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.

On May 17, 2017 Bayer reported that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for copanlisib for the treatment of relapsed or refractory follicular lymphoma (FL) patients who have received at least two prior therapies (Press release, Bayer, MAY 17, 2017, View Source [SID1234519171]). Copanlisib is an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms. FL is the most common subtype of indolent non-Hodgkin’s lymphoma (iNHL).

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"Patients with relapsed or refractory follicular lymphoma have a poor prognosis, and new treatment options which are well tolerated and effective are needed to prolong progression-free survival and improve quality of life for these patients," said Martin Dreyling, Professor of Medicine at the University of Munich Hospital in Grosshadern and lead investigator of the CHRONOS-1 study. "Based on the CHRONOS-1 results, where copanlisib showed durable efficacy with a manageable and distinct safety profile, the compound may have the potential to address this unmet medical need."

"Bayer is advancing one of the most diverse oncology portfolios and pipelines and our first priority is to deliver new treatments to cancer patients as quickly and prudently as possible," said Robert LaCaze, Executive Vice President and Head of the Oncology Strategic Business Unit at Bayer. "With this milestone, we are one step closer to making copanlisib available in the U.S. to the community of doctors and patients facing a very difficult-to-treat disease in follicular lymphoma. We look forward to continuing to work with the FDA throughout the review process."

The FDA grants Priority Review for the applications of medicines that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions, when compared to standard applications. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its review within six months (compared to 10 months under standard review).

The regulatory submission for copanlisib is based on data from the Phase II open-label, single-arm study CHRONOS-1 evaluating patients with relapsed or refractory indolent Non-Hodgkin’s Lymphoma (iNHL). The full analysis set comprised 142 patients, of which 141 patients had iNHL. At the time of analysis, median duration of treatment was 22 weeks and 46 patients remained on treatment. The results across all patient groups show an objective response rate (ORR) of 59.2%, with a 12% complete response (CR) rate, and a median duration of response (DOR) of more than 98 weeks (687 days). In the FL subset (n=104), copanlisib achieved an ORR of 58.7%, with 14.4% of these patients achieving a CR, and a median DOR of more than 52 weeks (370 days). The safety and tolerability were consistent with previously published data on copanlisib. The most common treatment-related adverse events were transient hyperglycemia (all grades: 49%/Grade ≥3: 40%), which did not show severity above Grade 4 and hypertension (all grades: 29%/Grade ≥3: 23%), which did not show severity above Grade 3. These data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017. Data from the FL subset of the CHRONOS-1 trial will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2017 in June.

Bayer is seeking accelerated approval of copanlisib for FL under FDA regulations 21 CFR Part 314 Subpart H. The compound was also granted Fast Track and Orphan Drug Designation by the FDA in this indication.

About CHRONOS-1
CHRONOS-1 is an open-label, single-arm Phase II study (ClinicalTrials.gov Identifier: NCT01660451) evaluating copanlisib as a monotherapy in patients with relapsed or refractory indolent NHL, including follicular lymphoma (FL), who received at least two prior therapies. The primary endpoint of CHRONOS-1 is the objective tumor response rate, with duration of response, overall survival, progression-free survival, quality of life, and safety serving as secondary endpoints.

About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s Lymphoma (NHL) is the most common hematologic malignancy and the tenth most common cancer worldwide, with nearly 386,000 new cases diagnosed in 2012. It accounts for nearly 200,000 deaths per year worldwide. NHL comprises a highly heterogeneous group of diseases that can be indolent or aggressive with a poor prognosis. Follicular lymphoma is the most common histological subtype of indolent NHL, for which there is a need to improve treatment options.

About Copanlisib
Copanlisib is a novel pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms, being developed by Bayer. The PI3K pathway is involved in cell growth, survival and metabolism, and its dysregulation plays an important role in non-Hodgkin’s lymphoma (NHL). Copanlisib is administered as a 1-hour infusion on an intermittent weekly basis (3 weeks on/1 week off).

The compound has shown promising clinical activity in Phase I and Phase II studies in heavily pretreated patients with recurrent indolent and aggressive NHL. The broad clinical development program also includes Phase III studies in indolent NHL patients who have relapsed or are refractory to prior therapies. Information about these trials can be found at www.clinicaltrials.gov and www.chronostrials.com.

Copanlisib has also been granted Orphan Drug Designation for the treatment of splenic, nodal, and extranodal subtypes of marginal zone lymphoma. The compound is not approved by the U.S. Food and Drug Administration, the European Medicines Agency or any other health authority.