CA-BIOCYTOGEN
30.8.2022 02:01:34 CEST | Business Wire | Press release
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen") and TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), today jointly announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for the initiation of a Phase 1/2 clinical study of YH001 in combination with envafolimab and doxorubicin for the treatment of sarcoma patients, including patients who have not received prior therapy.
The Phase 1/2 trial will assess the safety and efficacy of YH001 and envafolimab in patients with the rare sarcoma subtypes of alveolar soft part sarcoma and chondrosarcoma and assess the safety and efficacy of the combination of YH001, envafolimab and doxorubicin in the common sarcoma subtypes of leiomyosarcoma and dedifferentiated liposarcoma.
“YH001 was discovered using Biocytogen’s evidence-based in vivo drug efficacy screening platform and has demonstrated a favorable safety profile and promising anti-tumor activity in combination with a PD-1 antibody in an earlier phase 1 clinical study,” said Rong Chen, M.D., Ph.D., VP of Biocytogen, CEO and CMO of Eucure Biopharma. “As an antibody targeting the validated checkpoint CTLA-4, YH001 is expected to play a very important role in immune-oncology therapy. We are glad to learn that the combination therapy of YH001 + envafolimab and doxorubicin received IND approval by the FDA.”
“We are pleased to receive approval from the FDA to initiate our triplet combination therapy study in sarcoma, which includes our potentially best-in-class CTLA-4 antibody YH001 and the only subcutaneous checkpoint inhibitor approved anywhere in the world, envafolimab,” said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. “We look forward to enrolling patients in this study and giving patients additional options for their sarcoma treatment.”
About YH001
YH001 is an IgG1 antibody targeting CTLA-4 that was invented by Biocytogen, the parent company of Eucure Biopharma, and licensed by TRACON. YH001 has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro when compared with ipilimumab. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab as a single agent and when combined with a PD-(L)1 antibody in human transgenic mouse tumor models. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 has been dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756).
About Eucure Biopharma
As a wholly owned subsidiary of Biocytogen, Eucure Biopharma undertakes the mission of clinical development for Biocytogen’s R&D pipelines. Relying on a strong clinical development team and extensive clinical development experience, Eucure Biopharma focuses on antibody drug therapy for oncology and other indications. The company has established a product pipeline for more than 10 targets, with two products in launched phase II multi-regional clinical trials (MRCT) and two in phase I. For details, please visit www.eucure.com.
About Biocytogen
Biocytogen Pharmaceuticals (Beijing) Co., Ltd. is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Using its proprietary RenMabTM /RenLite® mice platforms for fully human monoclonal and bispecific antibody development, Biocytogen has integrated its in vivo drug efficacy screening platforms and strong clinical development expertise to streamline the entire drug development process. Biocytogen is undertaking a large-scale project to develop antibody drugs for more than 1000 targets, known as Project Integrum, and has entered ongoing collaborations with dozens of partners worldwide to produce a variety of antibody drugs. The company's pipeline includes 12 core products, among which two products are in phase II multi-regional clinical trials and two products are in phase I. Headquartered in Beijing, Biocytogen has branches in Haimen Jiangsu, Shanghai and Boston, USA. For more information, please visit www.biocytogen.com.cn.
About TRACON
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’s clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; YH001, a potential best-in-class CTLA-4 antibody in Phase 1 development; TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships through a profit-share or revenue-share partnership, or through franchising TRACON’s product development platform. TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the United States or who wish to become CRO-independent. To learn more about TRACON and its product pipeline, visit TRACON’s website at www.traconpharma.com.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220829005548/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Andersen Consulting tilføjer Multiplica3.4.2026 13:30:00 CEST | Pressemeddelelse
Andersen Consulting indgår en samarbejdsaftale med Multiplica, et digitalt konsulentfirma, der hjælper organisationer med at designe, bygge og skalere effektfulde digitale oplevelser. Multiplica, der er stiftet i Spanien og desuden har aktiviteter i Latinamerika og USA, fokuserer på brugerundersøgelser og behovsafdækning, research af kundeoplevelser, digital strategi, datamodellering og -analyse, rapportautomatisering og datavisualisering, konverteringsoptimering, produktdesign og design af brugeroplevelser. Virksomheden hjælper organisationer med at fremskynde den digitale transformation ved at opbygge digitale kompetencer, teams og aktiver, der fremmer ekspertise på tværs af digitale produkter, rådgivning og talentudvikling. Multiplica gør det muligt for kunder at prognosticere nye tendenser inden for digitale oplevelser og transformere deres forretninger gennem styrkede digitale kanaler og kundeengagement. "Samarbejdet med Andersen Consulting udgør en spændende mulighed for at udvid
Enry’s Island Unveils “Enry’s Island Adventures”: Venture Capital Becomes a Videogame and Launches the “Strap” Movement on Kickstarter3.4.2026 09:47:00 CEST | Press release
Gaming, finance, and lifestyle merge to democratize the startup ecosystem: Enry’s Island opens 2026 applications for game development studios seeking more than just capital. Enry’s Island SpA (WBAG: EIOS), the world’s first publicly traded Venture Builder, today announced the upcoming Kickstarter launch of Enry’s Island Adventures (EIA), developed by its New York-based portfolio company, Enry’s Island Adventures LLC. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260402548535/en/ The game is designed to make venture capital accessible to new generations, transforming startup creation into an engaging and social gaming experience. After three years of R&D, EIA introduces a "bleisure" model (business + leisure): players learn to launch and manage startups through gameplay that includes real business KPIs, a customizable and evolving personal island, synchronous and asynchronous multiplayer modes, social events, and community-d
SES Announces Results of the Annual General Meeting2.4.2026 16:49:00 CEST | Press release
SES (the “Company”) held the Annual General Meeting (“AGM”) of Shareholders today in Betzdorf, Luxembourg. Following the recommendations made by the Board of Directors of SES, the shareholders have voted in favor of all resolutions, including the Company’s 2025 annual accounts and the proposed annual dividend of EUR 0.50 per A-share (EUR 0.20 per B-share). The total dividend amount comprises the interim dividend of EUR 0.25 per A-share (EUR 0.10 per B-share), which has already been paid to shareholders on October 16, 2025. The final dividend of EUR 0.25 per A-share (EUR 0.10 per B-share) will be paid to shareholders on April 16, 2026. “I would like to sincerely thank our shareholders for their active engagement, visionary support and continued confidence in SES’ strategy,” said Adel Al-Saleh, CEO of SES. “The outcomes of today’s AGM underscore our shared commitment to a bold multi-orbit approach, with Medium Earth Orbit as the strategic backbone of a dynamically evolving global interco
Andersen Consulting styrker sine kompetencer med tilføjelsen af Lukkap2.4.2026 16:31:00 CEST | Pressemeddelelse
Andersen Consulting tilføjer samarbejdspartneren Lukkap, et konsulenthus med fokus på oplevelsesdrevne kompetencer, der er tilpasset kundernes skiftende behov inden for transformation af medarbejdere, kunder og det digitale område. Lukkap, der blev stiftet i 2009 og har hovedsæde i Spanien, leverer integrerede løsninger, der hjælper organisationer med at transformere, hvordan de betjener kunder, engagerer medarbejdere og frigør værdi gennem adfærdsindsigt og dataanalyse. Virksomhedens tværfaglige tilgang spænder over nytænkning af kunderejsen, effektive programmer for medarbejderoplevelser, talent- og ledelsesudvikling, prædiktiv analyse samt omfattende outplacement- og transitionsydelser. Lukkap arbejder på tværs af sektorer — herunder sundhedsvæsen, medicinalindustri, forbrugsgoder, detailhandel, finans og bankvæsen — for at opbygge menneskecentrerede strategier, der skaber målbare forretningsresultater. "Ved at kombinere vores erfaringsdrevne metode med Andersen Consultings globale
Forrester: Three Years Into GenAI, Enterprises Are Still Chasing Its True Transformative Value2.4.2026 16:00:00 CEST | Press release
Low AI fluency, uneven adoption, and marginal productivity gains are limiting enterprise-scale impact According to Forrester’s (Nasdaq: FORR) latest report, Accelerate Your AI Voyage, most enterprises are struggling to turn growing AI adoption and investment into measurable business impact. One of the key factors holding businesses back is low artificial intelligence quotient (AIQ) — Forrester’s measure of AI aptitude — with many employees lacking a clear understanding of how to use AI. Other barriers include an overemphasis on productivity-focused use cases, difficulty measuring impact, and siloed adoption within individual functions. While these challenges can leave firms frozen in doubt or indecision, the wait-and-see approach to AI adoption is no longer viable. To unlock AI’s full potential, organizations need to focus on four key areas: Define the business outcomes and success metrics for what they want AI to achieve; identify specific use cases for AI deployment aligned to those
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom