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Clinical Trial News

Nexcella's NXC-201 Shows Promise in Multiple Myeloma and AL Amyloidosis

  • Nexcella's NXC-201 demonstrates a 90% overall response rate in relapsed/refractory multiple myeloma patients, all of whom were triple-class refractory, indicating its potential in challenging cases.
  • In AL amyloidosis, NXC-201 achieved a 100% organ response rate and complete hematologic responses in all eight relapsed/refractory patients, showcasing its efficacy in this rare disease.
  • NXC-201 exhibits a favorable safety profile, potentially enabling outpatient CAR-T treatment, which could significantly expand access to this therapy in community hospitals.
  • An editorial in Haematologica highlighted NXC-201's efficacy in the context of FDA-approved BCMA CAR-T therapies, noting its comparable safety and efficacy profile.

NXC-201 (formerly HBI0101) Multiple Myeloma

NCT04720313Active, Not RecruitingPhase 1
Hadassah Medical Organization
Posted 1/1/2021

I-Mab Announces 2022 Financial Results and Pipeline Updates, Highlighting Key Clinical Milestones

  • I-Mab achieved thirteen key clinical milestones in 2022, including positive data readouts for lemzoparlimab, uliledlimab, and givastomig, alongside progress in eftansomatropin alfa and felzartamab.
  • The company is strategically prioritizing its pipeline, focusing on key clinical assets and streamlining operations, which has significantly reduced the cash burn rate.
  • I-Mab anticipates Phase 3 data readout for eftansomatropin alfa and potential BLA submission by late 2023 or early 2024, with ongoing collaborations with AbbVie on anti-CD47 antibody therapy.
  • With a strong cash position of RMB3.5 billion (US$514.2 million) at the end of 2022, I-Mab is well-funded to support its key business operations for the next three years.

Generic Manufacturers Secure Licenses for Long-Acting HIV Prevention Drug Cabotegravir

  • The Medicines Patent Pool has signed sublicense agreements with Aurobindo, Cipla, and Viatris to manufacture generic versions of cabotegravir long-acting for HIV pre-exposure prophylaxis in 90 countries.
  • Cabotegravir LA for PrEP is the first and only long-acting injectable antiretroviral approved for HIV prevention, administered six times per year and proven superior to daily oral options.
  • The agreements enable manufacturing in India and South Africa, potentially providing access to millions in regions most impacted by HIV where approximately 860,000 people acquired HIV in 2021.
  • ViiV Healthcare will provide technical support to the generic manufacturers given the complex nano-suspension formulation required for the long-acting injectable medicine.

COVID-19 Vaccine Landscape: mRNA and DNA Vaccine Efficacy and Development

• mRNA vaccines like Pfizer-BioNTech's BNT162b2 and Moderna's mRNA-1273 have demonstrated high efficacy (72-95%) against moderate-to-severe COVID-19 in adults, with ongoing studies evaluating their effectiveness against emerging variants. • DNA vaccines, including Zydus Cadila's ZyCov-D, have shown promise with good safety profiles and the ability to induce neutralizing antibodies and cellular immune responses, offering a cost-effective alternative, especially in developing countries. • Studies indicate that extending the interval between doses of mRNA vaccines may enhance immune responses, particularly in previously uninfected individuals, although the recognition of variants like Omicron may decline more rapidly. • Booster doses of mRNA vaccines, such as BNT162b2, have been shown to significantly improve neutralizing titers against Omicron variants, supporting a three-dose regimen for enhanced protection.

Evaluation of Efficacy, Safety and Immunogenicity of GX-19N in Healthy Individuals Who Have Received COVID-19 Vaccines

NCT05067946WithdrawnPhase 2
Genexine, Inc.
Posted 10/1/2021

Phase II / III Study of COVID-19 DNA Vaccine (AG0302-COVID19)

NCT04655625CompletedPhase 2
AnGes, Inc.
Posted 11/23/2020

A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19

NCT04470427CompletedPhase 3
ModernaTX, Inc.
Posted 7/27/2020

Atezolizumab Enhances Immunogenicity in Cervical Cancer Treatment

Atezolizumab, when used before and concurrently with chemoradiation (CRT), has shown to improve immunogenicity and disease-free survival in patients with locally advanced cervical cancer, according to findings from the NRG-GY017 trial presented at the Society of Gynecologic Oncology 2023 Annual Meeting.

Atezolizumab Before and/or With Chemoradiotherapy in Immune System Activation in Patients With Node Positive Stage IB2, II, IIIB, or IVA Cervical Cancer

NCT03738228Active, Not RecruitingPhase 1
National Cancer Institute (NCI)
Posted 1/7/2019

NIH Data Shows Improvement in Clinical Trial Results Reporting, but Deadlines Still Missed

  • NIH data reveals that 41% of clinical trial results were submitted to ClinicalTrials.gov in fiscal year 2022, marking an increase from previous years.
  • While the vast majority (96%) of trial results are eventually submitted, most are late, with only about one-third submitted by the required due dates.
  • A recently enacted NIH policy aimed at improving trial results reporting appears to be effective, but further action is needed to enhance timely compliance.
  • The NIH is prepared to take enforcement actions against trial sponsors who fail to comply with reporting requirements.

FDA Issues Draft Guidance to Improve Accelerated Approval Applications

  • The FDA has released draft guidance aimed at enhancing the quality of applications for accelerated approvals, particularly for oncology drugs.
  • The guidance emphasizes the importance of timely postmarketing confirmatory studies to reduce clinical uncertainty and ensure patient benefit.
  • Randomized clinical trials are favored for verifying clinical benefit, potentially streamlining the approval process and minimizing the need for separate trials.
  • Project Confirm was launched by the FDA's Oncology Center of Excellence to promote transparency and research related to accelerated approvals.

Thermosome's THE001 Receives Regulatory Approval for First-in-Human Trial in Soft Tissue Sarcoma

  • German regulatory authorities have approved Thermosome's Phase 1 trial for THE001, a novel thermosensitive liposomal formulation of doxorubicin, with patient enrollment expected to begin in Q2 2023.
  • THE001 utilizes a proprietary technology that enables targeted drug release triggered by mild heat, potentially creating up to 15-fold higher local drug concentrations at tumor sites compared to conventional treatments.
  • The trial will evaluate safety, tolerability, and anti-tumor activity in patients with locally advanced or metastatic soft tissue sarcoma, addressing a significant unmet need in an indication with current response rates below 30%.

Kala Pharmaceuticals Provides Safety Update and Completes Enrollment for CHASE Phase 2b Trial

  • Kala Pharmaceuticals announced a safety update from Cohort 1 of its CHASE Phase 2b clinical trial, indicating progress in the ongoing study.
  • The company has successfully completed patient enrollment for the CHASE Phase 2 clinical trial, marking a significant milestone in the development program.
  • These developments represent important progress for Kala's clinical pipeline, though specific safety data and enrollment numbers were not disclosed in the available information.

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