On December 21, 2018 CStone Pharmaceuticals ("CStone") reported the successful enrollment and dosing of the first three patients in a Phase I clinical trial in the United States for CS1001, China’s first fully human and full-length anti-PD-L1 monoclonal antibody (Press release, CStone Pharmaceauticals, DEC 21, 2018, View Source [SID1234532227]). The multi-center, dose-escalation bridging trial will investigate the safety, tolerability, preliminary efficacy of CS1001 in patients with advanced solid tumors. Study results will support CS1001’s future clinical trials in the U.S., and serve to accelerate this candidate drug’s global development.

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Dr. Frank Jiang, chairman and CEO of CStone, commented: "CStone is committed to providing patients around the world with innovative and differentiated oncology therapies. We have now successfully initiated over ten clinical trials on multiple drug candidates in Australia, the United States and China, demonstrating CStone’s growing ability to carry out global drug development."

"CS1001 has unique advantages and potential, and is one of the company’s backbone IO drug candidates", noted Dr. Jason Yang, Chief Medical Officer at CStone. "We currently have several registrational clinical trials as monotherapy and in combination under way for CS1001 in China. We will continue to explore CS1001’s full value in order to provide new treatment options for cancer patients as soon as possible."

About CS1001

CS1001 is an investigational monoclonal antibody directed against PD-L1 being developed by CStone Pharmaceuticals. Authorized by the U.S.-based Ligand Corporation, CS1001 is developed by the OMT transgenic animal platform, which can generate fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors natural G-type immune globulin 4 (IgG4) human antibody, which can reduce the risk of immunogenicity and potential toxicities in patients, a unique advantage over similar drugs.

CS1001 has completed a Phase I dose-escalation study in China, which showed the drug to be well-tolerated and produced sustained clinical benefit during the Phase Ia stage of development. Currently, two pivotal Phase II studies have been initiated in China: for natural killer cell/T-cell lymphoma (CS1001-201) and classical Hodgkin’s lymphoma (CS1001-202). Meanwhile, Phase III studies are under way or being prepared both in China and globally for various serious tumor indications.

On December 21, 2018 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T cell immunotherapy, reported that Usman "Oz" Azam, MD, President and Chief Executive Officer, will present at the 37th Annual J.P. Morgan Healthcare Conference on Tuesday, January 8, 2019 at 2:30 pm Pacific Time at the Westin St. Francis Hotel in San Francisco (Press release, Tmunity Therapeutics, DEC 21, 2018, View Source [SID1234532226]).

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A live webcast of the presentation will be available on the "Events and Presentations" page of the Tmunity website at View Source Tmunity will maintain an archived replay of the webcast on the website for 30 days after the conference.

On December 21, 2018 Novocure (NASDAQ: NVCR) reported that it will participate in the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, Jan. 9, 2019, in San Francisco (Press release, NovoCure, DEC 21, 2018, View Source [SID1234532225]). William Doyle, Novocure’s Executive Chairman, will speak on behalf of the company and address questions from analysts. He is scheduled to present at 2:30 p.m. PST.

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A live audio webcast of the presentation and all presentation materials can be access from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations/, and will be available for replay for at least 14 days following the event.

On December 21, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration and fibrotic diseases, reported that its Phase 2 TRAXAR trial evaluating TRC105 in combination with Inlyta (axitinib) in patients with advanced or metastatic renal cell carcinoma did not meet the primary endpoint of improving progression free survival (PFS) in the intent to treat population compared to Inlyta monotherapy (Press release, Tracon Pharmaceuticals, DEC 21, 2018, View Source [SID1234532224]).

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Prespecified statistical analyses of PFS according to expression of two plasma biomarkers, TGFβ receptor III and osteopontin, also did not achieve statistical significance. The safety profile observed in TRAXAR was consistent with that observed in previously reported studies of TRC105 in combination with VEGF inhibitors.

TRACON will work with investigators to appropriately conclude the study in a manner consistent with the best interests of each patient. Data from this study will be analyzed and submitted for presentation at an upcoming scientific congress.

"We are disappointed that TRC105 in combination with Inlyta did not demonstrate clinically meaningful efficacy in patients with advanced or metastatic renal cell carcinoma. Importantly, data from TRAXAR, including analyses of an extensive biomarker panel, will contribute to our understanding of the role of endoglin inhibition in combination with VEGF inhibitors, and may inform our broad TRC105 clinical development program," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We remain focused on the interim analysis to determine the final sample size of the Phase 3 TAPPAS trial of TRC105 and Votrient in angiosarcoma, which is expected in the first quarter of 2019."

About the TRAXAR trial in Advanced or Metastatic Renal Cell Carcinoma

The TRAXAR trial compared treatment with TRC105 and Inlyta to treatment with single agent Inlyta in 150 patients with advanced or metastatic renal cell carcinoma with a clear cell component. Patients were randomized in equal numbers and the primary endpoint was progression free survival by RECIST 1.1. Key secondary endpoints included objective response rate, safety and tolerability.

About Carotuximab (TRC105)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in a pivotal Phase 3 trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors, as well as in a Phase 1 trial with Opdivo. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

On December 21, 2018 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that the company will present at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco (Press release, Iovance Biotherapeutics, DEC 21, 2018, View Source;p=irol-newsArticle&ID=2381465 [SID1234532223]). Details of the presentation are as follows:

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Presenter: Maria Fardis, Ph.D., President and Chief Executive Officer
Date: Thursday, Jan. 10, 2019
Time: 10:30 a.m. PST
Webcast: A live and archived audio webcast of the presentation will be available in the "Investors" section at www.iovance.com.