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]).

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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.
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).

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]).

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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.

"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

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]).

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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.

"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.

On December 23, 2015 Agenus Inc. (NASDAQ: AGEN), an immunotherapy company developing innovative treatments for cancer, reported that it has acquired privately-held PhosImmune Inc., a company that has discovered an entirely new portfolio of cancer neoantigens (Press release, Agenus, DEC 23, 2015, View Source [SID:1234508637]). The acquisition provides Agenus the ability to accelerate the development of new cancer vaccines and other single agent immuno-oncology approaches, as well as combination therapies.

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"PhosImmune’s groundbreaking neoantigen assets significantly expand Agenus’ current efforts, and present exciting near-term opportunities for new products and partnerships," said Dr. Garo H. Armen, Chairman and Chief Executive Officer of Agenus. "This acquisition expands our immuno-oncology pipeline and strengthens our neoantigen capabilities to enable the development of best-in-class cancer vaccines and other novel therapies."

Novel Neoantigens

PhosImmune’s neoantigens have unique advantages in cancer immunotherapy. The company’s phosphopeptide tumor targets (PTTs) are fragments of proteins expressed in cancer cells. These fragments are phosphorylated due to signal dysregulation involved in the development of cancers and, as a result, appear as foreign to the immune system. The approach is synergistic with Agenus’ AutoSynVax vaccine program for targeting patient-specific tumor neoantigens. PTTs can expand AutoSynVax and other immunotherapeutic approaches to include patients with lower levels of mutations that may not have enough neoantigens to activate the immune system effectively. PTTs can also be shared by patients with specific cancers, providing the potential for "off-the-shelf" vaccines.

PhosImmune’s scientific founders, Donald Hunt, Ph.D. and Vic Engelhard, Ph.D., both of University of Virginia, and Mark Cobbold, M.D., Ph.D., of Massachusetts General Hospital, have identified a large number of proprietary, tumor-specific PTTs. These PTTs are found on a wide variety of cancer types.

"By acquiring PhosImmune, we are accessing a capability with transformational potential for both patient-specific and off-the-shelf cancer vaccine products," said Robert B. Stein, M.D., Ph.D., Chief Scientific Officer and Head of R&D for Agenus. "In addition, our entire portfolio will benefit from the world-class peptide analytics expertise of PhosImmune’s founders. We believe there are a number of near-term opportunities to advance potentially powerful cancer therapies into the clinic that build on and leverage the ongoing work at Agenus."

"Agenus has deep knowledge and expertise in the immunotherapy field, and we are excited to join forces with their research and development team," said Donald Hunt, President and Scientific Founder of PhosImmune. "We are confident that by working together we can more rapidly advance the development of immuno-oncology products and realize the potential of our extensive research into how the immune system recognizes cancers as non-self."

Terms

Under the terms of the agreement, Agenus paid PhosImmune’s equity holders an upfront payment of $2.5 million in cash and $7.4 million in shares of Agenus common stock at closing. Additional payments of up to $35 million in cash and/or stock at Agenus’ election are payable upon the achievement of certain milestones.

About Neoantigens

Both genetic mutations and abnormal phosphorylation processes found in cancer cells can result in the formation of aberrant proteins with altered function. When degraded inside cancer cells, these proteins are broken up into short peptide fragments that can be presented on the cell surface. These peptides, termed neoantigens, have the potential to alert the immune system that a cancer is developing.

About AutoSynVax

Agenus’ AutoSynVax (ASV) program targets cancer neoantigens with an autologous synthetic vaccine approach. By utilizing next generation sequencing and advanced bioinformatics, patient-specific tumor mutations are identified for rapid and accurate selection of neoantigens. The ASV platform generates synthetic peptide neoantigens complexed with heat shock proteins (HSPs) that shuttle these neoantigens to antigen presenting cells. The ASV program builds on Agenus’ extensive clinical experience with individualized and synthetic HSP vaccines.