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 Nordic Nanovector ASA (OSE: NANO) reported an update on its clinical development programme, including updated guidance on expected milestones for the pivotal PARADIGME trial, and its financial outlook (Press release, Nordic Nanovector, APR 4, 2018, View Source [SID1234553508]). A presentation by the company’s management team will take place tomorrow in Oslo at 10 am CEST, see details below.

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• A re-assessment of expected recruitment rates has led the company to revise its timelines for the pivotal PARADIGME Phase 2b trial with Betalutin in third line (3L) follicular lymphoma (FL) patients. Results from PARADIGME are targeted for 1H 2020 (previously 2H 2019) and first regulatory filing in 2020. The first patient is expected to be dosed in 1H 2018.

• The company will focus its resources towards PARADIGME and other Betalutin clinical programmes, which has led to the decision to postpone the start of the first-in-human clinical trial with Humalutin for the foreseeable future; this study was being prepared to start in 2H 2018.

• Guidance is unchanged for previously reported milestones for ARCHER-1 (Betalutin plus rituximab in second line FL; first patient dosed) and LYMRIT 37-05 (Betalutin in R/R diffuse large B cell lymphoma, DLBCL; preliminary data read-out), both anticipated in 2H 2018.

• Financial resources are expected to be sufficient to reach data read-out from PARADIGME

Lisa Rojkjaer MD, Nordic Nanovector CMO, said: "While we are encouraged with the progress being made to the start-up of the pivotal PARADIGME study, a re-analysis of the patient enrolment rate and the fact that it has taken longer than expected to enrol the first patient have led us to adjust the timelines we previously communicated. We now expect to deliver data from PARADIGME in the first half of 2020.

"The PARADIGME study reflects our conviction in the significant potential of Betalutin based on the promising clinical data generated to-date. We therefore remain committed to completing this robust study, which is designed to select the best dosing regimen to support Betalutin as an important new treatment option for 3L FL patients."

PARADIGME – clear focus for company

PARADIGME is a global randomised Phase 2b study comparing two Betalutin dosing regimens in 3L R/R FL patients, which have shown a promising clinical profile in the LYMRIT 37-01 Phase 1/2a trial. The pivotal PARADIGME study was initiated at the end of 2017 in Europe and the first patient is expected to be dosed during the first half of 2018. The trial is aiming to enrol 130 patients in 20 countries.

To date, PARADIGME is open for enrolment at 13 sites and in six countries.

In Norway, PARADIGME is pending approval and the company is working closely with the Norwegian regulators to address its questions.

In the USA, the Food & Drug Administration (FDA) has completed its review of the PARADIGME study and Nordic Nanovector expects US sites to be open for enrolment during mid-2018.

Humalutin – first human trials postponed

Nordic Nanovector was preparing a Phase 1 study of Humalutin, a novel 177Lu-conjugated chimeric anti-CD37 antibody, in NHL patients. The company previously guided that it expected to start this study in the second half of 2018. As a consequence of the revised timelines for PARADIGME and the need to conserve cash until data read-out, Nordic Nanovector has decided to put the Humalutin study on hold for the foreseeable future.

ARCHER-1 and LYMRIT 37-05 – on track

ARCHER-1 is a planned clinical study designed to evaluate the safety and efficacy of combining Betalutin with rituximab in second line (2L) FL patients. The company expects the first patient to be dosed in the second half of 2018 as previously guided.

LYMRIT 37-05 is an on-going Phase 1 study evaluating Betalutin in patients with R/R DLBCL. As previously guided, the company expects preliminary data read-out from this study in the second half of 2018.

Presentation and webcast

A presentation by Nordic Nanovector’s management team will take place tomorrow at 10 am CEST at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: Aker

The presentation will be recorded as a webcast and will be available, with the presentation, at www.nordicnanovector.com in the section: Investors & Media

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 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."