On June 18, 2019 Vivoryon Therapeutics AG, (Euronext Amsterdam: currently PBD, to be changed to VVY, ISIN: DE0007921835), a clinical stage precision medicine company focused on bringing first-in-class therapies to patients suffering from age-related diseases, and goetzpartners, an independent advisory firm for strategy, M&A and transformation, reported their collaboration to explore the expansion of Vivoryon’s proprietary platform based on its Glutaminyl-peptide cyclotransferase-like protein (QPCTL) technology into the field of immuno-oncology (Press release, Vivoryon Therapeutics, JUN 18, 2019, View Source [SID1234537421]). In this context goetzpartners has been mandated as the exclusive strategic business development advisor of Vivoryon Therapeutics.

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Vivoryon’s lead molecule, PQ912, is currently in clinical stage development for Alzheimer’s Disease (AD) and is a first-in-class, highly specific and potent inhibitor of Glutaminyl cyclases (QPCT and QPCTL). New research has shown that small molecule Glutaminyl cyclase inhibitors could also represent an attractive approach for myeloid immune checkpoint control.

Consequently, Vivoryon’s next platform project focuses on immune checkpoint inhibition and the Glutaminyl-peptide cyclotransferase-like protein (QPCTL). QPCTL is a posttranslational modifying enzyme that is essential for the pyroglutamate formation on CD47, a crucial signaling protein in immune response to cancer. Inhibitors of QPCTL, like PQ912 and other small molecule compounds protected under Vivoryon’s patents, have been shown to silence the checkpoint signal from the CD47/SIRPa axis, and thus are offering a novel strategy to augment the efficacy of anti-tumor antibody therapies. Based on Vivoryon’s data, PQ912 could readily be advanced into clinical Phase I studies in cancer. In addition, Vivoryon Therapeutics owns a broader set of highly promising QPCTL inhibitor compounds in advanced preclinical stages of development.

"When weighing our options on how to move forward our QPCTL technology into the field of immuno-oncology, we wanted to make sure we did everything possible to bring scientific excellence for the benefit of patients to other indications. Understanding this responsibility, we decided to seek out industry leaders in business development consulting who understood our strategic needs and could provide us with the support necessary to unlock the full potential of our platform by partnering with major pharma players. For this reason, we look forward to working with goetzpartners, who have robust business experience and the expertise to guide us through this process" said Dr. Ulrich Dauer, CEO of Vivoryon Therapeutics.

"We are proud to have been selected by Vivoryon Therapeutics as their strategic advisors," said Ulrich Kinzel, Managing Director at goetzpartners, "The Company is a technology leader with their patented proprietary Glutaminyl Cyclase inhibition platform, and it is an exciting opportunity for us to connect them with the right partner to explore its full potential."

For more information, please contact:

Vivoryon Therapeutics AG
Dr. Ulrich Dauer, CEO
Email: [email protected]

goetzpartners Corporate Finance GmbH
Ulrich Kinzel
Tel: +49 (0) 89 29 07 25 125

MC Services AG
Anne Hennecke, Susanne Kutter
Tel: +49 (0) 211 529 252 27
Email: [email protected]

On June 18, 2019 Physicians’ Education Resource (PER), a worldwide leading resource for continuing medical education, reported the full agenda for the 20th Annual International Lung Cancer Congress (Press release, Physicians’ Education Resource, JUN 18, 2019, View Source [SID1234537144]). The congress will be held July 25-27 at the Hyatt Regency Huntington Beach in California.

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"We are so proud to be celebrating 20 years of educational excellence at this year’s congress," said Phil Talamo, president of PER. "This is a major milestone for PER, and we wouldn’t be able to become one of the most comprehensive and detailed educational lung cancer meetings in the world without the support of our national and international faculty members and participants who attend our International Lung Cancer Congress every year."

The 20th Annual International Lung Cancer Congress is a three-day program for surgical, medical and radiation oncologists interested in the treatment of patients with lung cancer. During this meeting, the activity co-chairs—Drs. David R. Gandara and Roy S. Herbst—will be joined by renowned international and national experts who will present a series of cutting-edge lectures, case-based panel and interactive discussions, a molecular tumor board and several Medical Crossfire programs on how oncologists can incorporate the latest data on targeted agents, immunotherapy, surgery and radiation oncology in the clinic. Additionally, Gandara and Herbst will present the 12th annual Bonnie J. Addario Lung Cancer Foundation keynote lecture and award at this year’s congress.

On June 18, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Rozlytrek (entrectinib) for the treatment of adult and paediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours (Press release, Hoffmann-La Roche, JUN 18, 2019, View Source [SID1234537129]). Rozlytrek is the first tumour-agnostic medicine to be approved in Japan that targets NTRK gene fusions, which have been identified in a range of hard-to-treat solid tumour types, including pancreatic, thyroid, salivary gland, breast, colorectal, and lung.1 It has been granted Sakigake designation and orphan drug designation by the MHLW.2

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Rozlytrek is also undergoing regulatory review in Japan for the treatment of people with ROS1 fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).2

"Today’s approval of Rozlytrek represents a new chapter in personalised healthcare, applying advanced diagnostics to deliver precision medicines that target cancers based on their molecular drivers instead of their location in the body," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We are proud to be at the forefront of personalised medicine with this novel treatment approach, and we look forward to working with regulatory agencies around the world to bring Rozlytrek to more patients with NTRK fusion-positive cancer, as well as to those with ROS1 fusion-positive NSCLC, as soon as possible."

The data package for this first approval of Rozlytrek includes the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials, as well as data from the Phase I/II STARTRK-NG study in paediatric patients. Results showed:

In the pivotal Phase II STARTRK-2 study, Rozlytrek shrank tumours in more than half (objective response rate [ORR] = 56.9 percent) of people with NTRK fusion-positive solid tumours. Objective responses to Rozlytrek were seen across 10 different solid tumour types (median duration of response [DoR] = 10.4 months), including in people with and without CNS metastases at baseline.
Importantly, Rozlytrek also shrank tumours that had spread to the brain in more than half of people (intracranial response [IC] ORR = 50.0 percent).2
In the STARTRK-NG study, Rozlytrek shrank tumours also in children and adolescents who had NTRK fusion-positive solid tumours including the patients with primary CNS tumours.3
The most commonly reported adverse reactions include constipation, altered sense of taste (dysgeusia), diarrhoea, dizziness, fatigue, swelling (oedema), weight increase, anaemia, blood creatinine increase, shortness of breath (dyspnea), and nausea.2
Biomarker testing for NTRK gene fusions is the only way to identify people who may be eligible for treatment with Rozlytrek. Roche is leveraging its expertise in developing personalised medicines and advanced diagnostics, in conjunction with Foundation Medicine, to help identify people with NTRK gene fusions using a companion diagnostic that is undergoing review.

About the supporting data
The data package for this approval includes the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials. In addition, data from the Phase I/II STARTRK-NG study in paediatric patients were also included in the submission. The studies enrolled people across 15 countries and more than 150 clinical trial sites. Tumour types evaluated in the studies included breast, cholangiocarcinoma, colorectal, gynaecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.1,2

STARTRK-2 is a Phase II, global, multicentre, open-label basket study in people with solid tumours that harbour an NTRK1/2/3, ROS1 or ALK-positive gene fusion. The primary endpoint is objective response rate (ORR), and duration of response (DoR) is a secondary endpoint. Other secondary outcome measures include time to response, clinical benefit rate, intracranial tumour response, progression-free survival (PFS), central nervous system (CNS) PFS and overall survival (OS).4
STARTRK-1 is a Phase I, multicentre, open-label dose escalation study of a daily continuous dosing schedule in people with solid tumours with NTRK1/2/3, ROS1 or ALK gene fusions in the US and South Korea. The trial assessed the safety and tolerability of Rozlytrek via a standard dose escalation scheme and determined the recommended Phase II dose.5
ALKA-372-001 is Phase I, multicentre, open-label dose escalation study of an intermittent and continuous Rozlytrek dosing schedule in people with advanced or metastatic solid tumours with TRKA/B/C, ROS1 or ALK gene fusions in Italy.2
STARTRK-NG is a Phase I/II dose-escalation and expansion study evaluating the safety and efficacy of Rozlytrek in children and adolescent patients with no curative first-line treatment option, recurrent or refractory extracranial solid tumours or primary CNS tumours, with or without TRK, ROS1 or ALK fusions.3
About NTRK fusion-positive cancer
Neurotrophic tyrosine receptor kinase (NTRK) fusion-positive cancer occurs when the NTRK1/2/3 genes fuse with other genes, resulting in altered TRK proteins (TRKA/TRKB/TRKC) that can activate signaling pathways involved in proliferation of certain types of cancer. NTRK gene fusions are tumour-agnostic, meaning they are present in tumours irrespective of site of origin. These fusions have been identified in a broad range of solid tumour types, including breast, cholangiocarcinoma, colorectal, gynaecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.1

About Rozlytrek
Rozlytrek (RXDX-101) is an oral medicine for the treatment of locally advanced or metastatic solid tumours that harbour NTRK1/2/3, as well as in development for the treatment of ROS1 gene fusions. It is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins, whose activating fusions drive proliferation in certain types of cancer.6,7 Rozlytrek can block ROS1 and NTRK kinase activity and may result in the death of cancer cells with ROS1 or NTRK gene fusions.6,7

Rozlytrek has been granted Priority Review by the FDA for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumours in adult and paediatric patients who have either progressed following prior therapies or as an initial therapy when there are no acceptable standard therapies, and for the treatment of people with metastatic, ROS1 fusion-positive NSCLC. It has also been granted Priority Medicines (PRIME) designation by the European Medicines Agency (EMA) and Sakigake designation and orphan drug designation by MHLW.2

On June 18, 2019 ArQule, Inc. (Nasdaq: ARQL) reported that Marc Schegerin, Chief Financial Officer and Head of Strategy, will present at the BMO Prescriptions for Success Healthcare Conference on June 25, 2019 at 8:00 a.m. ET at the The Mandarin Oriental New York, New York (Press release, ArQule, JUN 18, 2019, View Source [SID1234537145]).

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The live webcast of the presentation will be available via the "Investors & Media" section of ArQule’s website, www.arqule.com, under "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation.

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