On November 5, 2019 Engitix Ltd (‘Engitix’), a private company focused on drug discovery for fibrosis and solid tumours based on its pioneering human extracellular matrix (ECM) platform, reported that its subsidiary Engitix, Inc, has been awarded a Golden Ticket to LabCentral by Takeda Pharmaceutical Company Limited (Takeda) (Press release, Engitix, NOV 5, 2019, View Source [SID1234550282]).

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The Golden Ticket provides Engitix one year of lab bench space at LabCentral, a world-class shared laboratory and office space in Cambridge, Massachusetts. It includes access to LabCentral’s shared infrastructure and services, such as first-class lab, facility, and administrative support, skilled laboratory personnel, and participation in LabCentral’s training programme and seminars. Engitix will use the Golden Ticket to advance its human extracellular matrix (ECM) research in fibrosis and solid tumours disease progression.

"We are honoured to have received this Golden Ticket from Takeda, bringing us immediate access to a world-class bioresearch facility. It is a first step in developing Engitix’s presence in the United States and I look forward to building our network in Cambridge and across the USA more widely. We are also delighted that Takeda, a leader in the area of gastrointestinal diseases, has recognised the potential in Engitix’s ECM technology," said Dr Giuseppe Mazza, Engitix co-founder and CEO.

Engitix has developed the world’s first proprietary drug discovery platform based on tissue-specific and disease-specific human ECM scaffolds. The company’s 3D human ECM scaffolds provide an enabling tool for a better understanding of the role of the ECM in disease development and progression, leading to the identification of more relevant targets for drug discovery and biomarker development. A key current limitation in developing more effective treatments in fibrosis and for various solid cancers has been the absence of human ECM in experimental models.

Engitix’s mission is to increase the quality of therapeutics targets selected for development and a reduction in the number of later-stage drug trial failures by establishing more advanced platforms for drug target identification and validation, in which healthy as well as diseased cells can be tested with potential therapeutic agents within their natural physiological and pathological microenvironment.

On November 4, 2019 ADC Therapeutics SA, a clinical-stage oncology-focused biotechnology company pioneering the development of highly potent and targeted antibody drug conjugates (ADCs) for patients suffering from hematological malignancies and solid tumors, reported that ADCT-402 (loncastuximab tesirine) data have been published in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), in a paper titled, "A Phase 1 study of ADCT-402 (Loncastuximab Tesirine), a Novel Pyrrolobenzodiazepine-Based Antibody Drug Conjugate, in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (Press release, ADC Therapeutics, NOV 4, 2019, View Source [SID1234596053])."

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The Phase 1 multi-center, open-label, single-arm, dose-escalation and dose-expansion clinical trial demonstrated the significant single-agent clinical activity and manageable tolerability profile of ADCT-402 in patients with CD19-positive relapsed or refractory B-cell non-Hodgkin lymphoma who had failed or were intolerant to established therapies. The published paper includes findings from the dose-escalation part of the trial. Notably, among the 61 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who were evaluable for efficacy, a 55 percent response rate was observed at doses ≥120 µg/kg. Eighty-seven of the 88 patients enrolled in the trial experienced at least one treatment-emergent adverse event (TEAE). The most common TEAEs were low blood cell counts, fatigue, liver test abnormalities, nausea, rash, shortness of breath and tissue swelling.

Brad S. Kahl, MD, Professor of Medicine at Washington University School of Medicine and lead author of the paper, said, "The first-in-human study of ADCT-402 justified its continued evaluation and identified the initial 150 µg/kg dose for the Phase 2 clinical trial. The promising clinical activity and manageable toxicities observed thus far highlight the potential utility of ADCT-402 as an off-the-shelf therapy for heavily pre-treated patients with DLBCL, a population for which a significant unmet medical need remains."

Jay Feingold, MD, PhD, Senior Vice President, Chief Medical Officer and Head of Oncology Clinical Development at ADC Therapeutics, added, "The publication of early ADCT-402 data in a peer-reviewed journal further validates the potential of our lead product candidate to become an important part of the treatment paradigm for relapsed or refractory DLBCL. With enrollment in our pivotal 145-patient Phase 2 clinical trial of ADCT-402 complete, we plan to submit a Biologics License Application to the U.S. Food and Drug Administration for accelerated approval of ADCT-402 for the treatment of relapsed or refractory DLBCL in patients who have failed two or more treatment regimens in the second half of 2020."

ADCT-402 is also being evaluated in an ongoing Phase 1b clinical trial in combination with ibrutinib for the treatment of relapsed or refractory DLBCL or mantle cell lymphoma (MCL) and a Phase 1b clinical trial in combination with durvalumab for the treatment of relapsed or refractory DLBCL, MCL and follicular lymphoma.

About ADCT-402

ADCT-402 (loncastuximab tesirine) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Once bound to a CD19-expressing cell, ADCT-402 is designed to be internalized by the cell, following which the warhead is released. The warhead is designed to bind irreversibly to DNA to create highly potent interstrand cross-links that block DNA strand separation, thus disrupting essential DNA metabolic processes such as replication and ultimately resulting in cell death. CD19 is a clinically validated target for the treatment of B-cell malignancies. ADCT-402 is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (NCT03589469), a Phase 1b trial in combination with ibrutinib in patients with R/R DLBCL or mantle cell lymphoma (MCL) (NCT03684694) and a Phase 1b trial in combination with durvalumab in patients with R/R DLBCL, MCL or follicular lymphoma (NCT03685344). The U.S. Food and Drug Administration granted orphan drug designation to ADCT-402 for the treatment of relapsed or refractory DLBCL and MCL.

On November 4, 2019 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics targeting infectious diseases and cancers based on its proprietary arenavirus platform, reported that it will announce financial results for the third quarter ended September 30, 2019 on Tuesday, November 12, 2019, after the NASDAQ market close (Press release, Hookipa Pharma, NOV 4, 2019, View Source [SID1234553431]).

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The Company will not be conducting a conference call in conjunction with this earnings release. Until otherwise noted, the Company will only conduct an earnings conference call in conjunction with its fourth quarter earnings releases.

On November 4, 2019 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to address unmet medical needs, reported that the company will hold a conference call and live webcast on Monday, November 18, 2019 at 4:30 p.m. Eastern Time (ET) to review its third quarter 2019 financial results and provide a business update (Press release, Ascendis Pharma, NOV 4, 2019, View Source [SID1234551451]).

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Conference Call Details

Date Monday, November 18, 2019
Time 4:30 p.m. ET/1:30 p.m. Pacific Time
Dial In (U.S.) (844) 290-3904
Dial In (International) (574) 990-1036
Access Code 5897398
A live webcast of the conference call will be available on the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will be available on this website shortly after conclusion of the event for 30 days.

On November 4, 2019,UroGen Pharma Ltd. (the "Company") reported that it entered into a lease agreement, dated effective October 31, 2019 (the "Lease"), with Witman Properties, L.L.C., a New Jersey limited liability company, and Alexander Road at Davanne, L.L.C., a New Jersey limited liability company, as tenants in common (collectively, "Landlord"), for the lease of approximately 20,900 square feet of rentable area, which consists of the entire fourth floor of the building located at 400 Alexander Road, West Windsor, New Jersey 08540 constituting approximately 18,300 square feet of usable square footage (the "Premises") (Filing, 8-K, UroGen Pharma, NOV 4, 2019, View Source [SID1234550755]). The commencement date of the Lease (the "Commencement Date") is expected to be in the fourth quarter of 2019. The Company plans to use the Premises as its principal executive offices along with other general operating uses. The term of the Lease (the "Initial Term") is for 38 months after the Commencement Date. The Company has the option to renew the Lease for two additional periods of three years each (each additional period, a "Renewal Period"). The aggregate base rent due over the Initial Term is approximately $1.7 million. For the Renewal Periods, the rent due shall be the fair market value of the Premises at the time of the commencement of the Renewal Period multiplied by the rentable square footage of the Premises. The Company will also be responsible for the payment of additional rent to cover the Company’s share of the annual operating expenses of the building, subject to certain exceptions, and the annual tax expenses of the building. In the event of a default of certain of the Company’s obligations under the Lease, Landlord would have right to terminate the Lease and recover damages as provided by the lease contract and by law.

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