23andMe Partners with 20 Lung Cancer Advocacy Groups on Lung Cancer Research Study
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23andMe Partners with 20 Lung Cancer Advocacy Groups on Lung Cancer Research Study
23andMe (Sunnyvale, Calif.) announced a collaboration with 20 lung cancer advocacy organizations on the Lung Cancer Genetics Study. The goal of the study is to improve understanding of lung cancer genetics and to advance detection, risk reduction, and care. Lung cancer is the number one cause of cancer deaths in men and women in the U.S.
The organizations include ALK Positive, Biomarker Collaborative, BRAF Bombers, EGFR Resisters, Exon 20 Group, Free ME from Lung Cancer, GO2 for Lung Cancer, The Happy Lungs Project, International Cancer Advocacy Network, KRAS Kickers, Lung Cancer Foundation of America, Lung Cancer Research Foundation, LUNGevity Foundation, MET Crusaders, NTRKers, Oncogene Cancer Research, PDL1 Amplifieds, RET Positive, RET Renegades, The ROS1ders, and Troper Wojcicki Philanthropies.
The study plans to recruit 10,000 people diagnosed with lung cancer, 18 years or older who live in the U.S. They can receive the 23andMe kits at no cost.
“Through the launch of the Lung Cancer Genetics Study, we hope to fill an unmet need for a comprehensive database that bridges the gap between genetic, clinical, and patient-reported data,” said Anne Wojcicki, Co-Founder and CEO of 23andMe. “Because lung cancer affects people from all communities, it’s important for this research to truly reflect the diversity of those impacted by the disease. This collaborative effort unites survivors, caregivers, researchers, and advocates who are all dedicated to improving the treatment and care of lung cancer.”
FDA Accepts Checkpoint’s Resubmission of Squamous Cell Carcinoma Therapy
Checkpoint Therapeutics (Waltham, Mass.) reported the U.S. FDA accepted its resubmission of its Biologics License Application (BLA) for cosibelimab, an anti-PD-L1 checkpoint inhibitor, for adults with metastatic or locally advanced cutaneous squamous cell carcinoma patients who are not candidates for curative surgery or curative radiation. The agency has issued a Complete Response Letter (CRL), basically a rejection, of the original BLA in December 2023. The CRL revolved around an inspection of the company’s third-party contract manufacturing organization (CMO); there were no concerns over the drug itself or its safety.
“We are pleased that the FDA has accepted our BLA resubmission as a complete response after we aligned on our BLA resubmission strategy,” said James F. Oliviero, President and CEO of Checkpoint. “We look forward to working closely with the FDA to finalize the review and to the potential opportunity to deliver cosibelimab’s unique dual mechanism of action to patients suffering from cSCC.”
FDA Grants AC Immune’s ACI-35.030 Fast Track Designation for Alzheimer’s Disease
AC Immune (Lausanne, Switzerland) announced the U.S. FDA had granted its ACI-35.030 (JNJ-2056) Fast Track designation for Alzheimer’s disease. The drug targets the pathologic form of the Tau protein, phosphorylated Tau (pTau). The drug is being developed in partnership with Janssen Pharmaceuticals, a Johnson & Johnson company, which recently initiated the Phase IIb ReTain trial. The drug came out of AC Immune’s SupraAntigen technology platform. Tau is one of two major abnormal proteins that accumulate in the brains of Alzheimer’s patients (the other is beta-amyloid). ACI-35.030 is engineered to improve the formation of broad-spectrum protective antibodies against pTau.
“Fast Track designation is an important recognition of the differentiation and potential value for patients of our anti-pTau active immunotherapy, ACI-35.030,” said Dr. Andrea Pfeifer, CEO of AC Immune.
Pfeifer went on to note that Fast Track designation offered opportunities for more efficient development and regulatory review.