Sinovant and Roivant Launch Cytovant Sciences in Partnership with Medigene to Develop Cellular Therapies in Asia

On April 4, 2019 Sinovant Sciences and Roivant Sciences reported the launch of Cytovant Sciences, a biopharmaceutical company focused on developing and commercializing innovative cellular therapeutics in Asia. Cytovant will focus on development programs that have the potential to transform the treatment of diseases that are prevalent in Asian patients (Press release, Sinovant Sciences, APR 4, 2019, http://www.cytovant.com/d65 [SID1234557522]). Concurrent with the company’s launch, Cytovant has entered into a multi-program license and collaboration agreement with Medigene AG, a clinical stage biotechnology company focusing on the development of T cell immunotherapies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Medigene has granted Cytovant exclusive licenses to develop, manufacture, and commercialize Medigene’s research-stage T cell immunotherapy targeting NY-ESO-1 as well as a DC vaccine targeting WT-1 and PRAME, in Greater China, South Korea, and Japan. In addition, Cytovant and Medigene have entered into a strategic collaboration and discovery agreement for T-cell receptor (TCR) immunotherapies for two additional targets. Medigene will be responsible for the generation and delivery of the TCR constructs using its proprietary TCR discovery and isolation platform. Following this research collaboration period, Cytovant will assume sole responsibility for the development and commercialization of these TCR therapies in the relevant countries. The TCRs to be generated by Medigene will be tailored specifically to Asian patients.

Under the terms of the transaction agreements, Medigene will receive an overall upfront payment of USD 10 million as well as potential development, regulatory, and commercial milestone payments which in aggregate could total over USD 1 billion for the four products across multiple indications. Furthermore, Medigene will be eligible to receive royalty payments on net sales of the products in a low double-digit percentage in the relevant countries. Additionally, Cytovant will reimburse all R&D costs incurred by Medigene within the collaboration.

"T cell receptors are the scouts of the immune system," said Prof. Dolores Schendel, CEO/CSO of Medigene. "They help T cells recognize and destroy cancer cells. We use our sophisticated screening systems to generate tailored TCR therapies for patient populations with specific genetic characteristics. This partnership implements Medigene’s strategy to discover TCRs with various HLA specificities in order to address different populations and markets. Cytovant, with its highly experienced management and scientific team was launched by Sinovant and Roivant to achieve excellence in cell therapies and we are proud to be part of this story of delivering various TCR projects as well as our DC vaccine for development in East Asia."

"The complexities of end-to-end cell therapy manufacturing, development, and commercialization in Asia require regional focus, specialization, and knowledge," said Benjamin Zimmer, President of Roivant Health. "Roivant and Sinovant have built Cytovant precisely to address these scientific and logistical complexities. We are excited to announce this strategic alliance with Medigene, one of the leading companies in the field of T cell-based therapies, to deliver important new cellular immunotherapies to Asian patients as quickly as possible."

Dr. John Xu, a molecular immunologist by training and translational scientist, has joined Cytovant and will serve as the company’s President. Prior to joining Cytovant, Dr. Xu was President and Chief Scientific Officer of Mab-Legend Biotech, a Shanghai-based antibody discovery company. Previously, Dr. Xu also served as Chief Scientific Officer of Shanghai Benemae Pharmaceutical Corporation and as Head of the Biologics Group at GSK China. He received his B.S. in cell biology and genetics from Peking University and his Ph.D. in biochemistry and molecular biology from Harvard University.

"We are thrilled to welcome John to Cytovant," said Dr. Xinan Chen, Executive Chairman of Sinovant. "John’s deep scientific expertise and knowledge of Asia’s health priorities make him an ideal leader for the company as we prepare to rapidly scale its research and development activities. The launch of Cytovant represents an important milestone in Sinovant’s evolution as a platform for entrepreneurs like John and we look forward to building Cytovant with him."

GlycoMimetics to Present at Upcoming Investor Conferences

On April 4, 2019 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that senior management will present corporate updates at two upcoming investor conferences in April (Press release, GlycoMimetics, APR 4, 2019, View Source [SID1234535009]). Details are as follows:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

HC WAINWRIGHT GLOBAL LIFE SCIENCES CONFERENCE
Who: Chief Financial Officer Brian Hahn
When: Tuesday, April 9 at 2:10 p.m. (GMT)
Where: London, UK

18TH ANNUAL NEEDHAM HEALTHCARE CONFERENCE
Who: Chief Executive Officer Rachel King
When: Wednesday, April 10 at 3:30 p.m. (ET)
Where: New York, NY

To access the live webcast and subsequent archived recordings for each of these presentations, please visit the GlycoMimetics website at www.glycomimetics.com.

Quest Diagnostics To Release First Quarter 2019 Financial Results On April 23

On April 4, 2019 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report first quarter 2019 results on Tuesday, April 23, 2019, before the market opens (Press release, Quest Diagnostics, APR 4, 2019, View Source [SID1234535027]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "Investor." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-480-3547 for domestic callers or 203-369-1551 for international callers, no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on April 23, 2019 until midnight Eastern Time on May 7, 2019.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

Puma Biotechnology Expands Cohorts in Phase II SUMMIT Trial of Neratinib in Cancer Patients with Tumors with Activating EGFR or HER2 Mutations

On April 4, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it has expanded two additional cohorts from the Phase II SUMMIT clinical trial investigating its lead drug candidate neratinib in patients with solid tumors who have an activating EGFR or HER2 mutation (Press release, Puma Biotechnology, APR 4, 2019, View Source [SID1234534994]). The cohorts that have been expanded are (i) HER2 mutant patients with metastatic salivary gland cancer and (ii) patients with EGFR exon 18 mutation-positive lung cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase II SUMMIT basket trial is an open-label, multi-center, multi-histology, international study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating EGFR, HER2 or HER4 mutations. The salivary gland cancer patients initially entered the study in the "other solid tumors with a HER2 mutation" cohort, and due to the preliminary activity seen in the trial, the Company has expanded a separate salivary gland cancer cohort pursuant to the protocol for the trial. The expanded HER2-mutant salivary gland cancer cohort and the expanded EGFR exon 18 mutant lung cancer cohort will each now enroll approximately 18 patients.

"We are pleased to expand our evaluation of neratinib in metastatic HER2 mutant salivary gland cancer and exon 18 mutated lung cancer from SUMMIT, as they both represent orphan and deadly diseases with few treatment options," said Alan H. Auerbach, Chief Executive Officer and President of Puma. "We believe this once again demonstrates the value of the basket study approach, in particular for developing targeted therapy for rare diseases with clinically-actionable mutations. We look forward to continuing enrollment into these expanded cohorts and presenting updated trial results."

Immunomic Therapeutics to Participate at World Vaccine Congress Washington 2019

On April 4, 2019 Immunomic Therapeutics, Inc. reported that it will participate at the World Vaccine Congress Washington being held in Washington, D.C. April 14-17, 2019 (Press release, Immunomic Therapeutics, APR 4, 2019, View Source [SID1234535010]). Teri Heiland, Ph.D., Immunomic’s Senior Vice President of Research and Development, will participate in a panel entitled "Strategies to enhance vaccine acceptance in future generations."
In addition to its panel participation, Immunomic has been nominated for the World Vaccine Congress Vaccine Industry Excellence (ViE) Award for Best New Vaccine Technology/Platform. The winner of the award is expected to be announced during the conference.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The World Vaccine Congress Washington is a multi-faceted conference experience with over 300 industry leading speaker, 10 conferences, 8 workshops, 100+ exhibitors providing the most exciting vaccine event on the planet.

Panel details are as follows:

Title: Strategies to enhance vaccine acceptance in future generations
Panel Category: Vaccine Safety
Panel Date and Time: Tuesday, April 16, 2019 9:40 AM
Location: Renaissance Washington DC Downtown Hotel, Washington D.C.

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.