On May 14, 2019 Exelixis, Inc. (Nasdaq: EXEL) reported that the company will be presenting at the following two investor conferences on Tuesday, May 21, 2019, in New York (Press release, Exelixis, MAY 14, 2019, View Source [SID1234536281]):

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UBS Global Healthcare Conference: Exelixis is scheduled to present at 10:00 AM EDT / 7:00 AM PDT.
RBC Capital Markets Global Healthcare Conference: Exelixis is scheduled to present at 3:05 PM EDT / 12:05 PM PDT.
To access the webcast links, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to each presentation to ensure adequate time for any software download that may be required to listen to the webcasts. Replays will also be available at the same location for 14 days following each presentation.

On May 14, 2019 Novocure (NASDAQ: NVCR) reported 13 presentations and a symposium on Tumor Treating Fields at the 70th Annual Meeting of the German Society of Neurosurgery (DGNC) on May 12 through May 15 in Würzburg, Germany (Press release, NovoCure, MAY 14, 2019, View Source [SID1234536280]). The presentations are part of a Tumor Treating Fields session, which is a first for Novocure at this conference. Of the presentations, six are oral presentations and seven are posters. A lunch symposium will feature seven speakers on Tumor Treating Fields-related topics.

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"We are pleased that Tumor Treating Fields has become a significant part of the dialogue at DGNC," said Thomas Hefti, Vice President of Europe and Emerging Markets at Novocure. "DGNC provides a forum for the exchange of important scientific information. We look forward to sharing our science on Tumor Treating Fields and contributing to the discussion."

Oral Presentations

(V001) The use of TTFields for newly diagnosed GBM patients in Germany in routine clinical care (TIGER – TTFields in Germany in routine clinical care). O. Bähr (Frankfurt am Main, Frankfurt), M. Glas (Essen). 8 to 8:10 a.m. CEST May 13
Studie zur Anwendung von TTFields in der klinischen Routine, bei Patientinnen und Patienten mit einem neudiagnostizierten Glioblastom in Deutschland (TIGER Studie).

(V002) Tumour-treating fields (TTF) with different settings in different glioma cell lines. G. Hatipoglu Majernik (Hannover). 8:10 to 8:20 a.m. CEST May 13
Tumortherapiefelder (TTF) mit unterschiedlichen Einstellungen in verschiedenen Gliomzelllinien

(V003) The blood brain barrier (BBB) permeability is altered by tumour treating fields (TTFields) in vitro and in vivo. E. Salvador (Würzburg). 8:20 to 8:30 a.m. CEST May 13
Die Permeabilität der Blut-Hirn-Schranke wird durch Tumor Treating Fields (TTFields) in vitro und in vivo beeinflusst

(V004) The effect of tumour treating fields on cell morphology and invasion of different cancer cells. A. Kinzel (München). 8:30 to 8:40 a.m. CEST May 13
Die Wirkung von Tumortherapiefeldern auf die Zellmorphologie und Invasion verschiedener Tumorzellen

(V005) Increased survival benefit for newly diagnosed glioblastoma patients with higher TTFields doses to the tumour bed. Z. Bomzon (Haifa, IL). 8:40 to 8:50 a.m. CEST May 13
Höhere TTFields Dosen im Tumorbett erhöhen den Überlebensvorteil bei Patienten mit einem neu diagnostizierten Glioblastom

(V006) Open-label phase 1 clinical trial testing personalised and targeted skull remodelling surgery to maximise TTFields intensity for recurrent glioblastoma – interim analysis and safety assessment (OptimalTTF-1). N. Mikic (Aarhus, DK). 8:50 – 9 a.m. CEST May 13
Open-label Phase 1 Studie zur Untersuchung einer personalisierten und zielgerichteten Remodellierungsoperation zur Maximierung der TTFields lntensität beim rezidivierenden Glioblastom – Interim-Analyse und Sicherheitsbewertung (OptimalTTF-1).

Poster Presentations

(P169) The dielectric properties of intracranial tumours. M. Proescholdt (Regensburg). 1:35 to 1:40 p.m. CEST May 14
Die bioelektrischen Eigenschaften von intrakraniellen Tumoren

(P201) Aurora kinase inhibition to enhance tumour treating fields (TTFields) efficacy in glioblastoma treatment. D. Krex (Dresden). 1:20 to 1:25 p.m. CEST May 14
Die Inhibition von Aurora-Kinasen erhöht die Effektivität einer Behandlung mit Tumor Treating Fields bei Glioblastom-Patienten

(P202) Simulation of TTFields distribution within patient-specific computational head models. Z. Bomzon (Haifa, IL) 1:25 to 1:30 p.m. CEST May 14
Simulation der TTFields Verteilung in patientenspezifischen Kopfmodellen

(P203) PriCoTTF – a phase I/II trial of tumour treating fields prior and concomitant to radiotherapy in newly diagnosed glioblastoma. L. Lazaridis (Essen). 1:30 to 1:35 p.m. CEST May 14
PriCoTTF – eine Phase I/II Studie zu Tumortherapiefeldern vorausgehend und konkomitant zu Strahlentherapie und Temozolomid im neudiagnostizierten Glioblastom

(P205) Safety and adverse event profile of tumour treating fields in elderly patients – a post-market surveillance analysis. L. Lazaridis (Essen). 1:40 to 1:45 p.m. CEST May 14
Sicherheitsprofil von Tumortherapiefeldern (TTFields) in älteren Patienten – eine Post-Market Surveillance Analyse

(P206) Safety and adverse event profile of tumour treating fields use in the EMEA region – a real-world data analysis. L. Lazaridis (Essen) 1:45 to 1:50 p.m. CEST May 14
Sicherheitsprofil von Tumortherapiefeldern (TTFields) in der EMEA Region – Datenanalyse aus der klinischen Routine

(P207) Effect of tumour-treating fields plus chemotherapy in patients with recurrent glioblastoma. P. Spindler (Berlin) 1:50 to 1:55 p.m. CEST May 14
Der Effekt von ‘tumor-treating fields’ als Zugabe zu Chemotherapie in Patienten mit Glioblastom-Rezidiv

Lunch Symposium

12:15 to 1:15 p.m. CEST May 14

• D. Krex: Aurora kinase inhibition in combination with tumour treating fields (TTFields) (German)
Aurora-Kinase-Inhibierung in Kombination mit Tumortherapiefeldern (TTFields)

• L. Lazaridis: Clinical experience with the combination of TTFields with CCNU/TMZ (CeTeG) (German)
Klinische Erfahrungen mit der Kombination von TTFields und CCNU/TMZ

• C. Kramm: TTFields in pediatric patients
TTFields bei pädiatrischen Patienten

• M. Stein: Proton boost and Optune therapy in glioblastoma
Protonenboost- und Optune-Therapie beim Glioblastom

• M. Glas: TTFields and radiation – recent data and clinical developments
TTFields in Kombination mit Strahlentherapie – aktuelle Daten und klinische Entwicklungen

• M. Proescholdt: Comptune: Identification of parameters relevant for compliance in TTFields therapy
Comptune: Identifikation compliance-relevanter Parameter bei TTFields Behandlung

• A. Kessler: Experience with TTFields and meetings of patients using TTFields in Wuerzburg (German)
Erfahrungen mit TTFields und Patiententreffen von TTFields Patienten in Würzburg

On May 14, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that it has entered into a licensing agreement that grants Iconic Therapeutics, Inc. (Iconic) non-exclusive rights to Zymeworks’ proprietary ZymeLink antibody-drug conjugate (ADC) platform for the development of its ICON-2 Tissue Factor ADC for cancer (Press release, Zymeworks, MAY 14, 2019, View Source [SID1234536279]). This is the first collaboration leveraging the ZymeLink platform and represents Zymeworks’ third technology platform licensed to a collaborator.

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"We believe this first ZymeLink licensing deal provides further validation of our novel ADC technology, which is already being used in Zymeworks’ own clinical candidate, ZW49," said Ali Tehrani, Ph.D., President and Chief Executive Officer of Zymeworks. "Historically, traditional ADC development has been plagued by a number of challenges related to toxicity and efficacy. Our research has shown that ZymeLink has the capacity to significantly enhance exposure and tolerability, broadening the therapeutic window and leading to potentially safer and more efficacious therapeutic candidates."

"Zymeworks’ technology provides properties and capabilities we believe will enhance and leverage Iconic’s Tissue Factor platform," commented William Greene, M.D., Iconic’s Chief Executive Officer. "Having evaluated several alternatives, we are confident that we can develop a truly differentiated ADC with ZymeLink. Tissue Factor is an important target in solid tumors, and we believe the combination of our best-in-class antibodies with Zymeworks’ next generation payload technology will deliver an ADC with enhanced safety and efficacy with the potential to be an important addition to the cancer armamentarium. We look forward to progressing ICON-2 to the clinic in 2020 and more broadly, to further developing our pipeline of therapeutic approaches to targeting Tissue Factor mediated diseases."

Under the terms of the agreement, Zymeworks will be eligible to receive development and commercial milestone payments and tiered royalties on worldwide net sales. The agreement also provides Zymeworks co-promotion rights with increased royalties for products developed using the Iconic ADC program. If Iconic outlicenses the program, in lieu of co-promotion rights, Zymeworks will receive a share of the revenue Iconic receives from any partners as well as tiered royalties on worldwide net sales.

About the ZymeLink Platform

The ZymeLink platform is a set of proprietary cytotoxic drugs and linkers designed to create stable, polar ADCs for the targeted delivery of therapeutics with significantly enhanced exposure and tolerability leading to increased efficacy against targets that traditionally have been challenging for ADCs. The ZymeLink platform is compatible with monoclonal and bispecific antibodies and is intended to facilitate the development of next-generation antibody-drug conjugates with broad therapeutic windows.

On May 14, 2019 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that it will announce its 2019 first quarter results on Wednesday, May 22, 2019 (Press release, Bavarian Nordic, MAY 14, 2019, View Source [SID1234536278]).

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The management of Bavarian Nordic will host a conference call at 2:00 pm CEST (8:00 am EDT) on the same day to present the interim results followed by a Q&A session. A live and replay version of the call and relevant slides will be available at http://bit.ly/2PNW058.

To join the Q&A session dial one of the following numbers and state the participant code 3096344: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495.

Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations & Communications. Phone +45 61 77 47 43
U.S.: Graham Morrell, Paddock Circle Advisors (US), Tel: +1 781 686 9600

On May 14, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, is reported a development update on its cancer vaccine program, the GD2-GD3 Vaccine (Press release, Y-mAbs Therapeutics, MAY 14, 2019, View Source [SID1234536277]).

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At the Advances in Neuroblastoma Research (ANR) conference in San Francisco in May 2018, Phase 2 data utilizing GD2-GD3 Vaccine for Stage 4 high-risk neuroblastoma was presented. A total of 84 pediatric patients received the GD2-GD3 Vaccine, all of whom had prior relapses and finally regained second or later remissions before vaccine treatment. An interim analysis shows a progression free survival (PFS) of 51% and overall survival (OS) of 90% at 2 years. The GD2-GD3 Vaccine appears to be well tolerated, with no reported grade 3 or grade 4 toxicities. To date, more than 230 patients have been treated with the GD2-GD3 Vaccine at Memorial Sloan Kettering Cancer Center (MSK) in New York under a MSK sponsored IND.

"Since Y-mAbs licensed the GD2-GD3 Vaccine in June 2018, we have explored our options to establish commercial scale cGMP production. We believe we now have a viable route forward for manufacturing, and plan to begin using the newly manufactured cGMP drug product in the fourth quarter of 2019. Establishment of a clear path towards approval has been a prerequisite for advancing the GD2-GD3 Vaccine program and we are very excited to move the program forward. We believe the GD2-GD3 Vaccine for relapsed high-risk neuroblastoma may offer meaningful improvement in the long-term treatment paradigm for pediatric patients, serving as a natural extension post immunotherapy treatment with our naxitamab antibody based product candidate," stated Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Møller, Chief Executive Officer continued, "We believe that the more than 230 patients treated to date represents the largest population ever to receive a neuroblastoma vaccine. The 84 patients reported on at ANR received seven subcutaneous injections of the GD2-GD3 Vaccine in the outpatient clinic without any measurable pain or significant adverse side effects. We are very encouraged with the two year OS of approximately 90% in these 84 patients. We hope to replicate these data with the newly manufactured cGMP drug product in a multicenter trial."