On May 17, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) reported that its partner Janssen Biotech, Inc. plans to start four new studies of daratumumab in multiple myeloma and amyloidosis (Press release, Genmab, MAY 17, 2017, View Source [SID1234519177]).

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The studies described below are currently planned to start between the second half of 2017 and the first quarter of 2018 and may be subject to change. DARZALEX is being developed under an August 2012 agreement in which Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize the product.
Phase III study of daratumumab in smoldering multiple myeloma
Phase III study comparing the subcutaneous and intravenous administration of daratumumab in relapsed and refractory multiple myeloma
Phase III study of daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone for amyloidosis

Phase II study of subcutaneous daratumumab in combination with standard of care regimens for frontline and relapsed multiple myeloma

The plans for the new studies were announced at Johnson & Johnson’s Pharmaceutical Business Review today.
"Janssen’s expansive development plans for daratumumab emphasize the commitment to test daratumumab broadly in many different clinical settings, which hopefully results in better treatment options for patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About DARZALEX (daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the United States 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 and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe 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 for use 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. 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).1,2,3,4,5

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. Five Phase III clinical studies with daratumumab in relapsed and frontline multiple myeloma settings are currently ongoing, and additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma, NK/T-cell lymphoma, amyloidosis, myelodysplastic syndromes and solid tumors. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as both a monotherapy and in combination with other therapies.

On May 17, 2017 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported an upcoming poster presentation for its lead product candidate, CX-072, a PD-L1 targeting Probody therapeutic for the treatment of cancer, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 2-6, 2017 in Chicago, Illinois (Press release, CytomX Therapeutics, MAY 17, 2017, View Source [SID1234519175]).

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"The occurrence of immune-related adverse events is emerging as the Achilles’ heel of cancer immunotherapy," said Rachel W. Humphrey, M.D., chief medical officer of CytomX Therapeutics. "Our recently initiated Phase 1/2 clinical trial, part of our umbrella PROCLAIM program, is investigating the potential of our differentiated, anti-PD-L1 Probody therapeutic, CX-072, to reduce overactivation of the immune system outside of the tumor, while remaining active as a single-agent and in combination therapy. This poster presentation at ASCO (Free ASCO Whitepaper) will review the design and objectives of this ongoing study."

Abstract Information

Title: PROCLAIM-001: A first-in-human trial to assess tolerability of the protease-activatable anti-PD-L1 Probody CX-072 in solid tumors and lymphomas
Author: Alexander I. Spira, M.D., Ph.D., F.A.C.P., Medical Oncologist and Director, Virginia Cancer Specialists Research Institute and Oncology Research
Session: Developmental Therapeutics—Immunotherapy
Date: Monday, June 5, 2017
Time: 8:00 a.m. – 11:30 a.m.
Location: Hall A
Abstract: TPS3107
About the PROCLAIM-CX-072 Trial
PROCLAIM-CX-072 is the first clinical trial under the international umbrella program, PROCLAIM. The trial is an open-label, dose-finding Phase 1/2 study evaluating CX-072 as monotherapy and in combination with Yervoy (ipilimumab) or Zelboraf(vemurafenib). As part of the study, CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial:

Tolerability: Demonstrate that CX-072 is well tolerated in patients and potentially improves safety, particularly in the combination setting.
Anti-cancer activity: Demonstrate initial evidence of CX-072’s anti-cancer activity as monotherapy and in combination.
Translational program and Probody platform proof-of-concept: Explore mechanistic aspects of Probody activity in patients as observed in preclinical studies.
More information about the trial is available at clinicaltrials.gov.

On May 17, 2017 Johnson & Johnson (NYSE: JNJ) and its Janssen Pharmaceutical Companies reported it will announce plans to launch or file for regulatory approval more than 10 new products with blockbuster potential between 2017 and 2021, as well as 50-plus line extensions of existing and new medicines that will bring the company’s transformational medicines to an even broader patient population (Press release, Johnson & Johnson, MAY 17, 2017, View Source [SID1234519174]). The company will also share its plans to continue driving sustainable growth by leveraging its strong portfolio of core blockbuster products, the industry-leading productivity of its innovation model, and the pending acquisition of Swiss-based biotech company Actelion.

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"With a growing core business of differentiated medicines and a strong line-up of innovative products expected to launch or file over the next five years, we are leading the industry in advancing the health of patients around the world," said Alex Gorsky, Chairman and Chief Executive Officer. "Our pharmaceutical business will continue to be a significant driver of innovation and growth for Johnson & Johnson. With our proven global commercial capabilities and robust pipeline, we are well-positioned to continue delivering strong, long-term, sustainable growth."

An industry leader in research productivity, Janssen has received US FDA approval for 11 new molecular entities (NMEs) since 2011. With a portfolio focused on five core therapeutic areas – Immunology, Infectious Diseases & Vaccines, Neuroscience, Cardiovascular & Metabolism, and Oncology – the Pharmaceutical segment of Johnson & Johnson is delivering transformational new medicines for unmet medical needs worldwide, and expects to add a sixth therapeutic area in Pulmonary Arterial Hypertension upon the completion of the acquisition of Actelion, which is expected to close by the end of the second quarter.

In 2016, the company filed two NMEs that it anticipates will be approved and launched later this year:

guselkumab for psoriasis; and
sirukumab for rheumatoid arthritis.
Additional late-stage blockbuster products1 projected to file for regulatory approvals between 2017 and 2021, include:

apalutamide (ARN-509) for pre-metastatic prostate cancer;
esketamine for treatment-resistant depression;
talacotuzumab (CSL362) for acute myeloid leukemia;
erdafitinib (FGFR Inhibitor) for solid tumors;
niraparib for prostate cancer;
imetelstat for myelofibrosis;
pimodivir (JNJ-3872) for influenza A;
lumicitabine (JNJ-1575) for respiratory syncytial virus (RSV) infection; and,
JNJ-7922 (orexin-2 antagonist) for adjunctive treatment for major depressive disorder.

On May 17, 2017 Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, reported the expansion of its clinical collaboration with Merck (known as MSD outside the United States and Canada) to include an additional Phase 2 clinical trial (Press release, Aduro Biotech, MAY 17, 2017, View Source [SID1234519173]). The companies will investigate the combination of CRS-207, Aduro’s LADD (live, attenuated double-deleted) based immunotherapy, with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, for the treatment of patients with malignant pleural mesothelioma (MPM) whose disease progressed following prior treatment. Earlier this year, Aduro announced a Phase 2 clinical collaboration with Merck, through a subsidiary, to evaluate the combination of CRS-207 with pembrolizumab for the treatment of gastric cancer.

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"Data from our ongoing Phase 1 clinical trial of CRS-207 with standard chemotherapy as frontline treatment for malignant pleural mesothelioma have been very encouraging, including disease control in 94 percent of patients treated with the CRS-207/chemotherapy combination," said Natalie Sacks, M.D., chief medical officer at Aduro. "Based on these clinical data, as well as data from preclinical studies that demonstrate synergistic activity of CRS-207 and anti-PD-1 therapy, we look forward to initiating a Phase 2 trial to evaluate the CRS-207/pembrolizumab combination in patients with malignant pleural mesothelioma who have failed prior treatment."

The multicenter, single-arm, open-label Phase 2 study is designed to evaluate the safety and efficacy of CRS-207 with pembrolizumab in adults with previously treated MPM. The trial is expected to involve approximately 35 patients who have failed one to two prior treatments.

About Malignant Pleural Mesothelioma
Mesothelioma is a form of cancer that affects the smooth layer of mesothelial cells that surround the chest, lungs, heart and abdomen. Malignant pleural mesothelioma, which affects the thin balloon-shaped lining of the lungs, is the most common form of this disease and accounts for approximately 13,000 cases a year in the United States, European Union and Japan. MPM is an aggressive disease with a poor prognosis. Most MPM patients are not candidates for surgical resection. Currently, there is no U.S. Food and Drug Administration-approved therapy for second- or third-line treatment of MPM.

About LADD and CRS-207
LADD is Aduro’s proprietary platform of live, attenuated double-deleted Listeria monocytogenes strains that have been engineered to generate an innate immune response and to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity. CRS-207, the company’s lead LADD product candidate, has been engineered to express the tumor-associated antigen mesothelin, which is over-expressed in many cancers including mesothelioma and pancreatic, non-small cell lung, ovarian, endometrial and gastric cancers.

On May 17, 2017 Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, reported that Dr. Richard Stone, Chief of Staff and Program Director, Acute Leukemia at the Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School has joined the Company’s Scientific Advisory Board (SAB)(Press release, Actinium Pharmaceuticals, MAY 17, 2017, View Source [SID1234519172]).

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Actinium’s SAB is comprised of independent physicians considered to be key opinion leaders (KOLs) in the field of hematology and bone marrow transplant that contribute to and advise Actinium on the development of Iomab-B. Iomab-B is Actinium’s lead asset that is in a pivotal Phase 3 clinical trial that, upon approval, is intended to be an induction and conditioning agent prior to a bone marrow transplant for patients with relapsed or refractory acute myeloid leukemia (AML) who are over the age of 55. The pivotal Phase 3 Iomab-B SIERRA clinical trial is currently enrolling patients at many of the leading bone marrow transplant centers in the U.S.

"It is an honor to welcome Dr. Stone to Actinium’s scientific advisory board," said Dr. Mark Berger, Actinium’s Chief Medical Officer. "Dr. Stone is a world renowned expert in adult leukemias and myeloproliferative disorders who is at the forefront of research and patient care. I have greatly respected Dr. Stone throughout my medical and drug development career and look forward to working with him at Actinium as we work to gain approval for Iomab-B for patients who lack effective methods of obtaining a potentially curative bone marrow transplant."

Dr. Richard Stone said, "I am excited to join Actinium’s scientific advisory board and to have the opportunity to contribute to the development of Iomab-B. Older patients with relapsed or refractory AML face dismal outcomes, particularly if they are unable to receive a bone marrow transplant. Through Iomab-B’s targeted radioimmunotherapy approach, we hope to improve outcomes for these patients. I look forward to working with Dr. Berger, the Actinium team and my fellow advisory board members on this endeavor."

Dr. Richard Stone is the Chief of Staff and Program Director, Adult Leukemia at the Dana-Farber Cancer Institute. In addition, Dr. Stone serves as Professor of Medicine at Harvard Medical School. He currently serves on the Medical Oncology Board of the American Board of Internal Medicine and is vice chair of the Leukemia Core Committee for the national cooperative trials group Cancer and Leukemia Group B. Dr. Stone’s clinical practice focuses on patients refractory, advanced or complex with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS) and myeloproliferative disorders. Dr. Stone received his M.D. in 1981 from Harvard Medical School, his internal medicine residency training at Bringham and Women’s Hospital and his hematology-oncology fellowship at the Dana-Farber Cancer Institute.

About Iomab-B

Iomab-B is Actinium’s lead product candidate that is currently being studied in a 150-patient, multicenter pivotal Phase 3 clinical trial in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above. Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B targets cells that express CD45, a pan-leukocytic antigen widely expressed on white blood cells with the monoclonal antibody, BC8, labeled with the radioisotope, iodine-131. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B will avoid the side effects of radiation on most healthy tissues while effectively killing the patient’s cancer and marrow cells. In a Phase 2 clinical study in 68 patients with advanced AML or high-risk myelodysplastic syndrome (MDS) age 50 and older, Iomab-B produced complete remissions in 100% of patients and patients experienced transplant engraftment at day 28. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it has been studied in almost 300 patients in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). Iomab-B has been granted Orphan Drug Designation for relapsed or refractory AML in patients 55 and above by the U.S. Food and Drug Administration and the European Medicines Agency.