Tagworks Pharmaceuticals Secures FDA Approval for TGW101's Clinical Trial and Welcomes New CMO
In a significant advancement in the fight against solid tumors, Tagworks Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has granted clearance for the investigational new drug (IND) application related to its promising new treatment, TGW101. This groundbreaking antibody-drug conjugate (ADC) is specifically designed to target tumor-associated glycoprotein 72 (TAG-72) and utilizes a unique monomethyl auristatin E (MMAE) payload.
TGW101 is remarkable for being the first bioorthogonal ADC that employs in vivo click chemistry to enhance the targeting of tumors. This innovative approach allows for precise control over the release and activity of the drug payload within the tumor microenvironment, circumventing the limitations typically faced by existing ADCs that require internalization by tumor cells to initiate their therapeutic functions.
Tagworks Pharmaceuticals has initiated a Phase 1 clinical trial to evaluate TGW101, marking a pivotal step in its development. This trial will comprise a multicenter, open-label, dose-escalation study involving up to 50 patients with advanced solid tumors across the United States. The primary aims of the trial are to assess the safety and tolerability of TGW101 while determining the maximum tolerated dose and recommended dosing regimen for subsequent cohorts.
According to Marc Robillard, the Chief Scientific Officer at Tagworks, "The validation of TAG-72 as a target in numerous hard-to-treat solid tumors makes TGW101 an innovative solution. Its capacity to achieve controlled release of MMAE sets it apart from conventional ADCs. This is made possible by a unique click reaction between the linker of the ADC and a secondary trigger molecule, allowing the active drug to diffuse into the tumor cells after binding to the TAG-72 targeted areas."
Preclinical studies of TGW101 have already shown promising results, exhibiting a favorable safety profile and significant therapeutic effects in various solid tumor models. The IND clearance, along with the commencement of the Phase 1 trial, is celebrated by Tagworks as a milestone in their commitment to advancing cancer treatment options.
Tagworks has also announced a strategic addition to its leadership team. Dr. Keith Orford, MD, PhD, has been appointed as the Chief Medical Officer (CMO). With over three decades of extensive experience in oncology research and drug development, Dr. Orford is expected to drive the clinical development of Tagworks’ innovative pipeline, which also includes various ADCs and targeted radiopharmaceuticals.
Ken Mills, the CEO of Tagworks, remarked, "We are thrilled to welcome Dr. Orford to our team. His extensive background and prowess in oncology will be invaluable as we navigate the complexities of developing innovative cancer therapies."
Excited about his new role, Dr. Orford stated, "Joining Tagworks presents an extraordinary opportunity to further develop the transformative Click-to-Release technology. My aim is to work closely with our investigators to ensure that TGW101 is thoroughly evaluated for multiple advanced solid tumors."
As an ADC, TGW101 functions by binding to the TAG-72 antigen found on the surface of certain tumor cells. It comprises a TAG-72-binding diabody linked with the potent therapy MMAE. The treatment is administered intravenously, enabling it to target the tumor effectively. The subsequent administration of a small molecule trigger then cleaves the linker, releasing the MMAE in the tumor environment, thus enhancing its therapeutic impact.
Tagworks' advancements signify a major leap in precision oncology, establishing a new paradigm for treating solid tumors that were previously deemed difficult to target due to various biological challenges. The continued development and testing of TGW101 may promise new hope in oncology, especially for patients with high unmet needs in advanced solid tumors. The company's unique Click-to-Release strategy positions it favorably among peers in the oncology landscape, aiming to set a new standard of care in cancer treatment.
TGW101 is remarkable for being the first bioorthogonal ADC that employs in vivo click chemistry to enhance the targeting of tumors. This innovative approach allows for precise control over the release and activity of the drug payload within the tumor microenvironment, circumventing the limitations typically faced by existing ADCs that require internalization by tumor cells to initiate their therapeutic functions.
Tagworks Pharmaceuticals has initiated a Phase 1 clinical trial to evaluate TGW101, marking a pivotal step in its development. This trial will comprise a multicenter, open-label, dose-escalation study involving up to 50 patients with advanced solid tumors across the United States. The primary aims of the trial are to assess the safety and tolerability of TGW101 while determining the maximum tolerated dose and recommended dosing regimen for subsequent cohorts.
According to Marc Robillard, the Chief Scientific Officer at Tagworks, "The validation of TAG-72 as a target in numerous hard-to-treat solid tumors makes TGW101 an innovative solution. Its capacity to achieve controlled release of MMAE sets it apart from conventional ADCs. This is made possible by a unique click reaction between the linker of the ADC and a secondary trigger molecule, allowing the active drug to diffuse into the tumor cells after binding to the TAG-72 targeted areas."
Preclinical studies of TGW101 have already shown promising results, exhibiting a favorable safety profile and significant therapeutic effects in various solid tumor models. The IND clearance, along with the commencement of the Phase 1 trial, is celebrated by Tagworks as a milestone in their commitment to advancing cancer treatment options.
Tagworks has also announced a strategic addition to its leadership team. Dr. Keith Orford, MD, PhD, has been appointed as the Chief Medical Officer (CMO). With over three decades of extensive experience in oncology research and drug development, Dr. Orford is expected to drive the clinical development of Tagworks’ innovative pipeline, which also includes various ADCs and targeted radiopharmaceuticals.
Ken Mills, the CEO of Tagworks, remarked, "We are thrilled to welcome Dr. Orford to our team. His extensive background and prowess in oncology will be invaluable as we navigate the complexities of developing innovative cancer therapies."
Excited about his new role, Dr. Orford stated, "Joining Tagworks presents an extraordinary opportunity to further develop the transformative Click-to-Release technology. My aim is to work closely with our investigators to ensure that TGW101 is thoroughly evaluated for multiple advanced solid tumors."
As an ADC, TGW101 functions by binding to the TAG-72 antigen found on the surface of certain tumor cells. It comprises a TAG-72-binding diabody linked with the potent therapy MMAE. The treatment is administered intravenously, enabling it to target the tumor effectively. The subsequent administration of a small molecule trigger then cleaves the linker, releasing the MMAE in the tumor environment, thus enhancing its therapeutic impact.
Tagworks' advancements signify a major leap in precision oncology, establishing a new paradigm for treating solid tumors that were previously deemed difficult to target due to various biological challenges. The continued development and testing of TGW101 may promise new hope in oncology, especially for patients with high unmet needs in advanced solid tumors. The company's unique Click-to-Release strategy positions it favorably among peers in the oncology landscape, aiming to set a new standard of care in cancer treatment.
Topics Health）
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