Externally sponsored scientific research

Brand /
Substance

Mechanism
of action

ESR - Areas of interest

AZD1656

Make a submission

Glucokinase (GK; hexokinase 4) activator

• Preclinical reprotoxicology data are available and have not identified any specific risks. Women of child-bearing potential using highly effective contraception can be included
• Proposed indications should be evaluated against the risk of hypoglycaemia in non-diabetic subjects

AZD4017

Make a submission

11-beta-hydroxysteroid dehydrogenase type 1 (11ß-HSD1) inhibitor

• Preclinical reprotoxicology data is not available for this compound. The inclusion of women of child-bearing potential using highly effective contraception in trials of modest size and duration could be considered based on the risk benefit and in accordance with territory specific requirements
• Preclinical safety studies support future clinical studies of up to 3 months duration with the need for monitoring liver enzymes, thyroid, and adrenal function

Brilinta /
Brilique’s (ticagrelor)

Make a submission

ADP receptor antagonist

• Brilinta/Brilique in CAD-PMI, CAD-T2DM and AIS (acute ischemic stroke).

Forxiga / Farxiga
(dapagliflozin))

Make a submission

SGLT2 inhibitor

Exploring the Renal and Heart Failure benefits of Dapagliflozin

• Observational research in prevention, treatment and clinical management of kidney disease, heart failure or other cardiovascular diseases.

Other research focus areas will be considered so as not to restrict scientific creativity

Plendil

(Felodipine)

calcium antagonist

• Medical areas related to hypertension

Accepting proposals in China only (previous confirmation with Xi Zang Kang Zhe Pharmaceutical development Co., Ltd.) 

Sodium Zirconium Cyclosilicate (SZC)

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Oral, non-absorbed potassium binder

• Until Lokelma is authorised in the country of the applicant, we need to defer the endorsement of any clinical proposals. 
• Real World Evidence: local K binder data for reimbursement support; proof of concept data in transplant, CKD-5 non-dialysis care, or hepatic encephalopathy
• Clinical Data in:
  • Real-world use of SZC/K binders in CKD/DKD: management of HK to keep RAASi and impact on HCRU and patient outcomes.
  • Real-world use of SZC/K binders for the chronic treatment of HK: patient characteristics; dose prescribed; duration of treatment; frequency of K monitoring; HCRU, morbidity/mortality data, QoL/PROs, and safety data
  • Real-world use of SZC/K binders in stage 5 CKD patients who elect not to go on dialysis: impact of treatment on the burden of uremia (sK, ammonium and urea levels; QoL).
  • Real-world use of SZC/K binders in HF: management of HK to keep RAASi and impact on HCRU and patient outcomes.
  • COVID-19: Real-world use of SZC/K binders and impact on HD.

Renal disease (no substance or brand involved) 

Make a submission

NA

• Research to further development of regulatory endpoints in renal trials
• Research to support understanding of early disease progression, and how it relates to progression of disease
• Research to support understanding of fast progressors versus patients with slower prognoses
• Mechanistic and biomarker studies to further novel segmentation of chronic kidney disease, which is not biopsy dependent

Roxadustat

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Oral, hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)

Real World Evidence: local data generation to describe anaemia and its management, CKD.
 

Active drug trials with Roxadustat: will only be considered after Roxadustat is authorised in the country of the applicant. Areas of interest will be:

• Outcomes: effect on CKD progression, peri-dialysis, ESA hyporesponsiveness, hospitalisations, CV risk and transfusion avoidance, impact on lipid metabolism
• Special populations: inflammation, elderly, peritoneal dialysis, incident dialysis
• Patient reported outcomes: including QoL, and nutrition
• Economic value: Resource utilization, HR QoL, adherence and persistence
• Iron metabolism: IOral vs IV iron requirements and utilisation, Hemoglobin variability, Hepcidin levels, restless legs syndrome (RLS)
• Treatment patterns: evaluation of monitoring, treatment protocols, dosing regimens
• New insights in the mode of action: potential pleiotropic effects, biochemical pathways and clinical effects of Roxadustat focusing on kidney physiology and pathophysiology

Other research focus areas will be considered as to not restrict scientific creativity

Lesogaberan /
AZD3355

Make a submission

Gamma-aminobutyric
acid receptor B (GABAB) agonist

• Preclinical reprotoxicology data is available and has not identified any specific risks. Women of child-bearing potential using highly effective contraception can be included
• Given the potential effects on liver enzymes, dosing regimen (level and duration) as well as inclusion/exclusion criteria should be selected carefully to support a favourable risk-benefit.

Nexium (esomeprazole)

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PPI inhibitor

• Proposals for ESR will not be endorsed, unless if a major data gap has been identified
• Accepting proposals in Japan and China only

Brand /
Substance

Mechanism
of action

ESR - Areas of interest

AZD1222

Make a submission

• Understand impact of COVID-19 overall burden on communities, spectrum of disease in communities, and level of herd immunity.   
• Understand the impact of COVID-19 vaccination with AZD1222 (COVID-19 AstraZeneca Vaccine) in at-risk groups and vulnerable populations

We are currently not accepting any ESRs related to Long Acting Antibodies research

Fluenz Tetra /

FluMist

Quadrivalent

(LAIV/QLAIV)

Make a submission

Live attenuated influenza vaccine

• Please contact medical team before submitting a study proposal

Brand /
Substance

Mechanism
of action

ESR - Areas of interest

AZD0328

Make a submission

Nicotinic acetylcholine

receptor alpha 7

(a7 nAChR) agonist

• The reproductive toxicology package indicates a risk of fetal toxicity. The inclusion of women of child-bearing potential would need to be assessed for any proposal based on the risk-benefit and the use of appropriate highly effective contraception
• AZD0328 is renally cleared and, therefore, future studies will require an assessment of the risk-benefit for subjects with renal impairment

AZD7325

Make a submission

Gamma-aminobutyric

acid receptor A alpha 2 & 3

(GABAAa2,3)

positive modulator ;

• Preclinical reprotoxicology data is available and has not identified any specific risks. Women of child-bearing potential using highly effective contraception can be included
• Subjects with past or present symptoms of alcohol or drug abuse/dependence and/or subjects suspected of abusing alcohol or illicit or prescription medications should probably be excluded

Cabocaine
(mepivacaine)

Make a submission

Mechanism of action not fully understood

• No additional indications are being sought for Cabocaine
• Proposals for safe and appropriate use of Cabocaine within currently approved indications may still be supported, if a major data gap has been identified

Citanest
(prilocaine)

Make a submission

Mechanism of action not fully understood

• No additional indications are being sought for Citanest
• Proposals for safe and appropriate use of Citanest within currently approved indications may still be supported, if a major data gap has been identified

Diprivan
(propofol)

Make a submission

Mechanism of action not fully understood

• No additional indications are being sought for Diprivan
• Proposals for safe and appropriate use of Diprivan within currently approved indications may still be supported, if a major data gap has been identified

EMLA
(lidocaine /
prilocaine)

Make a submission

Mechanism of action not fully understood

• No additional indications are being sought for EMLA
• Proposals for safe and appropriate use of EMLA within currently approved indications may still be supported, if a major data gap has been identified

Marcaine
(bupivacaine)

Make a submission

Mechanism of action not fully understood

• No additional indications are being sought for Marcaine
• Proposals for safe and appropriate use of Marcaine within currently approved indications may still be supported, if a major data gap has been identified

Movantik/Moventig (Naloxegol/NKTR-118)

Make a submission

Oral peripherally-acting mu opioid receptor antagonist

• Proposals that increase the knowledge of Movantik’s/Moventig’s efficacy and safety in OIC patients with chronic pain (non-cancer and cancer)
• Proposals that assess efficacy and safety of Movantik/Moventig in novel areas: eg OIC in acute pain, prophylaxis of OIC, other GI disorders
• Proposals that contribute to the understanding of Movantik’s/Moventig’s mechanism of action

Naropin
(ropivacaine)

Make a submission

Mechanism of action not fully understood

• No additional indications are being sought for Naropin
• Proposals for safe and appropriate use of Naropin within currently approved indications may still be supported, if a major data gap has been identified

Seroquel /
Seroquel
XR (quetiapine
fumarate)

Make a submission

Mechanism of action not fully understood

• No additional indications are being sought for Seroquel/Seroquel XR
• Proposals for safe and appropriate use of Seroquel/Seroquel XR within currently approved indications may still be supported, if a major data gap has been identified

Vimovo
(naproxen /
esomeprazole)

Make a submission

NSAID/
PPI

• No additional indications are being sought for Vimovo
• Proposals for safe and appropriate use of Vimovo within currently approved indications may still be supported, if a major data gap has been identified

Xylocaine
(lidocaine)

Make a submission

Mechanism of action not fully understood

• No additional indications are being sought for Xylocaine
• Proposals for safe and appropriate use of Xylocaine within currently approved indications may still be supported, if a major data gap has been identified

Zomig
(zolmitriptan)

Make a submission

Serotonin receptor (1b,1d) agonist

• No additional indications are being sought for Zomig
• Proposals for safe and appropriate use of Zomig within currently approved indications may still be supported, if a major data gap has been identified

Brand / Substance

Mechanism of action

ESR - Areas of interest

AZD4635

Oral inhibitor of adenosine 2a receptor (A2aR)

Acalabrutinib

Make a submission

Highly selective, potent BTK inhibitor

Proposals evaluating the use of acalabrutinib in B-cell hematological malignancies

• Novel combination approaches with acalabrutinib will be considered.  In particular, concepts that address an important scientific question and could be relevant across a range of B-cell diseases
• Evaluation of surrogate marker endpoints predictive of long-term outcomes with acalabrutinib treatment
• Data generation specific to regional needs where the standard of care may differ
• Evaluation of treatment duration, including the addition of other therapeutic agents to assess the clinical benefit of continuing acalabrutinib beyond initial progression
• Assessments of real world data, including comparison with other novel agents
• Studies evaluating the role of maintenance therapy with acalabrutinib
• Proposals will be prioritized accordingly based on scientific merit and fit with the clinical program.

AZD1390

Make a submission

Potent and Selective Brain Penetrant ATM inhibitor

• Areas of interest include exploration of monotherapy or combination treatment in indications where there is a strong scientific, translational, or clinical rationale to target ATM inhibition
• Proposals in combination with radiotherapy, other double strand break inducing agents or other novel combinations for solid tumour indications
• Proposals will be prioritzed accordingly based on scientific merit and fit with the core development program.

AZD2811

Make a submission

Proposals in Adult ES-SCLC or LS-SCLC that have a high translational medicine focus/assesses the SCLC subtypes will be considered.

Areas of interest include exploration of:

1. Neuro-endocrine (NE) BCL-2 co-dependent tumours e.g. NE-mCRPC, subtype specific SCLC
2. Tumours with a reasonable prevalence of  RB1 negative tumours e.g. NE-mCRPC; ER+ Breast cancer post CDK4/6i: Mesothelioma (in combination with IO); Merkel cell (in combination with IO)
3. Chromosome 22q11amplified tumours e.g. ER+ Breast cancer post CDK4/6i; NSCLC (EGFR+ resistant and broader); other tumor types with Chr22 amplification (Uterine,Osteosarcoma,Ovarian,Melanoma etc)

Proposals will be prioritzed accordingly based on scientific merit and fit with the core development program.

Currently unable to accept proposals which require financial support or paediatric proposals.  AZ will support on a drug only basis

AZD5153

BRD4/BET bromodomain inhibitor

Not accepting externally sponsored studies at this time.

Capivasertib / AZD5363

Make a submission

AKT Inhibitor

Accepting Externally Sponsored Research Proposals on a drug only basis at this time

AZD6738 Ceralasertib

Make a submission

ATR Inhibitor

• Proposals in combination with  durvalumab, paclitaxel, or  monotherapy ceralasertib will be considered
• New proposals for ceralasertib plus olaparib or ceralasertib plus platinum agents will not be approved
• Proposals for dose-finding new combinations are unlikely to be supported
• Proposals should be accompanied by a strong scientific rationale and ideally a preclinical data package, with a clear path to registration
• Requests for funding will be considered but the bar to approval is high and the likelihood of funding low

Lipid kinase PI3Kß /d

Not accepting Externally Sponsored Clinical Research Proposals.

Cediranib / AZD2171

Make a submission

Oral VEGF receptor -1-2-3 kinase inhibitor

•  As a combination with novel agents for which there is a strong scientific rationale and demonstrable pre-clinical evidence or translational science, with a preference to combining with existing AZ marketed or pipeline products.
• Monotherapy proposals must have an exceptionally strong rationale to be supported by AZ.

Durvalumab / MEDI4736

Make a submission

Immuno-modulator; a human mAb of the immunoglobulin G1 kappa (IgG1κ) subclass that inhibits binding of Programmed Death Ligand 1 (PD-L1) to PD-1 and CD80

• NSCLC
  • Durvalumab +/- tremelimumab in NSCLC patients excluded from the registration program (un-resectable Stage IIIA / IIIB and Stage IV)
  • Durvalumab-based combinations in immunotherapy pre-treated patients
  • Durvalumab +/- tremelimumab combinations with chemotherapy, radiotherapy or other agents (immunotherapy / targeted therapies)
  • Enhance biomarker knowledge to support clinical decision making for durvalumab-based combinations
  • Early predictors of clinical activity and immune-related adverse events
  • Patient reported outcomes and patient experience of patients receiving durvalumab +/- tremelimumab in NSCLC
• Urothelial Cancer
  • Durvalumab +/- tremelimumab combined with SoC chemotherapy in front-line metastatic urothelial cancer
  • Durvalumab +/- tremelimumab combined with novel agents or radiotherapy in front-line or relapsed bladder cancer
  • Optimal utilization of Durvalumab +/- tremelimumab in non-muscle invasive bladder cancer
  • Durvalumab +/- tremelimumab combined with SoC chemotherapy, novel agents, or radiotherapy in patients with stage II– IV non-metastatic disease
  • Real-world evidence (RWE) on treatment patterns and outcomes with introduction of checkpoint inhibitors in bladder cancer
  • Prognostic value of PD-L1 expression in patients with bladder cancer treated with the SOC
  • Patient reported outcomes and patient experience of patients receiving durvalumab +/- tremelimumab in bladder cancer
• Head & Neck Cancer
  • Durvalumab +/- tremelimumab in HNSCC patients excluded from the registration programs
  • Durvalumab +/- tremelimumab in locally advanced HNSCC sub-populations
  • Durvalumab +/- tremelimumab combined with targeted agents (e.g. cetuximab, AZ targeted small molecules etc.), radiotherapy and/or chemotherapy
  • Patient reported outcomes and patient experience of patients receiving durvalumab +/- tremelimumab in HNSCC
  • Generate data in historical recurrent/metastatic HNSCC cohorts based on biomarkers and current SoCs
• Other indications (e.g. SCLC, GI tumours) supported by robust preclinical data may be considered
  • Priority will be given to proposals that advance understanding of core development programs in NSCLC, Bladder and HNSCC
  • Pre-clinical studies will be considered through the AstraZeneca Open Innovation portal.
  • Studies that overlap or compete with AstraZeneca development program or where there is compromised or excessive safety risk will not be accepted
  • Non-oncology indications will not be supported at this time

Faslodex (fulvestrant)

Make a submission

Selective Estrogen Receptor Downregulator

Opportunities for development in Breast cancer:

Monotherapy studies:

• In early stage breast cancer
• First-line for patients with advanced breast cancer after adjuvant AI

Combinations studies with targeted biological agents:

• In early breast cancer
• Adding novel targeted agents after progression on Faslodex

ER+ subgroups:

• Peri- and pre-menopausal women as monotherapy or in combination (e.g. with GNRH agonists, novel targeted agents)
• Patients with ER mutations
• Patients with visceral disease
• Patients with different molecular pheonotypes (e.g Luminal B breast cancer)

Iressa (gefitinib)

Make a submission

EGFR Inhibitor

• Not accepting Externally Sponsored Clinical Research Proposals at this time. Externally Sponsored ‘Non-Clinical’ Research proposals might still be considered but only where sponsors require supply of drug and not funding support.

Lynparza
(olaparib)

Make a submission

PARP Inhibitor

• Studies in ovarian cancer patients with sBRCA or non-BRCA HRD mutations, examining prevalence, diagnostics, molecular profiles; or clinical outcomes following treatment with Lynparza
• Pre-clinical to proof of concept scale clinical studies of combination of Lynparza with targeted small molecules or Immunotherapy, in BRCA+ve patients will be considered through the AstraZeneca Open Innovation portal.
• gBRCAm, sBRCAm & HRRm studies as monotherapy or in combination with other products in breast cancer patients
• Exploring effective diagnostic screening strategies to identify BRCAm & HRRm/HRD patient cohorts
• Studies in prostate cancer patients with BRCAm/HRRm, examining prevalence, diagnostics, molecular profiles; or clinical outcomes following treatment with Lynparza
• Combination studies with currently approved therapies in prostate cancer, including targeting of specific patient groups by molecular signature
• Patient reported outcomes and patient preference studies
• Studies examining switching from or substituting olaparib for bevacizumab in ovarian cancer patients
• Studies in other tumours with DDR involvement
• Other studies for which a strong scientific rationale and/or supporting pre-clinical data can be provided
• PLEASE NOTE THAT ASTRAZENECA IS UNABLE TO REVIEW PROPOSALS FOR STUDIES INVOLVING PEMBROLIZUMAB AND LYNPARZA. IF YOUR IDEA INVOLVES THE USE OF PEMROLIZUMAB, THEN PLEASE SUBMIT YOUR APPLICATION TO MERCK, WHO ARE RESPONSIBLE FOR THIS COMBINATION.

MEDI551

Make a submission

MAb
Anti-CD19 B cell depleting agent

Accepting Externally Sponsored Clinical Research Proposals  for drug only in allogenic stem cell transplantation

Osimertinib / AZD9291

Make a submission

EGFR sensitising and T790M Resistance Mutations Inhibitor

EGFRm NSCLC

Resistance/What next?

• Rapid identification of 1L resistance mechanisms using tissue, to accelerate new combination options
• Benefit/risk of treatment beyond progression
• Understand biomarkers of poor initial response to 1L TAGRISSO
• Extend survival benefit using TAGRISSO in combination with  targeted and non-targeted approach’s
• Establish evidence to support appropriate position of IO agents in EGFRm patients (advanced and early disease)

Real World Evidence

• Generate RWE data on 1L TAGRISSO including patient preference 
•  Develop insights into the 1L treatment journey to reinforce the benefits of starting with the best EGFR TKI first
• Assess the risk of CNS disease progression with 1^st and 2^nd generation TKIs, including in Leptomeningeal patients
• Develop treatment insights into the early disease setting, including EGFR prevalence through early screening

CNS

• Build prospective evidence for CNS risk reduction
• Build efficacy in leptomeningeal metastases, and symptomatic CNS patients using the 80mg dose
• Use of TAGRISSO in combination with Stereotactic radiotherapy, and in combinations with other systemic agents

Early Disease

• Translational assessment of tumour micro-environment post-surgery in the neoadjuvant setting
• Address optimal treatment strategy for downstaging tumors (e.g. unresectable to resectable)
• Optimize treatment in unresectable patients (e.g. in non-CRT eligible EGFRm patients)
• Explore ctDNA and other biomarkers to help guide treatment decisions in the early disease setting (E.g. optimal duration of therapy)

EGFR Testing

• Optimization of 1L testing to improve turnaround times
• Identify new testing approaches to improve the quality and speed of treatment decisions in metastatic and early disease
• Understand the prevalence and impact of other biomarkers e.g. uncommon, PD-L1, emerging IO related biomarkers, and impact on outcomes

MEDI9197

Make a submission

TLR 7agonist

Accepting limited number of Externally Sponsored Clinical Research Proposals

MEDI0457

Make a submission

HPV vaccine

Accepting limited Externally Sponsored Clinical Research Proposals in combination with durvalumab in H&N”. 

MEDI0562

Make a submission

Humanized immunoglobulin G1 kappa (IgG1κ) monoclonal antibody (mAb) that specifically binds to and triggers signaling of human OX40

Accepting limited Externally Sponsored Clinical Research Proposals

Monalizumab

Make a submission

NKG2A

Accepting limited Externally Sponsored Clinical Research Proposals

Saracatinib / AZD0530

Make a submission

Src tyrosine kinase family inhibitor

• The reproductive toxicology package indicates a risk of foetal toxicity. The inclusion of women of child-bearing potential would need to be assessed for any proposal based on the risk benefit and the use of appropriate highly effective contraception.
• AZD0530 is a moderately potent CYP3A4 inhibitor; concomitant administration of medicines that are metabolised by this route should be avoided.
• We are not currently seeking proposals in oncology indications

Savolitinib

Make a submission

c-Met receptor tyrosine kinase inhibitor (TKI)

• Savolitinib monotherapy proposals in MET-driven solid tumours (ie tumours with MET gene amplification, activating MET mutations, MET fusions or HGF amplifications) will be considered in tumour types other than NSCLC, papillary renal cell carcinoma (pRCC), gastric cancer, castration resistant prostate cancer (CRPC) and paediatric brain tumours.
• Combinations with durvalumab in tumour types other than renal cell carcinoma and NSCLC. Proposals with a supporting translational / exploratory mechanistic research package to understand the role and interplay of MET and the immune-microenvironment will be prioritised.
• Resistance profiling - alternative combination studies where MET+ is a resistance mechanism. Proposals should be supported by a strong scientific rationale and preclinical data package (or proposals to generate such data)

Selumetinib /
AZD6244

Make a submission

MEK 1/2 Inhibitor
 

Accepting limited Externally Sponsored Clinical Research Proposals. Proposals should be supported by a strong scientific rationale, preclinical data package and specific hypotheses to address. Proposals shall be prioritized accordingly based on scientific merit and fit with the core development program. We will be prioritising drug-only requests.

Paediatric NF1-PN
Early use in PN patients prior to emergence of severe symptoms and need for surgery

Studies exploring re-treatment with selumetinib in patients who have come off therapy (for reasons other than toxicity or progression) for >3 months
 

Adjuvant/Neo adjuvant use in combination with debulking surgery
 

Country-specific real world evidence studies
 

Adult NF1-PN

Real world evidence in adult population

Studies exploring combinations to deepen the response in adult patients

Country-specific studies real world evidence studies
 

NF1 – associated disease

Treatment of MPNST

NF1-NSCLC

Pathway related paediatric tumours
Neuroblastomas; JMML; MAPK pathway driven paediatric tumours

Pathway related adult solid tumours
Limited to combinations outside of ongoing internal program with strong scientific rationale

Trastuzumab deruxtecan (DS-8201/T-DXd)

Make a submission

HER2-targeting Antibody Drug Conjugate (ADC)

HER2+ mBC

• Data to enable adverse event management guidelines and improvement in adherence to treatment
• Data on efficacy and safety in special populations not adequately represented in DESTINY clinical trials
• Real World Data on standard of care across geographies and lines of treatment

HER2 Low mBC

• Optimization of practice parameters that enhance reliability and accuracy of identification of patients with  HER2 low mBC
• Real world efficacy, adverse event, and patient reported outcome in mBC, including special populations not adequately represented in DESTINY clinical trials
• Biomarker studies, including circulating tumour (ct) DNA, to explore mechanisms of resistance to standard of care therapy and/or T-DXd, as well as identify patients w/ high response to T-DXd.

HER2+ mGC

• Patient selection and outcomes with liquid biopsy and concordance with tissue biopsy
• Data on optimal sequencing and maintenance therapy
• Clinical activity and safety in additional populations (e.g., performance status 2,  peritoneal only disease, esophageal adenocarcinoma)

HER2 Targetable NSCLC

• Interstitial Lung Disease management/mechanism in Lung Cancer and optimization of adverse event management
• Efficacy/safety in special patient population with HER2 mutated NSCLC (eg: Brain mets)
• Approaches and validated technologies to inform more efficient patient selection in HER2 mutated NSCLC

Pre-clinical studies will be considered through the AstraZeneca Open Innovation portal.

Tremelimumab

Make a submission

Anti-CTLA4 Mab

Proposals for Oncology indications using tremelimumab alone or in combination with other products (with the exception of durvalumab-based combinations - see the durvalumab areas of interest for further information), are not sought at this time. Proposals for non-oncological indications may be of interest.

Zibotentan /
ZD4054

Make a submission

Endothelin receptor A (ETA) antagonist

Proposals for Oncology indications are not sought at this time. Proposals for non-oncological indications may be of interest

Zoladex (goserelin)

Make a submission

LHRH agonist

Not accepting non-clinical Externally Sponsored Research Proposals at this time

Accepting the following clinical Externally Sponsored Research Proposals:

• No new proposals are being considered for the US and Japan
• Prostate Cancer early or locally advanced disease: combination with novel targeted agents
• Prostate Cancer Metastatic disease: in combination with chemotherapy, other therapies or novel targeted agents. Sequencing strategies and response after progression on anti-androgens
• Benign Gynaecology
• Breast cancer: comparison of Zoladex + Tamoxifen with modern chemo regimens in HR+ pre-menopausal patients in early BC

Brand/Substance

Mechanism of action

ESR - Areas of interest

anifrolumab

Make a submission

Monoclonal antibody to the type I IFN receptor subunit 1

• Studies in patients with SLE focus, including:
  • Assessments of organ disease responses in lupus (e.g. skin, joint, other)
  • Innovative patient-centric modalities to measure symptoms of disease and response to treatments, including QOL measures
  • High unmet need in SLE & associated comorbidity related to SLE
• Mechanistic or clinical studies regarding the role of IFN in other diseases
  • Diseases related to SLE
  • Role of interferon in other immunology diseases
  • IFN driven disease beyond rheumatologic disease

Benralizumab

Make a submission

Anti-IL-5Rα monoclonal antibody

• Studies in patients with eosinophilic asthma to:
  • Investigate and identify predictors of enhanced response to benralizumab
  • Understand the overlap between different T2 biomarkers and the effects of benralizumab
  • Investigate early onset of patient-centric and clinical benefits of benralizumab
• Mechanistic studies in relevant disease-state models to:
  • Study the effect of eosinophil depletion by benralizumab on airway structure/function and cellular/molecular pathology
  • Characterise the role and effect of benralizumab on other IL-5R expressing cells beyond eosinophils

• Benralizumab lifecycle management:
  • Real world studies in eosinophil-driven diseases other than asthma that provide information about patient characteristics and disease burden
  • Mechanistic or clinical studies in eosinophil-driven diseases other than asthma that are not addressed by currently sponsored development programmes

Budesonide

Make a submission

• Please contact company staff before submitting a study proposal

budesonide / glycopyrronium / formoterol FDC in COPD

Make a submission

ICS, LAMA, LABA

Areas of high priority

Studies related to exacerbations and/or suitable patient populations

• Prevalence of CV morbidities, and incidence of hospital readmission and mortality in COPD
• Identification/characterisation of COPD patients at increased risk of exacerbations, CV events and mortality
• Use of SABA and OCS in COPD patients and any associations with exacerbations, mortality and other conditions

Studies related to the clinical efficacy and real-world effectiveness

• Mechanistic studies on ICS or Triple therapy benefits on mortality/CV events
• RWE evidence supporting early intervention with COPD treatment/triple therapy
• Benefits of Breztri in COPD patients with various co-morbid conditions

Studies related to Risk prediction and Patient solutions

• Score system/algorithm for risk prediction of future events such as exacerbations and mortality
• Data on Integrated Patient Solutions

Considered on a case-by-case basis- Low priority

• COPD registries
• Research specifically targeting Asthma and COPD co-diagnosis
• Benefits of triple therapy on activity level or other symptom measurements
• Novel technologies, particularly imaging, that predict or indicate clinical response

Off strategy / Non-prioritized

• H2H studies with Breztri (particularly vs other fixed dose triples)
• Studies with Breztri 160
• Breztri in Asthma
• Breztri and AIR type studies

budesonide /
formoterol

Make a submission

Inhaled steroid/long acting Beta2 agonist

• Impact of asthma disease, treatment patterns, asthma control and asthma exacerbations on environment, e.g. CO2 burden
• Use and efficacy of anti-inflammatory reliever treatment regimen in seasonal asthma (pollen, virus)
• Anti-inflammatory reliever use in emergency setting, discharge protocols & readmission rates
• Efficacy and safety of anti-inflammatory reliever with ICS-formoterol maintenance in paediatric populations
• Impact of digital solutions (e.g. connected devices) on study outcomes

Tezepelumab

Make a submission

Anti-TSLP monoclonal antibody

• Novel studies to generate clinically differentiating data with tezepelumab in severe asthma, such as airway hyperresponsiveness
• Tezepelumab as an immunomodulator or potential to induce clinical remission in asthma
• Innovative tools to measure patients reported outcomes that capture holistic effects (e.g. emotional) of tezepelumab in asthma
• New mechanistic insights on role of TSLP activation and downstream inflammatory effects in airway pathophysiology, eosinophil biology, or epithelial function, particularly in patients without evidence of T2 inflammation
• Potential role of TSLP in epithelial driven diseases, i.e. COPD, fibrotic (systemic sclerosis), rheumatic, cardiovascular (heart failure), and nephrology (lupus nephritis, IgAN) diseases
• Mechanistic or proof of concept studies using tezepelumab to support emerging clinical development plan and other diseases with emerging biologic evidence (e.g. vasculitis, oncology)
• Role of TSLP in pediatric patients (excluding use of tezepelumab)
• Studies showing ability to step down other asthma therapy
• Tezepelumab in epithelial driven diseases such as fibrotic and vasculitis conditions

None

Make a submission

N/A

• Biomarkers of response to inhaled corticosteroid-containing therapies in COPD
• Biomarkers to characterize COPD pheno and/or endotypes that benefit from non-ICS-containing therapies
• Understand inflammation in COPD vs. non-inflammatory features of the disease (e.g. structural changes)
• Differentiation of COPD exacerbation types (e.g. infectious vs. non-infectious)
• ICS-containing therapy in early (vs. mild or severe) COPD, in order to prevent disease progression
• Role of PDE4 inhibition in COPD-related inflammation

AZD1236

Make a submission

Matrix metalloproteinase 9 & 12 (MMP9,12) inhibitor

• The reproductive toxicology package indicates a risk of fetal toxicity. The inclusion of women of child-bearing potential would need to be assessed for any proposal based on the risk-benefit and the use of appropriate highly effective contraception
• The risk of muscular skeletal syndrome (MSS; joint fibrodysplasia), while reversible, has been seen after chronic administration with other MPP inhibitors in humans and fibrodyplasia in the subcutis has been seen at high doses in the 12 month preclinical safety study with AZD1236. This risk must be considered when proposing a new indication and associated treatment regimen

AZD1981

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CRTh2 Inhibitor

• Preclinical reprotoxicology data is available and has not identified any specific risks. Women of child-bearing potential using highly effective contraception can be included
• Given the potential for DDI and LFT effects, dosing regimen (level and duration) as well as inclusion/exclusion criteria should be selected carefully to support a favourable risk-benefit
• There is currently no clinical data to support use in pediatric populations below 12 years of age, although existing preclinical data would support clinical studies in a pediatric population of > 5 years

AZD5904

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Myeloperoxidase (MPO) inhibitor

• The reproductive toxicology package indicates a risk of fetal toxicity. The inclusion of women of child-bearing potential would need to be assessed for any proposal based on the risk-benefit and the use of appropriate highly effective contraception
• AZD5904 is renally cleared, thus, requiring caution and PK monitoring if dosed to subjects with impaired renal function

MEDI551

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MAb

Anti-CD19 B cell depleting agent

• Autoimmune diseases that have B cell etiology. Of particular interest are autoimmune disease in the areas of neuro-inflammatory, rheumatoid and dermatology
• The Company will supply drug only (no funding is available at this time)

AZD1222 

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• Understand impact of COVID-19 overall burden on communities, spectrum of disease in communities, and level of herd immunity.   
• Understand the impact of COVID-19 vaccination with AZD1222 (COVID-19 AstraZeneca Vaccine) in at-risk groups and vulnerable populations

We are currently not accepting any ESRs related to Long Acting Antibodies research (LAAB)

• Please contact company staff before submitting a study proposal