TRACON Pharmaceuticals Announces Submission for Approval of Envafolimab (KN035) with the NMPA in China by its Corporate Partners Alphamab Oncology and 3D Medicines
TRACON Pharmaceuticals (NASDAQ:TCON) announced that its partners, Alphamab Oncology and 3D Medicines, have submitted a new drug application for envafolimab (KN035) to the National Medical Products Administration (NMPA) for treating MSI-H/dMMR cancers, including colorectal and gastric cancers. This submission signifies a key milestone in envafolimab's development. The drug, a subcutaneous PD-L1 inhibitor, is also being tested in various ongoing trials, including those for biliary tract cancer and sarcoma.
- New drug application submitted for envafolimab in MSI-H/dMMR cancers.
- Milestone achieved in the development of envafolimab.
- Ongoing studies include multiple registration trials for advanced cancers.
- None.
Submission for Approval Filed in Indication of MSI-H/dMMR Cancer, Including Colorectal and Gastric Cancer
SAN DIEGO, Nov. 16, 2020 (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 announced its corporate partners, Alphamab Oncology and 3D Medicines, have submitted a new drug application (NDA) for the approval of envafolimab (KN035) in the indication of MSI-H/dMMR cancer to the National Medical Products Administration (NMPA).
“We congratulate our partners on the regulatory submission of data from the registration trial of envafolimab in MSI-H/dMMR advanced solid tumors including colorectal and gastric cancer, which marks an important milestone in the development and potential commercialization of the program,” said Charles Theuer, M.D., Ph.D., TRACON Chief Executive Officer. “The submission for approval highlights the advanced status of envafolimab product development. Envafolimab is being studied in two additional registration trials, a randomized Phase 3 trial in biliary tract cancer in China being conducted by 3D Medicines and Alphamab, and TRACON’s ENVASARC trial in sarcoma in the U.S., which recently opened multiple sites and expects to dose multiple patients prior to the end of the year.”
About Envafolimab (KN035)
Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in registration trials. Envafolimab is currently being studied in the ENVASARC Phase 2 registration trial in the U.S. sponsored by TRACON, as well as in a Phase 2 registration trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 registration trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines have submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer. In the Phase 2 registration trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was
About ENVASARC (NCT04480502)
The ENVASARC registration trial is a multi-center, open-label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.
About TRACON
TRACON develops targeted therapies for cancer utilizing a capital efficient, CRO independent, product development platform. The Company’s clinical-stage pipeline includes: Envafolimab, a subcutaneous PD-L1 single-domain antibody being developed in a registration trial for the treatment of sarcoma; TRC253, a small molecule drug candidate for the treatment of prostate cancer; TRC102, a Phase 2 small molecule drug candidate being developed for the treatment of lung cancer and glioblastoma; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships whereby it leads U.S. regulatory and clinical development and shares in the cost and risk of clinical development and leads U.S. commercialization. In these partnerships TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the U.S. To learn more about TRACON and its product pipeline, visit TRACON's website at www.traconpharma.com.
About Alphamab Oncology
Alphamab Oncology is a biopharmaceutical company focusing on innovative biologics medicine for oncology. On December 12, 2019, the Company was listed in the mainboard of Hong Kong Stock Exchange with stock code 9966. Alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its pipeline includes eight anti-tumor drug candidates including mainly bi-specifics, and a Covid-19 multifunctional antibody. Four products have advanced into phase I-III clinical trials in China, the United States, and Japan. The Company also has state-of-the-art manufacturing capabilities designed and built to meet NMPA and EU/FDA’s cGMP standards and a complete quality system which has passed the on-site inspection of a European Union qualified person. Alphamab Oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in China and around the world. Visit http://www.alphamabonc.com for more information.
About 3D Medicines
3D Medicines is a clinical-stage biopharmaceutical company focused on the development of differentiated next-generation immuno-oncology drugs for cancer patients. The world's first subcutaneous inject
FAQ
What is the recent NDA submission by TRACON Pharmaceuticals related to?
What types of cancer does envafolimab target in the recent NDA submission?
What is the significance of the envafolimab drug application submission?
What are the ongoing trials for envafolimab by TRACON Pharmaceuticals?
What is the confirmed objective response rate for envafolimab in colorectal cancer patients?
