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bluebird bio to Present at the Evercore ISI HealthCONx Conference

On November 15, 2018 bluebird bio, Inc. (Nasdaq: BLUE) reported that members of the management team will present at the Evercore ISI HealthCONx Conference, Wednesday, November 28, at 4:15 p.m. ET at the Boston Harbor Hotel, Boston (Press release, bluebird bio, NOV 15, 2018, View Source [SID1234531365]).

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To access the live webcast of bluebird bio’s presentation, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source A replay of the webcast will be available on the bluebird bio website for 90 days following the conferences.

AVEO Oncology Announces $2M Milestone Payment from EUSA Pharma Related to German Commercialization of FOTIVDA®

On November 15, 2018 AVEO Oncology (NASDAQ: AVEO) reported the triggering of a $2 million milestone payment to AVEO from EUSA Pharma (Press release, AVEO, NOV 15, 2018, View Source [SID1234531364]). The milestone payment relates to the commercial launch and reimbursement in Germany of FOTIVDA (tivozanib) as a first line treatment of adult patients with advanced renal cell carcinoma (RCC). In the European Union, Norway and Iceland, tivozanib is indicated for the first line treatment of adult patients with RCC and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for RCC. Tivozanib is an oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI).

EUSA Pharma is the licensee for tivozanib in Europe, North and South Africa, Latin America and Australasia. The milestone payment is subject to a 30% sublicense fee due to AVEO’s partner Kyowa Hakko Kirin and is incremental to the previously-disclosed cash, cash equivalents and marketable securities at September 30, 2018, which AVEO reported would fund operations into the second quarter of 2019.

"Germany is among a growing list of countries in the European Union that recognize the benefit of expanding patient access to FOTIVDA," said Michael Bailey, president and chief executive officer. "As our partner EUSA continues to advance FOTIVDA in the approved European commercial market, we continue to work toward retrieving overall survival data not yet collected at the preliminary OS analysis of our pivotal TIVO-3 study, and toward the potential submission of a New Drug Application with the FDA for tivozanib as a treatment for advanced or metastatic RCC, a milestone we expect to reach in the first half of 2019."

Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay AVEO up to $384 million in future research and development funding and milestone payments, assuming successful achievement of specified development, regulatory and commercialization objectives, as well as a tiered royalty ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories. Thirty percent of milestone and royalty payments received by AVEO, excluding research and development funding, are due to Kyowa Hakko Kirin (KHK) as a sublicensing fee in Europe. In the United States, the royalty obligation to KHK ranges from the low- to mid-teens on net sales.

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models, enabling potentially enhanced activity when used in combination with immune modulating therapy.3 Tivozanib has been investigated in several tumors types, including renal cell, hepatocellular, colorectal and breast cancers.

Immunomic Therapeutics to Present at the 2018 World Vaccine & Immunotherapy Congress

On November 15, 2018 Immunomic Therapeutics, Inc. (ITI) reported that the company will present and participate at the 2018 World Vaccine & Immunotherapy Congress West Coast, being held November 28-29 in San Diego, CA (Press release, Immunomic Therapeutics, NOV 15, 2018, View Source [SID1234531363]).

Dr. Teri Heiland, Senior Vice President of R&D, and Sia Anagnostou, Senior Director of Corporate Development, will discuss ITI’s investigational UNiversal Intracellular Targeted Expression (UNITE) technology platform, designed to utilize the body’s natural biochemistry to generate broad immune responses, during a presentation and panel discussion. ITI’s UNITE platform has potentially broad therapeutic applications in oncology, including viral antigens, cancer antigens, neoantigens and antigen-derived antibodies as biologics. ITI has built a large pipeline from UNITE with seven oncology programs, with its lead program in Phase II for GBM, and an allergy program which is fully licensed to ITI’s partner, Astellas Pharma, Inc.

Details of ITI’s presentation and panel participation are listed below:

Presentation: "Immunomic is Addressing the Challenges of Viral Targets in Cancer"

When: Wednesday, November 28, at 12:50 p.m. PST
Who: Teri Heiland, Ph.D., Co-Founder and Senior Vice President of Research and Development at Immunomic Therapeutics, Inc.
Where: Loews Coronado Bay Resort, 4000 Coronado Bay Road, Coronado, CA 92118

Panel: "Immunotherapy in Cancer – Combinations Are Key"

When: Thursday, November 29, at 9:10 a.m. PST
Who: Moderated by Sia Anagnostou, Senior Director of Corporate Development at Immunomic Therapeutics, Inc.
Participants include:

Teri Heiland, Ph.D., Co-Founder and Senior Vice President of Research and Development at Immunomic Therapeutics
Sylvaine Cases, Ph.D., Vice President of Oncology Scientific Innovation at Janssen Research & Development
Peter Emtage, Ph.D., Senior Vice President and Global Head of Cell Therapy Research at Kite, a Gilead Company
Amy Conrad, Founder and CEO of Juniper Point
Raghuram Selvaraju, Ph.D., MBA, Managing Director & Head of Equity Research, H.C. Wainwright & Co.
Where: Loews Coronado Bay Resort, 4000 Coronado Bay Road, Coronado, CA 92118

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

Epizyme Announces Conference Call to Discuss Corporate Updates

On November 15, 2018 Epizyme, Inc. (Nasdaq: EPZM), a clinical-stage company developing novel epigenetic therapies, reported that management will host a conference call to discuss corporate updates today at 8:30 a.m. ET (Press release, Epizyme, NOV 15, 2018, View Source [SID1234531362]).

To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 5172457. A live webcast will be available in the investor section of the company’s website at www.epizyme.com. The webcast also will be archived for 60 days following the call and presentation

Boehringer Ingelheim and Epizyme Announce Worldwide Collaboration to Develop Novel Epigenetic Oncology Therapies

On November 15, 2018 Boehringer Ingelheim and Epizyme, Inc. (Nasdaq: EPZM) reported a new global collaboration focused on the research, development and commercialization of novel small molecule inhibitors directed toward two previously unaddressed epigenetic targets as potential therapies for people with cancer (Press release, Boehringer Ingelheim, NOV 15, 2018, View Source [SID1234531361]). Specifically, these targets are enzymes within the helicase and histone acetyltransferase (HAT) families that when dysregulated have been linked to the development of cancers that currently lack therapeutic options.

"Boehringer Ingelheim’s collaboration with Epizyme furthers our strategic vision to profoundly impact the oncology treatment landscape by enabling a new generation of precision medicines," said Clive R. Wood, Ph.D., Senior Corporate Vice President, Discovery Research, Boehringer Ingelheim. "We are excited to launch this partnership with Epizyme and to work together with them to advance epigenetic inhibitors that have the potential to transform the lives of patients and help win the fight against difficult-to-treat cancers."

Epigenetic modification affects how genes are biologically regulated. More than half of cancers can stem from functional errors in epigenetic modification. In particular cases, epigenetic dysregulation is associated with alterations in specific components of gene regulation, which can be used to identify patients most likely to benefit from the therapy. What makes both targets compelling is not only the clear role they play in cancer but that both targets have patient stratification biomarkers, which will enable a focus on the patients most likely to benefit from these potential treatments. Epizyme is a leader in the discovery of the roles of such enzymes and their development as therapy targets.

"This partnership with Boehringer Ingelheim to develop treatments for two novel epigenetic targets, which have been historically viewed as undruggable, further validates the promise of epigenetics for oncology and our pioneering leadership in this field," said Robert Bazemore, president and chief executive officer of Epizyme. "By combining our innovative target identification and research capabilities with Boehringer Ingelheim’s world-class drug development and commercialization expertise, we are aiming to realize the full potential of these targets and our platform, while continuing to focus on executing development of our lead program in multiple ongoing and planned clinical trials."

The collaboration has a strategic goal to focus on lung and other solid tumor cancers in patients with defined mutations, sub-populations that currently lack precision medicine treatments. Under the terms of the agreement, Boehringer Ingelheim and Epizyme will jointly research and develop a helicase program, with both parties sharing U.S. commercialization responsibilities and Boehringer Ingelheim assuming responsibility for commercialization outside the U.S. Epizyme and Boehringer Ingelheim will share research responsibilities for the HAT program, with Boehringer Ingelheim assuming responsibility for worldwide development and commercialization.

Epizyme will receive an upfront payment of $15 million and an additional $5 million in research funding in 2019. Epizyme is eligible to receive more than $280 million in additional payments for research, development, regulatory and commercial milestones. For the helicase program, Epizyme will fund a portion of the global development costs, retain a share of U.S. profits and receive tiered royalties on ex-U.S. sales. For the HAT program, Epizyme is eligible to receive tiered royalties on worldwide sales.