Immuneering announces positive data update from phase 2a trial of IMM-1-104 in pancreatic cancer
- IMM-1-104 shows a 43% overall response rate and 86% disease control rate in combination with modified gemcitabine/nab-paclitaxel for first-line pancreatic cancer.
- Initial data for IMM-1-104 with modified FOLFIRINOX shows target lesion shrinkage in all evaluable patients, including a 100% reduction.
- IMM-1-104 monotherapy in second-line pancreatic cancer shows a 67% reduction in target lesions, with a favorable tolerability profile.
- Plans to expand the trial with additional combination arms in 2025, including combinations with BRAF and immune checkpoint inhibitors.
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Rybrevant plus Lazcluze show significant improvement in overall survival
- The Phase 3 MARIPOSA study showed Rybrevant plus Lazcluze improved overall survival in EGFR-mutated NSCLC patients.
- The combination therapy exceeded the current standard of care, osimertinib, in median overall survival by more than a year.
- The study enrolled 1,074 patients and met its secondary endpoint of overall survival.
- Results will be presented at an upcoming major medical meeting and shared with global health authorities.
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Actuate Therapeutics receives EMA orphan medicinal product designation for elraglusib for the treatment of pancreatic cancer
- Actuate Therapeutics' elraglusib has been granted Orphan Medicinal Product Designation by the EMA for treating pancreatic ductal adenocarcinoma (PDAC).
- The designation follows positive interim results from a Phase 2 trial showing significant clinical benefits and anti-tumor activity.
- Elraglusib is being tested in a randomized Phase 2 trial as a first-line therapy in combination with gemcitabine/nab-paclitaxel for metastatic pancreatic cancer.
- The EMA designation offers benefits like potential 10-year market exclusivity and reduced regulatory fees in the EU.
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U.S. FDA granted priority review to Dizal's sunvozertinib new drug application
- The U.S. FDA has accepted and granted priority review to Dizal's NDA for sunvozertinib, an oral EGFR inhibitor for NSCLC patients with EGFR exon20ins mutations.
- The NDA is supported by data from the WU-KONG1 Part B study, which showed significant clinical benefits for relapsed or refractory NSCLC patients.
- Sunvozertinib has already received accelerated approval in China and is the first oral treatment for NSCLC patients with EGFR exon20ins.
- Two global pivotal studies are ongoing for sunvozertinib in NSCLC patients with EGFR exon20ins in both ≥ 2nd line and 1st line settings.
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Gortec announces new trial success for head and neck cancer treatment
- GORTEC's Phase 3 NIVOPOSTOP trial shows nivolumab improves disease-free survival in high-risk LA-SCCHN patients.
- The trial compared nivolumab with standard-of-care radiotherapy and cisplatin, showing significant DFS improvement.
- Safety profile of nivolumab was consistent with previous studies, with similar compliance to SOC treatments.
- A trend towards improved overall survival was observed, with final analysis pending.
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Asher Bio announces clinical supply agreement for NSCLC study
- Asher Bio partners with AstraZeneca to supply etakafusp alfa for a global Phase 1b/2 study.
- The study will evaluate etakafusp alfa with rilvegostomig in advanced/metastatic NSCLC patients.
- AstraZeneca will sponsor and manage the study, while Asher Bio retains ownership of etakafusp alfa.
- Etakafusp alfa is designed to selectively activate CD8+ T cells, avoiding NK and Treg cells.
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MAIA biotechnology announces clinical supply agreement with BeiGene for phase 2 trials
- MAIA Biotechnology partners with BeiGene to test THIO with tislelizumab in phase 2 trials for HCC, SCLC, and CRC.
- Preclinical studies showed THIO's potential in converting cold tumors to hot, enhancing immune response.
- MAIA will sponsor and fund the trials, while BeiGene provides tislelizumab.
- MAIA aims for accelerated FDA approvals in the studied indications.
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BerGenBio initiates trial for advanced adenocarcinoma lung cancer
- BerGenBio has commenced a clinical trial for bemcentinib in combination with pacritinib for advanced adenocarcinoma lung cancer.
- The trial is a Phase Ib/II, open-label study sponsored by the Mays Cancer Center at UT Health San Antonio.
- It aims to enroll 44 patients to evaluate safety, tolerability, and efficacy, focusing on overall response rate and progression-free survival.
- The study is funded by a grant from the National Cancer Institute (NCI) of the NIH.
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Avenzo Therapeutics and DualityBio announce exclusive global license for potential best-in-class EGFR/HER3 antibody-drug conjugate
- Avenzo Therapeutics and DualityBio have entered an exclusive license agreement for AVZO-1418/DB-1418, an EGFR/HER3 bispecific ADC.
- DualityBio will receive a $50 million upfront payment and up to $1.15 billion in milestone payments, plus tiered royalties.
- AVZO-1418/DB-1418 is designed to target EGFR and HER3, showing potential efficacy in preclinical studies across various solid tumors.
- IND-enabling studies are ongoing, with plans to initiate a first-in-human clinical study this year.
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Interius BioTherapeutics receives approval to expand phase 1 trial of INT2104 in Europe
- The Paul Ehrlich Institute in Germany approved the expansion of the INVISE Phase 1 trial for INT2104 into Europe.
- INT2104 is a gene therapy targeting CD20-positive B cells, generating CAR-T and CAR-NK cells in vivo.
- The trial is a global, two-part, multicenter, open-label study with a dose escalation design.
- Interim safety and proof-of-concept data will be presented in the second half of 2025.
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Hoth therapeutics achieves breakthrough in phase 2a trial: HT-001 delivers 100% success in combating cancer treatment skin toxicities
- Hoth Therapeutics reports 100% success in achieving the primary efficacy endpoint in the Phase 2a trial of HT-001.
- The trial targets skin toxicities linked to Epidermal Growth Factor Receptor Inhibitors (EGFRi) in cancer patients.
- No treatment-related adverse effects were observed, and patients maintained full EGFRi dosage.
- The trial uses the proprietary Acneiform Rash Investigator Global Assessment Scale (ARIGA) for precise measurement.
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ONCare Alliance and Ovation.io partner to create a multi-omics database and biobank
- ONCare Alliance and Ovation.io have partnered to create a multi-omics database and biobank for oncology.
- The initiative aims to accelerate biomarker discovery by integrating clinical trial-level data with real-world clinical data.
- The project involves collecting biospecimens from breast cancer and non-small cell lung cancer patients.
- Twelve cancer centers are currently active, with plans for expansion.
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MD Anderson and Myriad Genetics form strategic alliance to evaluate clinical utility of Myriad’s molecular residual disease assay
- MD Anderson Cancer Center and Myriad Genetics have announced a five-year strategic alliance.
- The collaboration aims to evaluate the clinical utility of Myriad’s Precise MRD assay in various cancers.
- Studies will focus on breast, gastrointestinal, genitourinary, and gynecological cancers.
- Myriad will provide funding and MRD testing, while MD Anderson will lead patient enrollment and data analysis.
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BrainChild Bio to advance BCB-276 CAR T-cell therapy for pediatric brain tumors
- BrainChild Bio is advancing BCB-276, a CAR T-cell therapy targeting B7-H3, for diffuse intrinsic pontine glioma (DIPG).
- The company plans a pivotal Phase 2 trial, supported by FDA alignment, to accelerate the Biologics License Application process.
- Preliminary Phase 1 data from Seattle Children's show promising safety and efficacy, with improved survival rates in DIPG patients.
- The trial aims to initiate by the end of 2025, focusing on children and young adults with this incurable brain cancer.
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Vergent Bioscience receives FDA fast track designation for abenacianine
- Vergent Bioscience's abenacianine for injection (VGT-309) has received FDA Fast Track designation.
- The agent aids in visualizing tumors during lung cancer surgeries, enhancing minimally invasive procedures.
- Phase 2 study showed 43% of patients had clinically significant events, improving tumor detection.
- Vergent plans to start a Phase 3 confirmatory study in 2025 to further evaluate efficacy and safety.
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