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]).

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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.

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]).

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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."

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 .

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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.

On November 6, 2019 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported the pricing of its initial public offering of 5,000,000 shares of common stock at a public offering price of $12.00 per share, for total gross proceeds of $60.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Galera (Press release, Galera Therapeutics, NOV 6, 2019, View Source [SID1234553561]). All of the common stock is being offered by Galera. In addition, Galera has granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of its common stock at the initial public offering price less the underwriting discounts and commissions. Galera’s common stock is expected to begin trading on the Nasdaq Global Market on November 7, 2019, under the ticker symbol "GRTX." The offering is expected to close on November 12, 2019, subject to customary closing conditions.

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BofA Securities, Citigroup and Credit Suisse are acting as joint book-running managers for the offering and BTIG is acting as co-manager for the offering.

A registration statement relating to the securities being sold in the offering has been declared effective by the U.S. Securities and Exchange Commission on November 6, 2019. This offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained, when available, by contacting: BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, by e-mail at [email protected], Citigroup Global Markets Inc. c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at +1 (800) 831-9146, or Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, Eleven Madison Avenue, 3rd Floor, New York, NY 10010, or by telephone at +1 (800) 221-1037, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

On November 6, 2019 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported the clinical and preclinical abstracts related to flotetuzumab, the Company’s investigational bispecific CD123 x CD3 DART molecule, to be presented at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in Orlando, Florida, from December 7-10, 2019 (Press release, MacroGenics, NOV 6, 2019, View Source [SID1234553169]).

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"We look forward to presenting updated data from the Phase 1 monotherapy study of flotetuzumab in patients with relapsed or refractory acute myeloid leukemia," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "The oral presentations will focus on patients with refractory AML, who represent an extremely challenging population to treat, and where we believe there may be an opportunity to address a significant unmet need with flotetuzumab."

Oral Presentations

Flotetuzumab, an Investigational CD123 x CD3 Bispecific DART Protein, in Salvage Therapy for Primary Refractory and Early Relapsed Acute Myeloid Leukemia (AML) Patients
Session Name: 613. Acute Myeloid Leukemia: Clinical Studies: Treatment of Relapsed/Refractory Disease
Date: Monday, December 9, 2019
Session Time: 2:45 PM – 4:15 PM
Presentation Time: 2:45 PM
Location: Orange County Convention Center, Tangerine 3 (WF3-4)

Immune Landscapes Predict Chemotherapy Resistance and Anti-Leukemic Activity of Flotetuzumab, an Investigational CD123 × CD3 Bispecific DART Molecule, in Patients with Relapsed/Refractory Acute Myeloid Leukemia
Session Name: 617. Acute Myeloid Leukemia: Biology, Cytogenetics, and Molecular Markers in Diagnosis and Prognosis: Novel Treatment and Analytical Approaches to Heterogenous AML
Date: Sunday, December 8, 2019
Session Time: 12:00 PM – 1:30 PM
Presentation Time: 12:45 PM
Location: Orange County Convention Center, Valencia BC (W415BC)

Poster Presentations

Flotetuzumab (FLZ), an Investigational CD123 x CD3 Bispecific DART Protein-Induced Clustering of CD3+ T Cells and CD123+ AML Cells in Bone Marrow Biopsies Is Associated with Response to Treatment in Primary Refractory AML Patients
Session Name: 617. Acute Myeloid Leukemia: Biology, Cytogenetics, and Molecular Markers in Diagnosis and Prognosis: Poster I
Date: Saturday, December 7, 2019
Presentation Time: 5:30 PM – 7:30 PM
Location: Orange County Convention Center, Hall B

Effect of Ara-C on T-Cell Function and Flotetuzumab Activity in Pediatric Acute Myeloid Leukemia
Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster I
Date: Saturday, December 7, 2019
Presentation Time: 5:30 PM – 7:30 PM
Location: Orange County Convention Center, Hall B

A Phase 1 Study of Flotetuzumab, a CD123 x CD3 DART Protein, Combined with MGA012, an Anti-PD-1 Antibody, in Patients with Relapsed or Refractory Acute Myeloid Leukemia
Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II
Date: Sunday, December 8, 2019
Presentation Time: 6:00 PM – 8:00 PM
Location: Orange County Convention Center, Hall B

The abstracts were published today on the ASH (Free ASH Whitepaper) website at View Source

Conference Call & Webcast

MacroGenics management and external guest speakers will host a conference call and audio webcast on Monday, December 9 at 8:00 P.M. ET to review the flotetuzumab data presented at the ASH (Free ASH Whitepaper) annual meeting and discuss ongoing clinical development plans.

To participate in the MacroGenics ASH (Free ASH Whitepaper) 2019 Conference Call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 3625435. A listen-only slide and audio webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days.