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Targovax ASA: Third Quarter 2019 Results

On November 7, 2019 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported its third quarter 2019 results (Press release, Targovax, NOV 7, 2019, View Source [SID1234550509]).

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A meeting for investors, analysts and press will take place in Oslo today at 10:00 CET (details below).

HIGHLIGHTS FOR THE THIRD QUARTER 2019

Targovax announced data from part 1 of the ONCOS-102 trial in checkpoint inhibitor refractory advanced melanoma, showing validated clinical responses in three out of nine patients (33% ORR), including one patient with a complete response and immune activation in all nine patients
The expansion part of the phase I/II trial of ONCOS-102 in combination with the checkpoint inhibitor Imfinzi in patients with advanced peritoneal malignancies opened for enrollment as the dose escalation part of the trial concluded successfully
Targovax announced the opening of Oslo University Hospital as site for ONCOS-102 trial in melanoma
POST-PERIOD HIGHLIGHTS

In October, Targovax was selected for oral presentation at Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Annual Meeting. The presentation will be given bv Dr. Alexander Shoushtari, Principal Investigator of ONCOS-102 trial in melanoma, Memorial Sloan Kettering Cancer Center, NYC
Øystein Soug, CEO commented: "Oncolytic viruses are increasingly recognized as an important future class of immune activators, and Targovax is well positioned as one of the leaders in this rapidly evolving field. Currently, our main focus is to deliver the expected data read-outs from our ongoing ONCOS-102 combination trials in 2020, which we hope will solidify Targovax position as a leader in the oncolytic virus space."

Presentation

The presentation will take place at 10:00 CET at:

Hotel Continental
Stortingsgaten 24/26
0117 Oslo

The presentation will also be webcast live and can be accessed here.

Reporting material

Targovax 3Q presentation

Targovax 3Q report

The quarterly report and presentation are also available at the website www.targovax.com.

BerGenBio ASA: Invitation to Third Quarter 2019 Results Presentation and Webcast

On November 7, 2019 BerGenBio ASA (OSE:BGBIO), reported that it will announce its results for the third quarter on Tuesday 19 November 2019 (Press release, BerGenBio, NOV 7, 2019, View Source [SID1234550508]). A presentation by BerGenBio’s senior management team will take place at 10am CET at:

Arctic Securities
Haakon VIIs gate 5
Oslo

The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and presentation will be available at www.bergenbio.com in the section: Investors/Financial Reports from 7:00 am CET the same day.

ADC Therapeutics Announces Presentations at 61st American Society of Hematology (ASH) Annual Meeting

On November 2019 ADC Therapeutics SA, a clinical-stage oncology-focused biotechnology company pioneering the development of highly potent antibody drug conjugates (ADCs) for patients suffering from hematological malignancies and solid tumors, reported that two abstracts on ADCT-402 (loncastuximab tesirine) have been selected for an oral and poster presentation at the upcoming 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held December 7-10, 2019, in Orlando, FL (Press release, ADC Therapeutics, NOV 6, 2019, View Source [SID1234596052]).

Jay Feingold, MD, PhD, Senior Vice President, Chief Medical Officer and Head of Oncology Clinical Development at ADC Therapeutics, said, "We look forward to sharing updated interim efficacy data from our pivotal Phase 2 clinical trial of ADCT-402 in relapsed or refractory diffuse large B-cell lymphoma (DLBCL), which demonstrate its encouraging single-agent clinical activity and manageable toxicity in a difficult-to-treat patient population and support our plans to submit a Biologics License Application to the U.S. Food and Drug Administration in the second half of 2020. In addition, we are pleased to share information about our Phase 1 trial evaluating ADCT-402 plus durvalumab. These presentations at the ASH (Free ASH Whitepaper) Annual Meeting validate the potential of ADCT-402 to fill a significant unmet medical need for heavily pretreated patients with B-cell non-Hodgkin lymphomas, both as a single agent and in combination with approved therapies."

Oral Presentation

Title: Interim Futility Analysis of a Phase 2 Study of Loncastuximab Tesirine, a Novel Pyrrolobenzodiazepine-Based Antibody-Drug Conjugate, in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Abstract Number: 757

Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Novel Therapies in Relapsed/Refractory Disease

Date and Time: Monday, December 9, 2019; 2:45 p.m. ET

Location: Orange County Convention Center, W304ABCD

Presenter: Carmelo Carlo-Stella, MD, Humanitas Cancer Center, Humanitas University

Poster Presentation

Title: Safety and Anti-Tumor Activity Study of Loncastuximab Tesirine and Durvalumab in Diffuse Large B-Cell, Mantle Cell, or Follicular Lymphoma

Abstract Number: 2807

Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II

Date and Time: Sunday, December 8, 2019; 6 – 8 p.m. ET

Location: Orange County Convention Center, Hall B

Presenter: Craig Moskowitz, MD, Sylvester Comprehensive Cancer Center, University of Miami Health System

For more information about the ASH (Free ASH Whitepaper) Annual Meeting, visit View Source

ADC Therapeutics to Host Event ADC Therapeutics will host an investor and analyst event beginning at 8 p.m. ET on Sunday, December 8, 2019. This event will not be webcast.

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.

Abbisko Therapeutics Enters into Licensing Agreement with AstraZeneca for Development and Commercialization of AZD4547

On November 6, 2019 Abbisko Therapeutics, a company dedicated to the discovery and development of innovative cancer therapies reported that it has entered into a licensing agreement with AstraZeneca PLC (LSE/STO/NYSE: AZN) for the development and commercialization of AZD4547, a novel small molecule inhibitor of fibroblast growth factor receptors (FGFRs) (Press release, Abbisko Therapeutics, NOV 6, 2019, View Source;article_id=132 [SID1234556280]).

Under the agreement, Abbisko has acquired an exclusive license for global rights to develop, manufacture and commercialize AZD4547 in all therapeutic, prophylactic, palliative and diagnostic uses in humans and animals including but not limited to FGFR-driven oncology indications. According to the terms of the agreement, AstraZeneca will receive an upfront payment as well as development and sales milestones upon achieving certain regulatory and commercial goals. In addition, AstraZeneca will be eligible to receive tiered royalty fees on net annual sales in the territory.
AZD4547 is a potent, highly selective, orally available clinical stage small molecule inhibitor of FGFR-1, 2 and 3. In preclinical studies, AZD4547 demonstrated strong single agent efficacy in molecularly defined tumor models with a safety profile representative that of the class of agents. In clinical studies, AZD4547 was well tolerated and demonstrated promising response in patients whose tumors harboring FGFR alterations.

Dr. Yao-chang Xu, Chief Executive Officer of Abbisko Therapeutics said "Aberrant activation of FGFR signaling has been implicated in multiple types of cancers. AZD4547 has demonstrated a favorable safety profile in clinical trials and positive signals in cancer patients with FGFR alterations. We believe AZD4547 is a highly competitive drug candidate with potential in a broad range of tumor indications and we look forward to further exploring and realizing AZD4547’s potential in treating patients with FGFR-dependent tumors."

"Susan Galbraith, Senior Vice President and Head of Research and Early Development, Oncology R&D, AstraZeneca said: "This collaboration will leverage Abbisko’s scientific expertise related to FGFR biology and sophisticated development capabilities to further explore AZD4547’s potential benefits to meet unmet medical needs."

LIDDS adds Lithuanian clinics to phase I study

On November 6, 2019 LIDDS AB (publ) reported that it has received approval from authorities in Lithuania to conduct its Phase I study, NZ-DTX-001 (Press release, Lidds, NOV 6, 2019, View Source [SID1234555903]). Previously the phase I study is approved in Sweden and Denmark .

The aim of the phase I dose escalation clinical trial is to assess the tolerability and safety of intratumoral injections of NanoZolid with docetaxel, a well-established cytostatic used in the treatment of cancer with an estimated global market of over USD 1 billion.

LIDDS enrolled the first patient in spring and further patients are planned to be treated in Q4, 2019.

– This is very exciting as we hope that NanoZolid combined with docetaxel will decrease the tumor size and improve surgery and radiation therapy outcomes. In the Phase I study, LIDDS aims to demonstrate that intratumoral injections with cytostatics are safe and we expect that following this study a wide range of different indications and NanoZolid combinations using chemotherapy drugs will emerge, says Monica Wallter, CEO.

– Our goal is to deliver drugs directly into the cancer tumor and thereby limit the severe side effects for cancer sufferers receiving systemic chemotherapy treatments which affect all cells in the body including the immune system, says Monica Wallter.

NZ-DTX-001 study description:
A phase Ia/Ib, first-in-human, open label, multicenter, dose-escalation and dose-expansion study of a novel NanoZolid-docetaxel depot formulation (NZ-DTX Depot) given as an intratumoral injection in patients with advanced solid tumors.