On April 8, 2019 Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported that it has entered into a promotion agreement in which Immunomedics will provide detailing services to Janssen Biotech Inc. (Janssen), for erdafitinib in the U.S (Press release, Immunomedics, APR 8, 2019, View Source [SID1234535071]).

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"We are delighted to be collaborating with Janssen and we look forward to working closely with the Janssen team to help promote erdafitinib," said Brendan Delaney, Chief Commercial Officer of Immunomedics. "We have built strong commercial capabilities at Immunomedics and this agreement allows us to leverage our experienced oncology sales force to educate the U.S. market on this potential new treatment option for patients with metastatic urothelial cancer upon FDA approval."

Under the terms of the agreement, Immunomedics’ sales team will provide product detailing from the launch of erdafitinib until the end of the First Quarter 2020, but only requires Immunomedics to support the product in first position detail until the FDA approval of sacituzumab govitecan. Immunomedics is eligible to receive low double digit royalties and milestone payments based on U.S. sales throughout 2019 and 2020, subject to sales thresholds in each year, respectively.

A New Drug Application (NDA) for erdafitinib is currently under review by the U.S. Food and Drug Administration for the treatment of patients with locally advanced or metastatic urothelial cancer and certain fibroblast growth factor receptor (FGFR) genetic alterations whose tumors have progressed after prior chemotherapy. Erdafitinib is an investigational, once-daily, pan-FGFR kinase inhibitor that received Breakthrough Therapy Designation from the FDA in March 2018

On April 8, 2019 Kymab, a clinical-stage biopharmaceutical company developing antibody-based therapeutics, reported the appointment of Simon Sturge as its new CEO, effective May 1, 2019 (Press release, Kymab, APR 8, 2019, View Source [SID1234537017]). Simon succeeds David Chiswell, who remains a scientific adviser to the Company.

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"We are delighted that such an experienced leader as Simon will lead Kymab to its next stage of growth," said Martin Nicklasson, Non-Executive Chair. "Led by Simon, Kymab will continue to progress its innovative portfolio of products through the clinic and to market, driving our strategy to transform patients’ lives. This appointment is part of Kymab’s strategy to position itself for long-term success, building on the incredibly strong R&D foundation of the Company. We’d also like to thank David for many years of leadership at Kymab as CEO and previously as Chair – his leadership has been instrumental to the Company’s evolution."

Mr. Sturge brings to Kymab over 30 years of international leadership experience in both the biotechnology and pharmaceutical industry. He joins Kymab from Merck KGaA, where he was Executive Vice President Global Strategy, Business Development & Global Operations. Previously, he was Chief Operating Officer of Merck Healthcare, responsible for company’s global commercial and manufacturing operations. Over the past five years, he has been responsible for the continued growth in global sales at Merck KGaA, as well as the commercial launches of BAVENCIO (anti-PD-L1 avelumab) in solid tumours and MAVENCLAD (cladribine) for relapsing multiple sclerosis. Prior to joining Merck KGaA, Mr. Sturge served as Corporate Senior Vice President, Biopharmaceuticals at Boehringer Ingelheim, where he had responsibility for the research, development and commercialisation of the company’s global biosimilar portfolio. Before that, he held CEO roles at a number of healthcare companies including Celltech Biologics, and he served as founder and CEO of Ribotargets, which was acquired by British Biotech and subsequently renamed Vernalis.

"I am excited to have this opportunity to head Kymab at such a transformative time in its development," said Simon Sturge. "With its competitive antibody research platforms and evolving clinical pipeline, Kymab is well positioned as it progresses into an integrated discovery and development company."

"It has been rewarding to guide Kymab through a period of significant growth. Kymab is now a recognized leader in the antibody space, with an extensive pipeline and two lead candidates in the clinic," said Dave Chiswell, former CEO of Kymab. "I have known Simon for some years and I am pleased to hand over the reins to him. Simon is highly experienced and well positioned to lead Kymab and its exceptional staff, pipeline and partnerships, as it continues to discover and develop transformative antibody therapies for patients in need."

On April 8, 2019 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company plans to release its first-quarter 2019 financial results after the close of the U.S. financial markets on Apr. 30, 2019 (Press release, Exact Sciences, APR 8, 2019, View Source [SID1234535039]). Following the release, company management will host a webcast and conference call at 5 p.m. ET to discuss financial results and business progress.

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First-Quarter 2019 Webcast & Conference Call Details

Date:

Tuesday, Apr. 30, 2019

Time:

5 p.m. ET, 4 p.m. CT

Webcast:

The live webcast can be accessed at www.exactsciences.com

Telephone:

Domestic callers, dial 877-201-0168
International callers, dial +1 647-788-4901
Access code for both domestic and international callers: 4989449

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 4989449. The webcast, conference call and replay are open to all interested parties.

On April 8, 2019 WuXi Biologics ("WuXi Bio") (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, and NBE-Therapeutics (NBE), a privately owned Swiss biotech company developing best-in-class, next-generation antibody-drug conjugate (ADC) products, reported a comprehensive development and manufacturing partnership for NBE’s first ADC lead product NBE-002 (anti-ROR1) (Press release, WuXi Biologics, APR 8, 2019, View Source [SID1234535055]). NBE-002 is a best-in-class immune-stimulatory ADC (iADC) treatment against the ROR1 cancer target and is planned to enter into clinical trials in mid 2020 in triple negative breast cancer and other indications.

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NBE-Therapeutics develops next-generation iADC products with the aim to improve the outcome for cancer patients, as it continues to develop iADCs based on its proprietary technology platforms. With its proprietary SMAC-TechnologyTM to generate site-specifically conjugated ADCs and its proprietary highly-potent anthracycline toxin platform, NBE has the ability to develop highly targeted treatments with long-lasting anti-tumor immunity. The partnership with WuXi Biologics will enable the supply of NBE’s product for clinical trials under Investigational New Drug (IND) applications worldwide. With the establishment of state-of-the-art integrated biologics solution center, WuXi Biologics provides comprehensive one-stop service to global partners for antibodies, ADC drug substances and drug products.

Dr. Ulf Grawunder, CEO of NBE-Therapeutics commented, "We are excited about our partnership with WuXi Biologics, which we consider one of the world-leading CDMOs for manufacturing of biologic therapeutics. WuXi Biologics will be a strong partner for our next step in the development of our highly promising cancer treatments with long-lasting anti-tumor immunity. This collaboration will accelerate the transition of our preclinical iADC development programs to clinical validation. We look forward to working with WuXi Biologics over the coming years to deliver improved treatment options for global cancer patients."

"We are glad that NBE-Therapeutics with one of the best ADC platforms in the industry selected WuXi Biologics as their long-term partner for its first highly promising anti-ROR1 ADC program. It is another testament to the premier quality and global excellence of our integrated services, which continue to drive rapid expansion of our market share in Europe. We are excited in working with 7 companies on over 10 programs in Switzerland alone," said Dr. Chris Chen, CEO of WuXi Biologics. "Through our global quality, world-class technical capabilities and unparalleled capacity, we aim to empower any global partners to discover, develop and manufacture any biologics to benefit patients worldwide."

On April 8, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 that confirm domatinostat’s mode of action in Merkel cell carcinoma (MCC) (Press release, 4SC, APR 8, 2019, View Source [SID1234535040]). The data were presented by Prof. Dr. Dr. Jürgen C. Becker, Department of Translational Skin Cancer Research at the University Hospital Essen, Germany, German Cancer Consortium (DKTK) and German Cancer Research Center (DKFZ), Heidelberg, Germany. The AACR (Free AACR Whitepaper) Meeting took place at the Georgia World Congress Center in Atlanta, USA, from 29 March to 3 April 2019.

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Merkel cell carcinoma – tumor cells hide from the immune system

MCC is a rare, highly aggressive skin cancer often caused by either infection with Merkel cell polyomavirus or extensive UV exposure. Patients suffer from rapidly enlarging nodules that are between 0.5 and 5 cm in diameter, while the tumor aggressively spreads through the blood vessels to lymph nodes and many organs.

Although immune checkpoint inhibitors have shown compelling clinical activity in MCC, in some patients the tumor cells are very adept at evading the immune system. The tumor cells and its microenvironment prevent immune cells from entering the tumor and limit the presentation of tumor-signals on their surface. For these patients, refractory to or relapsing on checkpoint inhibitor therapy, currently no further treatment options are available.

Prof. Dr. Dr. Jürgen C. Becker explained: "In previous experiments we demonstrated that the immune escape mechanisms of MCC cells were epigenetically reversible1. Therefore, we were highly interested in testing the effect of 4SC’s domatinostat, an orally available, epigenetically active small molecule inhibitor targeting histone deacetylases class I, on MCC cell lines.

"Our new data demonstrate that domatinostat increased the presentation of tumor signals on the cells’ surface, stopped MCC cells from dividing and even induced cell death. All these effects were specific for MCC cell lines and did not occur in healthy control cells."

Frank Hermann, M.D., Chief Development Officer of 4SC, said: "We thank our collaborators for the dedication and energy devoted to their research with domatinostat. The fact that domatinostat counteracts the immune escape of MCC at different levels suggests that the combination of domatinostat with checkpoint inhibitors is potentially a promising therapeutic strategy in MCC and we plan to initiate a potentially pivotal clinical trial later this year."

Abstract ID 2368: Domatinostat increases apoptosis, G2M cell-cycle arrest and immunogenicity of Merkel cell carcinoma

The poster is available on 4SC’s website.

Reference:

1 Epigenetic priming restores the HLA class-I antigen processing machinery expression in Merkel cell carcinoma. C. Ritter, K. Fan, A. Paschen, S. Reker Hardrup, S. Ferrone, P. Nghiem, S. Ugurel, D. Schrama, and J. C. Becker. Sci Rep. 2017 May 23;7(1):2290. doi: 10.1038/s41598-017-02608-0