On December 27, 2018 4SC AG (4SC, FSE Prime Standard: VSC) reported, that the Safety Review Committee (SRC) consisting of clinical and drug safety experts evaluated the safety data from the second dose cohort and recommended continuation with the third dose cohort in the ongoing Phase Ib/II SENSITIZE study (ClinicalTrials.gov identifier: NCT03278665) (Press release, 4SC, DEC 27, 2018, View Source [SID1234532291]).

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The SENSITIZE study is enrolling up to 40 patients suffering from unresectable advanced-stage cutaneous melanoma who are refractory or non-responding to prior treatment with anti-PD-1 antibodies (checkpoint inhibitors). In the first part of the study, three patient cohorts will be treated at three different dose levels of domatinostat in combination with pembrolizumab. In the second part, additional patients will be treated with the recommended dosing regimen defined in the first dose-finding part of the study. 4SC anticipates top-line data to be available around the middle of 2019.

Susanne Danhauser-Riedl, M.D., Chief Medical Officer of 4SC, commented: "Safety and tolerability are key requirements for patients and physicians considering a drug. We are encouraged by the positive outcome of the first safety review earlier this year and the recent second one and are looking forward to enrolling patients into the third dose cohort. By continuing with the SENSITIZE study and the soon to be initiated investigator-sponsored EMERGE study of domatinostat in combination with the checkpoint inhibitor avelumab in patients with gastrointestinal cancer, we will continue to execute on our clinical development plan for domatinostat, which is intended to lead to the initiation of a potentially pivotal trial in H2 2019."

On December 27, 2018 MannKind Corporation (NASDAQ: MNKD) reported that it will host a conference call on Friday, January 4, 2019 to discuss Company developments at 9:00 AM (Eastern Time) (Press release, Mannkind, DEC 27, 2018, View Source [SID1234532292]).

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Presenting from the Company will be its Chief Executive Officer, Michael Castagna.

To participate in the live call by telephone, please dial (800) 263-0877 or (646) 828-8143 and use the participant passcode: 1338434. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at View Source under News & Events.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 1338434#. A replay will also be available on MannKind’s website for 14 days.

On December 26, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will be presenting at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 9 at 10:30 a.m. PT / 1:30 p.m. ET. Dr. Helen Torley, president and chief executive officer, will provide a corporate overview (Press release, Halozyme, DEC 26, 2018, View Source [SID1234532274]).

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The presentation will be webcast through the "Investors" section of Halozyme’s corporate website at www.halozyme.com, and a recording will be made available for 90 days following the event. To access a live webcast, please visit Halozyme’s website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

On December 26, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, reported that TRACON has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical study of TJ4309 in patients with advanced solid tumors (Press release, Tracon Pharmaceuticals, DEC 26, 2018, View Source [SID1234532275]).

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TJ4309, also known as TJD5, is a CD73 antibody from I-Mab’s proprietary discovery pipeline that is being co-developed through an agreement between TRACON and I-Mab that was signed on November 28, 2018. The agreement between the two companies is part of a broad strategic partnership to develop multiple immuno-oncology programs with first-in-class and best-in-class potential from I-Mab’s immuno-oncology portfolio, including several proprietary bispecific antibodies under development by I-Mab.

"The IND filing for TJ4309 within four weeks of signing the strategic partnership agreement with I-Mab is an important milestone for TRACON in two ways," commented Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "We have both expanded our pipeline into immuno-oncology and further demonstrated the efficiency of our product development platform designed to reduce the cost and time of clinical development for our partners. We look forward to initiating this Phase 1 clinical trial in early 2019."

About TJ4309

TJ4309, also known as TJD5, is a novel, humanized antibody against CD73, highly expressed on various cancer cells that converts extracellular adenosine monophosphate (AMP) to adenosine, leading to the formation of immunosuppressive tumor microenvironment. TJD5 is expected to start a phase I clinical trial in the US in early 2019 to assess the tolerability and preliminary efficacy as a single agent and in combination with a PD-1/PD-L1 checkpoint inhibitor in patients with advanced solid tumors. The antibody is also expected to be studied in clinical trials in China sponsored by I-Mab.

On December 26, 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 positive top-line clinical results from a Phase 1 study of TRC105 and Opdivo (nivolumab) for the treatment of non-small cell lung cancer (Press release, Tracon Pharmaceuticals, DEC 26, 2018, View Source [SID1234532276]).

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In this Phase 1b trial, patients with refractory metastatic non-small cell lung cancer were enrolled regardless of baseline PD-L1 tumor expression. Patients were treated with 8 mg/kg or 10 mg/kg of TRC105 weekly for four doses and then 15 mg/kg every two weeks, in combination with the approved dose of Opdivo of 240 mg every two weeks. Best response was assessed by immune RECIST 1.1.

The combination of TRC105 and Opdivo was well-tolerated without the development of dose limiting toxicity in six patients who were treated as part of dose escalation. One of these six patients, whose archival tumor did not express PD-L1 and who had not received prior PD-1/PD-L1 checkpoint inhibition treatment, developed a partial response and remains on study after 10 months. Two of the other five patients, one of whom who progressed following prior Opdivo treatment, remain on trial with stable disease. Patients are currently enrolling into two parallel 12 patient expansion cohorts, one that includes patients who have relapsed following prior PD-1/PD-L1 checkpoint inhibition treatment and one that consists of patients who have not received prior PD-1/PD-L1 checkpoint inhibition treatment.

"We initiated this Phase 1 trial based on the potentiation of PD-1 checkpoint inhibition observed with TRC105 in pre-clinical models. We are pleased that TRC105 was well-tolerated with Opdivo, and with the early evidence of activity seen in the study," said Charles Theuer, M.D. Ph.D., President and CEO of TRACON. "We expect to present data from the expansion cohorts in mid-2019."

Further details of the dose escalation portion of the study will be presented at the International Association for the Study of Lung Cancer (IASLC) annual meeting in February 2019 in Santa Monica, CA, by Dr. Francisco Robert of the University of Alabama, Birmingham.

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.