Histiocytoma

TRACON Pharmaceuticals Announces Positive Results Based on Double-Digit Objective Response Rate in Each Cohort from the Ongoing ENVASARC Phase 2 Pivotal Trial

Retrieved on: 
Wednesday, December 14, 2022
Ipilimumab, Oxaliplatin, UPS, United, Sarcoma, SAN, Partnership, Therapy, Food, Histiocytoma, TRACON, Lung cancer, Safety, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IDMC, ORR, MFS, CD73, Patient, Chinese, United Kingdom, Pazopanib, COVID-19, TCON, PD-L1, Fine chemical, Pharmaceutical industry

SAN DIEGO, Dec. 14, 2022 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, today announced the IDMC for the ongoing ENVASARC Phase 2 pivotal trial recommended continued accrual as planned in both cohorts: single agent envafolimab and envafolimab in combination with Yervoy (ipilimumab).

Key Points: 
  • The double-digit ORR assessed by blinded independent central review in each cohort more than satisfied the prespecified futility rule.
  • Envafolimab monotherapy and in combination with Yervoy was well tolerated, with only a single related serious adverse event reported in 36 patients.
  • “We are also encouraged with the safety data showing that envafolimab monotherapy and in combination with Yervoy are well tolerated.
  • The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

TRACON Pharmaceuticals Announces Results of Independent Data Monitoring Committee Review of 12 Week Safety Data from ENVASARC Phase 2 Pivotal Trial - Trial to Proceed as Planned

Retrieved on: 
Thursday, October 6, 2022
SAN, Histiocytoma, CD73, Therapy, Review, Regulation of tobacco by the U.S. Food and Drug Administration, Sarcoma, Patient, TRACON, Partnership, Nasdaq, Private Securities Litigation Reform Act, Food, Lung cancer, MFS, UPS, Adult, Safety, Ipilimumab, United, TCON, GLOBE, United Kingdom, Chinese, PD-L1, COVID-19, Oxaliplatin, CRO, Pharmaceutical industry

Accrual continues to exceed projections and we remain on track for the Independent Data Monitoring Committee to review interim efficacy data in the fourth quarter of this year, said James Freddo, M.D., TRACONs Chief Medical Officer.

Key Points: 
  • Accrual continues to exceed projections and we remain on track for the Independent Data Monitoring Committee to review interim efficacy data in the fourth quarter of this year, said James Freddo, M.D., TRACONs Chief Medical Officer.
  • Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor.
  • The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.
  • TRACON is actively seeking additional corporate partnerships through a profit-share or revenue-share partnership, or through franchising TRACONs product development platform.

TRACON Pharmaceuticals Announces Fast Track Designation by the FDA for Envafolimab for the Treatment of the Soft Tissue Sarcoma Subtypes of UPS and MFS

Retrieved on: 
Wednesday, September 14, 2022
Adult, Oxaliplatin, TCON, Therapy, Safety, COVID-19, Sarcoma, FDA, Food, Biologics license application, United, CD73, Review, Private Securities Litigation Reform Act, Chinese, Partnership, Lung cancer, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Histiocytoma, CEO, United Kingdom, CRO, MFS, Nasdaq, Annual report, UPS, TRACON, SAN, PD-L1, GLOBE, Disease, Pharmaceutical industry

Soft tissue sarcoma is a disease in need of new treatments and we expect to provide data through the ENVASARC pivotal trial showing superior efficacy and safety of envafolimab compared to currently approved therapy for refractory soft tissue sarcoma.

Key Points: 
  • Soft tissue sarcoma is a disease in need of new treatments and we expect to provide data through the ENVASARC pivotal trial showing superior efficacy and safety of envafolimab compared to currently approved therapy for refractory soft tissue sarcoma.
  • TheFDAdesigned the fast track process to facilitate the development and expedite the review of drugs to treat serious or life-threatening diseases or conditions and fill unmet medical needs.
  • Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology and licensed by TRACON, is the first approved subcutaneously injected PD-(L)1 inhibitor.
  • In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America.

TRACON Pharmaceuticals Reports Regulatory Approval of Envafolimab in China

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Monday, November 29, 2021
MFS, Oxaliplatin, DNA, Company, TRACON, Hong Kong Stock Exchange, UPS, NMPA, MSI-H, Protein engineering, EU, Risk, GLOBE, Marketing, Histiocytoma, Private Securities Litigation Reform Act, Security (finance), CEO, PD-L1, TCON, Cancer, Sarcoma, U.S. Securities and Exchange Commission, Monoclonal antibody, CRO, HIV disease progression rates, COVID-19, PD-1, CRC, Irinotecan, Trial of the century, Progression-free survival, Therapy, CD73, Goal, Adult, Patient, Safety, Lung cancer, SAN, Survival rate, ORR, NASDAQ, Medication, Fine chemical, Medical imaging, Pharmaceutical industry

SAN DIEGO, Nov. 29, 2021 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., today reported that its partners Alphamab Oncology (stock code: 9966.HK) and 3D Medicines (Beijing) Co., Ltd. announced that envafolimab (KN035), the world's first single-domain PD-L1 antibody formulated for subcutaneous injection received marketing authorization from the Chinese National Medical Products Administration (NMPA).

Key Points: 
  • Envafolimab was well tolerated in this study and no cases of immune-related pneumonitis, immune-related colitis, or immune-related nephritis were reported.
  • In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America.
  • Four products have advanced into phase I-III clinical trials or pre-marketing stage in China, the United States, Japan and Australia.
  • The world's first subcutaneous injection PD-L1 antibody, envafolimab, is currently under clinical development in the United States, China and Japan.

TRACON Pharmaceuticals Announces Filing of Protocol for ENVASARC Pivotal Trial with the FDA

Retrieved on: 
Thursday, July 16, 2020
Neoplasms, Cancer, Clinical medicine, Checkpoint inhibitor, Sarcoma, Undifferentiated pleomorphic sarcoma, Histiocytoma, Soft-tissue sarcoma, Fibrosarcoma

TRACON previously reported results of a May 8 teleconference with the FDA whereby the agency agreed with TRACONs proposals regarding key elements of the pivotal ENVASARC trial for envafolimab in the soft tissue sarcoma subtypes of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).

Key Points: 
  • TRACON previously reported results of a May 8 teleconference with the FDA whereby the agency agreed with TRACONs proposals regarding key elements of the pivotal ENVASARC trial for envafolimab in the soft tissue sarcoma subtypes of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).
  • TRACON expects to initiate enrollment in the ENVASARC trial at 25 sites in the U.S. in the second half of 2020.
  • Key elements for the ENVASARC pivotal trial include:
    Eligible patients will have received one or two prior cancer therapies, but no prior immune checkpoint inhibitor therapy.
  • TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

TRACON Pharmaceuticals Announces Successful Type B Meeting with FDA for Pivotal Study of Envafolimab in Sarcoma

Retrieved on: 
Monday, May 11, 2020
Neoplasms, Cancer, Cancer in cats, Cancer in dogs, Undifferentiated pleomorphic sarcoma, Sarcoma, Fibrosarcoma, Histiocytoma

The FDA agreed with TRACONs proposals regarding key elements of the pivotal ENVASARC trial for envafolimab in the soft tissue sarcoma subtypes of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).

Key Points: 
  • The FDA agreed with TRACONs proposals regarding key elements of the pivotal ENVASARC trial for envafolimab in the soft tissue sarcoma subtypes of undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).
  • TRACON expects to initiate enrollment in the ENVASARC trial in the second half of 2020.
  • We appreciate the valuable discussions and guidance from our Type B meeting discussion with the FDA and concurrence on the design for the pivotal trials of envafolimab in sarcoma, said Charles Theuer, M.D., Ph.D., President and CEO.
  • Envafolimab is a novel, single-domain antibody against PD-L1 that is administered by subcutaneous injection without the need for an adjuvant.