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Acrivon Therapeutics' ACR-368 Shows Promise in Endometrial Cancer; ACR-2316 Cleared for Phase 1 Trials

  • Acrivon Therapeutics reported a 62.5% response rate in endometrial cancer patients treated with ACR-368, selected using the OncoSignature assay, with ongoing treatment and no median duration of response reached.
  • The FDA has cleared Acrivon's ACR-2316 for Phase 1 trials, with dosing scheduled to commence in Q4 2024, marking a significant milestone in the drug's development.
  • Acrivon Therapeutics maintains a strong financial position, with sufficient funding to sustain operations until the second half of 2026, supporting ongoing research and development efforts.

TransCon CNP Demonstrates Superior Growth Velocity in Achondroplasia Trial

  • Ascendis Pharma's TransCon CNP (navepegritide) met its primary endpoint in the ApproaCH trial, showing superior annualized growth velocity (AGV) compared to placebo in children with achondroplasia.
  • The overall AGV difference was 1.49 cm/year (p<0.0001), with a more significant difference of 1.78 cm/year (p<0.0001) observed in children aged 5-11 years.
  • TransCon CNP exhibited a favorable safety profile, comparable to placebo, and Ascendis plans to submit regulatory applications to the FDA and EMA in 2025.
  • The trial also demonstrated improvements in height Z-scores and potential benefits in health-related quality of life measures for children treated with TransCon CNP.

PDS Biotech's Versamune® HPV Plus Pembrolizumab Shows Promising Results in Head and Neck Cancer

  • PDS Biotech announced Phase 2 trial results of Versamune® HPV with pembrolizumab for HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
  • The combination therapy demonstrated a median overall survival of 30 months, significantly higher than pembrolizumab alone.
  • The trial also showed a 36% objective response rate and a 77% disease control rate, outperforming historical data for pembrolizumab monotherapy.
  • PDS Biotech plans to initiate a Phase 3 clinical trial (VERSATILE-003) this year to further evaluate the combination therapy.

PDS Biotech's Versamune-HPV and Keytruda Combo Shows Promising Survival in Head and Neck Cancer

  • PDS Biotechnology's Versamune-HPV, combined with Keytruda, demonstrated a median overall survival of 30 months in HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
  • The combination therapy achieved an objective response rate of 36%, surpassing the published rates of 19-25% for pembrolizumab alone in similar patient populations.
  • A disease control rate of 77% was observed, with 21% of patients experiencing significant tumor shrinkage (90-100%) and 9% achieving a complete response.
  • Treatment-related adverse events of Grade 3 or higher were reported in 9 patients, suggesting a manageable safety profile for the combination regimen.

Passage Bio's PBFT02 Shows Sustained Progranulin Increase in FTD-GRN Patients

  • Passage Bio's PBFT02 gene therapy demonstrated robust and sustained increases in CSF progranulin levels in FTD-GRN patients in the upliFT-D trial.
  • Dose 1 of PBFT02 was well-tolerated in patients receiving a revised immunosuppression regimen, with no serious adverse events reported.
  • The Phase 1/2 upliFT-D trial results support PBFT02's potential as a progranulin-raising therapy for neurodegenerative diseases.
  • CSF progranulin levels remained elevated up to 12 months post-treatment, exceeding levels found in healthy adult controls.

A Study of PBFT02 in Participants With FTD and Mutations in the Granulin Precursor (GRN) or C9ORF72 Genes

NCT04747431RecruitingPhase 1
Passage Bio, Inc.
Posted 9/14/2021

iValve: Novel Mechanical Heart Valve Mimics Tissue Valve Performance, Aims for Pediatric Use

  • Researchers at UBC Okanagan have developed the iValve, a novel mechanical heart valve designed to combine the durability of mechanical valves with the superior performance of tissue valves.
  • The iValve is specifically designed for high-heart-rate applications, making it particularly suitable for pediatric patients who have historically faced challenges with existing mechanical valve technology.
  • The new valve has demonstrated improved hemodynamic performance in lab tests, suggesting it could reduce the need for lifelong anticoagulant therapy typically required with mechanical valves.
  • Researchers plan to proceed with animal and clinical trials within two years, with future work focused on developing similar valves for mitral valve replacement.

Kisqali Demonstrates Sustained Benefit in HR+/HER2- Early Breast Cancer

  • Updated analysis of the NATALEE trial shows Kisqali plus endocrine therapy reduces recurrence risk by 28.5% compared to endocrine therapy alone in stage II and III HR+/HER2- early breast cancer.
  • The invasive disease-free survival benefit of Kisqali was consistent across all pre-specified patient subgroups, including those with node-negative disease.
  • Four-year post-hoc analysis presented at ESMO Congress 2024 also showed consistent results across secondary efficacy endpoints, with a trend for improvement in overall survival.
  • Kisqali, when added to endocrine therapy, demonstrates a deepening benefit beyond the three-year treatment period in patients with HR+/HER2- early breast cancer.

Imfinzi and Imjudo Combo Shows Unprecedented Survival in Liver Cancer

  • The combination of Imfinzi and Imjudo demonstrated an unprecedented overall survival rate in advanced hepatocellular carcinoma (HCC).
  • The STRIDE regimen, combining a single dose of Imjudo with Imfinzi, showed one in five patients surviving five years, a significant milestone.
  • The safety profile of the STRIDE regimen was consistent with the known profiles of each medicine, with manageable adverse events.
  • Imfinzi plus Imjudo is approved for advanced or unresectable HCC in the US, EU, Japan, and other countries, offering a new treatment option.

Strides Pharma Gains FDA Approval for Generic Fluoxetine 60mg Tablets

  • Strides Pharma has received FDA approval for its generic Fluoxetine 60mg tablets, expanding its portfolio of this antidepressant drug.
  • The approval allows Strides Pharma to offer a complete range of Fluoxetine products, including 10mg, 20mg, and 60mg tablets and capsules.
  • Fluoxetine capsules and tablets have a combined market size of $130 million, offering a substantial commercial opportunity for Strides Pharma.
  • Strides Pharma plans to launch all three strengths of Fluoxetine tablets in the near future, manufactured at its facility in Puducherry.

PDS Biotech's Versamune® HPV Plus Pembrolizumab Shows Promising Results in HPV16-Positive Head and Neck Cancer

  • Updated data from the VERSATILE-002 trial shows a median overall survival of 30 months in patients treated with Versamune® HPV plus pembrolizumab.
  • The combination therapy achieved an objective response rate of 36% and a disease control rate of 77% in patients with HPV16-positive recurrent/metastatic HNSCC.
  • A significant portion of patients, 21%, experienced deep tumor responses with 90-100% tumor shrinkage, highlighting the therapy's potential.
  • PDS Biotech plans to initiate the VERSATILE-003 Phase 3 clinical trial to further evaluate the combination as a first-line treatment option.

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