On March 18, 2016 Omnis Pharma, Inc. and Magnis Therapeutics, LLC, reported their strategic merger to form Vyriad, a clinical-stage oncolytic immunovirotherapy development company (Press release, Omnis Pharmaceuticals, MAR 18, 2016, http://www.vyriad.com/2016/03/18/omnis-pharma-magnis-therapeutics-merge-form-vyriad-clinical-stage-oncolytic-immunovirotherapy-development-company-combined-entity-aims-leader-oncolytic-virotherapy-discov/ [SID:1234509779]). The combined companies’ product development pipeline encompasses multiple clinical-stage and late preclinical-stage products targeting a broad range of human cancer indications, including a Phase 1 development program partnered with a large pharmaceutical company. Financial details of the transaction were not disclosed.

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!

"I am delighted to announce the completion of this merger, which consolidates two leading oncolytic platforms, a broad intellectual property portfolio, a strong collaborative research and development network, and a vibrant clinical-stage product pipeline that spans the cancer spectrum," said Stephen J. Russell, MD, PhD, President and CEO of Vyriad. "Given our broad clinical and advanced preclinical portfolio, product development engine, and scientific capabilities, I firmly believe that Vyriad is on course to become the leading oncolytic virotherapy company creating powerful new immunotherapies for patients with cancer."

The combined company results in:

A robust pipeline encompassing eight oncolytic virotherapies in clinical development and seven in late-stage preclinical development: Vyriad’s lead programs include Phase 2 product candidates in ovarian cancer and multiple myeloma, and Phase 1 programs in glioblastoma, mesothelioma, head and neck cancer, blood cancers, endometrial cancer, hematologic malignancies, and gastrointestinal cancer. The company’s seven pre-IND programs include initiatives that pair oncolytic vaccines with other cancer immunotherapy approaches such as checkpoint inhibitors, as well as other forms of cancer therapy such as chemotherapy.

Validated, industry-leading oncolytic virotherapy platforms: Vyriad unites vesicular stomatitis virus (VSV) and measles virus platforms licensed from Mayo Clinic, the University of Miami, and Yale University School of Medicine following more than 15 years of intensive research to identify the most promising oncolytic viruses based on selectivity, mechanism of action, and potency. In 2014, Vyriad’s Oncolytic Measles virus demonstrated successful treatment of a patient with multiple myeloma who had previously undergone 10 years of unsuccessful treatment and exhausted all traditional treatment options, and who remains disease-free two years following treatment.

Birinapant/TL32711 (1) is a bivalent antagonist of the inhibitor of apoptosis (IAP) family of proteins and was designed to mimic AVPI, the N-terminal tetrapeptide of the second mitochondria-derived activator of caspases (Smac/DIABLO). Birinapant bound to the BIR3 domains of cIAP1, cIAP2, and XIAP with K i values of 1, 36, and 45 nM, respectively. Birinapant-mediated activation of cIAP1 resulted in cIAP1 autoubiquitylation and degradation and correlated with inhibition of TNF-mediated NF-κB activation, induction of tumor cell death in vitro, and tumor regression in vivo. Birinapant is being evaluated in Phase 1/2 trials for the treatment of cancer and hepatitis B virus (HBV) infection. After one year at accelerated storage conditions, a formulation of 1 afforded four degradants in >0.1% abundance by HPLC analysis. The primary degradants (2 and 3) were formed via oxidation of the biindole core, while the secondary degradants (5 and 6) arose via [1,2]-rearrangement of 3 and 2, respectively. Forced degradation conditions were developed, which allowed the isolation of 2 and 3 in multigram quantities. Novel deuterated analogues of 1 were prepared to determine the site of oxidation, and NMR experiments confirmed the chemical structures of 5 and 6. The de novo synthesis of 2, 3, 5, and 6 confirmed these experimental findings.

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!

On March 18, 2016 Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, reported publication of abstracts on neratinib for the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2016 (Press release, Puma Biotechnology, MAR 18, 2016, View Source [SID:1234510445]). The AACR (Free AACR Whitepaper) Annual Meeting will be held at the Ernest N. Morial Convention Center in New Orleans from April 16 to April 20.

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!

Sun, Apr 17, 1:00 – 5:00 p.m. CDT – Abstract 298, Section 16, Poster Board 9: Amplification of mutant ERBB2 drives resistance to the irreversible kinase inhibitor neratinib in ERBB2-mutated breast cancer patients.
FJ Carmona, D Hyman, G Ulaner, J Erinjeri, N Bouvier, H Won, R Cutler, A Alani, M Berger, J Baselga, M Scaltriti.

Tue, Apr 19, 8:00 a.m. – 12:00 p.m. CDT – Abstract 3140, Section 22, Poster Board 7: Differential clonal selection in tumor tissue and cell-free DNA from a neratinib-treated refractory breast cancer patient harboring an activating ERBB2 (HER2) mutation.
L Joenson, CW Yde, O Østrup, M Mau-Sørensen, FC Nielsen, U Lassen

Wed, Apr 20, 8:00 a.m. – 12:00 p.m. CDT – Abstract 4760, Poster Board 11: Efficacy of EGFR/HER2 duel-kinase inhibitors in PDX models harboring known and novel HER2-mutations.
MJ Wick, M Farley, T Vaught, J Meade, M Glassman, A Moriarty, AW Tolcher, D Rasco, A Patnaik, KP Papadopoulos

The abstracts are available online at: View Source;DetailItemID=363#.Vusrr-IrKUk.

On March 17, 2016 Allergan plc (NYSE: AGN), a leading global pharmaceutical company, reported that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Paclitaxel Protein-Bound Particles for Injectable Suspension, 100 mg/vial (Press release, Allergan, MAR 17, 2016, View Source;p=irol-newsArticle&ID=2149174 [SID:1234509619]).

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!

Logo – View Source

Allergan’s ANDA product is a generic version of Celgene’s Abraxane, which is indicated for the treatment of metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy; locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy; and metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.

Based on available information, Allergan believes it is a "first applicant" to file an ANDA for the generic version of Abraxane and, should it’s ANDA be approved, may be entitled to 180 days of generic market exclusivity.

For the 12 months ending January 31, 2016, Abraxane had total U.S. sales of approximately $683 million, according to IMS Health data.

Abraxane is a registered trademark of Abraxis BioScience, LLC.

On March 17, 2016 Alligator presented the corporate presentation (Presentation, Alligator Bioscience, MAR 17, 2016, View Source [SID1234538697]).

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!