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Circle Pharma Secures $92.5 Million Series E Financing to Advance Cancer Drug into Clinical Trials

Circle Pharma Secures $92.5 Million Series E Financing to Advance Cancer Drug into Clinical Trials

Circle Pharma Secures $92.5 Million Series E Financing to Advance Cancer Drug into Clinical Trials

Experts urge FDA to set clear safety and access standards for psychedelic drugs (September 14)

Experts urge FDA to set clear safety and access standards for psychedelic drugs (September 14)

(Corrects quote attribution in paragraph 8 of September 14 story from Lynn Watkins, a U.S.

UCLA Health Jonsson Comprehensive Cancer Center Advances Colorectal and Prostate Cancer Research

UCLA Health Jonsson Comprehensive Cancer Center Advances Colorectal and Prostate Cancer Research

UCLA Health Jonsson Comprehensive Cancer Center has reported significant advancements in cancer research, particularly in the areas of colorectal and prostate cancer. For colorectal cancer, researchers are focusing on improving screening methods for younger adults and developing new immunotherapy and vaccine strategies. In prostate cancer, UCLA investigators are utilizing artificial intelligence to precisely map the boundaries of cancerous tissue. This AI-driven approach aims to enhance diagnostic accuracy, refine treatment planning, and improve the effectiveness of surgical procedures. These efforts are part of a broader mission at UCLA to accelerate discoveries that prevent and cure cancer, building on a legacy of transforming scientific hope into tangible progress for patients. The center has also been instrumental in the development of targeted therapies like Ibrance, which has redefined treatment for advanced ER+/HER2- breast cancer since its FDA approval in 2015.

Sling Therapeutics Secures $123 Million for Thyroid Eye Disease Drug Trial

Sling Therapeutics Secures $123 Million for Thyroid Eye Disease Drug Trial

Sling Therapeutics Secures $123 Million for Thyroid Eye Disease Drug Trial

Cullinan and Taiho Plan FDA Filing for Lung Cancer Pill Zipalertinib Despite Patient Deaths

Cullinan and Taiho Plan FDA Filing for Lung Cancer Pill Zipalertinib Despite Patient Deaths

Taiho Oncology and Cullinan Therapeutics are moving forward with plans to file for FDA approval of their oral drug candidate, zipalertinib, for non-small cell lung cancer (NSCLC), despite three patient deaths reported during a late-stage study. The Phase 3 REZILIENT3 trial demonstrated that zipalertinib, when combined with chemotherapy, significantly improved progression-free survival (PFS) in patients with first-line advanced non-squamous NSCLC harboring exon 20 mutations to the EGFR gene. Patients receiving the zipalertinib regimen experienced a 50% reduction in the risk of death or disease progression, with a median PFS of 14.5 months compared to 8.5 months in the control group. While adverse events of grade 3 or higher were more frequent in the zipalertinib arm (87% vs. 54.4%), analysts believe the robust efficacy and potential mitigation strategies will outweigh the safety concerns.

BioNTech's Experimental Drug Gotistobart Shows Significant Survival Benefit in Aggressive Lung Cancer Trial

BioNTech's Experimental Drug Gotistobart Shows Significant Survival Benefit in Aggressive Lung Cancer Trial

BioNTech SE has announced that its experimental drug, gotistobart, nearly doubled the median survival rate for patients suffering from an aggressive form of lung cancer when compared to traditional chemotherapy. The updated results from a late-stage study indicate that patients treated with gotistobart lived for a median of 18.5 months, in contrast to 10 months for those receiving standard-of-care chemotherapy. This trial focused on individuals with metastatic squamous non-small cell lung cancer whose disease had progressed despite prior immunotherapy and chemotherapy treatments. Earlier data from the study had shown that gotistobart reduced the risk of death by 54%, though median overall survival had not been reached at that point. Rama Balaraman, a principal investigator in the trial and a medical oncologist, highlighted that current survival expectations with established therapies are typically less than a year, and chemotherapy has remained the standard for over a decade in this setting. BioNTech is co...

Cell and Gene Therapy Industry Faces Scale-Up Challenges, Lifecycle Approach Proposed

Cell and Gene Therapy Industry Faces Scale-Up Challenges, Lifecycle Approach Proposed

Cell and Gene Therapy Industry Faces Scale-Up Challenges, Lifecycle Approach Proposed

Corbus Pharmaceuticals Announces New Obesity Drug CRB-913 with Fewer Side Effects Than GLP-1s

Corbus Pharmaceuticals Announces New Obesity Drug CRB-913 with Fewer Side Effects Than GLP-1s

Corbus Pharmaceuticals has announced promising results for its new anti-obesity drug, CRB-913, claiming it can achieve similar weight loss to GLP-1s with fewer gastrointestinal side effects. In a recent drug trial, CRB-913 demonstrated a 5% weight loss at a 60mg dose after 12 weeks. The drug is a CB1 inverse agonist, which works by reducing the influence of the CB1 receptor, thereby decreasing hunger signals. This mechanism differs from GLP-1 receptor agonists, which mimic the GLP-1 hormone. Previous attempts to target CB1 receptors for obesity treatment faced challenges due to psychiatric side effects, but Corbus Pharmaceuticals states that CRB-913 has minimal brain penetration, with psychiatric adverse events broadly in line with those experienced by GLP-1 users.

Evecxia Therapeutics Announces Positive Phase 1b Clinical Results for OCD and Depression Drug Candidate EVX-101

Evecxia Therapeutics Announces Positive Phase 1b Clinical Results for OCD and Depression Drug Candidate EVX-101

Evecxia Therapeutics, a clinical-stage neuroscience company, has announced positive results from its Phase 1b PK/PD target engagement trial for EVX-101, a drug candidate aimed at treating obsessive-compulsive disorder (OCD) and depression. The trial demonstrated that the active compound, 5-HTP, successfully entered the brain, elevated serotonin synthesis biomarkers, and increased serotonin activity beyond the effects of SSRI/SNRI therapy. EVX-101 is an oral, gastro-retentive, sustained-release tablet formulation of 5-HTP and low-dose carbidopa, designed to amplify serotonin synthesis. The company plans to initiate Phase 2 development for EVX-101 in OCD patients in the first half of 2027. This drug is intended as an adjunctive therapy for patients who do not adequately respond to first-line serotonin reuptake inhibitor antidepressants.

Coya Therapeutics Reaches 100th Participant Enrollment in ALS Trial for COYA 302

Coya Therapeutics Reaches 100th Participant Enrollment in ALS Trial for COYA 302

Coya Therapeutics, Inc., a clinical-stage biotechnology company, has announced the enrollment of its 100th participant in the Phase 2/3 ALSTARS Trial (NCT07161999) for COYA 302. This investigational drug, a combination of proprietary low-dose IL-2 and CTLA-4 Ig, is being evaluated for the treatment of amyotrophic lateral sclerosis (ALS). The company anticipates completing the full enrollment of 120 participants in the coming weeks, with topline data expected in early Q2 2027. COYA 302 has received FDA Fast Track designation for ALS treatment. The ALSTARS Trial is a randomized, multi-center, double-blind, placebo-controlled study designed to assess the efficacy and safety of COYA 302. Participants are randomized to receive one of two dosing regimens or a placebo over a 24-week double-blind treatment phase, followed by a 24-week blinded active-treatment extension phase. The primary endpoint focuses on changes in disease severity as measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised...

New Study Links GLP-1 Weight Loss Drugs to Rare Brain Condition

New Study Links GLP-1 Weight Loss Drugs to Rare Brain Condition

A recent Israeli study has identified a potential link between GLP-1 weight loss and diabetes drugs and a rare, serious brain condition called Wernicke encephalopathy. The study, which reviewed U.S. Food and Drug Administration’s adverse event reports and related literature, found 15 cases of Wernicke encephalopathy between 2023 and 2024 in individuals taking these medications. Wernicke encephalopathy is a life-threatening neurological disorder caused by a severe deficiency of vitamin B1, which can lead to permanent memory loss and an inability to form new memories. Experts emphasize that this condition is rare, with only 15 cases identified out of millions of people using GLP-1 drugs. Most of the reported cases involved patients experiencing gastrointestinal side effects such as vomiting, diarrhea, and loss of appetite, which can lead to malnutrition and vitamin B1 deficiency. The majority of these cases were associated with semaglutide-based drugs like Ozempic and Wegovy, or tirzepatide GLP-1s such as Ze...

Precision Oncology Shifts Towards Integrating Multiple Biomarkers for Treatment Decisions

Precision Oncology Shifts Towards Integrating Multiple Biomarkers for Treatment Decisions

Precision oncology is increasingly moving beyond the reliance on single biomarkers to guide treatment decisions, instead emphasizing the integration of multiple genomic and molecular tests. Experts in a roundtable discussion highlighted that understanding cancer now requires combining diverse sources of molecular information to better comprehend tumor biology and personalize patient care. For instance, in colorectal cancer, the presence of both BRAF V600E mutation and MSI-high status provides two actionable biomarkers, often leading to immunotherapy as the initial treatment. In breast oncology, gene expression assays like Oncotype DX, which evaluate 21 genes, have been used for decades to determine which patients with early-stage ER-positive, HER2-negative breast cancer would benefit from chemotherapy, sparing millions from unnecessary treatments. The discussion also touched upon the complementary roles of protein-based and genomic testing for markers like microsatellite instability and HER2 status, indica...