#USA #Boston #TGW101 #Keith Orford #Tagworks Pharmaceuticals

Tagworks Pharmaceuticals Achieves Milestone with FDA Approval

Tagworks Pharmaceuticals BV has reached a significant milestone in its quest to revolutionize cancer treatment with the recent approval from the FDA for its investigational new drug (IND) application. This approval paves the way for the commencement of a Phase 1 clinical trial for TGW101, a novel antibody-drug conjugate (ADC) targeting the tumor-associated glycoprotein TAG-72. This groundbreaking ADC is unique due to its utilization of proprietary Click-to-Release chemistry, which enhances the therapy's effectiveness in delivering cancer-fighting agents specifically to tumor cells while minimizing damage to healthy tissue.

Overview of TGW101

TGW101 represents a new generation of cancer therapeutics, classified as the first biorthogonal ADC activated by in vivo click chemistry. This innovative approach allows for precise control over the release of the MMAE payload into the tumor environment. Studies indicate that TAG-72 is overexpressed in numerous solid tumors, making it an ideal target for cancer therapies that seek to overcome the limitations of existing ADC designs that necessitate endocytosis for activation.

Tagworks' clinical trial aims to enroll up to 50 patients suffering from advanced solid tumors, focusing primarily on evaluating the safety profile and tolerability of TGW101. Additionally, the trial will seek to establish the maximum tolerated dose and recommended dosing schedule for future patient cohorts, marking a crucial step in TGW101’s development.

Dr. Keith Orford, MD, PhD, has been appointed as Chief Medical Officer (CMO) at Tagworks. With over 30 years of experience in oncology research and drug development, Dr. Orford will play a critical role in guiding the clinical strategy for TGW101 and other novel cancer treatments derived from the Click-to-Release platform. His previous positions include significant leadership roles in several biotechnology firms, where he has fostered advancements in clinical oncology and drug innovation.

Significance of the Approval

The approval by the FDA is viewed as a pivotal moment for Tagworks as they embark on the first human studies of TGW101. According to Marc Robillard, the Chief Scientific Officer and co-founder, the company's cutting-edge platform enables controlled drug release, providing a promising avenue to enhance treatment outcomes in patients with challenging solid tumors that remain unmet clinical needs.

Dr. Anthony Tolcher, the principal investigator for the Phase 1 trial and CEO of NEXT Oncology, emphasized TGW101's potential, noting its capacity to address the shortcomings observed in current ADC therapies. He anticipates that this innovative technology may yield improved tumor responses and better clinical outcomes for patients battling aggressive cancers.

In welcoming Dr. Orford, CEO Ken Mills expressed confidence that his extensive background and strategic insight would be invaluable as the company progresses through clinical development. Dr. Orford himself noted his enthusiasm about joining Tagworks and contributing to the advancement of the Click-to-Release technology while working collaboratively with various researchers to assess TGW101's therapeutic utility across multiple tumor types.

Future Directions

The clinical trial for TGW101 represents just the beginning of Tagworks' pipeline for expanding treatment modalities in oncology, leveraging its unique technological foundation. By targeting clinically validated tumor markers that have previously been difficult to reach, the company is looking to establish a new standard of care for patients with solid tumors.

In conclusion, Tagworks Pharmaceuticals is not only marking a significant point in its history with the FDA's approval but is also poised for a transformative impact on cancer therapeutic strategies. With TGW101 and the strategic leadership of Dr. Orford, the company aligns itself for success in the increasingly competitive field of precision oncology.