Novartis Scemblix FDA approved in newly diagnosed CML
- Scemblix (asciminib) received accelerated FDA approval for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).
- Approval is based on superior major molecular response (MMR) rates at week 48 from the ASC4FIRST Phase III trial compared to standard of care tyrosine kinase inhibitors (TKIs).
- Scemblix demonstrated fewer dose reductions and adverse reactions leading to treatment discontinuation compared to other TKIs.
- The ASC4FIRST trial continues with further analysis at week 96 to evaluate additional endpoints.
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Shorla Oncology receives FDA expanded approval for Jylamvo in pediatric indications
- The FDA has expanded the approval of Jylamvo (methotrexate) to treat pediatric patients with acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA).
- Jylamvo is the only oral liquid methotrexate approved for both adult and pediatric indications, offering a convenient alternative for patients who have difficulty swallowing pills.
- The drug remains stable at room temperature for 90 days, eliminating the need for refrigeration before dispensing.
- Next steps include ensuring the continuity of supply and expanding the portfolio of innovative therapies for underserved patient populations.
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Allogene Therapeutics receives FDA RMAT designation for ALLO-316 in renal cell carcinoma
- ALLO-316, an AlloCAR T investigational product, received RMAT designation from the FDA for treating CD70 positive advanced or metastatic renal cell carcinoma (RCC).
- The designation is based on positive data from the Phase 1 TRAVERSE trial, which showed potential for ALLO-316 in patients who have failed standard RCC therapies.
- RMAT designation aims to accelerate development and review, offering early interactions with the FDA and potentially streamlining market approval.
- Allogene plans to present updated Phase 1 data at the Society for Immunotherapy of Cancer (SITC) annual meeting.
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Immorta Bio's SenoVax reduces growth and stops metastasis of aggressive breast cancer
- SenoVax, an immune stimulatory therapy, successfully reduced tumor growth and metastasis in aggressive breast cancer animal models.
- The therapy works by removing senescent cells surrounding tumors, allowing the immune system to combat cancer effectively.
- SenoVax has shown potential in treating other cancers, such as lung cancer, and aids in blood cell recovery post-chemotherapy.
- The promising results are supported by several filed patents, indicating a potential new approach to treating triple-negative metastatic breast cancer.
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Biond Biologics partners with Merck KGaA for phase 1 trial of BND-35 with cetuximab
- Biond Biologics collaborates with Merck KGaA to evaluate BND-35 with cetuximab in a Phase 1 trial for solid tumors.
- Merck KGaA will supply cetuximab for the trial, which aims to assess the safety and efficacy of the combination therapy.
- BND-35 is an anti-ILT3 antibody designed to remodel the tumor microenvironment and enhance immune response.
- Enrollment for the BND-35 monotherapy arm has begun, with several patients already dosed.
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Shuttle Pharma doses first patients in phase 2 clinical trial of ropidoxuridine for treatment of patients with glioblastoma
- Shuttle Pharmaceuticals has dosed the first three patients in its Phase 2 trial of Ropidoxuridine for glioblastoma treatment.
- The trial targets IDH wild-type, methylation negative glioblastoma patients, who currently have limited treatment options.
- 40 patients will be randomized into two dose groups to determine the optimal dose, with an additional 14 patients to be added later.
- The trial aims to complete within 18 to 24 months, focusing on survival compared to historical controls.
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Immunome presents compelling preclinical data demonstrating robust anti-tumor activity for IM-1021
- Immunome presented preclinical data for IM-1021, a ROR1-targeted ADC, at the EORTC-NCI-AACR Symposium.
- IM-1021 showed superior efficacy in mantle cell lymphoma and triple negative breast cancer models.
- The ADC payload HC74 demonstrated higher potency and better ADME properties compared to deruxtecan.
- Immunome plans to submit an IND for IM-1021 to the FDA in Q1 2025, aiming to start clinical trials post-clearance.
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Revitope enters into a license agreement for next-generation T cell engagement technology
- Revitope has signed a license agreement with Genmab for its TwoGATEâ„¢ T Cell Engagement technology.
- Genmab gains rights to use TwoGATEâ„¢ for multiple drug target pairs, with options for exclusive worldwide development and commercialization of up to three products.
- Revitope will receive an upfront payment of $9 million, with potential milestone payments up to $600 million and tiered royalties on sales.
- TwoGATEâ„¢ technology aims to enhance precision in cancer immunotherapy by targeting dual antigens on tumor cells.
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Hoth Therapeutics announces promising preclinical results for cancer therapeutic HT-KIT
- Hoth Therapeutics reported early data from a preclinical study of HT-KIT, showing effective tumor growth inhibition.
- The study, conducted with NC State University, demonstrated stable tumor volumes in treated subjects, indicating potential therapeutic efficacy.
- Treated animals showed consistent tumor sizes with minimal variability, highlighting the treatment's reproducibility.
- Hoth plans to continue analyzing additional tissue data to further validate these promising results.
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Phase III results for Genentech’s Itovebi show significant progression-free survival in HR-positive advanced breast cancer
- The Phase III INAVO120 study results for Itovebi, in combination with palbociclib and fulvestrant, were published in the New England Journal of Medicine.
- Itovebi-based regimen reduced the risk of disease progression or death by 57%, with progression-free survival of 15.0 months compared to 7.3 months for the control group.
- The FDA has approved Itovebi for treating PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer.
- Data from INAVO120 are being used for submissions to other global health authorities, including the European Medicines Agency.
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Cardiff Oncology publishes phase 2 trial data for KRAS mutant mCRC
- Phase 2 trial shows onvansertib with FOLFIRI and bevacizumab is effective and well-tolerated in KRAS mutant mCRC.
- Post hoc analysis reveals a 7.7-fold higher clinical benefit in bev-naïve patients with an ORR of 77%.
- Findings support the transition of onvansertib to first-line RAS-mutant mCRC treatment.
- Initial data from the first-line CRDF-004 trial expected in the second half of 2024.
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Numab Therapeutics initiates phase 1 study of NM32 in solid tumors
- Numab Therapeutics has started a Phase 1 clinical trial for NM32, a tri-specific immuno-oncology therapeutic.
- NM32 targets ROR1 and CD3, with a third domain targeting serum albumin for half-life extension.
- The trial is a dose-escalation study to assess pharmacokinetics, pharmacodynamics, and safety.
- Up to 60 patients with ROR1-overexpressing solid tumors will be enrolled across major US clinical sites.
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Three phase 3 trials of datopotamab deruxtecan-based combinations initiated in patients with advanced nonsquamous non-small cell lung cancer
- Three global phase 3 trials have begun to evaluate datopotamab deruxtecan-based combinations in advanced nonsquamous NSCLC.
- TROPION-Lung10 compares datopotamab deruxtecan plus rilvegostomig or rilvegostomig alone against pembrolizumab in high PD-L1 expressing NSCLC.
- TROPION-Lung14 assesses datopotamab deruxtecan with osimertinib versus osimertinib alone in EGFR mutated NSCLC.
- TROPION-Lung15 evaluates datopotamab deruxtecan with or without osimertinib against platinum-based chemotherapy in EGFR mutated NSCLC post-osimertinib treatment.
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Akeso enrolls first patient in phase 3 trial for head and neck cancer treatment
- Akeso has initiated a Phase III trial (AK117-302) for head and neck squamous cell carcinoma (HNSCC).
- The trial compares ivonescimab and ligufalimab against pembrolizumab for first-line treatment of PD-L1 positive R/M HNSCC.
- This is the first global Phase III trial investigating a CD47 monoclonal antibody for solid tumors.
- Initial data shows significant tumor reduction and survival benefits, with further results expected at the 2024 ESMO Congress.
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SynOx Therapeutics raises $92 million in Series B financing and doses first patients in Phase 3 trial
- SynOx Therapeutics secured $92 million in Series B financing, led by Gilde Healthcare.
- Funds will support the Phase 3 TANGENT trial of emactuzumab for Tenosynovial Giant Cell Tumour (TGCT).
- The TANGENT trial is a global, multi-centre, randomized, double-blind, placebo-controlled study.
- First patients have been dosed, with a target enrollment of approximately 130 patients.
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