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Boehringer Ingelheim and OSE Immunotherapeutics Announce Global Immuno-Oncology Partnership to Develop a Pioneering Checkpoint Inhibitor for the Treatment of Advanced Solid Tumors

On April 4, 2018 Boehringer Ingelheim and OSE Immunotherapeutics, a biotechnology company focused on the development of innovative immunotherapies, reported a collaboration and exclusive worldwide collaboration and license agreement to jointly develop OSE-172, a SIRP-alpha antagonist targeting myeloid lineage cells (Press release, Boehringer Ingelheim, APR 4, 2018, View Source [SID1234525184]).

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SIRP-alpha is a receptor expressed by myeloid lineage cells such as Dendritic Cells (DCs), tumor-associated macrophages (TAMs) and Myeloid-Derived Suppressor Cells (MDSCs). In targeting SIRP- alpha, OSE-172 prevents the ligand CD47 from binding to and triggering the cellular inhibitory effects of SIRP-alpha. OSE-172 has the potential to enhance anti-tumor immunity by improving T cell activity through enhancement of DC antigen presentation functionality, potentiating the phagocytic and inflammatory properties of macrophages in the tumor microenvironment and enabling differentiation of MDSCs to an effector state.

"This partnership with Boehringer Ingelheim is a real recognition of the value of our innovative approach to treating cancer and will create an exciting new alliance to fuel the phase 1 development of OSE-172," said Dr. Dominique Costantini, CEO of OSE Immunotherapeutics. "Boehringer Ingelheim’s expertise and insights will be invaluable as we step up the clinical development and work to commercialize this new treatment paradigm."

"We are excited to partner with OSE Immunotherapeutics to develop this promising, novel cancer immunotherapy," said Jonathon Sedgwick, Ph.D., Global Head Cancer Immunology & Immune Modulation Research at Boehringer Ingelheim. "A key area of focus is the identification of drugs that target myeloid cell immune regulatory receptors of which SIRP-alpha is a leading example. We are dedicated to developing ground-breaking, first-in-class therapies that can transform the lives of patients and help win the fight against cancer."

Boehringer Ingelheim has acquired the global rights to develop, register and commercialize OSE-172, a monoclonal antibody targeting SIRP-alpha which is expressed in myeloid lineage cells, as part of their continued commitment to research and innovation in immuno-oncology. Under the terms of the agreement, OSE Immunotherapeutics will receive a €15 million upfront payment from Boehringer Ingelheim, and potential additional short-term milestones of up to €15 million upon initiation of a phase 1 clinical study. OSE Immunotherapeutics stands to receive more than €1.1 billion upon reaching pre-specified development, commercialization and sales milestones, plus royalties on worldwide net sales

NextCure Appoints Kevin N. Heller, M.D., as Chief Medical Officer and Steve Cobourn, CPA, as Chief Financial Officer

On April 4, 2018 NextCure, Inc. reported the appointment of Kevin N. Heller, M.D., as Chief Medical Officer and Steve Cobourn, CPA, as Chief Financial Officer (Press release, NextCure, APR 4, 2018, View Source [SID1234525183]).

"Kevin’s experience in clinical development of novel immune checkpoint therapeutics will provide great value to NextCure as we enter the clinic later this year with NC318, a first-in-class candidate," added Mr. Richman. "Steve brings significant expertise in financial management of biopharmaceutical companies and his leadership will be invaluble to NextCure."

Most recently Dr. Heller was Vice President, Head of mAb Clinical Development, Immuno-Oncology at Incyte Corporation where he led the clinical development of Incyte’s monoclonal antibody programs for cancer immunotherapy. He was also Chair of Incyte’s Immunotherapy Strategy Team. Prior to joining Incyte, Dr. Heller was the Senior Medical Director for Oncology at AstraZeneca where he led late stage clinical development programs. Dr. Heller also held various positions at Bristol-Myers Squibb (BMS) where he was Director, US Medical Lead for Ipilimumab and Global Lead, Oncology, Strategic Transactions Group. He received his M.D. from George Washington University and B.S. in Molecular Biophysics & Biochemistry from Yale University.

Mr. Cobourn has more than 20 years of experience in life sciences including financing, product launches, alliances, and operations. Previously, he was the Chief Financial Officer of Vaccinex, Inc., a privately held clinical-stage biotechnology company. Prior to joining Vaccinex, Mr. Cobourn was Vice President of Finance, Treasurer, and Corporate Officer of Otsuka America Pharmaceutical, Inc., the U.S. division of publicly traded Otsuka Holdings Co., Ltd. During his tenure, he participated in overseeing the growth of revenue from Otsuka’s U.S. operations from $10 million to $5 billion. He received his B.S. in Business Administration from Drexel University and is a Certified Public Accountant in the State of Pennsylvania.

IONTAS and IGEM Therapeutics Collaborate to Identify Novel IgE Antibodies for Cancer Targets

On April 4, 2018 IONTAS Limited (IONTAS), a leader in the discovery and optimisation of fully human antibodies, reported that it will collaborate with IGEM Therapeutics (IGEM), an immuno-oncology company developing novel immunoglobulin E (IgE) antibodies to treat cancer (Press release, Iontas, APR 4, 2018, View Source [SID1234525182]). The project will add to IGEM’s pipeline of drugs and expand upon IGEM-F, an IgE targeting ovarian and other cancers, currently in a Phase 1/2a study. IONTAS will utilise its proprietary antibody discovery technology to help IGEM identify novel IgE antibodies against two targets.

IgE antibodies have been shown to permeate tumour tissue more effectively, exhibit enhanced effector functions and stimulate significantly greater levels of cytotoxicity and phagocytosis than IgG antibodies. IONTAS will apply its proprietary antibody discovery libraries and technologies to identify specific, high-affinity antibodies against two tumour-associated targets. Functional screening of IgE-formatted antibodies will be carried out to identify the most appropriate candidates for therapeutic development.

John McCafferty, CEO at IONTAS, commented: "This collaboration capitalises on the antibody discovery capabilities at IONTAS which enable the generation of high-quality therapeutic antibodies using phage-display or mammalian-display. We maintain a strong interest in developing novel therapeutic approaches and recognise IgE therapeutics as an important addition to the armoury of novel cancer therapies. We are delighted to have the opportunity to work with fellow innovators at IGEM on these two exciting projects."

Tim Wilson, CEO at IGEM, commented: "IONTAS was selected as our development partner of choice because of their extensive experience and track record in delivering therapeutic antibodies. The combination of the IGEM IgE platform and the discovery capability of IONTAS will rapidly expand our portfolio of antibodies and help meet our ambitions to progress new leads into the clinic."

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VACCIBODY AS ANNOUNCES INFORMED CONSENT SIGNED BY FIRST PATIENT AND ENROLMENT PROCESS INITIATED IN THE CANCER NEOANTIGEN PHASE I/IIA CLINICAL TRIAL.

On April 4, 2018 Vaccibody AS, a clinical stage immunotherapy company focused on developing personalized neoantigen cancer vaccines to target solid tumors, reported that informed consent signed by the first patient and enrolment process initiated in the clinical trial. (Press release, Vaccibody, APR 4, 2018, View Source [SID1234525180]) The patient will be enrolled in Heidelberg, Germany at the National Center for Tumor Diseases by principal investigator, Prof. Dr. med. Jürgen Krauss, Head of Section for Clinical Immunotherapy.

Prof. Dr. med. Jürgen Krauss, said, "We are very pleased to have initiated this clinical phase I/IIa for Vaccibody’s neoantigen vaccine. The neoantigen vaccine holds the potential to assist the patient’s immune system to generate specific T-cell responses to its individual cancer neoantigens and in this way may help the patient to more effectively fight the cancer. We hope this clinical trial will help pave the way for a novel class of new efficacious and safe treatment for cancer patients."

Mads Axelsen, MD, Chief Medical Officer in Vaccibody, said "We are proud and very pleased to work with so experienced cancer experts in this trial as Prof. Jürgen Krauss from Heidelberg, Prof. Angela Krackhardt from Munich and Prof. Elke Jäger from Frankfurt. This first-in-man trial is planned to enroll up to 40 patients with locally advanced or metastatic non-small cell lung cancer, melanoma, renal, bladder or head and neck cancer. The VB10.NEO vaccine will be given in combination with standard of care checkpoint inhibitors as a new treatment modality to help patients with cancer."

Dr. Agnete Fredriksen, President and Chief Scientific Officer in Vaccibody, commented "The first patient marks an important new phase in Vaccibody and we are very excited to start to tailor-make one vaccine per patient using our proprietary vaccination technology. The unique ability to induce strong CD8 T cell responses to multiple neoepitopes that we have observed in preclinical models, in addition to the manufacturing advantages essential for individualized vaccines, are basis for our enthusiasm moving this concept into clinical trials."

Siamab Therapeutics to Present New Data on its ST1 Antibody Therapeutic Program Targeting Tumor-Associated STn and STn+ Myeloid Derived Suppressor Cells at the AACR Annual Meeting 2018

On April 4, 2018 Siamab Therapeutics, Inc., a biopharmaceutical company developing novel glycan-targeted cancer therapeutics, reported that it will present new research findings for its ST1 monoclonal antibody (mAb) therapeutic program during a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018, being held April 14-18, 2018, at McCormick Place in Chicago (Press release, Siamab Therapeutics, APR 4, 2018, View Source [SID1234525179]). Myeloid derived suppressor cells (MDSCs) are shown to express Sialyl-Tn (STn) across a wide range of patient tumor samples and may therefore represent an optimal therapeutic target for the ST1 program. MDSCs are major regulators of the tumor anti-immune response that act by suppressing T cells. Ovarian xenograft model data will be presented that further demonstrates the potential for targeting STn+ MDSCs with ST1 in a clinical setting. ST1, Siamab’s lead program, is in late stage preclinical development formatted as an antibody drug conjugate (ADC) for the treatment of STn-expressing solid tumors.

"We are pleased to present new patient tumor data and ovarian carcinoma xenograft data for our ST1 antibody drug conjugate targeting STn at the AACR (Free AACR Whitepaper) 2018 annual meeting," said Jeff Behrens, president and chief executive officer of Siamab. "These research findings are exciting as they continue to show that STn provides a uniquely glycan-specific target for the treatment of solid tumors. Importantly, the findings demonstrate that our antibody therapeutic targeting STn offers the potential to go beyond tumor targeting to also directly target and deplete immune-suppressive MDSCs, enabling immune system re-engagement and increasing the potential for better patient outcomes."

The poster presentation will highlight new data showing the presence of STn on the surface of MDSCs in a growing body of patient tumor samples, as well as data in patients and xenograft models linking STn expression on MDSCs to tumor cell STn expression. In addition, the poster will highlight data that demonstrates depletion of STn+ MDSCs after treatment with an anti-STn ADC in an ovarian carcinoma xenograft model.

Details for the poster presentation are as follows:

Abstract Title and Number: Myeloid derived suppressor cells (MDSCs) express Sialyl Tn (STn) and are a therapeutic target for anti-STn antibody drug conjugates (#6892)
Date: Wednesday, April 18, 2018
Time: 8:00 a.m.-12:00 p.m. CT
Session Title: Therapeutic Antibodies, including Engineered Antibodies 4
Location: McCormick Place, Poster Section 28
Poster Board Number: 20

Siamab’s proprietary technology platform enables the development of highly specific mAb therapeutics, including ADCs, targeting cancer cell surface glycans called tumor-associated carbohydrate antigens (TACAs). TACAs are an emerging set of tumor specific antigens implicated in immune suppression, chemoresistance and a cancer stem cell (CSC) phenotype. STn, the sialylated version of the carbohydrate Tn antigen, is broadly expressed in human cancers including ovarian, gastric, colon, prostate, pancreatic and lung. The presence of STn in tumors is associated with metastatic disease, poor prognosis, and reduced overall survival. Tumor STn expression is well-established and can be leveraged for targeted cancer therapy; however, its expression on immuno-suppressive tumor infiltrating lymphocytes, such as MDSCs, is a new finding. Siamab has identified and utilized the presence of STn on MDSCs to target and deplete MDSCs in vivo, providing a potential novel therapeutic approach for the treatment of solid tumors.

A copy of the poster will be made available on the company’s website after the presentation.