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Transgene to Present New Clinical Data
on Oncolytic Virus Pexa-Vec
at ASCO 2018

On May 17, 2018 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases, reported that new clinical data on the oncolytic virus Pexa-Vec will be presented at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from 1 to 5 June in Chicago (Press release, Transgene, MAY 17, 2018, View Source [SID1234526728]).

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These results were obtained from a clinical ("neoadjuvant") study that evaluated the biological effects of pre-operative intravenous (IV) administration of Pexa-Vec in patients with locally advanced or metastatic cancers, prior to planned surgical resection. University of Leeds (United Kingdom) is the sponsor of this trial that was supported by Transgene.

Poster title: Single intravenous preoperative administration of the oncolytic virus Pexa-Vec to prime anti-tumor immunity

Session Title: Developmental therapeutics – Immunotherapy
Poster and abstract number: 3092
Date, time, location: June 4, 8:00 AM-11:30 AM, Hall A
Presenter: Dr. Alan Anthoney, University of Leeds
The abstract is now available on the ASCO (Free ASCO Whitepaper) website (View Source).

Notes to editors

About Pexa-Vec
Pexa-Vec (JX594) is an oncolytic immunotherapeutic based on an oncolytic vaccinia virus armed with a GM-CSF gene that promotes an anti-tumor immune response. Pexa-Vec is designed to selectively target and destroy cancer cells through three different mechanisms of action: selectively destroy cancer cells through the direct lysis (breakdown) of cancer cells through viral replication, reduce the blood supply to tumors through vascular disruption, and stimulate the body’s immune response against cancer cells.
Pexa-Vec is currently being evaluated in a Phase 3 trial in hepatocellular carcinoma (HCC, liver cancer) in combination with sorafenib (current standard of care). Other trials evaluating the oncolytic virus in solid tumors are underway and expected to readout in 2018, including a Phase 2 trial in combination with nivolumab (HCC).
Transgene has exclusive rights to develop and commercialize Pexa-Vec for the treatment of solid tumors in Europe. Its partner SillaJen, Inc. is focused on developing Pexa-Vec for the North American market and has also granted exclusive development and commercial rights to Pexa-Vec in Hong Kong and The People’s Republic of China to Lee’s Pharmaceutical.

LIDDS signs license agreement for prostate cancer drug Liproca® Depot with major Chinese pharma company

On May 16, 2018 LIDDS AB (publ) reported that it has signed a license agreement for Liproca Depot with Jiangsu Ambition Medical, a Chinese pharmaceutical company specializing in global collaborations and in-licensing. Liproca Depot is LIDDS injectable cancer drug candidate for local treatment of prostate cancer (Press release, Lidds, MAY 16, 2018, View Source [SID1234555918]). LIDDS is receiving a signing fee exceeding USD 1 million followed by milestone payments and royalty. A phase III clinical trial will be conducted in China and will be fully financed by the licensee.

The strategic cooperation between Jiangsu Ambition Medical and LIDDS is expected to result in market approval for Liproca Depot in China as the first country in the world. Jiangsu Ambition Medical originates from Jiminkexin Group which ranks as one of the top 10 pharma companies in China. Jiangsu Ambition Medical has also expressed a strong interest for other drugs formulated in the NanoZolid technology platform.

LIDDS is very pleased to enter into the license agreement with Jiangsu Ambition Medical which has the highly regarded expertise to perform necessary clinical trials, and also an impressive sales organization to manage a future launch of Liproca Depot. The agreement is also a clear recognition of the international interest for the NanoZolid technology and Liproca Depot as treatment for prostate cancer, says Monica Wallter, CEO of LIDDS.

The prostate cancer market is substantial in China with around 500 000 patients being diagnosed annually. Oncology is a focus area at Jiangsu Ambition Medical and the company expects that the sales of Liproca Depot will reach yearly sales of 50 000 to70 000 treatments in 3 to 5 years after launch.

Jiangsu Ambition Medical views NanoZolid technology and specifically the Liproca Depot product as a very promising treatment for prostate cancer, a disease that is also very common in China. We are very happy to enter the agreement with LIDDS and will immediately start to prepare for conducting the Liproca Depot clinical trial in China. We hope to extend the partnership and get other products based on the NanoZolid technology into our pipeline, says Mr. Mark Dai, CEO of Jiangsu Ambition Medical.

Jiangsu Ambition Medical has its own regulatory and clinical departments and a highly recognized marketing and sales organization. Being deeply connected with the Chinese regulatory authorities and key clinical opinion leaders, their sales network covers 1,130 large scale public hospitals and an additional 4,592 hospitals in China. The sales team has launched four different drug products with an annual revenue of more than RMB 1.5 billion each and three drug products with revenues of RMB 1 billion respectively. LIDDS and Jiangsu Ambition Medical will work together to optimise the time to market for launching Liproca Depot in China.

FogPharma Secures $66 Million Series B Financing

On May 16, 2018 FogPharma reported the closing of a $66 million Series B financing (Press release, FogPharma, MAY 16, 2018, View Source [SID1234552458]). The round was led by 6 Dimensions Capital, with participation by additional new investors, including GV (formerly Google Ventures), Blue Pool Capital, Horizons Ventures, Nan Fung Group, and Leerink Partners. All existing investors participated in the round including Deerfield Management, Boyu Capital, WuXi AppTec Corporate Ventures, and a prominent international group of non-institutional investors.

FogPharma was founded by renowned scientist-entrepreneur Dr. Gregory Verdine, whose Harvard lab invented cell-penetrating miniproteins and who coined the term "drugging the undruggable" to describe his life’s mission. FogPharma’s research and development strategy is unique in that it pairs a broadly-enabling new drug class, designed to access the cell interior, with a massively parallelized engine to discover – rapidly and on-demand – drugs that engage the most intractable of disease targets. FogPharma’s drug discovery engine has been configured to deliver multiple new medicines in rapid succession, with clinical entry for the first product, a first-in-class beta-catenin antagonist, by the end of 2019, followed by a steady stream of first-in-class clinical product candidates addressing other intractable targets.

While FogPharma’s approach has many therapeutic applications, the company’s early focus is on drugging the major, intractable drivers of cancer and on pharmacological management of the immune response.

"One of the most important challenges of our time is making actionable the enormous, inactionable trove of biological data on human disease targets. FogPharma is addressing this challenge by bringing forward a new class of medicines that combine the cell-penetrating ability of small molecules with the broad, target power of biologics, and by learning how to discover these medicines better, faster and smarter," said Verdine, chief executive officer and chief scientific officer, FogPharma.

Added Verdine, "We are thrilled to have such an incredible group of investors who share our vision of fundamentally advancing the treatment of cancer and other serious diseases with few if any current treatment options. We are excited at the opportunity provided by this financing to propel our programs and drug discovery engine forward."

Proceeds from the Series B raise will enable the company to advance its first-in-class beta-catenin inhibitor (iCat) program into Phase 2 development for cancer indications involving Wnt pathway activation. The financing will also be used to advance clinical development of its first-in-class Cbl-b inhibitor program and a third as-yet-undisclosed program through IND-enabling studies, and FogPharma’s drug discovery platform for three additional, distinct and differentiated forms of cell-penetrating miniproteins.

In association with the Series B financing, FogPharma has appointed to its board of directors: Dr. Leon Chen, chief executive officer, 6 Dimensions Capital; Dr. Krishna Yeshwant, general partner, GV; and Dr. Rick Klausner, founder and director, Juno Therapeutics, GRAIL and Mindstrong.

"There is substantial and persistent interest in tackling targets like beta-catenin and Cbl-b, which are clearly important biologically and medically, but untouchable by conventional therapeutics. I was captivated by the FogPharma team’s unprecedented ability to go after these and other intractable targets," said Klausner, formerly director of the National Cancer Institute and executive director of the Bill and Melinda Gates Foundation.

"The opportunity in the near term to bring cell-penetrating miniproteins to the 20-25 percent of cancer patients whose disease is driven by the Wnt pathway is tremendous, and the opportunity beyond that to be the first to drug Cbl-b for immuno-oncology indications, is extraordinary. On behalf of 6 Dimensions Capital, I am thrilled to have led this exceptional investor syndicate and foster FogPharma’s mission," said Chen, chief executive officer, 6 Dimensons Capital, and member of the FogPharma board of directors.

Through seed and Series A financing, FogPharma previously secured $11 million bringing the company’s total funding to-date to $77 million.

In addition to FogPharma, Verdine founded and leads LifeMine Therapeutics, which has buit a first-of-its-kind, genomically-enabled drug discovery platform that can rapidly develop new drugs from fungi. Both LifeMine Therapeutics and FogPharma are headquartered in Cambridge, Mass. and were established operationally in 2016. Verdine is highly regarded for having moved seamlessly between successful roles as life scientist, entrepreneur, investor, and chief executive throughout his career. He is Erving Professor at Harvard University and Harvard Medical School and has founded multiple NASDAQ-listed biotech companies including Wave Life Sciences, Enanta, Eleven Bio, Variagenics, Tokai, Aileron, and a private company, Gloucester Pharmaceuticals, acquired by Celgene in 2010.

GT BIOPHARMA ANNOUNCES UPDATE TO OXS-3550 IND FILING, ITS MOST ADVANCED TRI-SPECIFIC KILLER ENGAGER

On May 16, 2018 GT Biopharma Inc. (OTCQB: GTBP and Euronext Paris "GTBP.PA" or the "Company")), an immuno-oncology biotechnology company focused on innovative treatments based on the Company’s proprietary platforms, has reported that it expects to file the Investigational New Drug Application ("IND") for OXS-3550, the Company’s most advanced Tri-specific Killer Engager ("TriKE") product candidate, in mid-2018 (Press release, GT Biopharma , MAY 16, 2018, View Source [SID1234539530]).

GT Biopharma is working in collaboration with the Masonic Cancer Center at the University of Minnesota under a program led by Dr. Jeffrey Miller, Deputy Director. Dr. Miller is a recognized leader in the field of Natural Killer ("NK") cell and IL-15 biology and their therapeutic potential.

"The expected filing of the IND for our first TriKE product candidate in mid-2018 is representative of the overall progress we are making as a company," said Shawn M. Cross, Chairman and Chief Executive Officer of GT Biopharma. "We look forward to updating our shareholders on our progress throughout 2018 as we continue to execute on our objectives."

The IND for OXS-3550 was filed in June 2017 by the University of Minnesota. Before the IND was transferred to the Company in October 2017, the FDA requested that additional preclinical toxicology be conducted prior to initiating clinical trials. The FDA also requested additional information and clarifications on the manufacturing (CMC) and clinical packages. The Company has reported that the requested additional information and clarifications have been completed and are being incorporated into the IND in eCTD format and that it expects to file the IND in mid-2018.

Genosco/Yuhan Announce Results from Phase 1/2 Study of YH25448(GNS-1480), a 3rd-Generation EGFR-TKI, in Advanced NSCLC to be Presented at ASCO 2018

On May 16, 2018 Genosco, a clinical-stage biotechnology company focused in immunology and oncology, reported that the abstract from a Phase 1/2 study evaluating YH25448 (GNS-1480) in patients with advanced Non-Small Cell Lung Cancer (NSCLC) is now available on the website of the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. YH25448 (GNS-1480), Genosco’s 3rd-generation EGFR-TKI candidate partnered for clinical development and commercialization with Yuhan Corporation, is an oral, potent, irreversible EGFR-TKI that is highly selective for activating (EGFRm) and T790M resistance mutations.

"We are encouraged by the safety and efficacy results shown in these data and look forward to the presentation of the full data set which will inform the future clinical trials," said Jong Sung (John) Koh, Ph.D., Genosco CEO.

Results from an open-label, multi-center Phase 1/2 study of YH25448 (GNS-1480) for patients with advanced NSCLC with or without CNS metastases will be presented in a poster session (Abstract 9033) by Byoung Chul Cho, M.D., Ph.D., Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea, at ASCO (Free ASCO Whitepaper) in Chicago. The poster (#356) is titled YH25448, a 3rd-generation EGFR-TKI, in patients with EGFR-TKI-resistant NSCLC: Phase I/II study results and will be presented in the Lung Cancer—Non-Small Cell Metastatic session on Sunday, June 3, 2018, 8:00 AM – 11:30 AM CT.

A total of 105 patients with EGFRm advanced NSCLC with acquired resistance to EGFR-TKIs with or without brain metastasis were enrolled in a Phase 1/2 study with dose-escalation and expansion cohorts.

Updated data will be presented at ASCO (Free ASCO Whitepaper).

About YH25448
YH25448 (GNS-1480) is an oral, potent, highly mutant-selective and irreversible, investigational 3rd-generation EGFR-TKI that penetrates the blood-brain barrier (BBB). It targets the activating EGFR mutations Del19 and L858R, as well as the T790M mutation, while sparing wild type. EGFR mutations are present in approximately 10-15% of NSCLCs. YH25448 (GNS-1480) is being evaluated in advanced NSCLC as both first- and second-line treatments.