#Netherlands #Nijmegen #TGW101 #Tagworks Pharmaceuticals #Solid Tumors

Tagworks Pharmaceuticals Advances Clinical Trial for TGW101

Tagworks Pharmaceuticals, a clinical-stage precision oncology company, has recently announced the initiation of the third dose level in their ongoing Phase 1 clinical trial for TGW101. This novel antibody-drug conjugate (ADC) is designed to target TAG-72, a glycoprotein associated with solid tumors, and delivers a potent payload, monomethylauristatin E (MMAE). The innovative treatment utilizes Tagworks’ proprietary Click-to-Release technology, representing a cutting-edge approach in oncology.

Overview of TGW101

TGW101 stands out as the first bio-orthogonal ADC activated by click chemistry in vivo, enabling precise control over the release of its therapeutic payload directly within the tumor microenvironment. This mechanism is pivotal in overcoming the limitations often encountered with traditional ADCs, offering a promising solution for patients with advanced solid tumors who have limited treatment options. The Phase 1 study is crucial as it seeks to establish the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of TGW101.

Ken Mills, CEO of Tagworks, expressed excitement about the continuation of the trial, stating that the decision to escalate to the third dose level is a testament to TGW101’s favorable safety profile observed thus far. He highlighted the company’s commitment to addressing significant unmet medical needs in the treatment of advanced solid tumors with this highly differentiated therapy.

Trial Details

The ongoing Phase 1 trial is a multicentric, open-label, dose-escalation study designed to assess the safety and efficacy of TGW101 specifically in patients with relapsed or refractory solid tumors. Key objectives of the trial include:

• - Determination of the maximum tolerated dose (MTD)
• - Establishment of the recommended Phase 2 dose (RP2D)
• - Assessment of the dosing regimen for cohort expansion

Currently, the trial has initiated at three escalating dose levels following positive safety evaluations by the Safety Oversight Committee (SOC). The study plans to evaluate up to seven dose levels, adjusting as necessary based on emerging safety and pharmacokinetic data. Up to 50 patients will be recruited for this study across various sites in the United States, with potential expansion to additional regions.

Looking Ahead

Tagworks Pharmaceuticals is set to announce preliminary results related to safety and pharmacokinetics, alongside any early insights into clinical efficacy, by the first half of 2026. These findings could significantly contribute to the body of knowledge regarding the effectiveness of TGW101 in the treatment landscape of solid tumors.

Conclusion

As the oncology community continues to seek novel treatments for some of the most challenging cancers, the advancements presented by Tagworks Pharmaceuticals with TGW101 illuminate the potential for innovative therapeutic strategies that may provide hope for patients facing dire prognoses. With its unique targeting mechanism and ongoing commitment to research, Tagworks is poised to play a pivotal role in the evolution of cancer treatment modalities. For further information about TGW101 or Tagworks Pharmaceuticals, visit their official website at www.tagworkspharma.com.