On December 28, 2015 Immune Pharmaceuticals Inc. (NASDAQ:IMNP) ("Immune") a clinical-stage company developing novel therapies for the treatment of immuno-inflammatory diseases and cancer, reported it has entered into an exclusive license with Atlante Biotech SAS, to the patents and know-how for a new format of bispecific antibodies (Press release, Immune Pharmaceuticals, DEC 28, 2015, View Source [SID:1234508650]). Schedule your 30 min Free 1stOncology Demo! Dr. Daniel Teper, CEO of Immune commented, "This is an important milestone as we make progress with our immuno-oncology pipeline. Our research will focus on the application of this novel bispecific platform to target immune checkpoints. Our plan is to generate additional pre-clinical data with selected bispecific drug candidates in 2016."
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The R&D work on the bispecific antibodies will be performed in Immune’s recently established Immunology R&D unit at the Alexandria Center for Life Sciences in New York City, under the leadership of Dr. Boris Shor, Executive Director of R&D, who joined the company from Pfizer Oncology.
In recently presented data, the platform prototype bispecific antibody was shown to retain effector functions and mediate redirect killing of target cells by cytokine induced killer T cells. The bispecific antibody demonstrated direct anti-cancer effects in vitro, as well as in vivo anti-tumor activity and improved survival in a mouse xenograft model of disseminated leukemia. A collaborative European consortium led by Dr. Kadouche from Atlante Biotech, and funded by a European grant developed the novel platform for production of tetravalent IgG1-like bispecific antibodies.
Author: [email protected]
Sunshine Biopharma Acquires All Remaining Worldwide Patents For Its Adva-27a Anticancer Compound
On December 28, 2015 Sunshine Biopharma Inc. (OTCQB: SBFM), a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, reported that it has acquired all of the remaining rights, title and interest in and to all worldwide patents for the Company’s Adva-27a anticancer compound (Press release, Sunshine Biopharma, DEC 28, 2015, View Source [SID:1234508649]). Schedule your 30 min Free 1stOncology Demo! The Patent Purchase Agreement executed today provides Sunshine with direct ownership of all issued and pending Adva-27a related patents, which include all rights to this intellectual property worldwide. Prior, Sunshine had ownership of only the U.S. patent.
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The purchase price paid by Sunshine for these patent rights was $12,822,499, which will be paid pursuant to the terms of a secured promissory note, with quarterly payments of principal and interest due through December 2020.
About Adva-27a
Adva-27a is Sunshine Biopharma’s lead anticancer compound, a Topoisomerase II inhibitor, small molecule that has recently been shown to be effective at killing Pancreatic Cancer cells, Multidrug Resistant Breast Cancer cells, Small-Cell Lung Cancer cells and Uterine Sarcoma cells (Published in ANTICANCER RESEARCH, Volume 32, Pages 4423-4432, October 2012). Adva-27a is currently in the IND-Enabling stage of development. The original U.S. patent covering Adva-27a was issued on August 7, 2012 under U.S. patent number 8,236,935. The Company is planning Phase I clinical trials of Adva-27a for Pancreatic Cancer and in parallel Multidrug Resistant Breast Cancer to be conducted at McGill University’s Jewish General Hospital in Montreal (Canada).
Epizyme Announces FDA Acceptance of Investigational New Drug Application for Tazemetostat in Diffuse Large B-cell Lymphoma
On December 28, 2015 Epizyme, Inc. (NASDAQ:EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for cancer patients, reported the U.S. Food and Drug Administration’s (FDA) Division of Hematology Products has accepted the company’s investigational new drug (IND) application for tazemetostat for the treatment of adults with diffuse large B-cell lymphoma (DLBCL), the most common type of Non-Hodgkin Lymphoma (NHL) (Press release, Epizyme, DEC 28, 2015, View Source [SID:1234508643]). Schedule your 30 min Free 1stOncology Demo! An ongoing five-arm registration-supporting, international phase 2 clinical trial assessing the safety and activity of tazemetostat in patients with relapsed or refractory B-cell NHL was initiated in July 2015 (NCT02601950). The IND acceptance will allow the company to enroll DLBCL patients in the United States into this ongoing trial.
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"Tazemetostat has demonstrated clinically meaningful anti-tumor activity and an acceptable safety profile in patients with NHL in our phase 1 study," said Robert Bazemore, President and Chief Executive Officer. "We are excited to enable U.S. investigators to gain experience with tazemetostat in DLBCL."
"Patients with relapsed or refractory NHL have a significant need for new treatment options," said Dr. Peter Ho, M.D., Ph.D., Chief Medical Officer, Epizyme. "We believe tazemetostat has the potential to become an important therapy for B-cell NHL patients, both as a monotherapy and in combination, and look forward to extending the ongoing five-arm NHL study to allow access to DLBCL patients in the U.S."
About the Tazemetostat Clinical Trial Program
The phase 2 NHL trial is a five-arm, multi-center, international study that will use a two-stage design to assess the safety and activity of tazemetostat in multiple populations of patients with relapsed or refractory Non-Hodgkin Lymphoma. The study will enroll up to 30 patients in each arm. Patients will be prospectively stratified for EZH2 mutation status and cell-of-origin. The five study arms are enrolling relapsed/refractory patients with:
Germinal center DLBCL with mutant EZH2
Germinal center DLBCL with wild-type EZH2
Non-germinal center DLBCL
Follicular lymphoma with mutant EZH2
Follicular lymphoma with wild-type EZH2
Epizyme expects to present interim data from the phase 2 study in NHL at a medical conference in mid-2016.
In the first half of 2016, the Company also plans to initiate additional clinical evaluations of tazemetostat, including a combination study with R-CHOP in front-line, high-risk patients with DLBCL, and a combination study with a B-cell signaling agent or immuno-oncology agent in B-cell NHL.
In August 2015, the FDA’s Division of Oncology Products 2 accepted Epizyme’s IND application to study adult and pediatric patients with INI1-negative solid tumors or synovial sarcoma.
About Tazemetostat
Epizyme is developing tazemetostat for the treatment of patients with Non-Hodgkin Lymphoma and for patients with INI1-negative solid tumors, certain SMARCA4-negative solid tumors or synovial sarcoma. Tazemetostat is a first-in-class small molecule inhibitor of EZH2 created by Epizyme using its proprietary product platform. In some human cancers, aberrant EZH2 enzyme activity results in misregulation of genes that control cell proliferation resulting in the rapid and unconstrained growth of tumor cells. Tazemetostat is the WHO International Non-Proprietary Name (INN) for compound EPZ-6438.
Additional information about this program, including clinical trial information for the adult five-arm NHL study, can be found here: View Source
Information about the company’s Phase 2 clinical trial of tazemetostat in adults with INI1-negative solid tumors, certain SMARCA4-negative solid tumors or synovial sarcoma can be found here: View Source
Information about the company’s Phase 1 clinical trial of tazemetostat in children with INI1-negative solid tumors, certain SMARCA4-negative solid tumors or synovial sarcoma can be found here: View Source
Eagle Pharmaceuticals Announces FDA Approval of Docetaxel Injection, Non-Alcohol Formula
On December 24, 2015 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported that the U.S. Food and Drug Administration ("FDA") has approved Docetaxel Injection, Non-Alcohol Formula for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer (Press release, Eagle Pharmaceuticals, DEC 24, 2015, View Source [SID:1234508639]). Eagle entered into an exclusive licensing agreement with Teikoku Pharma USA Inc. in October 2015 to market, sell and distribute Docetaxel Injection in the U.S.
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Docetaxel Injection is the first alcohol-free formulation approved in the U.S. Additional features of this product are:
presents as one, pre-filled vial that does not require mixing;
is available in three different dosages: 20mg/1ml, 80mg/4mL, and 160mg/8mL; and
24 hours of stability at final dilution strength.1
The need for an alcohol-free docetaxel gained visibility in June 2014 when the FDA issued a Drug Safety Communication warning patients that docetaxel may cause symptoms of alcohol intoxication after treatment. Manufacturers of docetaxel formulations for domestic use were subsequently required to revise their product labels to reflect alcohol content and include a drug safety warning. Some U.S. hospitals and clinics require patients to wait two or more hours after treatment with docetaxel before they can be released. This formulation of docetaxel was specifically developed to address these concerns.
"Docetaxel Injection addresses a compelling need in the docetaxel market. As the first alcohol-free formulation approved in the U.S., we believe the benefits of this novel formulation will provide an option for patients with alcohol sensitivity or a preference for an alcohol-free treatment. We are excited to add alcohol-free docetaxel to our growing portfolio of differentiated injectable products and believe it has the potential to improve the lives of patients, resolve concerns among health care professionals at hospitals and infusion centers, and ultimately drive value for Eagle stakeholders," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
Eagle expects to begin shipping Docetaxel Injection in January 2016. Eagle estimates that annual sales of generic docetaxel are approximately $75 million.
About Docetaxel
Docetaxel is a taxane product indicated for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.
Docetaxel was originally developed by Sanofi and marketed under the Taxotere brand. Since its patent expiration in 2011, several generics entered the market. The alcohol content of these docetaxel formulations, including Taxotere, ranges from 2.0 to 6.4 grams in a 200 mg dose2.
Cellectis Files First Clinical Trial Application for UCART19, an Allogeneic Gene Edited CAR T-Cell Product for Hematological Malignancies
On December 23, 2015 Cellectis (Alternext: ALCLS – Nasdaq: CLLS) reported the submission of a clinical trial application (CTA) to the Medicines & Healthcare products Regulatory Agency (MHRA) requesting approval to initiate UCART19 First-in-Human clinical investigation in leukemia in the United Kingdom (Press release, Cellectis, DEC 23, 2015, View Source [SID:1234508638]). Schedule your 30 min Free 1stOncology Demo! This study aims to include CD19-positive Acute Lymphoblastic Leukemia (ALL) patients. Other eligibility criteria to enter clinical trials will be assessed by the investigators.
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"It has been a privilege preparing this application with our team, partners, investigators and subcontractors, in close interaction with MHRA, rewarding many years of intense work to overcome the challenges that are inherent to advanced therapy medicinal products. This achievement marks an important step toward making UCART19 available to patients," said Stephan Reynier, Chief Regulatory and Compliance Officer, Cellectis.
"The UCART19 CTA filing is a great recognition for the Company’s preclinical and manufacturing accomplishments in developing a therapeutic for Acute Lymphoblastic Leukemia. We are all pleased with Cellectis’ progress to date with UCART19, including the filing of this CTA, and we look forward to following the progress of this program through the course of its clinical development," said Dr. Mathieu Simon, EVP, Chief Operating Officer, Cellectis.
About UCART19
UCART19 is a potential best-in-class allogeneic TALEN gene edited T-cell product for treatment of CD19 expressing hematological malignancies, initially developed in Chronic lymphocytic leukemia (CLL) and Acute lymphoblastic leukemia (ALL). Engineered allogeneic CD19 CAR T-cells currently stand out as a real therapeutic innovation for treating various types of leukemia and lymphoma. Cellectis’ approach with UCART19 is based on the preliminary positive results from clinical trials using products based on the CAR technology and has the potential to overcome the limitation of the autologous current approach by providing an allogeneic frozen, "off the shelf" T-cell based medicinal product.
On November 18, 2015 Servier exercised its worldwide option to license UCART19 and entered into a global development and commercialization collaboration with Pfizer on UCART19. According to their recent agreement, Cellectis will hand over the clinical development of UCART19 to Servier and their US partner Pfizer. Due to the early exercise, Cellectis is no longer responsible for funding the UCART19 Phase I clinical program.