Novo Nordisk's Alhemo recommended for European approval
- The EMA's CHMP has recommended Alhemo (concizumab) for approval as the first once-daily subcutaneous prophylactic treatment for haemophilia A or B with inhibitors.
- Alhemo is an anti-TFPI monoclonal antibody designed to block a protein that stops blood from clotting, allowing for thrombin production and blood clotting even in the presence of inhibitors.
- The recommendation is based on the phase 3 explorer7 study, which showed an 86% reduction in treated spontaneous and traumatic bleeds with concizumab prophylaxis.
- Novo Nordisk anticipates a final decision from the European Commission within two months.
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Phase III trial results of novel triple combination pill for hypertension published in The Lancet
- The Phase III trial of GMRx2, a triple combination pill for hypertension, showed significant blood pressure reduction compared to dual therapies.
- GMRx2 met all primary efficacy and safety endpoints, with superior blood pressure control rates and good tolerability.
- The trial was conducted in seven countries and included 1,385 patients, comparing GMRx2 with dual combinations of its component drugs.
- A New Drug Application (NDA) for GMRx2 was filed with the FDA in August 2024, with plans for additional global regulatory filings.
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Novartis receives positive CHMP opinion for Kisqali to help reduce risk of recurrence in people with HR+/HER2- early breast cancer
- The CHMP of the EMA has given a positive opinion for Kisqali (ribociclib) for adjuvant treatment in HR+/HER2- early breast cancer at high risk of recurrence.
- The recommendation is based on the Phase III NATALEE trial, which showed a 25% reduction in recurrence risk when Kisqali was added to endocrine therapy.
- Kisqali was approved by the FDA in September 2024 for the same indication.
- The European Commission is expected to make a final decision within two months.
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Bright Peak Therapeutics begins dosing in phase 1/2a trial of BPT567
- Bright Peak Therapeutics has dosed the first patient in a Phase 1/2a trial for BPT567, a bifunctional PD1-IL18 immunoconjugate.
- The trial targets patients with locally advanced/unresectable or metastatic solid tumors.
- BPT567 combines PD-1/PD-L1 checkpoint blockade with IL-18 delivery to T cells, aiming for enhanced anti-tumor activity.
- The open-label trial will assess safety, antitumor activity, pharmacokinetics, and pharmacodynamics, enrolling approximately 100 patients.
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Evergreen Theragnostics opens CCK2-VIEW, a Phase II small cell lung cancer clinical trial, in the European Union
- Evergreen Theragnostics has launched a Phase II trial for 68Ga-EVG321 in the EU, targeting small cell lung cancer (SCLC).
- The trial is a multi-center, open-label, non-randomized imaging study approved by the European Medicines Agency (EMA).
- 68Ga-EVG321 targets CCK2R, a protein highly expressed in SCLC, facilitating tumor-specific delivery and PET diagnosis.
- The trial aims to quantify 68Ga-EVG321 radioactivity and distribution, laying groundwork for future theragnostic applications.
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Keio University research reveals genomic insights for personalized cancer treatment
- Keio University's study analyzed genomic data from 48,627 Japanese cancer patients, highlighting significant differences in mutation patterns compared to white populations.
- The research identified a higher frequency of TP53 mutations in Japanese patients, suggesting racial differences in mutation prevalence.
- Clinically actionable genetic alterations were found in 15.3% of the Japanese cohort, with the highest frequencies in thyroid cancer.
- The study emphasizes the need for population-specific cancer treatment strategies to improve personalized therapies for Japanese patients.
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Verastem Oncology presents positive updated RAMP 201 data for avutometinib and defactinib combination in recurrent low-grade serous ovarian cancer
- Phase 2 RAMP 201 trial shows a 31% overall response rate (ORR) in patients with recurrent low-grade serous ovarian cancer (LGSOC).
- KRAS mutant patients had a 44% ORR, while KRAS wild-type patients had a 17% ORR.
- Median progression-free survival was 12.9 months, with KRAS mutant patients showing 22 months.
- Verastem plans to submit a New Drug Application to the FDA in October 2024, seeking Accelerated Approval for KRAS mutant LGSOC.
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LaNova Medicines initiates phase 1 trial of LM-299 and completes $42 million financing
- LaNova Medicines has started a Phase 1 clinical trial in China for LM-299, an anti-PD-1/VEGF bispecific antibody, targeting advanced solid tumors.
- The trial follows promising preclinical results showing strong tumor growth inhibition and a well-tolerated safety profile.
- A US IND submission for LM-299 is expected in the second half of 2024.
- The $42 million Series C1 financing, led by Sino Biopharmaceuticals, will support the development of LaNova's pipeline, including LM-299, LM-302, and LM-108.
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Sanofi and Orano join forces to develop next-generation radioligand medicines
- Sanofi and Orano Med have partnered to develop next-generation radioligand therapies (RLTs) for rare cancers.
- The collaboration focuses on lead-212 (212Pb) alpha-emitting isotopes, leveraging Orano Med's expertise.
- Sanofi will invest €300 million for a 16% equity stake in a new entity valued at €1.9 billion.
- The agreement aims to accelerate the development of RLTs and is subject to standard regulatory approvals.
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Etcembly and University of Surrey launch study to unlock next-generation cancer treatments
- Etcembly collaborates with the University of Surrey to study immune cells of cancer survivors.
- The research aims to identify new targets for immunotherapies by analyzing T cell receptors and antibodies.
- Proprietary single-cell sequencing and AI-driven platform, EMLyTM, will be used for analysis.
- The study expects to identify and prioritize targets within 12 to 18 months.
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