Tagrisso approved in the US for patients with unresectable, stage III EGFR-mutated lung cancer
- AstraZeneca’s Tagrisso (osimertinib) has been approved by the FDA for treating adult patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC).
- The approval is based on the LAURA Phase III trial results, which showed an 84% reduction in the risk of disease progression or death compared to placebo.
- Median progression-free survival (PFS) was 39.1 months for Tagrisso-treated patients versus 5.6 months for those on placebo.
- Tagrisso is currently under review by regulatory authorities in other countries for this indication.
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Cocrystal Pharma advances oral pan-viral protease inhibitor CDI-988 into phase 1 multiple-ascending dose cohorts
- Cocrystal Pharma has initiated dosing in the multiple-ascending dose (MAD) portion of the Phase 1 study for CDI-988.
- CDI-988 is a broad-spectrum, oral pan-viral protease inhibitor targeting noroviruses and coronaviruses.
- The Phase 1 study is randomized, double-blind, and conducted at a single center in Australia, focusing on safety, tolerability, and pharmacokinetics.
- Topline results from the MAD portion are expected in late 2024 or early 2025.
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ReCode Therapeutics doses first patient in Phase 1b clinical study of RCT2100 for the treatment of cystic fibrosis
- ReCode Therapeutics has dosed the first patient in a Phase 1b study of RCT2100, an investigational inhaled mRNA therapy for cystic fibrosis (CF).
- RCT2100 aims to deliver CFTR mRNA directly to lung cells, potentially restoring CFTR protein function and addressing the root cause of CF.
- The study has received global regulatory authorization and is currently enrolling patients in the Netherlands, with plans to expand to France, the U.S., and the UK.
- RCT2100 is formulated using ReCode’s proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform.
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Longboard Pharmaceuticals initiates Phase 3 DEEp SEA study evaluating bexicaserin in Dravet syndrome
- Longboard Pharmaceuticals has initiated the global Phase 3 DEEp SEA Study for bexicaserin in Dravet syndrome.
- The study will evaluate the efficacy and safety of bexicaserin in ~160 participants aged 2-65 years.
- Participants will undergo a 5-week screening, 3-week dose titration, and 12-week maintenance period.
- Eligible participants can enroll in a 52-week open-label extension study.
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Enanta Pharmaceuticals announces positive topline results for EDP-323 in a Phase 2a human challenge study of healthy adults infected with respiratory syncytial virus (RSV)
- EDP-323 demonstrated an 85-87% reduction in viral load AUC by qRT-PCR and a 97-98% reduction in infectious viral load AUC by viral culture.
- The study was a randomized, double-blind, placebo-controlled human challenge study involving 142 healthy adult participants.
- EDP-323 showed a 66-78% reduction in total clinical symptoms score AUC compared to placebo.
- The drug was generally safe and well-tolerated, with no serious or severe adverse events reported.
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Septerna initiates phase 1 trial for SEP-786 in hypoparathyroidism
- Septerna has started dosing participants in a Phase 1 clinical trial for SEP-786, an oral small molecule PTH1R agonist.
- The trial includes single-ascending dose (SAD) and multiple-ascending dose (MAD) phases to assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD).
- SEP-786 aims to provide a convenient, disease-modifying treatment for hypoparathyroidism, potentially normalizing serum calcium levels.
- The trial will enroll up to 180 healthy adult participants, with dosing already underway in the SAD portion.
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Tempus expands collaboration with Takeda for oncology R&D
- Tempus and Takeda expand their collaboration to enhance oncology research and development.
- Takeda will use Tempus' multimodal real-world datasets and biological modeling capabilities.
- The collaboration includes a multi-phase biological modeling project with 60 organoids across 10 cancer indications.
- Tempus' analytics platform, Lens, will provide real-time access to de-identified patient records and AI-enabled tools.
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Detalimogene demonstrates 71% complete response rate in preliminary analysis of LEGEND pivotal cohort
- Preliminary data from the LEGEND study shows a 71% Complete Response (CR) rate at any time, 67% at three months, and 47% at six months.
- Detalimogene was generally well-tolerated with no treatment-related discontinuations; common adverse events were mainly Grade 1/2.
- The LEGEND study is evaluating detalimogene in BCG-unresponsive NMIBC patients with carcinoma in situ (Cis).
- Enrollment for additional cohorts in the LEGEND study is expected to begin in Q4 2024, with a Biologics License Application (BLA) filing planned for mid-2026.
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Anbogen announces drug supply collaboration with BeiGene to evaluate combination therapy in colorectal cancer
- Anbogen and BeiGene to evaluate ABT-301 and tislelizumab combination in pMMR/MSS metastatic colorectal cancer (mCRC).
- BeiGene will supply tislelizumab for the global Phase II trial.
- ABT-301 has shown promising preclinical results, enhancing the effectiveness of anti-PD-1/anti-PD-L1 therapies.
- The study will begin enrollment in Q1 2025 and will assess safety, tolerability, and preliminary efficacy.
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BeiGene provides update on FDA advisory committee vote on benefit-risk profile of PD-1 inhibitors, including Tevimbra, for treatment of ESCC and gastric/GEJ cancers
- FDA's Oncologic Drugs Advisory Committee (ODAC) recognizes the favorable benefit-risk profile of PD-1 inhibitors, including Tevimbra, for first-line treatment of ESCC and G/GEJ cancers with PD-L1 >1%.
- ODAC voted against the use of PD-1 inhibitors for G/GEJ and ESCC patients with PD-L1 <1%.
- RATIONALE-305 and RATIONALE-306 studies met their endpoints of overall survival, showing a significant reduction in the risk of death.
- Tevimbra's Biologics License Applications (BLAs) for these indications are still under FDA review.
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