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 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 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

On December 24, 2018 On December 24, 2018, Delcath Systems, Inc. (the "Company") reported that it entered into an Exchange Agreement with an institutional investor (the "Holder") with respect to the following previously issued to Holder (I) that certain Warrant to Purchase Common Stock (the "Existing February Warrant"), issued to the Holder on February 9, 2018 (pursuant to (i) that certain Placement Agency Agreement, dated February 8, 2018, (ii) the Company’s Registration Statement on Form S-1 (File number 333-220898) and (iii) the Company’s final prospectus dated as of February 8, 2018) and which Existing February Warrant is currently exercisable into 130,000 shares of Common Stock (as defined in the Existing February Warrant) and (II) that certain Warrant to Purchase Common Stock (the "Existing November Warrant", and together with the Existing February Warrant, the "Existing Warrants"), issued to the Holder pursuant to that certain Exchange Agreement, dated November 15, 2017, by and between the Company and the Holder, (in exchange, in part, for that certain senior secured convertible note originally issued pursuant to that certain Securities Purchase Agreement, dated June 6, 2016, by and among the Company, the Holder and certain other buyers signatory thereto) and which Existing November Warrant is currently exercisable into 12,540 shares of Common Stock (Filing, 8-K, Delcath Systems, DEC 24, 2018, View Source [SID1234532278]). The Company issued to the Holder 142,540 shares of Common Stock (the "Exchange Shares") in exchange for the Existing Warrants (the "Exchange"). The Exchange was made in reliance upon the exemption from registration provided by Section 3(a)(9) of the Securities Act of 1933, as amended. Concurrently therewith, the Holder has executed and delivered to the Company a leak-out agreement which contains certain trading restrictions with respect to the Exchange Shares.

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On December 24, 2018 Allergan plc (NYSE: AGN), a leading global biopharmaceutical company, reported that Chairman and CEO Brent Saunders will present at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, California (Press release, Allergan, DEC 24, 2018, View Source [SID1234532277]). The presentation will begin at 3:30 p.m. Pacific Time (6:30 p.m. Eastern Time) on Monday, January 7, 2019 at the Westin St. Francis.

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The presentation will be webcast live and can be accessed on Allergan’s Investor Relations website at View Source The webcast can also be accessed through the following URL: View Source

An archived version will be available within 24 hours of the live presentation and can be accessed at the same location for 90 days.