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Clinical Trial News

FDA Approves Eli Lilly's Ebglyss (lebrikizumab) for Moderate-to-Severe Atopic Dermatitis

  • The FDA has approved Eli Lilly's Ebglyss (lebrikizumab-lbkz) for treating moderate-to-severe atopic dermatitis in adults and adolescents (12+ years, >=40kg).
  • Ebglyss, a targeted IL-13 inhibitor, is indicated for patients whose atopic dermatitis is not adequately controlled by topical prescription therapies.
  • Clinical trials (ADvocate1, ADvocate2, ADhere) demonstrated that Ebglyss, as monotherapy or with topical corticosteroids, significantly improved skin clearance and itch relief.
  • Ebglyss offers a convenient once-monthly maintenance injection following an initial treatment phase, providing long-lasting symptom relief for eczema patients.

Blenrep Combination Receives Breakthrough Therapy Designation in China for Multiple Myeloma

  • GSK's Blenrep (belantamab mafodotin) combined with bortezomib and dexamethasone (BorDex) has been granted Breakthrough Therapy Designation (BTD) in China for relapsed or refractory multiple myeloma.
  • The designation was based on Phase III DREAMM-7 trial results, which showed statistically significant improvements in progression-free survival (PFS) compared to daratumumab plus BorDex.
  • Multiple myeloma is a growing health concern in China, with approximately 30,000 new cases each year, underscoring the need for novel treatment options.
  • The DREAMM-7 trial demonstrated clinically meaningful improvements across secondary efficacy endpoints, including deeper and more durable responses, with a safety profile consistent with individual agents.

BioNTech to Present Oncology Pipeline Data at ESMO Congress 2024

  • BioNTech will present clinical trial data from its multi-platform oncology pipeline at the ESMO Congress 2024 in Barcelona, Spain, from September 13-17, 2024.
  • The presentations will cover mRNA-based cancer vaccines, next-generation immunomodulators, and targeted therapy approaches, showcasing the breadth of BioNTech's oncology programs.
  • BioNTech believes that combining immunomodulators, targeted therapies, and mRNA-based therapies will drive the future of cancer treatment, according to Prof. Özlem Türeci, M.D.

FDA Lifts Partial Clinical Hold on Zentalis' Azenosertib Studies

• The FDA has lifted the partial clinical hold on Zentalis Pharmaceuticals' azenosertib studies, allowing the company to resume enrollment in ongoing clinical trials. • Zentalis plans to present azenosertib monotherapy data and provide updates on clinical development at a corporate event later this year. • The company remains confident in azenosertib's therapeutic potential for addressing unmet needs in gynecologic malignancies. • Zentalis is on track to meet all previously disclosed data guidance for 2024, including key clinical study results expected in Q4.

Japan Approves CSL and Arcturus' Self-Amplifying mRNA COVID-19 Vaccine, Kostaive

• Japan's MHLW has approved Kostaive, a self-amplifying mRNA (sa-mRNA) COVID-19 vaccine developed by CSL and Arcturus Therapeutics, targeting the JN.1 Omicron subvariant. • Meiji Seika Pharma, CSL's partner in Japan, will distribute Kostaive for the October COVID-19 vaccination campaign, marking the first commercially available sa-mRNA COVID-19 vaccine for adults. • Clinical data supports Kostaive's safety and superior immunogenicity against Omicron BA 4/5 compared to conventional mRNA vaccines, with immunity lasting up to one year. • The approval aligns with WHO recommendations to update COVID-19 vaccines to target the JN.1 lineage, offering a more durable option against the virus in Japan.

PG2® Plus Chemoradiotherapy Improves Survival in Esophageal Cancer Patients

  • A clinical study by PhytoHealth Corporation shows that Astragalus Polysaccharides (PG2®) combined with chemoradiotherapy (CCRT) significantly improves survival in advanced esophageal cancer patients.
  • Patients receiving PG2® with CCRT had longer overall survival and a higher tumor objective response rate compared to those receiving CCRT alone, indicating enhanced treatment efficacy.
  • PG2® modulates the tumor immune microenvironment (TIME), strengthens the immune system, and suppresses tumor growth, offering a new approach to esophageal cancer treatment.
  • The study suggests PG2® can help patients complete cancer treatment by reducing inflammation, improving strength, and mitigating cancer-related fatigue, leading to better therapeutic outcomes.

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.

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