1stOncology™: Cancer Intelligence Service – Page 17240 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Sanofi to acquire Protein Sciences

On July 11, 2017 Sanofi reported it will acquire Protein Sciences, a privately held vaccines biotechnology company based in Meriden, Connecticut in the United States. Under the terms of the agreement, Sanofi will make an upfront payment of $650 million and pay up to $100 million upon achievement of certain milestones.

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!

Protein Sciences received approval from the US Food and Drug Administration (FDA) in October 2016 for their Flublok Quadrivalent Influenza Vaccine (QIV). Flublok is the only recombinant protein-based influenza vaccine approved by the FDA.

"The acquisition of Protein Sciences will allow us to broaden our flu portfolio with the addition of a non-egg based vaccine," said David Loew, Sanofi Executive Vice President and Head of Sanofi Pasteur, Sanofi’s vaccines division.

"Protein Sciences was actively looking for an opportunity to grow its business, particularly in the US," said Manon M.J. Cox, President and Chief Executive Officer, Protein Sciences. "As part of Sanofi Pasteur, we expect our Flublok influenza vaccine to benefit from Sanofi Pasteur’s expertise in the field of influenza vaccines."

The acquisition, which has been unanimously approved by the board of directors of Protein Sciences and a majority of Protein Sciences shareholders, is expected to close in the third quarter of 2017, subject to customary regulatory approvals.

(Press release, Sanofi, JUL 11, 2017, View Source [SID1234670341])

10-Q – Quarterly report [Sections 13 or 15(d)]

Exicure has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Exicure, 2017, JUL 11, 2017, View Source [SID1234521827]).

Daiichi Sankyo, Max Planck Innovation and Lead Discovery Center Announce Cancer Research Collaboration

On July 11, 2017 Daiichi Sankyo Co., Limited (hereafter, Daiichi Sankyo), Max Planck Innovation GmbH and the Lead Discovery Center GmbH reported that they have signed an agreement providing Daiichi Sankyo with the option to receive the exclusive rights to a new lead compound for the treatment of cancer to be discovered and developed at the Lead Discovery Center.

Know more, wherever you are:
Latest on Collaborations in Cancer, book your free 1stOncology demo here.

This new partnership builds on biology insights in the field of transcriptional regulation from the work of Prof. Matthias Geyer at the Max Planck Institute of Molecular Physiology in Dortmund and the Research Center caesar (Center of Advanced European Studies and Research) in Bonn, Germany. Combined with the Lead Discovery Center’s strong drug discovery expertise in the design of highly selective kinase inhibitors, Daiichi Sankyo, Max Planck researchers and the Lead Discovery Center will now closely cooperate to further optimize these novel compounds that target cancer cell transcription and proliferation.

Daiichi Sankyo together with the Max Planck Society, supported by Max Planck Foundation, will jointly fund the respective drug discovery efforts at the Lead Discovery Center. Once the project has achieved proof-of-concept in relevant in vivo models, Daiichi Sankyo has the exclusive rights to license the program at pre-defined terms for subsequent preclinical and clinical development. The agreement includes an upfront payment as well as development and sales milestones plus royalties. The licensing revenues will be shared between Max Planck Society, the Lead Discovery Center and all contributing researchers and institutions.

"The Lead Discovery Center is our prime partner for innovative drug discovery projects and developing novel compounds with a high therapeutic potential from the Max Planck Institutes. This agreement with Daiichi Sankyo, a recognized leader in the development and supply of innovative pharmaceutical products, again shows the high quality of research projects driven at the Max Planck laboratories. Moreover, the agreement is a great opportunity to advance the research findings into pharmaceutical development, providing potential new treatment options for patients with cancer," according to Dr. Matthias Stein-Gerlach, patent and licensing manager at Max Planck Innovation, Max Planck Society´s technology transfer organization.

"This project collaboration and option agreement is building on the excellent experiences that Daiichi Sankyo and the Lead Discovery Center previously made from a discovery alliance that started in 2014, as well as close ties and many interactions between Daiichi Sankyo and the Max Planck Society, such as the collaboration with the Axel Ullrich lab. Max Planck Innovation has been instrumental to close this partnership," adds Dr. Bert Klebl, Managing Director and CSO at the Lead Discovery Center.

"It is a great pleasure for us to start this research collaboration with Max Planck Innovation and the Lead Discovery Center to further generate innovation for our cancer drug discovery efforts," said Antoine Yver, MD, MSc, Executive Vice President and Global Head of Oncology Research and Development, Daiichi Sankyo. "We are excited about the integration of Max Planck Society’s high quality science and the Lead Discovery Center’s expertise in lead discovery into Daiichi Sankyo’s drug research and development platform."

Daiichi Sankyo, the Lead Discovery Center and the Max Planck Society aim to further expand their collaboration into additional programs in the future.

About Max Planck Innovation
Max Planck Innovation is responsible for the technology transfer of the Max Planck Society and, as such, serves as a link between industry and basic research. With its interdisciplinary team it advises and supports scientists in evaluating their inventions, filing patents, and founding companies. Max Planck Innovation offers the industry unique access to the innovations of the Max Planck Institutes, and therefore performs an important task: the transfer of basic research results into products, which contributes to economic and social progress. Further information at: www.max-planck-innovation.de

About the Lead Discovery Center
The Lead Discovery Center was established in 2008 by the technology transfer organization Max Planck Innovation, as a novel approach to capitalize on the potential of excellent basic research for the discovery of new therapies for diseases with high medical need. The Lead Discovery Center takes on promising early-stage projects from academia and transforms them into innovative pharmaceutical leads that reach initial proof-of-concept in animals. In close collaboration with high-profile partners from academia and industry, the Lead Discovery Center is building a strong and growing portfolio of small molecule leads with exceptional medical and commercial potential.

The Lead Discovery Center sustains a preferred partnership with the Max Planck Society and has formed alliances with AstraZeneca, Bayer, Boehringer Ingelheim, Merck KGaA, Daiichi Sankyo, Qurient, Johnson & Johnson Innovation, Roche and Sotio as well as leading translational drug discovery centers around the globe. Further information at: www.lead-discovery.de

About Daiichi Sankyo Cancer Enterprise
The vision of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking in order to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by our Antibody Drug Conjugate (ADC) and Acute Myeloid Leukemia (AML) Franchises, our cancer pipeline includes more than 20 small molecules, monoclonal antibodies and ADCs stemming from our powerful research engines: our two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. Compounds in development include: quizartinib, an oral FLT3 inhibitor, for newly-diagnosed and relapsed/refractory AML with FLT3-ITD mutations; DS-8201, an ADC for HER2-expressing breast and gastric cancer, and other HER2-expressing solid tumors; and pexidartinib, an oral CSF-1R inhibitor, for tenosynovial giant cell tumor (TGCT), which is also being explored in a range of solid tumors in combination with the anti-PD1 immunotherapy pembrolizumab. For more information, please visit: www.DSCancerEnterprise.com

Cytovia Inc, Immune Pharmaceuticals’ Oncology Subsidiary, Enters into a Definitive Agreement with Pint Pharma for the Licensing and Commercialization of Ceplene® in Latin America

On July 11, 2017 Cytovia Inc. ("Cytovia") the oncology subsidiary of Immune Pharmaceuticals Inc. (NASDAQ: IMNP) ("Immune") reported that it has entered into a licensing agreement with Pint Pharma International S.A. ("Pint") a pharmaceutical company focused on Latin America and other markets, for the marketing and distribution of Ceplene throughout Latin America (the "territory") (Press release, Immune Pharmaceuticals, JUL 11, 2017, View Source [SID1234519793]). Pint Gmbh will separately enter into an investment agreement, which will lead to an investment of $4 million into Cytovia. Dr. Massimo Radaelli, Executive Chairman of Pint, will also join the board of Cytovia upon completion of the investment and effective spin off of Cytovia from Immune.

"Following the acquisition from Mylan of Ceplene rights in Europe and Asia, Cytovia is pleased to confirm the partnership with Pint for Latin America markets. This will provide Cytovia an opportunity to generate revenues from Latin American sales of Ceplene. This potential is incremental to revenues expected from European sales where Ceplene is approved in thirty countries." said Daniel Teper, of Cytovia.

"We intend to immediately initiate regulatory registration of Ceplene in the LATAM markets based on the European approval. Furthermore, Pint has extensive experience with Early Access Programs for orphan drugs and is planning to offer a similar program to AML patients who are candidates for treatment with Ceplene" added David Munoz, CEO of Pint.

Ceplene is the only drug currently approved in 30 European countries and Israel for the maintenance of first remission in Acute Myeloid Leukemia (AML). Ceplene has a reimbursed cost of therapy of approximately $25,000/year in Europe based on a full course of treatment. The addressable market for remission maintenance in AML is estimated at 7000 patients in Europe. Additionally the addressable market in Latin America is estimated at 4000 patients. There are currently no alternative drugs approved in the remission setting.

About Ceplene
Ceplene (histamine dihydrochloride) is administered in conjunction with low dose interleukin-2 (IL-2), for maintenance of first remission in patients with Acute Myeloid Leukemia (AML). It has been shown in clinical studies to prevent leukemic relapses in AML patients in first remission and prolong leukemia-free survival, while maintaining good quality of life during treatment. Ceplene acts by enhancing the immunostimulatory effect of IL-2 and countering reactive oxygen species-induced dysfunction and apoptosis of T and NK cells, thereby inducing immune-mediated killing of leukemic cells, providing a strong rationale for this combination therapy. A recent Phase IV study presented at the meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in 2016 confirmed the safety and efficacy of Ceplene in the international study that supported European approval.

About Acute Myeloid Leukemia (AML)
AML patients receive intensive induction treatment with chemotherapeutic drugs at diagnosis and typically become free of detectable leukemia, achieving "complete remission." However, within 1-2 years, the majority (75-80%) of adult patients will experience a relapse of leukemia, with a survival prognosis of 33% in younger patients and 15-20% in patients over 60 years of age. According to the American Cancer Society, there will be approximately 21,380 new cases of AML and 10,590 deaths from AML in the US in 2017. The prognosis following first remission is poor and there are no other effective remission therapies currently available. AML represents an orphan condition with high unmet need.

FDA Advisory Committee Votes in Favor of Pfizer’s MYLOTARG (gemtuzumab ozogamicin) for Acute Myeloid Leukemia

On July 11, 2017 Pfizer Inc. (NYSE:PFE) reported that the U.S. Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted that the results of ALFA-0701 demonstrated a favorable risk:benefit profile for MYLOTARG (gemtuzumab ozogamicin) 3 mg/m2 on days 1, 4 and 7 added to chemotherapy for patients with newly-diagnosed CD33-positive acute myeloid leukemia (AML) (Press release, Pfizer, JUL 11, 2017, View Source [SID1234519788]). The role of the Advisory Committee is to provide recommendations to the FDA. The FDA decision on whether or not to approve the MYLOTARG application is anticipated by September 2017.

"We are extremely pleased with the Committee’s recommendation and believe this is an important step toward our goal of making MYLOTARG available to patients with newly-diagnosed AML," said Mace Rothenberg, MD, Chief Development Officer, Oncology, Pfizer Global Product Development. "We look forward to working closely with the FDA as we continue the regulatory process. We are grateful to both the investigators who led MYLOTARG clinical trials and the patients who participated."

The ODAC discussions were based on the Biologics License Application (BLA) currently under review by the FDA. The BLA includes Pfizer-sponsored studies from the original New Drug Application (NDA) for MYLOTARG, an investigator-led Phase 3 randomized, open-label study (ALFA-0701) and an individual patient data meta-analysis from over 3,000 patients in five randomized Phase 3 studies (including ALFA-0701). These studies span 10 years of research and include more than 4,300 patients.

"Clinical studies investigating MYLOTARG have provided a significant body of evidence supporting the risk:benefit profile of MYLOTARG in AML," said Jorge Cortes, MD, University of Texas, MD Anderson Cancer Center. "Based on the totality of the efficacy and safety data, MYLOTARG, if approved, has the potential to be an important treatment option for adult patients with AML."

Due to the critical unmet need for patients with newly-diagnosed AML, there has been great interest among AML investigators to evaluate MYLOTARG in this population using different doses and different schedules of MYLOTARG. These investigator-led clinical trials have provided more information on the efficacy and safety of MYLOTARG.

ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational cancer treatments and makes recommendations to the FDA. Its vote is not binding, but is considered by the FDA in its decision-making process.

About AML

Acute myeloid leukemia (AML) is the most common type of acute leukemia in adults and accounts for approximately 80% of all cases of acute leukemia.1 About 21,380 people are expected to be diagnosed with AML in the United States in 2017.2 Despite recent developments in understanding the scientific basis of AML and its treatment, there has been little progress in increasing the long-term survival rate in AML patients.3 Only one in four patients with AML survive longer than five years.2

About MYLOTARG (gemtuzumab ozogamicin)

MYLOTARG is an investigational antibody-drug conjugate (ADC) comprised of the cytotoxic agent calicheamicin, attached to a monoclonal antibody (mAB) targeting CD33, an antigen expressed on the surface of myeloblasts in more than 90 percent of AML patients.4,5,6 When MYLOTARG binds to the CD33 antigen on the cell surface it is absorbed into the cell and calicheamicin is released causing cell death.4,5

MYLOTARG was originally approved under the FDA’s accelerated approval program in 2000 for use as a single agent in patients with CD33-positive AML who had experienced their first relapse and were 60 years or older. In 2010, Pfizer voluntarily withdrew MYLOTARG after a confirmatory Phase 3 trial (SWOG S0106) did not show a clinical benefit, and the rate of fatalities as a result of treatment-related toxicity was significantly higher in the MYLOTARG arm.

While ODAC discussed MYLOTARG for newly-diagnosed CD33-positive AML, Pfizer is currently seeking approval in the U.S. for MYLOTARG in two indications:

In combination with standard chemotherapy for the treatment of previously untreated de novo CD33-positive AML.
As monotherapy for the treatment of CD33-positive AML patients in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy.
MYLOTARG is commercially available in Japan where it is approved for the treatment of patients with relapsed or refractory CD33-positive AML who are not considered candidates for other cytotoxic chemotherapy.

MYLOTARG originates from a collaboration between Pfizer and Celltech, now UCB. Pfizer has sole responsibility for all manufacturing and clinical development activities for this molecule.