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Clinical Trial News

Tivic Health's Non-Invasive Vagus Nerve Stimulation Shows Promising Results in Clinical Trial

  • Tivic Health's pilot study demonstrated significant physiological responses to their non-invasive cervical vagus nerve stimulation (ncVNS) technology, including a 97% increase in heart rate variability, a key indicator of vagus nerve activity.
  • The 20-person clinical trial, conducted with the Feinstein Institutes for Medical Research, showed measurable effects on brain activity with a 24% increase in frontal theta power and 66% reduction in frontal gamma power, consistent with reduced anxiety.
  • Researchers believe the technology may have clinical applications for conditions including epilepsy, post-traumatic stress disorder, and ischemic stroke, potentially offering non-surgical alternatives in the growing $8.3B neurostimulation market.

Apple Watch's AFib History Feature Gains FDA Qualification for Clinical Trials

  • The Apple Watch's Atrial Fibrillation (AFib) History feature is the first digital tool qualified under the FDA's Medical Device Development Tools (MDDT) program.
  • This qualification allows the Apple Watch to be used as a secondary endpoint in clinical trials, specifically for cardiac ablation devices.
  • The AFib History feature provides a non-invasive method to estimate AFib burden, measuring the amount of time spent in atrial fibrillation.
  • The FDA's decision validates the Apple Watch as a reliable tool for monitoring arrhythmia and assessing the effectiveness of cardiac treatments.

FDA Approves Sunlenca (Lenacapavir), a First-in-Class HIV-1 Capsid Inhibitor

• The FDA has approved Sunlenca (lenacapavir) as the first capsid inhibitor for heavily treatment-experienced adults with multi-drug resistant HIV-1 infection. • Sunlenca, administered twice-yearly, offers a novel mechanism of action by blocking the HIV-1 virus's protein shell, addressing a critical unmet need. • Clinical trial data from the CAPELLA trial demonstrated that 83% of participants achieved undetectable viral load at Week 52 with lenacapavir plus an optimized background regimen. • The approval marks a significant advancement, potentially improving outcomes for patients with limited treatment options and complex resistance profiles.

CRISPR Gene Editing Shows Promise in Treating Rare Form of Blindness

  • A CRISPR-based gene editing therapy, EDIT-101, has shown promising results in treating Leber Congenital Amaurosis (LCA) Type 10, a rare genetic form of blindness.
  • In the BRILLIANCE trial, 79% of participants experienced measurable improvements in vision after receiving the experimental treatment.
  • The study demonstrated that EDIT-101 was safe and well-tolerated, with no dose-limiting toxicities reported among the 14 participants.
  • These findings offer hope for individuals with LCA Type 10, for which there is currently no FDA-approved treatment.

Arcturus Therapeutics Announces Positive Clinical Updates and Financial Results for Q1 2024

  • Arcturus Therapeutics is on track to deliver initial 4 million doses of Kostaive® in Q3, with European approval decision expected in the same quarter.
  • Phase 1b interim data for ARCT-032 (LUNAR-CF) and Phase 2 data for ARCT-810 (LUNAR-OTC) are scheduled for release on July 1st, providing updates on mRNA therapeutic programs.
  • Arcturus' bivalent COVID-19 vaccine candidate, ARCT-2301, met its primary endpoint in a Phase 3 clinical study in Japan, demonstrating non-inferiority.
  • The company's cash runway extends to the first quarter of fiscal year 2027, supported by strategic alliances and collaborations, including ongoing development with CSL.

Novartis Acquires Mariana Oncology for $1 Billion to Strengthen Radioligand Therapy Pipeline

Oncology
  • Novartis announced a $1 billion acquisition of Mariana Oncology with up to $750 million in milestone payments to expand its radioligand therapy capabilities.
  • The deal provides access to Mariana's lead candidate MC-339, an actinium-based radioligand therapy targeting small cell lung cancer currently in preclinical development.
  • Mariana brings specialized radiopharmaceutical manufacturing capabilities and an oncology radio-conjugation platform using both alpha- and beta-emitting radionuclides.
  • The acquisition strengthens Novartis' position in the competitive radioligand therapy space, following similar billion-dollar deals by AstraZeneca, Bristol Myers Squibb, and Eli Lilly.

Denali Therapeutics Announces Positive Clinical Updates and Financial Results for Q1 2024

• Denali Therapeutics reported positive two-year clinical data for tividenofusp alfa in MPS II, showing sustained normalization of heparan sulfate in CSF and improvements in clinical outcomes. • The company initiated a Phase 1/2 clinical trial for DNL126, an enzyme replacement therapy for children with MPS IIIA, with biomarker and safety data expected by the end of 2024. • Enrollment is complete in the Phase 2/3 HEALEY ALS Platform Trial for DNL343, an eIF2B activator being developed for the treatment of amyotrophic lateral sclerosis (ALS). • Denali completed a private investment in public equity (PIPE) financing with gross proceeds of $500 million and divested its preclinical small molecule portfolio.

D3S-001 Shows Superior KRAS G12C Inhibition with Rapid Target Engagement and Promising Clinical Activity

  • D3S-001 demonstrates substantially improved covalent potency with a kinact/KI of 1.43 × 10⁶ mol/L⁻¹ second⁻¹, representing one to two orders of magnitude improvement over approved KRAS G12C inhibitors sotorasib and adagrasib.
  • The compound achieves rapid target engagement with a t1/2 of 5.8 minutes compared to 44 and 34 minutes for sotorasib and adagrasib respectively, and uniquely maintains efficacy even in the presence of growth factor stimulation.
  • Early clinical data from a first-in-human phase 1 trial shows durable RECIST responses across all dose cohorts from 50-900 mg daily, with two NSCLC patients achieving sustained partial responses lasting over 8-16 months.
  • D3S-001 exhibits favorable CNS penetration properties and demonstrates robust antitumor activity in brain metastasis models and acquired resistance xenografts where sotorasib and adagrasib showed limited efficacy.

Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation

NCT05737706TerminatedPhase 1
Mirati Therapeutics Inc.
Posted 3/6/2023

A Phase 1/2 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway

NCT05578092RecruitingPhase 1
Mirati Therapeutics Inc.
Posted 12/2/2022

A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation

NCT04973163Active, Not RecruitingPhase 1
Boehringer Ingelheim
Posted 9/9/2021

Phase I Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation

NCT05533463RecruitingPhase 1
Jiangsu HengRui Medicine Co., Ltd.
Posted 9/15/2022

JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation

NCT05194995Active, Not RecruitingPhase 1
Allist Pharmaceuticals, Inc.
Posted 2/17/2022

Study to Evaluate D-1553 in Subjects With Solid Tumors

NCT04585035Active, Not RecruitingPhase 1
InventisBio Co., Ltd
Posted 10/2/2020

A Study of MK-1084 in KRAS Mutant Advanced Solid Tumors (MK-1084-001)

NCT05067283RecruitingPhase 1
Merck Sharp & Dohme LLC
Posted 12/17/2021

A Study of ASP3082 in Adults With Advanced Solid Tumors

NCT05382559RecruitingPhase 1
Astellas Pharma Inc
Posted 6/8/2022

Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation

NCT06252649RecruitingPhase 3
Amgen
Posted 7/17/2024

Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation (KRYSTAL -19)

NCT05840510TerminatedPhase 1
Mirati Therapeutics Inc.
Posted 8/7/2023

Study of Pembrolizumab With or Without Defactinib Following Chemotherapy as a Neoadjuvant and Adjuvant Treatment for Resectable Pancreatic Ductal Adenocarcinoma

NCT03727880Active, Not RecruitingPhase 2
Lei Zheng
Posted 6/4/2019

Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

NCT05198934Active, Not RecruitingPhase 3
Amgen
Posted 4/19/2022

A Study of D3S 001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation

NCT05410145RecruitingPhase 1
D3 Bio (Wuxi) Co., Ltd
Posted 8/3/2022

Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7

NCT04613596RecruitingPhase 2
Mirati Therapeutics Inc.
Posted 12/2/2020

Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients

NCT05074810RecruitingPhase 1
Verastem, Inc.
Posted 4/12/2022

ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer With Kinase Inhibition of FAK

NCT03287271RecruitingPhase 1
Michael McHale
Posted 2/6/2018

Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)

NCT04956640RecruitingPhase 1
Eli Lilly and Company
Posted 7/19/2021

Phase I Trial of Adagrasib (MRTX849) in Combination With Cetuximab and Irinotecan in Patients With Colorectal Cancer

NCT05722327Active, Not RecruitingPhase 1
M.D. Anderson Cancer Center
Posted 12/6/2023

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

NCT04449874RecruitingPhase 1
Genentech, Inc.
Posted 7/29/2020

A Study of Avutometinib (VS-6766) + Defactinib in Recurrent KRAS G12V, Other KRAS and BRAF Non-Small Cell Lung Cancer

NCT04620330CompletedPhase 2
Verastem, Inc.
Posted 12/31/2020

A Phase 1/2 Study of Inlexisertib (DCC-3116) in Patients With RAS/MAPK Pathway Mutant Solid Tumors

NCT04892017RecruitingPhase 1
Deciphera Pharmaceuticals, LLC
Posted 6/15/2021

Ladarixin With Sotorasib in Advanced NSCLC

NCT05815173RecruitingPhase 1
NYU Langone Health
Posted 8/1/2023

Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors

NCT05462717Active, Not RecruitingPhase 1
Revolution Medicines, Inc.
Posted 9/19/2022

A Phase 1 study to evaluate IK-930 in subjects with advanced solid tumors

2022-502622-40-00CompletedPhase 1
Ikena Oncology Inc.

Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

NCT03785249RecruitingPhase 1
Mirati Therapeutics Inc.
Posted 1/15/2019

Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)

NCT04793958Active, Not RecruitingPhase 3
Mirati Therapeutics Inc.
Posted 6/24/2021

Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib (MRTX849) in Combination With the PARP Inhibitor Olaparib in Patients With KRAS G12C Mutated Advanced Solid Tumors, With a Focus on Gynecological, Breast, Pancreatic and KEAP1 Mutated Non-small Cell Lung Cancers

NCT06130254RecruitingPhase 1
M.D. Anderson Cancer Center
Posted 1/30/2024

A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)

NCT03600883Active, Not RecruitingPhase 1
Amgen
Posted 8/27/2018

Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors

NCT06040541RecruitingPhase 1
Revolution Medicines, Inc.
Posted 9/7/2023

A Study of IBI351 in Combination With Cetuximab in Subjects With KRAS G12C Mutated Metastatic Colorectal Cancer

NCT05497336RecruitingPhase 1
Innovent Biologics (Suzhou) Co. Ltd.
Posted 8/18/2022

Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)

NCT04975256TerminatedPhase 1
Mirati Therapeutics Inc.
Posted 7/28/2021

Study of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

NCT04699188Active, Not RecruitingPhase 1
Novartis Pharmaceuticals
Posted 2/24/2021

Study of RMC-6291 in Combination With RMC-6236 in Participants With Advanced KRAS G12C Mutant Solid Tumors

NCT06128551RecruitingPhase 1
Revolution Medicines, Inc.
Posted 11/14/2023

Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)

NCT05178888CompletedPhase 1
Mirati Therapeutics Inc.
Posted 1/20/2022

Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation

NCT05358249Active, Not RecruitingPhase 1
Novartis Pharmaceuticals
Posted 10/24/2022

A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC

NCT04959981CompletedPhase 1
Erasca, Inc.
Posted 9/2/2021

Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

NCT04665206RecruitingPhase 1
Vivace Therapeutics, Inc
Posted 3/24/2021

KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors

NCT06026410RecruitingPhase 1
Kura Oncology, Inc.
Posted 10/18/2023

Study of D3S-002 as Monotherapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations

NCT05886920Active, Not RecruitingPhase 1
D3 Bio (Wuxi) Co., Ltd
Posted 7/10/2023

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

NCT04185883RecruitingPhase 1
Amgen
Posted 12/17/2019

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