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Clinical Trial News

Abridge Secures $300M Series E Funding, Reaches $5.3B Valuation for AI Clinical Documentation Platform

AI
  • Abridge raised $300 million in Series E funding led by Andreessen Horowitz, bringing its valuation to $5.3 billion for its ambient listening technology that automates clinical documentation.
  • The AI-powered platform serves over 150 health systems including Kaiser Permanente, UPMC, and Sutter Health, generating clinical notes from medical conversations across 55 specialties and 28 languages.
  • The company reports significant clinical impact with 60-70% reduction in burnout and over 90% clinician retention rate, while projecting support for more than 50 million medical conversations in 2025.
  • This funding round follows a $250 million raise in February, representing one of the most substantial health tech deals of 2024 as AI scribes gain rapid adoption to address clinician burnout.

Inventprise's Novel COVID-19 Conjugate Vaccine Shows Broad Protection Against Multiple Variants in Preclinical Study

  • Inventprise published preclinical data in Vaccine Journal demonstrating its bivalent SARS-CoV-2 conjugate vaccine elicited broad neutralizing antibody responses across up to five COVID-19 variants.
  • The 18-month study showed the vaccine stimulated both B-cell and T-cell immunity, including memory T-cell formation, potentially offering longer-lasting protection than current mRNA vaccines.
  • The conjugate platform uses a detoxified diphtheria-derived carrier protein conjugated to SARS-CoV-2 Beta and Delta strain surface proteins expressed in CHO cells.
  • The technology could address cold-chain requirements and booster logistics challenges, particularly benefiting global health equity in resource-limited settings.

Xenon Pharmaceuticals Appoints Darren Cline as Chief Commercial Officer Ahead of Azetukalner Phase 3 Data

  • Xenon Pharmaceuticals has appointed Darren Cline as Chief Commercial Officer to lead commercial strategy for azetukalner, the company's lead Phase 3 candidate targeting epilepsy, major depressive disorder, and bipolar depression.
  • Cline brings over 30 years of biopharmaceutical commercial experience, including successful launches of Epidiolex at GW Pharmaceuticals and Adcetris at Seagen.
  • The appointment comes as Xenon prepares for Phase 3 azetukalner data expected in early 2026, positioning the company for its first potential commercial launch in epilepsy.
  • Azetukalner is a novel Kv7 potassium channel opener currently in Phase 3 trials for epilepsy and major depressive disorder, with a Phase 3 trial in bipolar depression planned for 2025.

Biocon Biologics Partners with Malaysia's National Cancer Society to Launch Biosimilar Access Program

OncologyMonoclonal Antibody
  • Biocon Biologics has partnered with the National Cancer Society of Malaysia to launch a Patient Assistance Programme providing affordable oncology biosimilars to underserved cancer patients.
  • The program will initially focus on providing trastuzumab to patients facing treatment delays due to financial constraints, with plans to expand to pegfilgrastim and bevacizumab.
  • This collaboration builds on Biocon's previous success in Malaysia's diabetes care, where the company has served over 345,000 patients through affordable treatment programs.
  • The partnership combines Biocon's biosimilar expertise with NCSM's community outreach capabilities to enhance cancer care accessibility in Malaysia.

Starton Therapeutics Partners with Bend Bioscience to Develop Oral Sustained-Release Lenalidomide for Multiple Myeloma

  • Starton Therapeutics has entered a collaboration agreement with Bend Bioscience to develop STAR-LLD, an oral sustained-release formulation of lenalidomide designed to improve tolerability and efficacy in multiple myeloma treatment.
  • Preclinical studies demonstrated that STAR-LLD achieved 100% overall response rate with continuous delivery compared to 0% with standard daily dosing, while also showing 80% tumor shrinkage over 28 days.
  • A Phase 1b clinical study in six relapsed/refractory multiple myeloma patients showed all participants achieved objective responses with no grade >2 drug-related hematologic toxicity through 12 treatment cycles.
  • The partnership leverages Bend's controlled release formulation expertise to optimize STAR-LLD's performance and scalability for potential commercial manufacturing.

NCT/UCC Dresden Launches Phase 2 Trial of Personalized mRNA Vaccine for Pancreatic Cancer

  • NCT/UCC Dresden becomes the only site in Saxony to offer patients access to BioNTech and Genentech's personalized mRNA vaccine Autogene Cevumeran for pancreatic cancer treatment.
  • The Phase 2 IMCODE003 study combines the mRNA vaccine with checkpoint inhibitor Atezolizumab and chemotherapy to reduce recurrence risk in post-surgical pancreatic cancer patients.
  • Previous Phase 1 results showed that half of patients treated with Autogene Cevumeran developed strong T-cell immune responses and experienced significantly reduced relapse risk.
  • The trial addresses the urgent need for new treatments in pancreatic cancer, where only one in three to four patients survives five years despite surgery and chemotherapy.

A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC

NCT05968326RecruitingPhase 2
Genentech, Inc.
Posted 10/18/2023

Study of Personalized Tumor Vaccines (PCVs) and a PD-L1 Blocker in Patients With Pancreatic Cancer That Can be Treated With Surgery

NCT04161755Active, Not RecruitingPhase 1
Memorial Sloan Kettering Cancer Center
Posted 12/13/2019

Priothera Secures €1.7 Million Government Funding to Enhance CAR-T Cell Therapy with Novel S1P Receptor Modulator

CAR-T
  • Priothera received €1.7 million in non-dilutive funding from France's i-Nov innovation competition to support the MOCART clinical program evaluating mocravimod as an adjunct to CAR-T cell therapy.
  • The novel oral S1P receptor modulator mocravimod aims to address the significant toxicity challenges of CAR-T therapy, where 40-60% of patients experience high-grade side effects including cytokine release syndrome and neurological toxicity.
  • Mocravimod's dual mechanism of action is designed to reduce the incidence and severity of CAR-T-related toxicities while potentially improving response rates and treatment durability.
  • The funding represents an expansion of Priothera's clinical development beyond their ongoing Phase 3 MO-TRANS trial in acute myeloid leukemia patients undergoing allogeneic stem cell transplantation.

AstraZeneca Faces Patent Challenges for Diabetes Drug as Sandoz Seeks Revocation

  • AstraZeneca has lost a bid to revive a patent for its diabetes drug, marking a significant setback in the company's intellectual property protection strategy.
  • Sandoz has joined other companies in seeking revocation of AstraZeneca's patent, indicating broader industry challenges to the pharmaceutical giant's patent portfolio.
  • The patent disputes could potentially impact AstraZeneca's market exclusivity for its diabetes treatment and open opportunities for generic competition.

Vector BioMed Partners with Indian Cancer Hospital to Deliver Affordable CAR-T Therapy to Rural Populations

CAR-T
  • Vector BioMed has formed a strategic partnership with Kailash Cancer Hospital in rural Gujarat, India, to provide affordable CAR-T cell therapy starting in Q1 2026.
  • The collaboration will make KCHRC the first site in Gujarat and among the first in India to deliver advanced CAR-T treatments outside major metropolitan areas.
  • Vector BioMed's LENTIVERSE™ platform enables treatment of one patient per day at significantly reduced costs compared to proprietary systems, making it ideal for resource-limited settings.
  • The partnership aims to expand access to life-saving cancer therapies for underserved populations, with KCHRC serving over 70,000 outpatients annually and providing reduced or no-cost care to more than 60% of patients.

Cellectar Biosciences Submits Phase 1b Protocol for CLR 125 Radiopharmaceutical in Triple-Negative Breast Cancer

Targeted Therapy
  • Cellectar Biosciences has submitted a Phase 1b dose-finding study protocol to the FDA for CLR 125, an iodine-125 Auger-emitting radiopharmaceutical targeting relapsed triple-negative breast cancer.
  • The study will evaluate three different dosing regimens in 45 patients, utilizing imaging to determine tumor uptake and establish the recommended Phase 2 dose.
  • CLR 125 leverages Cellectar's proprietary Phospholipid Drug Conjugate platform to deliver targeted radiation therapy with enhanced cytotoxicity and improved safety profile.
  • Triple-negative breast cancer represents approximately 12% of breast cancer diagnoses in the U.S., with 25% of cases relapsing after standard treatments, creating significant unmet medical need.

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