On September 26, 2019 FibroGen, Inc. (NASDAQ: FGEN) reported first patient dosed in the company’s Phase 2 clinical study of roxadustat, a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of chemotherapy-induced anemia (CIA) in cancer patients receiving chemotherapy (Press release, FibroGen, SEP 26, 2019, View Source [SID1234539817]).

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"There is a significant unmet need among cancer patients experiencing anemia," said John Glaspy, M.D., M.P.H., professor of medicine and co-chair of the Division of Hematology/Oncology at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). "Investigation of roxadustat as a potential therapy that may be able to overcome the shortcomings of current treatments and alleviate the challenges faced by cancer patients undergoing chemotherapy is welcome."

"Chemotherapy-induced anemia is a devastating side effect of chemotherapy that can interfere with quality-of-life, exposes patients to risks associated with red blood cell transfusion, and may even set limitations on the dose of chemotherapeutic agents that can be used; yet, it is undertreated," said Nashat Gabrail, M.D., Gabrail Cancer Center, Canton, Ohio.

Chemotherapeutic agents are known suppressors of red cell production by the bone marrow, and 30% to 90% of patients treated with myelosuppressive chemotherapy develop anemia, resulting in decreased functional capacity, and impaired quality of life. In contrast to other common side effects experienced by patients undergoing treatment for cancer, CIA is often a "silent" side effect with insidious symptoms. CIA can be one of the most common underlying etiologies of the fatigue in cancer patients, and is associated with cognitive dysfunction, dyspnea, and depression. As a result of such reduced quality of life, some patients choose to discontinue or delay chemotherapeutic treatment, increasing the potential for suboptimal outcomes.

"Roxadustat has been studied in anemia associated with chronic kidney disease in global Phase 3 studies enrolling over 9,000 patients, and is approved for treatment of anemia in CKD patients on dialysis and not on dialysis in China, and in CKD patients on dialysis in Japan, with preparation of the U.S. NDA submission and the European MAA submission underway," said K. Peony Yu, M.D., Chief Medical Officer of FibroGen. "We and our partners, AstraZeneca and Astellas, are committed to investigating roxadustat’s potential in the treatment of anemia that currently affects a majority of cancer patients undergoing chemotherapy."

This 16-week Phase 2 study is designed to evaluate the efficacy and safety of roxadustat in anemic subjects undergoing chemotherapy treatments when the anticipated outcome is non-curative. The trial will enroll up to 100 anemic cancer patients with non-myeloid malignancy (solid tumor) having a hemoglobin level at or below 10 g/dL, while undergoing myelosuppressive chemotherapy and continuing such chemotherapy for at least another 8 weeks. Patients are to receive oral roxadustat three times a week for

16 weeks. The primary efficacy endpoint is maximum change in hemoglobin level from baseline without red blood cell transfusion. Secondary endpoints include hemoglobin change from baseline, number (%) of patients with hemoglobin response, and % of patients that require red blood cell transfusion(s).

For more information regarding this study please visit www.clinicaltrials.gov (NCT04076943).

About Roxadustat

Roxadustat (FG-4592) is a first-in-class, orally administered small molecule HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, improving iron regulation, and overcoming the negative impact of inflammation on hemoglobin syntheses and red blood cell production by downregulating hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of chronic kidney disease (CKD) patients, including in the presence of inflammation and without a need for supplemental intravenous iron. Roxadustat is currently approved in China for the treatment of anemia in CKD patients on dialysis and patients not on dialysis and approved in Japan for the treatment of anemia in CKD patients on dialysis. Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes (MDS), and in a Phase 2 U.S. trial for treatment of chemotherapy-induced anemia.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.

About Chemotherapy-Induced Anemia

Although chemotherapy-induced anemia is one of the most common side effects of chemotherapy, it is often not recognized and is frequently undertreated. CIA can adversely affect long-term patient outcomes, as the anemic environment may limit the effectiveness of some chemotherapy agents. The incidence and severity of CIA depend on a variety of factors, including the type, schedule, and intensity of therapy administered, or whether the patient has received prior myelosuppressive chemotherapy, radiation therapy, or both. An estimated 30% to 90% of cancer patients receiving chemotherapy develop anemia. Approximately 1.3 million cancer patients undergo chemotherapy every year in the United States.

On September 26, 2019 Luminex Corporation (NASDAQ: LMNX) reported that Homi Shamir, President and Chief Executive Officer, and Harriss Currie, Senior Vice President of Finance and CFO, will participate in investor meetings and present at the Cantor Global Healthcare Conference on Wednesday, October 2, 2019 in New York, NY (Press release, Luminex, SEP 26, 2019, View Source [SID1234539834]).

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A live webcast of Luminex’s presentation will be available at 1:50 p.m. Eastern Time on Wednesday, October 2nd and may be accessed at Luminex Corporation’s website at www.luminexcorp.com. Simply log on to the web at the address above, go to the About Company section and access the Investor Relations link. The presentation will be archived for six months on the website using the ‘replay’ link.

On September 26, 2019 Genmab A/S (Nasdaq: GMAB) reported that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of DARZALEX (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant (ASCT) (Press release, Genmab, SEP 26, 2019, View Source [SID1234539818]). The supplemental Biologics License Application (sBLA) for this indication was submitted by Genmab’s licensing partner, Janssen Biotech, Inc. (Janssen) in March 2019. The U.S. FDA subsequently granted priority review to the sBLA, with a Prescription Drug User Fee Act (PDUFA) target date of September 26, 2019. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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The approval was based on data from part one of the Phase III CASSIOPEIA study of daratumumab in combination with VTd as treatment for patients newly diagnosed with multiple myeloma who are candidates for ASCT. The study is sponsored by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen.

"Today’s approval is an important step forward for patients with multiple myeloma. There are now three different treatment combinations that include DARZALEX for patients newly diagnosed with multiple myeloma, whether they are eligible for ASCT or not. We are grateful for the efforts of the IMF, HOVON and Janssen that led to the strong data from the CASSIOPEIA trial, which formed the basis of this new approval," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the CASSIOPEIA (MMY3006) study
This Phase III study is a randomized, open-label, multicenter study, run by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen, including 1,085 newly diagnosed patients with previously untreated symptomatic multiple myeloma who are eligible for high dose chemotherapy and stem cell transplant. In the first part of the study, patients were randomized to receive induction and consolidation treatment with daratumumab combined with bortezomib, thalidomide (an immunomodulatory agent) and dexamethasone (a corticosteroid) or bortezomib, thalidomide and dexamethasone alone. The primary endpoint is the proportion of patients that achieve a stringent Complete Response (sCR). In the second part of the study (currently ongoing), patients that achieved a response will undergo a second randomization to either receive maintenance treatment of daratumumab 16 mg/kg every 8 weeks for up to 2 years versus no further treatment (observation). The primary endpoint of this part of the study is progression free survival (PFS).

About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 26,000 new patients were expected to be diagnosed with multiple myeloma and approximately 13,650 people were expected to die from the disease in the U.S. in 2018.3 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

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 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.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe 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 therapy. 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 is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma and 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. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United Stated, Europe and Japan. For more information, visit www.DARZALEX.com.

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).6,7,8,9,10

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, NKT-cell lymphoma and B-cell and T-cell 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 September 26, 2019 Vigeo Therapeutics, a clinical-stage biopharmaceutical company developing novel therapeutics to reprogram the tumor immune microenvironment (TIME), reported that data from its Phase 1 study evaluating VT1021 in patients with advanced solid tumors will be presented at a poster session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress, September 27-October 1 in Barcelona, Spain (Press release, Vigeo Therapeutics, SEP 26, 2019, View Source [SID1234539835]).

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Vigeo is developing therapies that target the TIME via induction of thrombospondin-1 (Tsp-1) by replicating the biological activity of prosaposin (Psap). Tsp-1 is a naturally occurring, potent anti-tumorigenic protein that has been shown to reprogram the TIME and block tumor growth and progression.

"The more we study VT1021 in the clinic, the more reason we have to believe that it may significantly benefit patients by prolonging stable diseases and shrinking target lesions," said Jing Watnick, Ph.D., M.B.A., chief executive officer of Vigeo. "We look forward to initiating the expansion cohorts, in which patients will be enrolled based on tumor types and CD36 expression. This will help us understand the safety and efficacy of VT1021 in selected indications, including but not limited to ovarian cancer, triple negative breast cancer, pancreatic cancer and glioblastoma."

VT1021 in Patients with Advanced Solid Tumors
The dose escalation phase of the first-in-human study with VT1021 is near completion. Through the first eight dose levels tested, VT1021 has been shown to be safe and well tolerated, with no serious drug-related adverse events. Enrollment for expansion cohorts in specific tumor types is expected to begin in the fourth quarter of 2019.

"The data continue to suggest that Vigeo’s VT1021 is safe and well tolerated, and Tsp-1 induction has been observed both in circulation and in the tumor microenvironment. This confirms VT1021’s pharmacodynamic effect, which initiates the reprogramming of the TIME from one that is tumor-promoting to one that activates the immune system and is tumor-inhibiting," said Gregory Berk, MD, chief medical officer of Vigeo.

Presentation information is as follows:

Session Type: Poster Session
Title: A Phase 1 open label dose escalation trial evaluating VT1021 in patients with advanced solid tumors.
Session: Developmental Therapeutics and Tumor Biology
Abstract: #2683
Date & Time: Saturday September 28, 2019 from 12:00PM to 1:00PM CET
Location: 456P
Presenter: Michael Cieslewicz, Ph.D., Vice President, Program Management and Operations, Vigeo Therapeutics

About VT1021
Vigeo’s lead molecule, VT1021, is a small peptide agent derived from Psap that triggers Tsp-1 production, reprogramming the tumor microenvironment and making it inhospitable for tumor growth. Pre-clinical results have demonstrated that VT1021, when administered systemically, can cause tumor regression in animal models at both the primary and metastatic sites. VT1021 is currently being evaluated in a Phase 1, open label, multicenter trial that assesses the drug’s safety, tolerability, and preliminary anti-tumor efficacy. The trial’s dose escalation phase was launched in late 2017, and the expansion phase will begin in the fourth quarter of 2019. An interim readout is expected in the second half of 2020.

On September 26, 2019 ArQule, Inc. (Nasdaq: ARQL) reported that Peter Lawrence, President and Chief Operating Officer, and Marc Schegerin, Chief Financial Officer and Head of Strategy, will present at the 2019 Cantor Global Healthcare Conference on Thursday, October 3, 2019 at 2:25 p.m. ET at the InterContinental New York Barclay in New York City (Press release, ArQule, SEP 26, 2019, View Source [SID1234539803]).

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The live webcast of the presentation will be available via the "Investors & Media" section of ArQule’s website, www.arqule.com, under "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation.