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.

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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."

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.

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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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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]).

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"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.

On April 4, 2018 Arvinas LLC, a private biotechnology company creating a new class of drugs based on protein degradation, reported the closing of a $55 million Series C financing (Press release, Arvinas, APR 4, 2018, View Source [SID1234529237]). The financing was led by new investor Nextech Invest, with participation from additional new investors Deerfield Management, Hillhouse Capital, and Sirona Capital. All existing investors also participated in this financing round, including Canaan Partners, 5AM Ventures, RA Capital Management, OrbiMed, and New Leaf Venture Partners.

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Proceeds from the financing will support the advancement of the Company’s two lead programs toward clinical investigation. The two programs, which target the androgen receptor for castration resistant prostate cancer and the estrogen receptor for ER+ positive breast cancer, both nominated orally available clinical candidates in the fourth quarter of 2017. These proceeds will also advance the Company’s early stage oncology pipeline, CNS pipeline, and efforts on undruggable targets.

"This past year has been exciting for us with two clinical candidate nominations, the expansion of our collaboration with Genentech and the announcement of a new collaboration with Pfizer," said John Houston, Ph.D., President and Chief Executive Officer of Arvinas. "With this additional financial support from existing and new investors who believe in our innovative protein degradation platform, we will continue executing on our strategy of progressing our lead programs to the clinic, expanding the use of the platform outside of oncology, and tackling undruggable targets."

In connection with the financing, Jakob Loven, Ph.D., partner with Nextech Invest, will join the Arvinas board of directors.

"The Arvinas PROTAC platform is an elegant, novel therapeutic modality that circumvents delivery challenges associated with existing therapeutic approaches to eliminate protein function, and Arvinas has proven to be the clear leader in developing a new era of targeted medicines using its protein degradation technology," said Dr. Loven.

The Company’s PROTAC Platform offers potential improvements over traditional small molecule inhibitors by using the cell’s natural and selective ubiquitin proteasome system to degrade disease-causing proteins. By removing target proteins directly rather than simply inhibiting them, PROTACs can provide multiple advantages over small molecule inhibitors which can require high systemic exposure to achieve sufficient inhibition, often resulting in toxic side effects and eventual drug resistance. With multiple protein targets, Arvinas’ PROTAC platform has demonstrated that a transient binding event at a range of binding sites and affinities can translate into very potent degradation of the target protein.

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