{"id":768911,"date":"2023-07-11T10:30:37","date_gmt":"2023-07-11T14:30:37","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/tracon-pharmaceuticals-announces-collection-of-arbitration-award-from-i-mab-biopharma\/"},"modified":"2023-07-11T10:30:37","modified_gmt":"2023-07-11T14:30:37","slug":"tracon-pharmaceuticals-announces-collection-of-arbitration-award-from-i-mab-biopharma","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/tracon-pharmaceuticals-announces-collection-of-arbitration-award-from-i-mab-biopharma\/","title":{"rendered":"TRACON Pharmaceuticals Announces Collection of Arbitration Award from I-Mab Biopharma"},"content":{"rendered":"

\nCollection of Award Extends Cash Runway into early 2024 and Past Expected Full Accrual of the ENVASARC Pivotal Trial
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SAN DIEGO, July 11, 2023 (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 it has collected the previously announced arbitration award from I-Mab Biopharma.<\/p>\n

\u201cWe are pleased to collect the award. As we previously announced in April, the net proceeds extend our cash runway into early 2024 and past expected full accrual of the ENVASARC pivotal trial,\u201d said Charles Theuer, M.D., Ph.D., TRACON\u2019s Chief Executive Officer.\u00a0\u00a0 \u201cWe look forward to reporting the interim efficacy assessment from ENVASARC in the third quarter of 2023, which includes a futility analysis that we have already met based on responses seen to date.\u201d<\/p>\n

\n About Envafolimab<\/strong>\n <\/p>\n

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. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H\/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. 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. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON\u2019s corporate partners, Alphamab Oncology and 3D Medicines. TRACON has received orphan drug designation from the U.S. Food and Drug Administration for envafolimab for patients with soft tissue sarcoma and fast track designation from the U.S. Food and Drug Administration for envafolimab (KN035) for patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) who have progressed on one or two prior lines of chemotherapy.<\/p>\n

\n About ENVASARC (NCT04480502) <\/strong>\n <\/p>\n

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. ENVASARC is enrolling patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor. A total of 80 patients will receive treatment with single agent envafolimab at 600 mg every three weeks. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.<\/p>\n

\n About TRACON<\/strong>\n <\/p>\n

TRACON is 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. The Company\u2019s clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the ENVASARC pivotal trial for sarcoma; YH001, a potential best-in-class CTLA-4 antibody in Phase 1 development; and TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer. TRACON is actively seeking additional corporate partnerships through a profit-share or revenue-share partnership, or through franchising TRACON\u2019s product development platform. TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in\u00a0the United States\u00a0or who wish to become CRO-independent.\u00a0\u00a0 To learn more about TRACON and its product pipeline, visit TRACON\u2019s website at www.traconpharma.com<\/u><\/a>.<\/p>\n

\n Forward-Looking Statements<\/strong>\n <\/p>\n

Statements made in this press release regarding matters that are not historical facts are \u201cforward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward\u2010looking statements. Such statements include, but are not limited to, statements regarding TRACON\u2019s expectations for its cash runway into early 2024, the timing and scope of its clinical trials as well as timely achievement of expected endpoints and goals, the availability and expected results of clinical data, and the timing of reporting the interim efficacy assessment from ENVASARC in the third quarter of 2023. Risks that could cause actual results to differ from those expressed in these forward\u2010looking statements include: risks associated with clinical development and regulatory approval of pharmaceutical product candidates; risks relating to cost variability of clinical trials; whether other therapies are developed and compete with TRACON\u2019s product candidates; whether TRACON or others will be able to complete or initiate clinical trials on TRACON\u2019s expected timelines, if at all, including due to risks associated with macroeconomic and geopolitical events; the fact that future clinical results may not be consistent with preliminary results or results from prior studies; the fact that TRACON has limited control over whether or when third party collaborators complete on-going trials, initiate additional trials or seek regulatory approval of TRACON\u2019s product candidates; the fact that TRACON\u2019s collaboration agreements are subject to early termination; whether TRACON will be able to enter into additional collaboration agreements on favorable terms or at all; expectations on the timing of TRACON\u2019s recovery of the award from the arbitration with I-Mab and the effects of any recovery on TRACON’s cash runway; potential changes in regulatory requirements in\u00a0the United States\u00a0and foreign countries; TRACON\u2019s reliance on third parties for the development of its product candidates, including the conduct of its clinical trials and manufacture of its product candidates; whether TRACON will be able to obtain additional financing on favorable terms or at all; and other risks described in TRACON\u2019s filings with the\u00a0Securities and Exchange Commission\u00a0under the heading \u201cRisk Factors\u201d. All forward\u2010looking statements contained in this press release speak only as of the date on which they were made and are based on management\u2019s assumptions and estimates as of such date. 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 except as required by law.<\/p>\n\n\n\n\n\n\n
\n Company Contact<\/u>:<\/td>\n\n Investor Contact<\/u>:<\/td>\n<\/tr>\n
Charles Theuer<\/td>\nBrian Ritchie<\/td>\n<\/tr>\n
Chief Executive Officer<\/td>\nLifeSci Advisors LLC<\/td>\n<\/tr>\n
(858) 550-0780<\/td>\n(212) 915-2578<\/td>\n<\/tr>\n
\n ctheuer@traconpharma.com<\/a>\n <\/td>\n\n britchie@lifesciadvisors.com<\/a>\n <\/td>\n<\/tr>\n<\/table>\n

\u00a0<\/p>\n


\n
\n \n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

Collection of Award Extends Cash Runway into early 2024 and Past Expected Full Accrual of the ENVASARC Pivotal Trial SAN DIEGO, July 11, 2023 (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 it has collected the previously announced arbitration award from I-Mab Biopharma. \u201cWe are pleased to collect the award. As we previously announced in April, the net proceeds extend our cash runway into early 2024 and past expected full accrual of the ENVASARC pivotal trial,\u201d said Charles Theuer, M.D., Ph.D., TRACON\u2019s Chief Executive Officer.\u00a0\u00a0 \u201cWe look forward to reporting … <\/p>\n

Continue reading “TRACON Pharmaceuticals Announces Collection of Arbitration Award from I-Mab Biopharma”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-768911","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nTRACON Pharmaceuticals Announces Collection of Arbitration Award from I-Mab Biopharma - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/tracon-pharmaceuticals-announces-collection-of-arbitration-award-from-i-mab-biopharma\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"TRACON Pharmaceuticals Announces Collection of Arbitration Award from I-Mab Biopharma - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Collection of Award Extends Cash Runway into early 2024 and Past Expected Full Accrual of the ENVASARC Pivotal Trial SAN DIEGO, July 11, 2023 (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 it has collected the previously announced arbitration award from I-Mab Biopharma. \u201cWe are pleased to collect the award. 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