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

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 DiaMedica Therapeutics Inc. ("DiaMedica") (TSX VENTURE:DMA) (OTCQB:DMCAF), reported that Mr. Rick Pauls, President and CEO, will present at The MicroCap Conference at the Essex House, 160 Central Park South New York on Tuesday April 10th at 12:30pm ET (Press release, DiaMedica, APR 4, 2018, View Source [SID1234525174]).

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The MicroCap Conference is an exclusive event for investors who specialize in small and microcap stocks. It is an opportunity to be introduced to and speak with management at some of the most attractive small companies, learn from various expert panels, and mingle with other microcap investors.

For more information please visit www.microcapconf.com.

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