overall survival for paxalisib-treated newly diagnosed unmethylated glioblastoma patients.
- The trial involved 313 newly diagnosed and recurrent patients, with paxalisib showing a median overall survival of 15.54 months in newly diagnosed patients.
- Paxalisib was well tolerated with no new safety signals identified.
- Kazia plans to discuss potential accelerated approval pathways with the FDA based on these results.
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Can-Fite applies for FDA orphan drug designation for Namodenoson in the treatment of pancreatic cancer
- Can-Fite BioPharma has submitted an application to the FDA for Orphan Drug Designation for Namodenoson in treating pancreatic carcinoma.
- Orphan Drug Designation provides benefits like seven-year marketing exclusivity, tax credits, and assistance in drug development.
- A Phase IIa clinical study is planned, involving 20 patients with advanced pancreatic adenocarcinoma to evaluate safety and clinical activity.
- Namodenoson has previously been granted Orphan Drug Status for advanced liver cancer by both the FDA and EMA.
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ADM Korea announces niclosamide-based metabolic anticancer drug's first clinical trial target as prostate cancer patients resistant to hormone therapy
- ADM Korea to submit IND for clinical study in August 2024.
- Target population: prostate cancer patients resistant to hormone therapy.
- Niclosamide-based drug aims to block signaling pathways to combat drug resistance.
- Combination therapy with hormone therapy expected to enhance anticancer effects.
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Ipsen and Foreseen Biotechnology announce exclusive global licensing agreement for antibody-drug conjugate with first-in-class potential
- Ipsen secures exclusive global rights to develop, manufacture, and commercialize FS001, an antibody-drug conjugate (ADC) with first-in-class potential.
- FS001 targets a novel tumor-associated antigen identified through Foreseen’s proprietary proteomic platforms, showing robust preclinical efficacy and a favorable safety profile.
- Foreseen Biotechnology is eligible to receive up to $1.03bn in upfront, development, regulatory, and commercial milestone payments, plus tiered royalties on global sales.
- Ipsen will handle Phase I preparation activities, including the submission of the Investigational New Drug (IND) application, and all subsequent clinical development, manufacturing, and global commercialization activities.
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Moleculin completes end of phase 2 meeting with FDA for Annamycin in AML
- Moleculin Biotech completed its End of Phase 2 (EOP2) meeting with the FDA for its Phase 1B/2 trial of Annamycin in combination with Cytarabine (AnnAraC) for AML treatment.
- The company expects to report outcomes from the EOP2 meeting by the end of Q3 2024.
- In the ongoing MB-106 trial, 45% of subjects achieved a composite complete remission (CRc), with 40% achieving complete remission (CR).
- Annamycin has Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML and soft tissue sarcoma.
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Patent rights jointly owned by the National Cancer Center and the University of Pennsylvania, licensed to ARC Therapies, Inc.
- The National Cancer Center and the University of Pennsylvania have licensed CCR4 CAR-T cell therapy patent rights to ARC Therapies Inc.
- ARC Therapies will focus on developing cell therapy targeting T-cell cancers, including adult T-cell leukemia/lymphoma (ATLL).
- The potential application of CCR4 CAR-T cell therapy to solid cancers will also be explored.
- ARC Therapies, a startup from the National Cancer Center, aims to accelerate the practical application of new T-cell therapies.
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Context Therapeutics acquires phase 1-ready T cell engager CT-95
- Context Therapeutics has acquired CT-95, a mesothelin x CD3 bispecific antibody, from Link Immunotherapeutics.
- CT-95 has received IND clearance from the U.S. FDA and is set to begin Phase 1 trials in Q1 2025.
- The acquisition aligns with Context's strategy to build a pipeline of T cell engaging assets for solid tumors.
- CT-95 targets mesothelin, prevalent in cancers like ovarian, lung, and pancreatic, and aims to minimize the impact of the shed mesothelin sink.
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Tr1X announces first patient dosed in proof of concept GvHD trial evaluating TRX103
- TRX103 is designed to reset the immune system and improve clinical outcomes for autoimmune and inflammatory disorders.
- The first patient has successfully cleared the safety period with no serious adverse events.
- The trial aims to determine the safety, pharmacokinetics, and pharmacodynamics of TRX103.
- Preliminary safety and effectiveness data readouts are expected by Q4 2024.
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MEKanistic Therapeutics' MTX-531 shows significant tolerability and tumor regressions in preclinical models
- MTX-531 is a dual-targeting therapy inhibiting both EGFR and PI3K, showing high potency and selectivity.
- Preclinical studies demonstrated significant tumor regression in head and neck squamous cell carcinoma (HNSCC) models.
- MTX-531 did not cause hyperglycemia in mice, unlike other pan-PI3K inhibitors.
- Combination therapy with MEK or KRAS inhibitors achieved a 100% objective response rate in multiple tumor models.
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