On July 10, 2019 The U.S. Food and Drug Administration (FDA) reported that it has accepted for review the Biologics License Application (BLA) for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) (Press release, Sanofi Genzyme, JUL 10, 2019, View Source [SID1234537461]). The target action date for the FDA decision is April 30, 2020. Isatuximab is an investigational monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell.

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The BLA is based on positive results from ICARIA-MM, an open-label pivotal Phase 3 clinical trial of isatuximab in patients with RRMM. ICARIA-MM is the first positive randomized Phase 3 trial to evaluate an antibody in combination with pomalidomide and dexamethasone. Results from this trial were presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the 2019 European Society of Hematology (EHA) (Free EHA Whitepaper) Annual Meeting.

Multiple myeloma is the second most common hematologic malignancy[1], affecting more than 138,000[2] people worldwide. Multiple myeloma results in significant disease burden. Patients with multiple myeloma continue to relapse over time making it a difficult to treat and incurable malignancy.

Isatuximab targets a specific epitope on the CD38 receptor. It is designed to trigger multiple, distinct mechanisms of action that are believed to directly promote programmed tumor cell death (apoptosis) and immunomodulatory activity.

Isatuximab received orphan designation for relapsed/refractory multiple myeloma from both the FDA and the European Medicines Agency (EMA), and in the second quarter of 2019 the EMA accepted for review the Marketing Authorization Application.

Isatuximab is currently being evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments for people with relapsed/refractory or newly-diagnosed multiple myeloma. It is also under investigation for the treatment of other hematologic malignancies and solid tumors. Isatuximab is an investigational agent and its safety and efficacy have not been fully evaluated by any regulatory authority.

On July 10, 2019 Moleculin Biotech, Inc. (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported it has filed new patents covering the production and reconstitution of Annamycin, which is currently in two clinical trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) (Press release, Moleculin, JUL 10, 2019, View Source [SID1234537460]).

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Moleculin Biotech, Inc. is a clinical-stage pharmaceutical company focused on the treatment of highly resistant cancers.

"Annamycin already has Orphan Drug Designation for the treatment of AML," commented Walter Klemp, Moleculin’s Chairman and CEO, "but these new patent applications, if these patent applications are approved, would give us 20 years of protection for our drug."

Mr. Klemp continued: "Since we have recently announced promising preclinical data showing the potential for Annamycin to become an important treatment for lung metastases, having this broad coverage should add considerable value to this asset."

On July 10, 2019 Alexion Pharmaceuticals (Nasdaq:ALXN) reported that the Company will report its financial results for the second quarter ended June 30, 2019 before the US financial markets open on July 24, 2019 (Press release, Alexion, JUL 10, 2019, View Source [SID1234537459]). Following the release of the financial results, Alexion management will conduct a conference call and audio webcast at 8:00am Eastern Time (ET).

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To participate in this conference call, dial 866-762-3111 (USA) or 210-874-7712 (International), conference ID 5564357 shortly before 8:00 a.m. ET. The audio webcast can be accessed on the Investor page of View Source and an archived version will be available for a limited time following the presentation.

On July 10, 2019 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company has signed a definitive agreement under which Jazz has acquired Redx Pharma’s (Redx) pan-RAF inhibitor program for the potential treatment of RAF and RAS mutant tumors (Press release, Jazz Pharmaceuticals, JUL 10, 2019, View Source [SID1234537445]). Redx will perform certain pre-clinical activities for the program under a separate collaboration agreement with Jazz. Jazz will be responsible for further development, regulatory activities and commercialization.

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Under the terms of the agreement, Jazz will pay Redx an upfront payment of $3.5 million. Redx is eligible to receive up to $203 million in development, regulatory and commercial milestone payments from Jazz, and incremental tiered royalties in mid-single digit percentage, based on any future net sales.

"We are excited to acquire Redx’s pan-RAF inhibitor program. It has the potential to work in RAF driven tumors where current selective B-RAF inhibitors and their respective combinations are ineffective due to acquired resistance mechanisms. In addition, there is the potential to address RAS driven tumors," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals. "We look forward to advancing the pan-RAF inhibitor program that is part of a novel class of next generation precision oncology drugs and is highly complementary to our growing R&D portfolio of early-stage, innovative, hematology/oncology therapies."

About Pan-RAF Inhibitors1,2,3
Mutations leading to uncontrolled signalling via the RAS-RAF-MAPK pathway are seen in more than one third of all cancers. The pan-RAF inhibitor program aims to overcome resistance mechanisms associated with clinically approved B-RAF selective drugs.

The RAF kinases (A-RAF, B-RAF and C-RAF) are an integral part of this pathway, with B-RAF mutations commonly seen in the clinic. Although most B-RAF V600E mutant skin cancers are sensitive to approved B-RAF selective drugs, B-RAF V600E mutant colorectal cancers are surprisingly insensitive to these agents as monotherapy due to the functions of other RAF family members and require combination therapy.

B-RAF selective therapies fail to show clinical benefit against atypical B-RAF (non-V600E), other RAF and RAS driven tumors. Pre-clinical study results of Redx’s pan-RAF program have demonstrated in vivo efficacy in a B-RAFV600E mutant colorectal cancer xenograft model as a single agent, where approved B-RAF selective drugs are ineffective as monotherapy. It has also shown promising activity in RAS-mutated cancer cells.

On July 9, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of antibody drug conjugates (ADCs), reported the final close of a $103 million Series E financing expansion, bringing the total gross proceeds of the Series E round to $303 million (Press release, ADC Therapeutics, JUL 9, 2019, View Source [SID1234596058]). The final close of the expansion round includes a $25 million investment from a new U.S.-based institutional investor, as well as additional investment from existing investors that participated in the previously announced $76 million Series E financing expansion.

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Chris Martin, DPhil, Chief Executive Officer of ADC Therapeutics, said, "We are delighted to welcome a new blue-chip institutional investor to our shareholder base. This financing provides us with a strong balance sheet to fund preparations for a potential Biologics License Application (BLA) for ADCT-402 (loncastuximab tesirine) in relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in the second half of 2020, as well as for initiating in the coming months a pivotal Phase II trial of ADCT-301 (camidanlumab tesirine) in Hodgkin lymphoma based on our recent end of Phase I meeting with the U.S. Food and Drug Administration."

ADC Therapeutics plans to complete enrollment in its pivotal Phase II trial of ADCT-402 in a broad population of patients with relapsed or refractory DLBCL imminently and report interim results in the second half of 2019. ADCT-402 is also being evaluated in a Phase Ib trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma (MCL) and a Phase Ib trial in combination with durvalumab in patients with relapsed or refractory DLBCL, MCL or follicular lymphoma. In addition, the Company plans to commence a pivotal Phase II trial of ADCT-301 in patients with relapsed or refractory Hodgkin lymphoma in the coming months. ADCT-301, with its novel mechanism of action targeting regulatory T cells, is also being evaluated in a Phase Ib trial in patients with selected advanced solid tumors.