On November 15, 2018 Rakuten Aspyrian, a biotechnology company developing precision-targeted cancer therapies based on its proprietary Photoimmunotherapy platform, reported the appointment of Mickey Mikitani as chief executive officer (Press release, Rakuten Aspyrian, NOV 15, 2018, View Source [SID1234531388]). Mr. Mikitani, a global business leader, will also continue in his role of chairman. In conjunction, former CEO Miguel Garcia-Guzman, Ph.D. will transition to serve as Rakuten Aspyrian’s vice chairman and chief scientific officer to continue to build the company’s pipeline and drive innovation.

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Rakuten Aspyrian also announced the appointment of Takashi Toraishi, Ph.D. as chief operating officer. Dr. Toraishi will oversee clinical trials and commercialization of Rakuten Aspyrian’s products, as well as manage the growth of the organization.

"With our Photoimmunotherapy platform, Rakuten Aspyrian holds tremendous potential to offer alternative options for treating cancer," said Mr. Mikitani. "As CEO, I will harness this potential as we build a fully integrated biopharmaceutical company with research, development and world-wide commercialization capabilities. Our mission is to develop and commercialize a strong pipeline of treatment options based on Photoimmunotherapy to create a new platform for cancer treatments."

Mr. Mikitani joined the company as chairman in 2016 and has provided strategic direction and investment to support its corporate and clinical development. He is also the Chairman and CEO of Rakuten, Inc. [RKUNF], a leading Japanese global innovation company in e-commerce, communications and fintech, with the mission to contribute to society by creating value through innovation and entrepreneurship. Rakuten is also recognized as the Official Innovation and Entertainment Partner of one of the world’s most admired soccer clubs, FC Barcelona, as well as the jersey partner of NBA Champions, the Golden State Warriors.

Mr. Mikitani was awarded the Legion of Honour by the French government in recognition of contributions to the economy and culture of France. He also serves on the boards of the Tokyo Philharmonic Orchestra and Lyft, Inc. Mr. Mikitani received his B.A. of Commerce at Hitotsubashi University in Tokyo and his MBA at Harvard Business School. At Harvard, he was awarded the Alumni Achievement Award, one of the school’s highest honors.

Prior to his appointment as chief operating officer, Dr. Toraishi led operations as president of Rakuten Aspyrian Japan. Previously he was president of new service development company at Rakuten, Inc., where he spearheaded company-wide innovation initiatives and multiple joint ventures, shared economy and other companies. For nine years, Dr. Toraishi worked with McKinsey & Company, Tokyo, completing his tenure as partner and consultant to global medical device and equipment companies. He started his career as an assistant professor of engineering at the University of Tokyo and led the nuclear chemistry division of the Japan Atomic Energy Agency. Dr. Toraishi received his B.A. of Engineering and his Master of Engineering at the University of Tokyo, his Licentiate of Engineering, Nuclear Chemistry at the Royal Institute of Technology at Stockholm, as well as his Ph.D. in Nuclear Chemistry from the University of Tokyo.

On November 15, 2018 DCprime bv, a clinical stage biotechnology company focused on cancer immunotherapies, reported that the first patient has been dosed with DCP-001 in a phase 2 study, called ADVANCE-II (Press release, DCPrime, NOV 15, 2018, View Source [SID1234531456]). Patients with Acute Myeloid Leukemia (AML) in complete remission after induction therapy but with persistence of measurable residual disease (MRD) will be included in this multi-centre study. Effects on MRD and cellular and humoral immune responses will be monitored to evaluate the efficacy of this cancer vaccine.

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Prof Dr Arjan van de Loosdrecht, Amsterdam UMC, VU University Medical Center, The Netherlands commented: "We are very glad that the first patient was treated with the DCP-001 vaccine in the ADVANCE-II study. This is an important study to show the potential efficacy of this cancer vaccine in patients who have measurable residual disease and are at great risk of disease relapse."

The study is currently open for recruitment of patients in The Netherlands and Germany, with additional request for regulatory approval in Norway, Sweden and Finland pending.

Dr Jeroen Rovers, Chief Medical Officer at DCprime added: "Start of the phase 2 study marks an important step for DCprime in development of its technology. It will provide additional evidence whether DCP-001 can initiate immunological control of aggressive cancers, such as AML. We are grateful to all investigators and patients committed to contribute to this study."

Last month data from the phase 1 study with DCP-001 in AML were published in Cancer Immunology, Immunotherapy (van de Loosdrecht, A.A., van Wetering, S., Santegoets, S.J.A.M. et al. Cancer Immunol Immunother (2018) 67: 1505.).

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]).

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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.

On November 15, 2018 MorphoSys and I-Mab Sign Strategic Partnering Agreement for MorphoSys’s Novel Immuno-Oncology Agent MOR210 (Press release, MorphoSys, NOV 15, 2018, View Source [SID1234531391])

MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) and I-Mab Biopharma ("I-Mab"), a biotech company focusing exclusively on innovative biologics in immuno-oncology and autoimmune diseases, jointly announced today that they have entered into an exclusive strategic collaboration and regional licensing agreement for MOR210. MOR210 is MorphoSys’s proprietary, preclinical-stage antibody directed against C5aR, which has potential to be developed as an immuno-oncology agent. I-Mab will have exclusive rights to develop and commercialize MOR210 in China, Hong Kong, Macao, Taiwan and South Korea, while MorphoSys will retain rights in the rest of the world. The agreement deepens the existing partnership between the two companies, building upon the ongoing collaboration on MorphoSys’s anti-CD38 antibody MOR202.

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Under the terms of the agreement, I-Mab will exercise its exclusive license rights for development and commercialization of MOR210 in its territories. With support from MorphoSys, I-Mab will perform and fund all global development activities for MOR210, including clinical trials in China and the U.S., towards clinical proof-of-concept (PoC) in oncology.

MorphoSys will receive an upfront payment of USD 3.5 million from I-Mab and will be eligible for development and commercial milestone payments of up to USD 101.5 million, as well as tiered, mid-single-digit royalties on net sales of MOR210 in I-Mab’s territories. In return for the execution of a successful clinical proof-of-concept study, I-Mab is eligible to receive low-single-digit royalties on net sales generated with MOR210 outside its territories and a tiered percentage of sub-licensing revenue.

"This deal builds on our excellent existing relationship with I-Mab for MOR202. We are delighted to grant rights for MOR210 in the Chinese region to I-Mab and enable them to conduct clinical proof-of-concept studies while we focus on other priorities", said Dr. Simon Moroney, Chief Executive Officer of MorphoSys. "The deal takes advantage of our very close working relationship to the benefit of both companies".

"The release of immune checkpoint blockades within the tumor has become a successful strategy to fight cancers. MOR210 is a novel immuno-oncology asset directed against C5aR made by MorphoSys. By adressing this target molecule, we seek to modulate the tumor microenvironment. We look forward to seeing I-Mab drive this interesting program forward into clinical studies, while we retain rights to continue development of MOR210 outside of I-Mab’s territories after clinical proof of concept," commented Dr. Markus Enzelberger, Chief Scientific Officer of MorphoSys AG.

"This agreement is part of our continued efforts to develop innovative biologics with First-in-Class and Best-in-Class potentials," said Dr. Jingwu Zang, Chief Executive Officer of I-Mab. "Through partnership with global innovative companies such as MorphoSys, we expand our innovative oncology portfolio to address unmet medical needs in China and jointly develop drug candidates for the world."

"We look forward to deepening our productive partnership with MorphoSys. We are thrilled to pursue the therapeutic potential of MOR210 with the ultimate goal of translating it into a new treatment option for patients in immuno-oncology," Zang added.

About MOR210 and C5aR
MOR210 is a preclinical-stage human antibody directed against C5aR derived from MorphoSys’s HuCAL Platinum(R) technology. C5aR, the receptor of the complement factor C5a, is investigated as a potential new drug target in the field of immuno-oncology and autoimmune diseases. Tumors have been shown to produce high amounts of C5a which, by recruiting and activating myeloid-derived suppressor cells (MDSCs), is assumed to contribute to an immune-suppressive pro-tumorigenic microenvironment. MOR210 is intended to block the interaction between C5a and its receptor, thereby being expected to neutralize the immune suppressive function of the MDSCs and to enable immune cells to attack the tumor.

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).

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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.