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.

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.

On November 15, 2018 INmune Bio, Inc., an immunotherapy company developing treatments to reprogram the patient’s innate immune system, reported that Lazar Vujanovic, Ph.D., a research instructor at the University of Pittsburgh, presented results from a preliminary study at the 33rd annual Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting on November 9 (Press release, INmune Bio, NOV 15, 2018, View Source [SID1234531521]). The results of the research conducted at the University of Pittsburgh, demonstrated the potential effectiveness of INB03TM, the company’s lead drug candidate in treatment of drug-resistant melanoma, which was developed from patented intellectual property licensed from the University of Pittsburgh.

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"The study’s findings indicate a potential shift in approach to how clinicians may treat patients who harbor treatment-resistant cutaneous melanomas by using TNF receptors as biomarkers," said Dr. Vujanovic. "These results, showing the effectiveness of biomarker-guided soluble TNF-targeting strategy, are an encouraging development in potentially raising the standard of care for patients with treatment-resistant melanoma, which kills thousands each year."

Soluble TNF (sTNF) is an immunologic protein that has multiple functions in the development of cutaneous melanoma, the deadliest form of skin cancer. In a cohort of patients, sTNF facilitates tumor growth and drug resistance. Dr. Vujanovic’s data shows that sTNF may induce drug resistance and suggests that some melanoma patients may benefit from neutralization of sTNF with a drug like INB03. As an innate immunotherapy drug currently in Phase I trials, INB03 is being used in patients to neutralizes sTNF using a novel Dominant-Negative TNF technology.

"At INmune Bio we believe that, when possible, a patient’s cancer therapy should be guided by biomarkers that can better predict a favorable response to therapy," said INmune Bio co-founder and CEO, Raymond J. Tesi, M.D. "Dr. Vujanovic’s work is an example of how laboratory studies are the foundation of important concepts that can alter the treatment of cancer patients."

SITC is one of the leading organizations for the exchanging of ideas and discovery in the cancer immunotherapy field.

On November 15, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, reported that management will participate at both the Bryan, Garnier & Co 6th European Healthcare Conference and the Piper Jaffray 30th Annual Healthcare Conference (Press release, Celyad, NOV 15, 2018, View Source [SID1234532509]).

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The Bryan, Garnier & Co 6th European Healthcare Conference will take place in Paris, France, on November 22-23, 2018. The Company will participate in investor meetings at the Conference.

The Piper Jaffray 30th Annual Healthcare Conference will take place in New York, NY on November 27-29, 2018 and the Company is scheduled to participate in a fireside chat on Tuesday, November 27 at 11:30 am Eastern Time. A live webcast of the discussion can be accessed here. An archived webcast recording will also be available under Events & Webcasts in the Investors section of the Company’s website.