On December 26, 2018 Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation presented the corporate presentation (Presentation, Intrexon, DEC 26, 2018, View Source [SID1234532283]).

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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.

On December 25, 2018 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported that it received manufacturing and marketing approval in Japan for the first time for the OncoGuide NCC Oncopanel System (the "System"), which the Company developed jointly with the National Cancer Center (Location: Tokyo, Japan; President: Hitoshi Nakagama), to be used in cancer genome profiling (Press release, Sysmex, DEC 25, 2018, View Source [SID1234532273]). The System constitutes a combination medical device,1 comprising the OncoGuide NCC Oncopanel Analysis Program and the OncoGuide NCC Oncopanel Kit, and is used in combination with a next-generation sequencer.2

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In recent years, attention has focused on clinical cancer gene testing that obtains a tumor genome profile3 which analyzes abnormalities in cancer-specific genes in cancer patients and elicits useful information to aid in cancer diagnosis and treatment and the selection of anti-cancer drugs.

With the aim of introducing clinical cancer gene testing into clinical settings at an early stage, in October 2015 Sysmex opened the Sysmex Cancer Innovation Laboratory (SCI-Lab), which conforms to international standards, within the National Cancer Center Hospital. At this facility, we used the System when participating in the TOP-GEAR Project, performing clinical research to determine treatment methods for cancers with actionable genomic aberrations. Based on the results of this research, Sysmex applied for the Ministry of Health, Labour and Welfare’s Sakigake Designation4 of the System and a next-generation sequencer used in combination with the System, as in vitro diagnostic pharmaceutical and medical devices. We obtained this designation on February 28, 2017. (Designation number: Sakigake screening (28) No. 1)

Thereafter, Sysmex completed development of the System as a combination medical device and applied for manufacturing and marketing approval in June 2018. We have now received this approval. The System targets all solid tumors and is intended for use in obtaining profiles pertaining to 114 cancer-related genes from patients’ tumor tissue (including cytology samples).

Meanwhile, on April 1, 2018, "Multiplex Gene Panel Testing to Advance Personalized Medicine" received approval as the Advanced Medical Care.5 This System and next-generation sequencers have been used in 350 cases at 50 core hospitals for cancer genomic medicine, including the National Cancer Center Hospital, and affiliated hospitals.

To expand opportunities for patients to receive this testing, we plan to apply for health insurance coverage for the System. Our aims are to deliver a new method for diagnosing cancer as quickly as possible and to promote the advancement of healthcare.

New Product Overview

General name: Gene mutation analysis set (for cancer genome profiling)
Product name: OncoGuide NCC Oncopanel System (Approval no.: 23000BZX00398000)
Launch: February 2019 (expected)
Target market: Japan
Target facilities: Medical institutions that have in place diagnostic systems appropriate for cancer genome profiling6

Features

・ A system developed by NCC and Sysmex
・Targets for analysis all solid tumors, regardless of cancer type
・Obtains from tumor tissue profiles pertaining to 114 cancer-related genes, checks them against a database of gene abnormalities, and provides annotation information

Terminology

1 Combination medical device:
A combination of two or more types of items (pharmaceuticals, medical devices or regenerative medicines) constituting a medical device to be manufactured and marketed.

2 Next-generation sequencer:
An analyzer for reading large volumes of DNA base sequences.

3 Tumor genome profile:
Information obtained by simultaneously analyzing mutations, copy number alterations and fusion of multiple genes of significance to cancer diagnostics.

4 Sakigake Designation System：
This system was designed to fast-track the provision of leading-edge global therapeutic drugs to Japanese patients. Novel drugs that satisfy the four conditions outlined below may be designated under the Sakigake Designation System at a comparatively early stage of development, and are given priority for clinical trial consultation and review. The system also aims to encourage applicants to create production systems in accordance with the approval review schedule, and put these into practical use more quickly by facilitating post-approval provision in medical settings. Four designation conditions apply: (1) an innovative mechanism of action, (2) targeting serious and life-threatening diseases, (3) demonstration of prominent effectiveness, and (4) the treatment being developed with the aim of conquering international competition, to receive approval in Japan prior to other countries.

5 Advanced Medical Care:
Based on a "fundamental accord" in December 2004 between the Minister of Health, Labour and Welfare; the Cabinet Office Minister of State in charge of special missions (regulatory reform, industrial revitalization); the minister in charge of administrative reform; and the minister in charge of special zones for structural reform and regional revitalization, this system was approved in combination with healthcare provided with insurance coverage from the perspective of ensuring the safety of Japanese citizens, containing patient burdens, expanding citizens’ choices, and increasing convenience.

6 Medical institutions that have in place diagnostic systems appropriate for cancer genome profiling:
On December 25, 2017, the Ministry of Health, Labour and Welfare submitted a notification outlining requirements, titled "The Establishment of Core Hospitals for Cancer Genomic Medicine."
Overview of requirements
Institutions must have in place the following systems:
・ System for ensuring the quality of gene panel testing (may be outsourced)
・ Review committee to interpret test results
・ System to perform genetic counseling
・ System for introducing and conducting clinical trials and clinical studies
・ System for gathering, managing and registering appropriate clinical information