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Clinical Trial News

Personalized mRNA Cancer Vaccine Shows Promise in Groundbreaking Bowel Cancer Trial

  • A 43-year-old bowel cancer patient became one of the first people globally to receive a personalized mRNA cancer vaccine designed to prevent cancer recurrence.
  • The vaccine uses genetic analysis of tumor samples to identify abnormal proteins and employs mRNA technology similar to COVID vaccines to train the immune system.
  • Early results from similar approaches in advanced skin cancers show promise, with researchers expecting clearer efficacy data within two to five years.
  • The patient received nearly 20 doses over a year, with initial side effects including fever and shaking that diminished over time.

Supernus Pharmaceuticals Acquires Sage Therapeutics for $795 Million, Strengthening Neuropsychiatry Portfolio

Drug Approval
  • Supernus Pharmaceuticals announced a definitive agreement to acquire Sage Therapeutics for $8.50 per share upfront plus contingent payments up to $3.50 per share, totaling up to $795 million.
  • The acquisition adds ZURZUVAE (zuranolone), the first and only FDA-approved oral treatment for postpartum depression, to Supernus' neuropsychiatry portfolio.
  • The deal is expected to be significantly accretive in 2026 with potential cost synergies of up to $200 million annually and strengthen Supernus' CNS discovery platforms.
  • ZURZUVAE generated $36.1 million in collaboration revenue for 2024, with Supernus receiving 50% of net revenue recorded by partner Biogen in the U.S.

Solu Therapeutics Appoints Enda Moran as COO to Scale CyTAC Platform Operations

Monoclonal Antibody
  • Solu Therapeutics has appointed Enda Moran, PhD, MBA as Chief Operating Officer to lead operational functions as the company advances its Phase 1 clinical trial of STX-0712.
  • Dr. Moran brings over three decades of biomanufacturing experience from Pfizer, GSK, and other major pharmaceutical companies to support Solu's CyTAC and TicTAC platforms.
  • The appointment comes as Solu progresses STX-0712 through Phase 1 development for resistant/refractory chronic myelomonocytic leukemia and other hematologic malignancies.
  • Dr. Moran will oversee chemistry manufacturing and controls, quality, program management, and infrastructure development to support multiple clinical and regulatory milestones.

Supernus Pharmaceuticals Acquires Sage Therapeutics for Up to $795 Million, Securing Postpartum Depression Drug Zurzuvae

Drug Approval
  • Supernus Pharmaceuticals agreed to acquire Sage Therapeutics for up to $795 million, offering $8.50 per share in cash plus contingent value rights worth $3.50 per share based on sales milestones.
  • The deal significantly exceeds Biogen's rejected $469 million unsolicited offer from January 2025, providing Sage shareholders with a 36% premium over previous trading levels.
  • Supernus gains exclusive U.S. rights to Zurzuvae, the only FDA-approved oral treatment for postpartum depression, which generated $36.1 million in 2024 sales and $13.8 million in Q1 2025.
  • The acquisition allows Supernus to diversify its CNS portfolio beyond its existing Parkinson's disease and ADHD treatments, while positioning the company for significant growth if Zurzuvae reaches projected sales milestones.

Liso-cel Achieves 95.5% Response Rate in Relapsed/Refractory Marginal Zone Lymphoma

CAR-TOncology
  • Lisocabtagene maraleucel (liso-cel) demonstrated a 95.5% overall response rate and 62.1% complete response rate in 66 patients with relapsed/refractory marginal zone lymphoma in the TRANSCEND FL trial.
  • The therapy showed durable responses with 24-month duration of response, progression-free survival, and overall survival rates of 88.6%, 85.7%, and 90.4%, respectively.
  • Safety profile remained consistent with previous reports, with 76% experiencing any-grade cytokine release syndrome and only 4% experiencing grade 3 events.
  • The results address a significant unmet need for patients with marginal zone lymphoma, where median overall survival after multiple relapses is currently 3 to 5 years.

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

NCT04245839RecruitingPhase 2
Celgene
Posted 7/14/2020

Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)

NCT02631044CompletedPhase 1
Juno Therapeutics, a Subsidiary of Celgene
Posted 1/6/2016

Single Psilocybin Dose Provides Two-Year Depression Relief in Cancer Patients

  • A phase 2 clinical trial demonstrated that a single 25 mg dose of psilocybin combined with psychological support provided sustained depression relief for 53.6% of cancer patients over two years.
  • Half of the 28 cancer patients with major depressive disorder maintained significant depression reduction and remission throughout the entire two-year follow-up period.
  • The treatment also reduced anxiety symptoms in 42.9% of patients at the two-year mark, offering a potentially paradigm-changing alternative to conventional antidepressants.
  • A randomized, double-blind trial is currently underway to evaluate up to two doses of psilocybin versus placebo for treating depression and anxiety in cancer patients.

RE104 Safety and Efficacy Study in Postpartum Depression

NCT06342310CompletedPhase 2
Reunion Neuroscience Inc
Posted 6/14/2024

RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses

NCT07002034RecruitingPhase 2
Reunion Neuroscience Inc
Posted 7/30/2025

ViroGates and GENSPEED Achieve Breakthrough in Point-of-Care Chronic Inflammation Testing for Longevity Market

  • ViroGates and GENSPEED have successfully demonstrated proof of concept for their enhanced suPARnostic® POC+ product, achieving improved sensitivity for measuring chronic inflammation biomarkers in the 2-6 ng/mL range critical for longevity testing.
  • The collaboration has overcome previous limitations in precision and consistency at lower suPAR levels by modifying system components and procedures, bringing assay results closer to ELISA standards.
  • The improved point-of-care test uses only finger-prick blood and delivers results in approximately 20 minutes, enabling suPAR testing in smaller healthcare settings without access to larger analyzers.
  • Both companies plan to launch the enhanced product by the end of Q4 2025, pending final validation, with equal cost-sharing demonstrating their commitment to innovation in longevity diagnostics.

MBX Biosciences Submits IND Application for Once-Monthly Obesity Drug MBX 4291

  • MBX Biosciences has submitted an Investigational New Drug application to the FDA for MBX 4291, a long-acting GLP-1/GIP receptor co-agonist prodrug designed for once-monthly administration in obesity treatment.
  • The drug demonstrated similar weight loss efficacy to tirzepatide in preclinical studies while showing extended duration of action, supporting its potential for monthly dosing with improved gastrointestinal tolerability.
  • Pending IND clearance, the company plans to initiate a Phase 1 clinical trial in healthy overweight volunteers during the third quarter of 2025.
  • MBX 4291 was developed using the company's proprietary Precision Endocrine Peptide platform, which aims to overcome limitations of current peptide therapies through optimized pharmaceutical properties.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MBX 4291 in Adult Participants With Obesity

NCT07142707RecruitingNot Applicable
MBX Biosciences
Posted 9/3/2025

Novo Nordisk Loses Canadian Semaglutide Patent Protection Over Missed $450 Fee, Opening Door to Generics in 2026

  • Novo Nordisk permanently forfeited Canadian patent protection for semaglutide after failing to pay a routine $450 maintenance fee in 2019, clearing the path for generic competitors.
  • The patent lapse affects Ozempic and Wegovy, which generated approximately $2.5 billion in Canadian sales last year, making Ozempic the nation's top-selling drug.
  • Generic manufacturers including Sandoz, Hikma Pharmaceuticals, and Aspen Pharmacare have confirmed semaglutide dossiers ready for launch once data exclusivity expires in January 2026.
  • The decision also invalidates Novo's certificate of supplementary protection that would have extended exclusivity until March 2028, potentially costing the company two additional years of market protection.

BDD Pharma's OralogiK System Advances Timed-Release Drug Delivery for ADHD and Rheumatoid Arthritis

  • BDD Pharma has developed OralogiK, a breakthrough tablet technology that releases medication at precisely timed intervals to optimize therapeutic outcomes for conditions like ADHD and rheumatoid arthritis.
  • The system allows patients to take medication before bedtime, with the drug releasing during sleep to provide symptom relief upon waking, eliminating morning pain and stiffness.
  • The company's first OralogiK therapy for ADHD is expected to launch next year, offering once-daily dosing instead of multiple daily doses.
  • BDD Pharma recently opened a £2 million GMP manufacturing facility in Glasgow to accelerate development and maintain Scottish production capabilities.

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