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 26, 2018 Delcath Systems, Inc. (OTCQB: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the company has entered into a definitive licensing agreement for CHEMOSAT commercialization in Europe with medac Gesellschaft für klinische Spezialpräparate mbH (medac), a privately held, multi-national pharmaceutical company based in Hamburg area, Germany (Press release, Delcath Systems, DEC 26, 2018, View Source;p=RssLanding&cat=news&id=2381596 [SID1234532279]). Founded in 1970, medac specializes in the treatment and diagnosis of oncological, urological and autoimmune diseases. The company has offices globally, worldwide partner agreements in over 90 countries, and approximately 1,200 employees.

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Under the terms of the seven-year agreement, Delcath’s European subsidiary, Delcath Systems, Ltd. exclusively licenses medac to sell and market CHEMOSAT in all member states of the European Union, Norway, Liechtenstein, Switzerland, and the United Kingdom. medac will pay Delcath €6,000,000 in a combination of upfront and success-based milestone payments. Additionally, Delcath will receive a fixed transfer price per unit of CHEMOSAT as well as royalties. The agreement has a projected value of up to $45 million over the first seven-year term and includes an optional five-year extension.

"With offices throughout Europe and a well-established network among oncology key opinion leaders, medac is a well-suited partner to help advance CHEMOSAT commercialization in the European Union and neighboring countries," said Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath. "medac provides the organizational scale, expertise and market reach necessary to help us strive to firmly establish CHEMOSAT in the European treatment landscape for cancers of the liver. Additionally, through this agreement, we obtain immediate resources to support our efforts to advance our clinical development program. This is a highly significant development for Delcath, and we are pleased to be working with a market leader like medac to help this therapy fully realize its potential."

Heiner Will, Chief Marketing Officer of medac, said, "We are excited to build upon the growing customer and revenue base that Delcath has built in Europe to provide patients with liver metastases a promising treatment modality. We are convinced by the assessment of European clinicians about the very meaningful impact CHEMOSAT has on the quality of life of these patients who, because of the safety profile of CHEMOSAT can receive multiple treatments." This substantial new business opportunity strengthens and expands medac’s expertise in the treatment of cancer. medac is currently working diligently with Delcath launching commercial efforts in Europe in January 2019.

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 Pharma major Lupin Limited (Lupin) and global biopharmaceutical company AbbVie Inc., reported that AbbVie has licensed Lupin’s MALT1 (Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1) inhibitor program (Press release, Lupin, DEC 24, 2018, View Source [SID1234532263]). Through this partnership, AbbVie gains exclusive global rights to develop and commercialize Lupin’s MALT1 inhibitors. MALT-1 is a protein involved in T-cell and B-cell lymphocyte activation and AbbVie intends to pursue development across a range of hematological cancers, many with limited current treatment options.

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Commenting on the development, Nilesh Gupta, Managing Director, Lupin Limited said, "Delivering on new drugs was a key element of Dr. Deshbandhu Gupta’s vision. We are extremely proud of being able to realize his vision to bring new treatments to patients in need. We are very pleased to partner with AbbVie who share a commitment to deliver high quality medicines in areas that lack approved treatment and have a dire medical need. Their proven success in rapidly commercializing new targeted oncology treatments made them our partner of choice for this program."

Commenting on the partnership announcement, Dr. Raj Kamboj, President of Lupin’s Novel Drug Discovery and Development (NDDD) stated, "We are delighted with the success of our NDDD program to bring India’s first pharmaceutical innovation in this space. This is a first-in-class drug discovery program delivered exclusively by Lupin right from concept generation through the various stages of drug discovery and development. We are proud of the conceptualization, strategic direction and impeccable execution done by the team at Lupin that meets the global standard of pharmaceutical research."

Tom Hudson, M.D., Vice President, Discovery, AbbVie commented, "Lupin’s MALT1 program is exploring a new and innovative approach in difficult-to-treat cancers. AbbVie is committed to pursuing advanced treatment options for patients and we look forward to partnering our expertise in hematological oncology with Lupin’s discovery program to offer new hope to patients."

Under the terms of the agreement, AbbVie will pay Lupin an upfront payment of US$ 30 million for an exclusive license to the program. Upon successful completion of regulatory, development and commercial milestones, Lupin is eligible to receive total milestone payments of up to US$ 947 million. Additionally, Lupin will be entitled to receive a double-digit royalty on the sales of the product and will retain commercial rights to the program in India.

Lupin’s Novel Drug Discovery and Development team is focused on building a pipeline of highly differentiated and innovative new chemical entities in the therapeutic areas of Oncology, Immunology and Metabolic disorders. Lupin’s NDDD activities were started in 2010 with the vision to use cutting-edge research in bringing novel molecules that address unmet medical needs in multiple therapeutic areas to market globally.