On February 18, 2017 Nektar Therapeutics (Nasdaq: NKTR) reported that positive Phase 1 clinical data for Nektar’s lead immuno-oncology agent, NKTR-214, in patients with renal cell carcinoma (RCC) were presented at ASCO (Free ASCO Whitepaper) GU 2017 (Press release, Nektar Therapeutics, FEB 18, 2017, View Source [SID1234517754]). NKTR-214 is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting T cells and Natural Killer (NK) cell abundance directly in the tumor micro-environment and increase expression of PD-1 on these immune cells. The results were presented by Michael Hurwitz, MD, PhD, Assistant Professor of Medicine, Department of Medical Oncology at Yale Cancer Center and were entitled "A Novel Immune Agonist, NKTR-214, Increases the Number and Activity of CD8+ Tumor Infiltrating Lymphocytes in Patients with Advanced Renal Cell Carcinoma."

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"NKTR-214 resulted in dramatic increases in tumor-infiltrating lymphocytes (TILs) and also demonstrated encouraging anti-tumor activity, with 40% of RCC patients experiencing tumor reductions, including one patient with a partial response," said Dr. Mary Tagliaferri, Vice President, Clinical Development at Nektar. "We know that high TIL levels are correlated with clinical response and longer survival in patients treated with checkpoint inhibitor therapies and can be the best predictor of response. NKTR-214’s unique mechanism, favorable safety profile and clinical activity support our combination trials of NKTR-214 with existing checkpoint inhibitors, such as nivolumab and atezolizumab, but also with other I-O mechanisms in development."

Clinical benefit and safety data were presented on 15 patients from the trial with renal cell carcinoma who were treated with single-agent NKTR-214:

6/15 (40%) patients with RCC had radiographic reductions in tumor size per RECIST 1.1 on NKTR-214, including:
3 patients who had progressed on 1 prior tyrosine kinase inhibitor (TKI) and had also progressed on 1 prior checkpoint therapy
3 patients who had progressed on 1 prior tyrosine kinase inhibitor (TKI) and were checkpoint therapy naïve, including 1 patient who experienced an unconfirmed partial response (uPR)
NKTR-214 continues to demonstrate a favorable safety and tolerability profile with convenient, outpatient q3w or q2w administration in all patients evaluable for safety to-date.
Immune pheno-typing was conducted and biomarkers of immune activation were measured in patients with evaluable tumor biopsies and blood samples. Treatment with NKTR-214 produced a robust elevation in immune cell frequency and activation, including:

Increase in total lymphocytes and newly proliferating (Ki67+) CD4+ T cells, CD8+ T cells, and NK cells, with increases greater than 50-fold observed
Increase in CD8+ T cells of up to 10-fold in the tumor micro-environment in patients with evaluable tumor biopsies (pre-dose and post-dose at week 3)
Increase in expression of cell-surface PD-1 on T cell subsets of up to 2-fold in the tumor micro-environment
Nektar and Bristol-Myers Squibb are collaborating to develop NKTR-214 as a potential combination treatment regimen with Bristol-Myers Squibb’s Opdivo (nivolumab) in five tumor types and eight potential indications. The Phase 1/2 clinical program will enroll up to 260 patients and will evaluate the potential for the combination of Opdivo (nivolumab) and NKTR-214 to show improved and sustained efficacy and tolerability above the current standard of care in melanoma, kidney, triple-negative breast cancer, bladder and non-small cell lung cancer patients. The initial dose-escalation trial is underway with Opdivo (nivolumab) and NKTR-214 in the indications of first-line melanoma, second-line RCC checkpoint therapy-naïve, and second-line non-small cell lung cancer (NSCLC) checkpoint therapy-naïve.

NKTR-214 is an experimental therapy designed to stimulate cancer-killing immune cells in the body by targeting CD122 specific receptors found on the surface of these immune cells, known as CD8+ effector T cells and NK cells. In preclinical studies, treatment with NKTR-214 resulted in a rapid expansion of these cells and mobilization into the tumor micro-environment.1 NKTR-214 has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines. A Phase 1/2 clinical study is ongoing to evaluate single-agent NKTR-214 in cancer patients.

The ASCO (Free ASCO Whitepaper) GU 2017 poster can be downloaded at the following url:

View Source

AMAG Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, AMAG Pharmaceuticals, FEB 17, 2017, View Source [SID1234517772]).

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AbbVie has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, AbbVie, FEB 17, 2017, View Source [SID1234517751]).

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On February 17, 2017 Ethicon, Inc. reported a definitive agreement to acquire Torax Medical, Inc., a privately held medical device company that manufactures and markets the LINX Reflux Management System, a novel minimally invasive device for the surgical treatment of GERD (Press release, Johnson & Johnson, FEB 17, 2017, View Source [SID1234517770]). The acquisition of Torax Medical will enable Ethicon to offer patients a safe and effective alternative to the anatomy-altering laparoscopic Nissen fundoplication surgical procedure.1

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This LINX Reflux Management System, a small implant comprised of interlinked titanium beads with magnetic cores which augment the body’s natural barrier function to prevent reflux. LINX is currently used by physicians in over 300 hospitals in the United States and Europe. This acquisition is consistent with Ethicon’s strategy of advancing innovation and investing in areas of unmet medical needs such as esophageal health.

Financial terms of the transaction have not been disclosed. The closing of the transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. The transaction is expected to close during the first quarter of 2017.

On February 17, 2017 Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or "the Company") reported that sacituzumab govitecan (IMMU-132) is active in patients with metastatic urothelial cancer (UC) and has the potential to become a second line or later treatment to platinum-based or immuno-oncology therapy for these patients (Filing, 8-K, Immunomedics, FEB 17, 2017, View Source [SID1234517768]).

"With larger numbers than the initial report, I remain impressed with the safety and efficacy results produced by sacituzumab govitecan in a difficult-to-treat patient population that had a median of two prior therapies and had extensive metastatic disease," commented Dr. Scott T. Tagawa, the Richard A. Stratton Associate Professor in Hematology and Oncology, and an Associate Professor of Clinical Medicine and of Clinical Urology at Weill Cornell Medicine and an oncologist at NewYork-Presbyterian, who presented the results at the GU conference.

"While patients with metastatic UC usually respond well to initial therapy with a platinum-containing regimen, few options are available after they become refractive. Second-line immune checkpoint-inhibitor (IO) therapy was recently approved by the FDA, such as atezolizumab and nivolumab, with expected approval of pembrolizumab as well. Although responders to the new IO therapy may do well for a prolonged period of time, about three-fourths do not respond and overall median PFS is less than 2.5 months and median OS less than 13 months have been reported," added Dr. Tagawa, who has served as a consultant to Immunomedics.

In the ongoing Phase 2 study with sacituzumab govitecan in metastatic UC, the ORR among 36 assessable patients was 31% (11/36), including one confirmed CR and ten confirmed PRs. The median duration of response for these ten patients was 7.5 months (95% confidence interval [CI], 4.4 to 12.9 months), with one patient having a PR for more than 18 months and continuing therapy. Overall, 69% of patients showed tumor shrinkage from baseline with sacituzumab govitecan therapy, and 14 patients are still under therapy.

For the 41 intention-to-treat patients, median PFS was 7.2 months (95% CI, 6.7 to 11.7 months) and median OS was 15.5 months (95% CI, 8.9 to 17.2 months). Of the twelve patients with progression after prior IO therapy and chemotherapy, there were one unconfirmed PR and six patients with stable disease following sacituzumab govitecan treatment.

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The Company announced on February 10, 2017 that an exclusive global licensing agreement was entered into with Seattle Genetics (NASDAQ: SGEN), providing Seattle Genetics worldwide rights to develop, manufacture and commercialize sacituzumab govitecan in multiple indications, including UC.

"We are pleased with these promising results, especially the long-term control of advanced disease in patients who failed multiple prior therapies, and look forward to working closely with Seattle Genetics to bring this important investigational product to cancer patients expeditiously," stated Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics. Ms. Sullivan added, "We remain on target to commence our Phase 3 randomized trial in patients with advanced triple-negative breast cancer in March, and are working diligently to complete the submission of our Biologics License Application to FDA for Accelerated Approval of this indication."

In addition to Dr. Tagawa, other clinical investigators participating in this study include Drs. Allyson J. Ocean, Bishoy Faltas, and Ana Molina, his colleagues at NewYork-Presbyterian and Weill Cornell Medicine, New York, NY; Dr. Elaine Lam, University of Colorado Cancer Center, Aurora, CO; Drs. Philip Saylor and Aditya Bardia, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA; Dr. Julio J. Hajdenberg, UF Health Cancer Center-Orlando Health, Orlando, FL; Dr. Alicia K. Morgans, Vanderbilt-Ingram Cancer Center, Nashville, TN; Drs. Kevin Kalinsky and Emerson Lim, NewYork-Presbyterian/Columbia University Medical Center-Herbert Irving Comprehensive Cancer Center, New York, NY; and Dr. Matthew D. Galsky, Icahn School of Medicine Mount Sinai, Tisch Cancer Institute, New York, NY.

A total of 44 patients with metastatic UC had been enrolled into this open-label multicenter study. Sites of metastases included liver (N=9; 25%), lymph nodes (N=14; 39%), lungs (N=14; 39%, pelvis (N=9, 25%), and bone (N=4; 11%). Patients received a median of six doses (range, 1-50) of sacituzumab govitecan, which was administered at 8 or 10 mg/kg on days 1 and 8 of 3-week cycles. Despite repeated dosing, grade 3 or higher adverse events were limited to neutropenia (30%), febrile neutropenia (11%), fatigue (11%), and diarrhea (3%).

Treatment response was assessed by computed tomography (CT) every 8 weeks. Patients with more than 30% tumor shrinkage required confirmation within 4 to 6 weeks after the initial response in accordance with by RECIST 1.1 for single-arm studies.