CA-BIOCYTOGEN
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 udvider sit udbud af humankapital med tilføjelsen af Jakarta Consulting Group16.1.2026 21:09:00 CET | Pressemeddelelse
Andersen Consulting styrker sine kompetencer gennem en samarbejdsaftale med Jakarta Consulting Group (JCG), der er et rådgivningsfirma, som er kendt for sin ekspertise inden for organisatorisk transformation, humankapitalstrategi og ledelsesudvikling. Med hovedsæde i Indonesien har JCG rådgivet virksomheder inden for brancher som ejendom, minedrift og produktion gennem strategisk og kulturel transformation. Med kerneydelser, der omfatter virksomheds- og administrationsrådgivning, hr-rådgivning, vurdering samt virksomheds- og ledelsestræning, er virksomheden kendt for sin evne til at transformere virksomheder og ledere med agilitet, kulturel intelligens og handlingsorienterede løsninger. "Vi har altid ment, at bæredygtig transformation begynder med mennesker – når ledere udvikler sig, følger organisationer med," siger Patricia Susanto, CEO for Jakarta Consulting Group. "Ved at kombinere Andersen Consultings globale perspektiv med vores regionale indsigt kan vi tilbyde kunderne mere helh
ClickHouse Raises $400M Series D Led by Dragoneer to Accelerate Expansion Across Analytics and AI Infrastructure16.1.2026 15:30:00 CET | Press release
Company acquires Langfuse to enter LLM observability and introduces a native Postgres service to unify transactional and analytical workloads ClickHouse, a leader in real-time analytics, data warehousing, observability, and AI/ML, announced today the close of its Series D financing, raising $400 million. The round was led by Dragoneer Investment Group, with participation from Bessemer Venture Partners, GIC, Index Ventures, Khosla Ventures, Lightspeed Venture Partners, accounts advised by T. Rowe Price Associates, Inc., and WCM Investment Management. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260116008883/en/ ClickHouse Co-Founders (left to right): Yury Izrailevsky, Aaron Katz, Alexey Milovidov The financing follows a period of sustained, accelerating growth for ClickHouse. The company now serves more than 3,000 customers on its fully managed service, ClickHouse Cloud, with ARR growing more than 250 percent year over year
Qualcomm Announces Quarterly Cash Dividend16.1.2026 15:00:00 CET | Press release
Qualcomm Incorporated (NASDAQ: QCOM) today announced a quarterly cash dividend of $0.89 per common share, payable on March 26, 2026, to stockholders of record at the close of business on March 5, 2026. About Qualcomm Qualcomm relentlessly innovates to deliver intelligent computing everywhere, helping the world tackle some of its most important challenges. Building on our 40 years of technology leadership in creating era-defining breakthroughs, we deliver a broad portfolio of solutions built with our leading-edge AI, high-performance, low-power computing, and unrivaled connectivity. Our Snapdragon® platforms power extraordinary consumer experiences, and our Qualcomm Dragonwing™ products empower businesses and industries to scale to new heights. Together with our ecosystem partners, we enable next-generation digital transformation to enrich lives, improve businesses, and advance societies. At Qualcomm, we are engineering human progress. Qualcomm Incorporated includes our licensing busine
Nominations open for The MIDORI Prize for Biodiversity 2026 by AEON Environmental Foundation and the Secretariat of the Convention on Biological Diversity16.1.2026 09:00:00 CET | Press release
The MIDORI Prize recognizes outstanding individual contributions to the conservation and sustainable use of biodiversityThe unique prize contributes to raising public awareness of the essential role biodiversity plays for human well-being and in addressing global challenges such as climate changeThe Award Ceremony and Award Winners Forum will be held on 27 August 2026 in Tokyo, Japan The call for nominations for The MIDORI Prize for Biodiversity 2026 is open from 2 February to 31 March 2026. Nominations are invited from members of the public through the AEON Environmental Foundation website at https://www.aeonkankyozaidan.or.jp/en/prize/. The Award Ceremony and Award Winners Forum of the 2026 edition of the Prize will be held on 27 August in Tokyo, Japan. These events will contribute to the global mobilization around COP 17 of the Convention on Biological Diversity (CBD), which will take place in Yerevan (Armenia) under the theme of “Taking action for Nature”. Co-organized by the AEON
Tigo Energy and Weco Certify MLPE-Inverter Compatibility to Simplify PV System Design16.1.2026 06:00:00 CET | Press release
Tigo MLPE technology and hybrid inverters of Italian manufacturer Weco are now certified to work together to enhance design flexibility, system performance, and seamless integration. Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced the Company has signed a certificate of compatibility with Weco S.r.l., documenting the compatibility between Tigo Flex MLPE products and hybrid solar inverters from Weco. The certification covers certain single-phase and three-phase Weco products and members of the Tigo TS4-A and TS4-X product families, when properly designed and installed. Together, these products are designed to deliver high-quality, enhanced value through a system that generates and manages solar energy more efficiently and delivers the features residential energy customers demand. “The compatibility between our inverter solutions and Tigo optimizers represents a significant step forward for the
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