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 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

On April 4, 2018 Molecular Partners AG (ticker: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin therapies*, reported that new pre-clinical data from two of its pipeline candidates, MP0310 and its lead proprietary oncology drug MP0250, as well as the DARPin toolbox will be presented at the Annual Meeting 2018 of the American Association of Cancer Research (AACR) (Free AACR Whitepaper) in Chicago (Press release, Molecular Partners, APR 4, 2018, View Source [SID1234525191]).

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MP0310 targets simultaneously 4-1BB and FAP and is the first of a series of tumor-restricted agonists that only activate immune cells in the tumor and not in the rest of the body thereby allowing full activation and potentially opening the therapeutic window for combinations.

MP0250 is a phase 2 multi-DARPin candidate targeting simultaneously VEGF and HGF, two prominent escape pathways, and has the potential to reverse resistance that has built to standard of care cancer therapies.

The four abstracts to be presented include the most recent pre-clinical data of MP0310 as well as the rationale of MP0250 in EGFR mutated NSCLC (Non-small Cell Lung Cancer).

"We are very pleased with the progress of our portfolio showcasing the innovation power of the DARPin technology in the multi-specific biologics space," commented Michael T. Stumpp, Chief Scientific Officer. "With MP0250 and MP0310, we are moving forward with two candidates that have the potential to add significant patient benefit and support existing therapies."

The data will be presented in the following sessions under the following titles:

MP0310:
Tuesday, 17 April 2018, 8.00 am: PO.IM02.07 – Immunomodulatory Agents and Interventions 1: 3752 / 2 – Preclinical pharmacology of MP0310: A 4-1BB/FAP bispecific DARPin drug candidate promoting tumor-restricted T-cell co-stimulation (Link et al.)
Tuesday, 17 April 2018, 8.00 am: PO.TB07.01 – Cancer Imaging: Immunology and Systems Analysis in Vivo: 3029 / 2 – FAP-mediated tumor accumulation of a T-cell agonistic FAP/4-1BB DARPin drug candidate analyzed by SPECT/CT and quantitative biodistribution
(Reichen et al.)
Portfolio:
Tuesday, 17 April 2018, 1.00 pm: PO.CL06.05 – Immune Checkpoints 4: 4552 / 7 – Tumor-restricted immune modulation by multispecific molecules from the DARPin toolbox (Fiedler et al.)
MP0250:
Tuesday, 17 April 2018, 1.00 pm: PO.CT05 – Phase I/II, II, and III Trials in Progress: CT149 / 1 – MP0250, a VEGF- and HGF-blocking multi-DARPin drug candidate, in combination with tyrosine-kinase-inhibitors targeting EGFR-mutated NSCLC: Preclinical rationale and phase Ib/II study outline (Kiemle-Kallee et al.)
Full details on the Molecular Partners’ sessions at AACR (Free AACR Whitepaper) 2018 as well as all presentations can be found here. Following their presentation at the AACR (Free AACR Whitepaper), the posters will also be available one the Molecular Partners website.

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates are potent, specific, safe and very versatile. They can engage in more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapies have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin drug candidates in oncology. The most advanced global product candidate is abicipar, a molecule currently in Phase 3, in partnership with Allergan.

Several DARPin molecules for various ophthalmic indications are also in development. The most advanced systemic DARPin molecule, MP0250, is in Phase 1 clinical development for the treatment of solid tumors and in Phase 2 development for hematological tumors. In addition, Molecular Partners intends to further evaluate MP0250 for solid tumors in a phase 1b/2 trial for EGFR-mutated NSCLC. MP0274, the second-most advanced DARPin drug candidate in oncology, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 has moved into Phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin is a registered trademark owned by Molecular Partners AG.

On April 4, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and DarwinHealth reported they have entered into a research agreement providing Daiichi Sankyo with exclusive access to DarwinHealth’s proprietary novel cancer target database in order to identify potential new targets for cancer drug development (Press release, Daiichi Sankyo, APR 4, 2018, View Source [SID1234525189]).

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DarwinHealth’s proprietary database and technology were created to identify critical mechanisms linked to tumor dependencies and maintenance beyond genetic mutations, and include information on Master Regulators of specific tumor subtypes, as well as direct upstream modulators (both necessary for cancer cell maintenance) across more than 35 tumor and 90 tumor subtypes.

"The purpose of this agreement is to identify novel, high-value cancer targets that can subsequently be prioritized and undergo rigorous experimental validation to drive drug development for a new generation of anti-cancer therapies that would be designed, developed, and owned by Daiichi Sankyo," said Gideon Bosker, MD, Chief Executive Officer, DarwinHealth.

DarwinHealth will receive an upfront payment and has the potential to receive development and commercialization milestone payments should specified events occur relating to DarwinHealth’s novel cancer targets. Daiichi Sankyo will receive exclusive access to DarwinHealth’s novel cancer target database for a predetermined amount of time with an option to extend. Financial terms of the agreement were not disclosed.

We believe that the combination of both molecular and computational techniques used by DarwinHealth coupled with the expertise of our scientists in designing small molecules and antibodies may offer a disruptive approach to accelerating the discovery of precision-medicine cancer compounds," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "This new agreement is a natural next step in expanding our current ongoing translational research collaboration and we look forward to working with DarwinHealth to further science to create meaningful treatments for patients with cancer."

"The novel cancer targets will be selected and prioritized based on their role as either Master Regulators (MRs) or their most specific Master Regulator Upstream Modulators (MRUMs) within a tumor-specific checkpoint module," said Professor Andrea Califano, Co-Founder and Chairman of Scientific and Medical Advisory Board, DarwinHealth. "Therefore, they are expected to represent highly valuable targets for anti-tumor therapy, cancer drug design, and preclinical development."