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 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."

On April 4, 2018 AstraZeneca and MedImmune, its global biologics research and development arm, reported it will present updates from their early and late stage oncology pipelines at two major congresses this month. In total, 98 abstracts were accepted for the European Lung Cancer Conference (ELCC) in Geneva,11-14 April, and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Chicago,14-18 April (Press release, AstraZeneca, APR 4, 2018, View Source [SID1234525172]). The abstracts cover key data updates from the Phase III FLAURA and PACIFIC trials in non-small cell lung cancer (NSCLC), and the Phase III OlympiAD trial in BRCA-mutated metastatic breast cancer. They also highlight promising next-generation research from the company’s extensive pipeline in DNA damage response, Immuno-Oncology and Tumour Drivers & Resistance.

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Dave Fredrickson, Executive Vice President, Head of Oncology Business Unit said: "Building on major regulatory approvals in the first quarter of 2018, AstraZeneca continues to deliver strong results from our innovative science and accelerated development programmes in oncology. At ELCC, we are sharing new data from two pivotal trials in lung cancer that will help inform treatment strategies for patients who, until now, have had very few options. At the AACR (Free AACR Whitepaper) meeting, we will share pioneering early science across multiple tumour types."

ELCC

As part of the ‘Best of ELCC’ sessions, AstraZeneca will present post-progression outcomes from the FLAURA trial of Tagrisso versus the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) erlotinib or gefitinib in 1st-line EGFR mutation-positive NSCLC (Abstract #128O). In addition, patient-reported outcomes data will also be presented from the FLAURA trial, showing improvements in key symptoms, supporting the potential use of Tagrisso in this setting (Abstract #139PD).

Patient-reported outcomes will be presented from the PACIFIC trial of Imfinzi in unresectable, Stage III NSCLC (Abstract #703), following its approval in the US for this indication.

AACR annual meeting

DNA Damage Response (DDR)

AstraZeneca will present data on its expanded portfolio of potential medicines which exploit DDR dependencies to selectively kill cancer cells across multiple tumour types. The first-in-class PARP inhibitor, Lynparza, will report final overall survival data from the pivotal OlympiAD trial in BRCA-mutated metastatic breast cancer (Abstract #CT038). Data exploring the clinical properties of Lynparza and four other PARP inhibitors will illustrate clinical efficacy and safety profiles (Abstract #LB-273/17).

New data will also be presented on AZD6738, an Ataxia Telangiectasia and Rad3-related (ATR) inhibitor (Abstracts #CT026/19, #LB-263/7 and #337/18) and AZD0156, a first-in-class inhibitor of Ataxia telangiectasia mutated (ATM) (Abstract #4909/5).

Immuno-Oncology (IO)

A series of presentations will share new insights into the science of Imfinzi, including IO-IO combination data from Study 006 (Abstract #CT113) and Study 10 (Abstract #CT113) in 2nd-line NSCLC patient populations.

Beyond Imfinzi, MedImmune will feature progress in its early IO pipeline, including the novel bispecific antibody MEDI5752, designed to target dual checkpoints on immune cells and leverage the synergistic potential of combined mechanisms in immunotherapy (Abstract #2776/9).

Tumour Drivers & Resistance

Data on AZD4573, a CDK9 inhibitor, will demonstrate rapid cell-death induction in haematological tumour models through depletion of MCL1 (Abstract #310/17). And early monotherapy and combination data on the novel ERK inhibitor AZD0364, (Abstract #1647/2) will show its effect on KRAS-mutated tumours when used in combination with MEK inhibitor, selumetinib (Abstract #1856/14).

Crowd-sourcing combinations

AstraZeneca is presenting the results of the DREAM challenge, an open competition combining crowd-sourcing and the application of machine learning to generate new algorithms that predict the best therapeutic combinations for treating different types of cancer (Abstract #3886/5).

AstraZeneca/MedImmune key presentations at ELCC 2018

Lead author

Abstract title

Presentation details

Tagrisso (osimertinib)

Planchard D et al.

Osimertinib vs standard of care (SoC) EGFR-TKI as first-line therapy in patients (pts) with untreated EGFRm advanced NSCLC: FLAURA post-progression outcomes

ORAL

Abstract #128O

ESMO-IASLC Best Abstracts

Friday, 13 April

5:30-5:45pm

Room B

Leighl N et al.

Patient-reported outcomes from FLAURA: osimertinib versus standard of care (SoC) epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) in patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC)

POSTER DISCUSSION

Abstract #139PD

Thursday, 12 April

8:07am

Room A

Imfinzi

Hui R et al.

Time to deterioration of symptoms with durvalumab in Stage III, locally advanced, unresectable NSCLC: post-hoc analysis of PACIFIC patient-reported outcomes

ORAL

Abstract #703

ESMO-IASLC Best Abstracts

Friday, 13 April

3:00-5:00pm TBD

AstraZeneca/MedImmune key presentations at AACR (Free AACR Whitepaper) 2018 Annual Meeting

Lead author

Abstract title

Presentation details

DNA Damage Response

Robson M et al.

Lynparza

OlympiAD final overall survival: Olaparib versus chemotherapy treatment of physician’s choice (TPC) in patients with HER2-negative metastatic breast cancer (mBC) and a germline BRCA mutation (gBRCAm)

ORAL

Abstract #CT038

Session CTMS01 – New Treatment Approaches for Breast and Ovarian Cancer

Sunday, 15 April

3:50-4:05pm

Room N427 (North, Level 4)

Chen Y et al.

Lynparza + ATM inhibitor

Adaptive oncology phase 1 study of first-in-class inhibitor of ataxia telangiectasia mutated protein kinase (ATM), in combination with olaparib

POSTER

Abstract #4909/5

Session PO.ET05.02 – Pharmacokinetics and Pharmacodynamics

Tuesday, 17 April

1:00-5:00pm

Hall A, Section 41

Krebs M et al.

Lynparza or Imfinzi + ATR inhibitor

Phase I study of AZD6738, an inhibitor of ataxia telangiectasia Rad3-related (ATR), in combination with olaparib or durvalumab in patients (pts) with advanced solid cancers

POSTER

Abstract #CT026/19

Session PO.CT01 – Phase I Clinical Trials 1

Sunday, 15 April

1:00-5:00pm

Hall A, Section 42

Leo E et al.

Lynparza

A head-to-head comparison of the properties of five clinical PARP inhibitors identifies new insights that can explain both the observed clinical efficacy and safety profiles

POSTER

Abstract #LB-273/17

Session LBPO.ET03 – Late-Breaking Research: Experimental and Molecular Therapeutics 3

Tuesday, 17 April

1:00-5:00pm

Hall A, Section 43

Lloyd R et al.

Lynparza + ATR inhibitor

The PARP inhibitor olaparib is synergistic with the ATR inhibitor AZD6738 in ATM deficient cancer cells

POSTER

Abstract #337/18

Session PO.MCB07.03 – Cancer Predisposition and Synthetic Lethality

Sunday, 15 April

1:00-5:00pm

Hall A, Section 15

Young LA et al.

Calquence + ATR inhibitor

Pre-clinical efficacy of AZD6738 in combination with the Bruton’s tyrosine kinase inhibitor, Calquence (acalabrutinib), in models of activated B-cell like diffuse large B-cell lymphoma (DLBCL)

POSTER

Abstract #LB-263/7

Session LBPO.ET03 – Late-Breaking Research: Experimental and Molecular Therapeutics 3

Tuesday, 17 April

1:00-5:00pm

Hall A, Section 43

Immuno-Oncology

Balar A et al.

Durvalumab + tremelimumab in patients with metastatic urothelial cancer

ORAL

Abstract #CT112

Session CTMS02 – Updates in Immuno-oncology Trials

Monday, 16 April

3:35-3:50pm

N Hall C

Chaft J et al.

Phase 1b dose-expansion study of the safety and antitumor activity of durvalumab plus tremelimumab in pretreated advanced NSCLC

ORAL

Abstract #CT113

Session CTMS02 – Updates in Immuno-oncology Trials

Monday, 16 April

3:50-4:05pm

N Hall C

Dovedi SJ et al.

MEDI5752: A novel bispecific antibody that preferentially targets CTLA-4 on PD-1 expressing T-cells

POSTER

Abstract #2776/9

PO.IM02.11 – Therapeutic Antibodies, Including Engineered Antibodies 2

Monday, 16 April

1:00-5:00pm

Hall A, Section 34

O’Donnell P et al.

Updated efficacy and safety profile of durvalumab monotherapy in urothelial carcinoma

POSTER

Abstract #CT031/24

Session PO.CT01 – Phase I Clinical Trials 1

Sunday, 15 April

1:00-5:00pm

Hall A, Section 42

Tumour Drivers & Resistance

Ortiz-Cuaran S et al.

Longitudinal circulating-tumour DNA profiling of EGFR-mutated non-small cell lung cancer patients treated with EGFR-tyrosine kinase inhibitors

ORAL

Abstract #937

Session MS.CL10.01 – Liquid Biopsy 1

Sunday, 15 April

3:20-3:35pm

McCormick Place South (Level 1), Room S105

Cidado J et al.

AZD4573, a novel CDK9 inhibitor, rapidly induces cell death in haematological tumour models through depletion of Mcl1

POSTER

Abstract #310/17

Session PO.MCB02.01 – BCL-2 Family and Mitochondrial Apoptosis

Sunday, 15 April

1:00-5:00pm

Hall A, Section 14

Flemington V et al.

Combination of the novel ERK inhibitor AZD0364 with the MEK inhibitor selumetinib significantly enhances antitumour activity in KRAS mutant tumour models

POSTER

Session PO.ET02.03 – Cell Cycle, Drug Resistance, and Combinations

Abstract #1856/14

Monday, 16 April

8:00am-12:00pm

Hall A, Section 37

Simpson I et al.

Discovery of AZD0364, a potent and selective oral inhibitor of ERK1/2 that is efficacious in both monotherapy and combination therapy in models of NSCLC

POSTER

Abstract (#1647/2)

Session PO.CH01.01 – Target Based Drug Discovery

Monday, 16 April

8:00am-12:00pm

Hall A, Section 30

Innovative Methodologies

Dry JR et al.

A large cancer pharmacogenomics combination screen powering crowd-sourced advancement of computational drug synergy predictions

ORAL

Abstract #3886/5

Session PO.ET05.01 – Pharmacogenetics and Pharmacogenomics

Tuesday, 17 April

8:00am-12:00pm

Hall A, Section 37*

*part of official press programme