On May 28, 2020 Ipsen reported that its Board of Directors has appointed David Loew as its new Chief Executive Officer (CEO) and as Board member (Press release, Ipsen, MAY 28, 2020, View Source [SID1234558652]). The CEO appointment will take effect on July 1st, 2020.

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The Board of Directors expresses its gratitude to Aymeric Le Chatelier, who steered the group very well in an exceptionally challenging environment and who will remain in the role of acting CEO until July 1st, 2020 and will continue in his role of Chief Financial Officer.

David Loew will be based at Ipsen’s headquarters in Boulogne-Billancourt, France. His mission will be to ensure Ipsen’s continued growth and to advance its pipeline via a long-term value-adding external innovation strategy, while fostering a culture of entrepreneurship, agility and patient-centricity. David is a Swiss citizen.

Since 2016, David has been CEO of Sanofi Pasteur Vaccines. During his tenure, he piloted a successful worldwide growth strategy via acquisitions and licensing deals. He also undertook a series of transformational initiatives: developing a global pipeline, reinforcing production strategy to strengthen compliance and increase capacity and building key programs to bring the company to best-practice level in talent acquisition, medical affairs, R&D productivity and shaping the external environment.

David brings nearly thirty years of leadership and experience across a range of therapeutic areas, including oncology, CNS and cardio-metabolism, as well as consumer healthcare. He has worked in the US, European and international markets. He started his career at Coopers & Lybrand and Hewlett Packard in 1990 before joining Roche in 1992. Over the following two decades, David held a variety of positions, including Global Oncology Head, Global Chief Marketing Officer & Head of Global Product Strategy and Region Head Eastern Europe, Middle East and Africa for the Pharma Division of Roche. He joined Sanofi in July 2013 as Senior Vice President Commercial Operations Europe, where he was responsible for the prescription, consumer healthcare and generics businesses across the EU region.

"The Board and I are delighted to welcome David Loew as Ipsen’s new CEO. David is a seasoned leader with extensive worldwide experience in business areas of key importance to Ipsen," said Marc De Garidel, Chairman of Ipsen. "I have full confidence that David will provide the leadership and expertise needed to guide the group through its next phase of growth and realize Ipsen’s vision of being a global biotechnology leader through the identification, development and commercialization of transformative and differentiated products."

"I am deeply honored by this appointment and am particularly excited to join Ipsen at this point in its history. For the past five years, the group has maintained a remarkable growth trajectory thanks to its focus on delivering innovative solutions to patients with high unmet medical needs," noted David Loew. "I look forward to working with my new colleagues and the Board so that together we can continue to develop life-improving solutions for patients."

On May 28, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported it will host a conference call to review clinical updates and financial results for the three months ended March 31, 2020 on Monday, June 1, 2020 at 8:30 a.m. EDT (Press release, Can-Fite BioPharma, MAY 28, 2020, View Source [SID1234558599]). A press release reviewing the first quarter results and clinical updates will be issued prior to the call.

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Investors in the U.S. are invited to dial 877-423-9813. International investors may dial 201-689-8573. The conference ID is 13704594.

Investors may also participate via webcast: View Source

A replay of the webcast will be archived on Can-Fite’s website for a period of time.

On May 28, 2020 Genmab A/S (Nasdaq: GMAB) reported positive topline results from the Phase III ANDROMEDA (AMY3001) study of subcutaneous (SC) daratumumab in combination with cyclophosphamide, bortezomib and dexamethasone (CyBorD) for patients with newly diagnosed light-chain (AL) amyloidosis (Press release, Genmab, MAY 28, 2020, View Source [SID1234558618]). The study, conducted by Janssen Biotech, Inc. (Janssen), met the primary endpoint of percentage of patients with hematologic complete response. Patients in the study treated with daratumumab in combination with CyBorD had a 53.3% hematologic complete response compared to 18.1% of patients who were treated with CyBorD alone (odds ratio of 5.1 (95% CI 3.2 – 8.2, p<0.0001)).

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Overall, the safety profile of daratumumab SC in combination with CyBorD is consistent with the known safety profile of the CyBorD regimen and the known safety profile of daratumumab.

"We are very pleased with the topline results from the Phase III ANDROMEDA study in AL amyloidosis. We believe the data supports the potential of daratumumab in the treatment of this devastating, progressive disease, for which no approved treatments are available," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Janssen, which obtained an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab in 2012, will discuss with health authorities the potential for a regulatory submission for this indication.

About the ANDROMEDA (AMY3001) study

The Phase III study (NCT03201965) included 388 patients newly diagnosed with AL amyloidosis. Patients were randomized to receive treatment with either subcutaneous daratumumab in combination with cyclophosphamide (a chemotherapy), bortezomib (a proteasome inhibitor) and dexamethasone (a corticosteroid) or treatment with cyclophosphamide, bortezomib and dexamethasone alone. The primary endpoint of the study is the percentage of patients who achieve hematologic complete response.

About Light-chain (AL) Amyloidosis

Amyloidosis is a disease that occurs when amyloid proteins, which are abnormal proteins, accumulate in tissues and organs. When the amyloid proteins cluster together, they form deposits that damage the tissues and organs. AL amyloidosis most frequently affects the heart, kidneys, liver, nervous system and digestive tract. There is currently no cure or existing approved therapies for AL amyloidosis though it can be treated with chemotherapy, dexamethasone, stem cell transplants and supportive therapies.1 It is estimated that there are approximately 3,000 to 4,000 new cases of AL amyloidosis diagnosed annually in the U.S.2

About DARZALEX (daratumumab)

DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple

LEI Code 529900MTJPDPE4MHJ122

Genmab Announces Positive Topline Results in Phase III ANDROMEDA Study of Daratumumab in Light-chain (AL) Amyloidosis

myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.3 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in Europe: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy4. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.5 DARZALEX FASPRO is the first subcutaneous CD38-directed antibody approved in the U.S. for the treatment of multiple myeloma.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).3,5,6,7,8,9

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

On May 28, 2020 bluebird bio, Inc. (NASDAQ: BLUE) reported that the company will host a live webcast to review new data presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting on Friday, June 12 at 8:00 am ET (Press release, bluebird bio, MAY 28, 2020, View Source [SID1234558634]).

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Investors may listen to the call on June 12, 2020 at 8:00 am ET by dialing (844) 825-4408 from locations in the United States or +1 (315) 625-3227 from outside the United States. Please refer to conference ID number 2796099.

In addition, members of the management team will participate in the following upcoming investor conferences:

Jefferies Virtual Healthcare Conference, Thursday, June 4, at 3:30 pm ET
Goldman Sachs 41st Annual Global Healthcare Conference, Wednesday, June 10, at 9:40 am ET
To access the live webcasts of bluebird bio’s presentations, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source Replays of the webcasts will be available on the bluebird bio website for 90 days following the events.

On May 28, 2020 orma Therapeutics, Inc. ("Forma"), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported that two abstracts for the company’s investigational IDH1m inhibitor, olutasidenib, have been accepted as part of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 (ASCO20) Virtual Scientific Program taking place May 29-31, 2020 (Press release, Forma Therapeutics, MAY 28, 2020, View Source [SID1234558600]).

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The abstracts, currently available on the ASCO (Free ASCO Whitepaper) website, are:

Abstract Number 2505
Oral Presentation: A phase 1b/2 study of olutasidenib in patients with relapsed/refractory IDH1 mutant gliomas: Safety and efficacy as a single agent and in combination with azacitidine.
Date and Time: Available on ASCO (Free ASCO Whitepaper)’s website beginning May 29, 2020, at 8:00 a.m.
Oral Abstract Session: Central Nervous System Tumors
Presenter: Macarena de la Fuente, M.D., Sylvester Cancer Center, University of Miami

Abstract Number e16643
Online Publication: A phase 1b/2 study of olutasidenib in patients with relapsed/refractory IDH1 mutant solid tumors: Safety and efficacy as a single agent.

Dr. de la Fuente will present findings regarding olutasidenib monotherapy in 26 patients (23 enhancing, three non-enhancing) with confirmed IDH1 gene-mutated advanced glioma, including data that indicate:

Olutasidenib, dosed twice daily at 150 mg, was well-tolerated in patients with mIDH1 glioma and no dose-limiting toxicities were observed with monotherapy;
As dosed, olutasidenib demonstrated clinically relevant concentrations in the cerebrospinal fluid, confirming the blood-brain barrier penetration observed in preclinical models;
Olutasidenib demonstrated a preliminary disease control rate of 50% in heavily pre-treated patients with predominantly enhancing, recurrent mIDH1 glioma, specifically:
One patient achieved a partial response, per investigator assessment by response assessment in neuro-oncology (RANO)
Four patients achieved tumor reduction greater than 50%, per a blinded independent central volumetric assessment (BICR)
Nine patients exhibited stable disease for more than four months
"These data indicate that olutasidenib is well-tolerated and may provide clinical benefit in patients with recurrent glioma, a patient population with very limited treatment options," said Patrick Kelly, M.D., chief medical officer of Forma Therapeutics.

Copies of the abstracts and the oral presentation will be available on Forma’s website here upon presentation at the meeting.

About Olutasidenib, or FT-2102

Olutasidenib is an oral, potent and small molecule investigational agent designed to selectively bind to and inhibit mutated IDH1 enzymes. This targeted treatment has the potential to provide therapeutic benefit by reducing 2-HG levels and restoring normal cellular differentiation. Forma is currently evaluating olutasidenib in a registrational Phase II trial for relapsed/refractory AML and in an exploratory Phase I trial for glioma.

IDH1 is a natural enzyme that is part of the normal metabolism of all cells; when mutated, its activity can promote blood malignancies and solid tumors. IDH1 mutations are present in 6-8% of patients with AML and as many as 70 to 80% of patients with grade II/III gliomas and secondary glioblastoma. In gliomas, IDH1 mutations occur early in the tumor pathogenesis and persist throughout progression from a neural stem or progenitor cell. Gliomas are the most common, aggressive and difficult-to-treat primary brain tumors, and high-grade gliomas are associated with poor long-term prognosis. Treatment options for relapsed glioma are limited.