On March 7, 2016 Celgene Corporation (NASDAQ: CELG, CELGZ) reported that it has received a Paragraph IV Notice Letter advising that Actavis LLC submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) seeking authorization from the FDA to manufacture and market a generic version of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin bound) 100 mg/vial in the United States (Press release, Celgene, MAR 7, 2016, View Source [SID:1234509390]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Notice Letter contains Paragraph IV certifications against certain patents relating to ABRAXANE. Celgene is assessing the notice. Celgene intends to vigorously defend its extensive intellectual property rights relating to ABRAXANE.

About ABRAXANE

In the U.S., ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ABRAXANE is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ABRAXANE is also indicated for the first-line treatment of metastatic adenocarcinoma of the pancreas in combination with gemcitabine.

On March 07, 2016 Molecular Partners AG (ticker: MOLN), a clinical-stage biopharmaceutical company that is developing a powerful new class of therapies known as DARPins, reported additional details about its immuno-oncology pipeline, including two early-stage multi-DARPin programs (Press release, Molecular Partners, MAR 7, 2016, View Source [SID:1234509389]). The first program targets the validated immune checkpoint PD-1 as well as VEGF-A, aiming to enhance PD-1 efficacy. The second program is designed to potently activate T-cells in the tumor without activating circulating T-cells, thus circumventing systemic toxicities.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Christian Zahnd, Chief Executive Officer of Molecular Partners, will present additional details about these discovery programs at the 36th Annual Cowen Health Care Conference in Boston, Mass. on Wed., March 9 at 10:40 a.m. Eastern Time.

"The DARPin platform is ideally suited to develop highly differentiated immuno-oncology therapies with the potential to overcome the limitations of first-generation approaches," said Dr. Michael Stumpp, Chief Scientific Officer at Molecular Partners. "We are excited to contribute to the rapidly evolving field of immuno-oncology as we build our proprietary oncology pipeline. Our early-stage programs evaluate exciting new principles that were previously out of reach: enhanced immune checkpoint blockers and locally activated agonists."

Immuno-oncology is a revolutionary approach to anti-cancer treatment that redirects the body’s immune system to fight cancer cells. Investigators are studying many different ways to modulate immune checkpoints used by the body to regulate the immune system. While many of these clinical studies are yielding promising results, novel approaches are needed.

On March 7, 2016 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported that the Company has initiated the planned Phase 2 clinical study for Poziotinib, its novel pan-HER inhibitor (Press release, Spectrum Pharmaceuticals, MAR 7, 2016, View Source [SID:1234509387]). The Phase 2 trial is an open-label study that will enroll approximately 70 patients with HER2-positive metastatic breast cancer, who have failed at least two prior HER2-directed therapies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We believe Poziotinib has the potential to be the best in class pan-HER inhibitor," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "The U.S. Phase 2 trial was designed on learnings from Hanmi’s Phase 1 studies as well as the ongoing Phase 2 breast cancer trial in Korea. The target market for HER2-positive agents is large, and we are encouraged by early data showing that Poziotinib could potentially be another treatment option for patients."

Poziotinib is a novel, oral pan-HER inhibitor that irreversibly blocks signaling through the Epidermal Growth Factor Receptor (EGFR, HER) Family of tyrosine-kinase receptors, including HER1 (erbB1; EGFR), HER2 (erbB2), and HER4 (erbB4), and importantly, also HER receptor mutations; this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, gastric cancer, etc. Currently, Poziotinib is being investigated by Hanmi in several mid-stage trials in different solid tumor indications including HER2-positive breast cancer. (Phase 2 sponsored by National OncoVenture, a funding initiative by the Korean government’s National Cancer Center).

On March 7, 2016 Celsion Corporation (NASDAQ: CLSN), a fully-integrated oncology company focused on the development of a portfolio of innovative cancer treatments, reported the launch of the OPTIMA Study in China (Press release, Celsion, MAR 7, 2016, View Source [SID:1234509386]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company held an Investigators’ Meeting for the OPTIMA Study on March 5, 2016 in Shanghai, China. Professor Ronnie T.P. Poon, MD, MBBS, MS, PhD, FRCS (Edin), FACS, Medical Director at the Hong Kong Integrated Oncology Center, Honorary Professor of Surgery at the University of Hong Kong Queen Mary Hospital, and member of the International Liver Cancer Association (ILCA) Governing Board provided the Keynote Address entitled "Treatment Strategies for Early/Intermediate HCC." Professor Poon discussed strategies for treating different stages of primary liver cancer, also known as hepatocellular carcinoma (HCC); including intermediate stage HCC which has been previously thought to be incurable. New treatment strategies, most notably an optimized RFA procedure with the investigational drug, ThermoDox, show clear promise as a potential cure for intermediate HCC in the years ahead. Investigators and their staff from 20 sites in mainland China and Hong Kong were in attendance. The OPTIMA Study is the Company’s global pivotal, double-blind, placebo-controlled trial, evaluating ThermoDox, Celsion’s proprietary heat-activated liposomal encapsulation of doxorubicin, in combination with radiofrequency ablation standardized to 45 minutes (sRFA) versus sRFA alone to treat newly diagnosed patients with HCC.

"Following a very successful Investigator’s startup meeting in Shanghai this past weekend, we are eager to accelerate site initiation and patient enrollment, and expect to complete the process already underway by the end of the second quarter," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "Our researchers and principal investigators recognize the importance of the OPTIMA Study to the medical community and its potential to significantly improve overall survival of newly diagnosed HCC patients. With approximately 50% of the 850,000 new cases of primary liver cancer diagnosed each year originating in China, China represents a significant market opportunity and key element of our global development strategy for ThermoDox."

The Phase III OPTIMA Study is expected to enroll up to 550 patients globally, and has been successfully enrolling patients at 50 clinical sites in 12 different countries in North America, Europe and Asia Pacific. In December 2015, the Company announced that it had received a Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct the ongoing Phase III OPTIMA Study at up to 20 additional clinical sites in China. The Company aims to enroll more than 200 patients in the China territory, the minimum number required by the CFDA to file a New Drug Application (NDA), assuming positive clinical results.

"With an extremely high incidence rate of HCC in China, the compelling survival data from the Chinese subgroup analysis in the HEAT Study underscores the importance of further exploring the potential that exists for ThermoDox in combination with sRFA to serve as a new curative treatment for primary liver cancer, a disease with limited treatment options," said Professor Min Hua Chen, MD, Chief Expert, Department of Ultrasonography, School of Oncology, Peking University, Lead Investigator for the OPTIMA Study in China, and former HEAT Study Investigator. "It is a great honor to be involved with the OPTIMA Study, and I look forward to working with Celsion and my research colleagues as the study progresses."

The primary endpoint for the OPTIMA Study is overall survival (OS). The statistical plan calls for two preplanned interim efficacy analyses by an independent Data Monitoring Committee (iDMC). The design of the OPTIMA Study is supported by a retrospective analysis of a large subgroup of 285 patients in the Company’s previous 701 patient HEAT Study in primary liver cancer. In a subgroup of 285 HEAT Study participants, ThermoDox plus standardized RFA demonstrated a statistically significant improvement in survival of over two years compared to standardized RFA alone. In this large subgroup, the median overall survival in the ThermoDox plus standardized RFA arm was approximately 80 months (6 ½ years), which is considered a curative treatment for HCC.

On March 07, 2016 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported that the independent Data Safety and Monitoring Board (DSMB) has determined, based on a preplanned interim analysis, that continuation of the Phase 3 ACT IV study of RINTEGA (rindopepimut) in patients with newly diagnosed EGFRvIII-positive glioblastoma will not reach statistical significance for overall survival in patients with minimal residual disease, the primary endpoint of the study, as both the RINTEGA arm and the control arm are performing on par with each other (Press release, Celldex Therapeutics, MAR 7, 2016, View Source [SID:1234509385]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In the ACT IV study, RINTEGA has performed consistently with prior Phase 2 studies but the control arm has significantly outperformed expectations (Hazard ratio = 0.99; median OS: RINTEGA 20.4 months vs. control 21.1 months). Based on this recommendation, Celldex is discontinuing the study and does not anticipate incurring substantial additional costs related to RINTEGA at this time. All patients on the RINTEGA arm of the ACT IV study, prior Phase 2 studies and existing compassionate use recipients will be offered ongoing access to RINTEGA on a compassionate use basis. Celldex first received the data after market close on Friday, March 4th and is in the process of reviewing the results.

"We are extremely disappointed for patients that the ACT IV study was not successful," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "On behalf of Celldex, I want to express our gratitude to the ACT IV investigators, patients and families who participated in this trial. While this is certainly not the desired outcome, we remain steadfast believers in the power of immunotherapy to transform the future of cancer treatment."

Celldex currently has seven company-led clinical trials across five product candidates ongoing. The Company expects to report data from a number of these studies over the next three to 18 months, including a registration study in triple negative breast cancer and a number of Phase 1 and 2 cancer immunotherapy combination trials.