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Inovio Presents Progression Free Survival & PSA Doubling Time Improvements in Prostate Cancer Patients Treated with INO-5150

On October 22, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported that new data from the company’s recently completed Phase 1b study with INO-5150 demonstrated a slowing of Prostate-Specific Antigen Doubling Time (PSADT) in men with prostate cancer (Press release, Inovio, OCT 22, 2018, View Source;PSA-Doubling-Time-Improvements-in-Prostate-Cancer-Patients-Treated-with-INO-5150/default.aspx [SID1234530272]). Eighty six percent (86%) of patients remained progression-free at Week 72 of the study. These data were presented in a poster entitled "Synthetic DNA immunotherapy in Biochemically Relapsed Prostate Cancer" at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 congress in Munich today.

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In this study, Inovio evaluated the tolerability and immunogenicity of INO-5150, a DNA vaccine encoding PSA and PSMA, with or without INO-9012 (encoding IL-12 immune adjuvant), in men with biochemically relapsed prostate cancer. The study demonstrated a slowing of PSA doubling time, a measure of disease progression, in a majority of patients on the study. In addition, 86% of patients were progression-free at Week 72 of the study, which in this treatment-refractory, high-risk patient population, is thought to be clinically promising. Importantly, analyses demonstrated that immunogenicity was observed in 77% (47/61) of patients by multiple immunologic assessments.

Previous results from the Phase 1b study were presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting and demonstrated that of the 61 evaluable patients, 77% (47/61) demonstrated T cell immunogenicity, and 38% (19/50) exhibited CD38+, Perforin+CD8+ T cell responses. Results presented at ASCO (Free ASCO Whitepaper) provided clinical data through week 72 and immunology data through week 27. The latest results being presented at ESMO (Free ESMO Whitepaper) update these data and report that 80% of evaluable patients in the trial demonstrated either INO-5150 specific T cell or antibody reactivity.

Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, "The follow-up data and opportunity to showcase INO-5150 from our Phase 1 prostate cancer study further helps Inovio’s efforts to enter into a strategic development partnership to expand into a Phase 2 study. These follow-up results support the rationale for further development and provides the basis for a novel checkpoint combination cancer trial."

This patented approach of INO-5150 in combination with CELLECTRA delivery device is designed to help the body’s immune system overcome its "self-tolerance" to prostate cancer cells and mount a strong targeted CD8+ killer T cell response to eliminate the cancerous cells displaying these antigens. Moreover, PSMA is also one of 3 antigens comprising INO-5401, which is being tested in two separate Phase 1/2 trials as an immunotherapy to treat glioblastoma and metastatic bladder cancer in combination with Regeneron and Genentech/Roche’s checkpoint inhibitors, respectively.

About Prostate Cancer and Biochemically Recurrent Prostate Cancer (BRPC)

Prostate cancer is the second most frequently diagnosed cancer in men. Nearly three-quarters of the registered cases occur in developed countries. Accounting for nearly 300,000 deaths each year, prostate cancer is the sixth leading cause of death from cancer in men. There are about 60,000 patients each year in the US that develop biochemically recurrent prostate cancer (BRPC). The development of a new treatment for prostate cancer would be a significant medical advance given that current standard-of-care treatment options (surgery, radiation and hormone deprivation), while somewhat effective, all carry deleterious side effects and are often not a long-term cure.

NuCana Reports Additional Promising Clinical Data on NUC-1031 (Acelarin®) as Front-Line Treatment of Advanced Biliary Tract Cancer at ESMO 2018

On October 22, 2018 NuCana plc (NASDAQ: NCNA), a clinical-stage biopharmaceutical company focused on significantly improving treatment outcomes for patients with cancer, reported combined results from cohorts one and two of the ABC-08 Study at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2018 in Munich, Germany (Press release, Nucana BioPharmaceuticals, OCT 22, 2018, View Source [SID1234530269]). In this Phase Ib multi-center, open-label study in front-line treatment of patients with advanced biliary tract cancer, Acelarin combined with cisplatin was observed to continue to achieve approximately a doubling of the response rate expected with the standard of care, gemcitabine plus cisplatin. In addition, results showed the combination was well-tolerated and several patients achieved significant reductions in their tumor volume as well as further tumor shrinkage over time.

Fourteen patients with advanced/metastatic biliary tract cancer received Acelarin (625mg/m2 or 725mg/m2) and cisplatin (25mg/m2) on days one and eight of a three-week cycle. In the intent-to-treat group of patients, a Complete Radiological Response was achieved in one patient and a Partial Response in six patients, resulting in an Objective Response Rate of 50%. In the eleven Efficacy Evaluable patients (defined as those patients who received at least one cycle of therapy), an Objective Response Rate of 64% was achieved.

"Building upon the interim analysis presented in January 2018 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, these data continue to be encouraging and suggest that the combination of Acelarin and cisplatin may represent an important advance in the standard of care treatment of advanced biliary tract cancer, a devastating disease for which there are no approved medicines," remarked Professor Juan Valle, Co-Chief Investigator of the ABC-08 Study and Professor and Honorary Consultant in Medical Oncology at the University of Manchester and The Christie NHS Foundation Trust, Manchester, United Kingdom.

Dr. Mairéad McNamara, Co-Chief Investigator of the ABC-08 Study and Senior Lecturer and Honorary Consultant in Medical Oncology at the University of Manchester and The Christie NHS Foundation Trust, added, "In addition to the encouraging response rate observed, which is approximately double that of the standard of care, I believe the ability of this combination to continue to shrink the tumor volume over time is also noteworthy. Some patients showed sustained and durable tumor shrinkage, which is not typically seen in this setting."

Additionally, the combination of Acelarin and cisplatin was well-tolerated over multiple cycles with no unexpected adverse events, no dose-limiting toxicities, no discontinuations due to Acelarin-associated toxicity and no Grade 4 adverse events.

Based on these data from the ABC-08 study and discussions with the U.S. Food and Drug Administration (FDA), NuCana anticipates initiating a global randomized Phase III clinical study comparing Acelarin (625mg/m2) and cisplatin (25mg/m2) with gemcitabine (1,000mg/m2) and cisplatin (25mg/m2) in patients with front-line advanced biliary tract cancer.

Hugh Griffith, NuCana’s Chief Executive Officer, said: "We are excited by the results achieved in this study. We have also been encouraged by the ongoing constructive dialogue with the FDA and look forward to initiating a front-line Phase III study of Acelarin plus cisplatin in patients with advanced biliary tract cancer."

A comparison of these data from the ABC-08 Study and the earlier ABC-02 Study, that established the current standard of care, is provided in the table below:

Objective Response Rates in ABC-08 and ABC-02

ABC-08 Study

ABC-02 Study*

NUC-1031 + cisplatin

625 mg/m2 or 725 mg/m2 + 25 mg/m2

gemcitabine + cisplatin

000 mg/m2 + 25 mg/m2

Complete Response

7% (1/14)

0.6% (1/161)

Partial Response

43% (6/14)

25.5% (41/161)

Objective Response Rate

50% (7/14)

26.1% (42/161)

*Valle et al. N Eng J Med 2010; 363:1273-1281

Celgene Corporation Announces Appointment of Dr. Alise Reicin to President, Global Clinical Development

On October 22, 2018 Celgene Corporation (NASDAQ:CELG) reported the appointment of Dr. Alise Reicin to President, Global Clinical Development, reporting to Mark J. Alles, Chairman and Chief Executive Officer, effective November 1, 2018 (Press release, Celgene, OCT 22, 2018, View Source [SID1234530266]). In this role, Dr. Reicin will be responsible for all aspects of mid- to late-stage clinical development across Celgene’s portfolio and will serve on the company’s Executive Committee.

"Dr. Reicin is an accomplished physician with an excellent record of developing important therapeutics for multiple cancer and inflammatory indications," said Mark J. Alles, Chairman and CEO of Celgene Corporation. "Led by Alise, our clinical development organization will be structured to more completely align with our strategy and mission to discover, develop and commercialize innovative therapies for patients with unmet need. She joins Dr. Rupert Vessey, President, Research & Early Development, and Dr. Jay Backstrom, Chief Medical Officer, as we deliver the potential of our deep and broad pipeline."

The appointment of Dr. Reicin is part of a deliberate strategy to strengthen Celgene for long-term success. This organizational change further establishes clinical development as another center of excellence and enhances strategic leadership in discovery, development and commercialization. Dr. Rupert Vessey continues to lead early research and development. Dr. Reicin will lead mid- to late-stage clinical development, clinical operations, biostatistics, project leadership and project management. Dr. Jay Backstrom maintains responsibility for our global regulatory strategy, drug safety, regulatory operations and pharmacovigilance. Nadim Ahmed and Terrie Curran continue to lead our global commercial and medical affairs organizations for the Hematology & Oncology and Inflammation & Immunology franchises, respectively.

Dr. Reicin was most recently Senior Vice President and Head of Global Clinical Development in Research and Development (R&D) at EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany. In this role, she has been responsible for the clinical development of assets across oncology and inflammatory indications, including anti-PD-L1 avelumab in solid tumors and cladribine in relapsing multiple sclerosis. Since joining EMD Serono in 2015, she has led clinical development, biostatistics, clinical operations, and the Japan and China R&D hubs. Prior to joining EMD Serono, Dr. Reicin served as Vice President, Project and Pipeline Leadership, Oncology Franchise at Merck, Sharp & Dohme (Merck). She led Merck’s immuno-oncology program and oversaw initial development and filing activities worldwide, including the first approval for pembrolizumab (KEYTRUDA) in the United States. Before joining Merck, Dr. Reicin was a faculty member at Columbia Medical School, and a physician and researcher at Columbia Presbyterian Hospital. She has a degree in biochemistry from Barnard College of Columbia University. She received her Medical Degree from Harvard Medical School, where she was enrolled in the Health Sciences and Technology program with MIT (Massachusetts Institute of Technology).

Actinium Pharmaceuticals Announces Webinar Showcasing Actimab-A Post Phase 2 Trial Plans and Actimab-MDS Regulatory Update

On October 22, 2018 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) reported that it will host a conference call and webinar to provide key updates on the advancement of its CD33 program on Friday, October 26, 2018 at 11:00 AM ET (Press release, Actinium Pharmaceuticals, OCT 22, 2018, View Source [SID1234530262]). Actinium’s CD33 program utilizes the Antibody Radio-Conjugate (ARC), lintuzumab-Ac-225 for hematologic indications including Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Multiple Myeloma (MM). Actinium recently completed its Phase 2 Actimab-A trial in patients newly diagnosed with AML who are over the age of 60 and unfit for intensive chemotherapy. Dr. Gary Schiller Professor Medicine, Hematology-Oncology at UCLA Medical Center and Dr. Tapan Kadia, Assistant Professor of Medicine, Department of Leukemia at the MD Anderson Cancer Center will highlight Actinium’s post Phase 2 trial development plans for Actimab-A in AML.

Actinium is also developing Actimab-MDS, which is intended to be a single dose, chemotherapy-sparing targeted conditioning agent for patients with high-risk MDS. Currently, this patient population either cannot undergo a bone marrow transplant or have poor outcomes. Management will provide an update on the regulatory pathway for Actimab-MDS following positive interactions with the U.S. Food and Drug Administration (FDA).

Dr. Mark Berger, Actinium’s Chief Medical Officer said, "Our CD33 program has progressed significantly in 2018 resulting in a highly valuable body of data that we are using to inform our ongoing development strategy. Our Antibody Radio-Conjugate approach, given its differentiated mechanism of action, has allowed us to expand this program beyond a traditional AML directed approach which is where other CD33 programs in the industry are focused. The unique ability of our ARC’s enable cell killing to occur not just via internalization of the antigen but also from the cell surface and by crossfire. In addition, our ARCs labeled with radioactive actinium are characterized by the high linear energy transfer of alpha radiation which is able to cause double stranded DNA breaks via a single alpha particle hit. This potent cell killing power of alpha radiation when used in an efficiently targeted manner as in our Actimab program enables us to expand into other radio-sensitive CD33 expressing malignancies such as multiple myeloma and now for targeted conditioning for MDS, both of which are indications where Actinium is developing the only CD33 targeting agent. In addition, we have moved into a novel combination trial for patients with significant unmet need with our Actimab-A CLAG-M study. We are pleased to have made this progress, but we believe the next evolution of our CD33 program will be even more exciting. As such, we look forward to highlighting our post Phase 2 trial development plans for Actimab-A with Dr. Schiller and Dr. Kadia."

Sandesh Seth, Actinium’s Chairman and Chief Executive Officer said, "We are excited to introduce these latest initiatives as they clearly establish Actinium’s Antibody Radio-Conjugate based CD33 program as the industry leader. Further, we are about to enter a period that will showcase data from several of the CD33 program initiatives that this team has advanced. Given the inherent nature of our technology, the expertise of our team and strong relationships with thought leaders, we have been able to craft a development strategy that leverages the strengths of our drug candidates and Antibody Warhead Enabling technology platform into indications with high unmet medical needs. The webinar will showcase the attractiveness of using our Antibody Radiation-Conjugate approach in meeting these needs. In addition, it will establish the strategic importance of Actimab-MDS in enabling our company to develop a multi-asset pipeline of targeted conditioning agents which have the potential to improve access and outcomes for patients undergoing bone marrow transplant and cellular therapy in a chemotherapy-free or chemotherapy-sparing manner."

Conference call and webcast Participation Information
Date: Friday, October 26, 2018
Time: 11:00 AM ET
Webcast Registration: View Source
U.S. Participant Dial-in: (718) 865-8336
U.S./Canada Toll Free Dial-in: (855) 427-0225
Conference ID: 4831

Centers for Medicare & Medicaid Services publish final rate of $192 for Epigenomics’ colorectal cancer screening blood test Epi proColon®

On October 22, 2018 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) reported that the Centers for Medicare & Medicaid Services (CMS) published a final rate of $192 for Epi proColon, the first and only FDA-approved blood test for colorectal cancer screening (Press release, Epigenomics, OCT 22, 2018, View Source [SID1234530232]).

This announcement confirms the preliminary gapfill rate as determined by the Medicare Administrative Contractors, published on June 11, 2018. The $192 per test rate will be included in the 2019 Clinical Laboratory Fee Schedule that is expected to be published in November 2018.

"The final CMS rate of $192 is an important accomplishment for the company as it appropriately values our innovative blood-based colorectal cancer screening test," said Greg Hamilton, CEO of Epigenomics AG. "Medicare pricing sets a benchmark for value and it’s an important component of our commercialization strategy."

About Epi proColon

Epi proColon is indicated for colorectal cancer screening in average-risk patients who are unwilling or unable to perform colorectal cancer screening by colonoscopy and stool-based methods.

For patients, the test only requires a simple blood sample drawn as part of routine healthcare provider visits. There are no dietary restrictions or alterations in medication required for the test. The sample will be analyzed at a national or regional diagnostic laboratory.