AstraZeneca aims to transform cancer treatment and advance clinical practice with data presented at ESMO 2020

On September 8, 2020 AstraZeneca reported that it will present new developments in pursuit of its ambition to eliminate cancer as a cause of death at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, 19 to 21 September.

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AstraZeneca medicines and pipeline molecules feature in 114 abstracts at ESMO (Free ESMO Whitepaper), a record for the Company, including 20 oral presentations and two Presidential Symposia. The data highlight the breadth of the portfolio of cancer medicines and the early-stage pipeline. Whether it is by treating cancer early or by developing tailored medicines across all stages of disease, these data have the potential to transform patient outcomes and survival.

Key presentations include:

Practice-changing overall survival (OS) data from the PROfound Phase III trial presented in a Presidential Symposium confirming the long-term benefit of Lynparza (olaparib) in biomarker-selected patients with metastatic castration-resistant prostate cancer (mCRPC)
Exploratory data from the ADAURA Phase III trial showing further support for the unprecedented patient benefit of Tagrisso (osimertinib) in the adjuvant treatment of epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) also presented in a Presidential Symposium
Data from the PACIFIC Phase III trial in unresectable Stage III NSCLC and the CASPIAN Phase III trial in extensive-stage small-cell lung cancer (ES-SCLC), two late-breaking presentations strengthening the Company’s leadership in the treatment of lung cancer
José Baselga, Executive Vice President, Oncology R&D, said: "The data being presented at ESMO (Free ESMO Whitepaper) will reshape clinical practice in the months and years ahead. The final PROfound overall survival data show the power of biomarker-directed medicines in prostate cancer, while the ADAURA and PACIFIC data reflect our continued focus on early detection, interception and treatment of cancer. We continue to work with urgency throughout this extraordinary period to accelerate the development of medicines in our pipeline, turning innovative science into improved outcomes for patients."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "Our data at ESMO (Free ESMO Whitepaper) reflect our vision to transform the cancer treatment landscape, achieving more durable outcomes, treating with curative intent, and changing what it means to live with and beyond a cancer diagnosis. Our ability to detect and treat cancer early is key in bringing new treatment options to later stages of disease. We are eager to translate our pivotal research into clinical practice and help patients live better, longer lives."

Redefining treatment options for advanced disease across tumour types

One Presidential Symposium will present the final OS analysis of the PROfound Phase III trial of Lynparza versus enzalutamide or abiraterone in patients with mCRPC and homologous recombination repair (HRR) gene mutations, including BRCA, ATM, CDK12 and 11 other HRR genes.

Beyond the PROfound trial, a presentation of five-year follow-up data from the SOLO-1 Phase III trial will highlight the sustained progression-free and recurrence-free survival benefits of Lynparza for patients with newly diagnosed BRCA-mutated advanced ovarian cancer. These exploratory analyses are the longest follow-up for any PARP inhibitor in this setting and expand on the positive SOLO-1 results previously published in The New England Journal of Medicine and presented at the ESMO (Free ESMO Whitepaper) 2018 Congress.

In addition, a late-breaking presentation of data from the PAOLA-1 Phase III trial will demonstrate that the addition of maintenance Lynparza to bevacizumab, a standard treatment, significantly improved the time to second disease progression (PFS2) compared with bevacizumab alone in patients with advanced ovarian cancer with homologous recombination deficiency positive status (defined by BRCA mutation and/or genomic instability). PFS2 is a key secondary endpoint in the PAOLA-1 trial and reinforces the positive results previously published in The New England Journal of Medicine and presented at the ESMO (Free ESMO Whitepaper) 2019 Congress.

Leadership in early lung cancer treatment

A second Presidential Symposium will present exploratory data from the ADAURA Phase III trial highlighting the impact of treatment with Tagrisso on sites and types of disease recurrence, including brain metastases, in patients with early-stage (Stages IB-IIIA) EGFRm NSCLC. Tagrisso was recently granted Breakthrough Therapy Designation in this setting in the US.

Data will also be presented from the PACIFIC and CASPIAN Phase III trials highlighting the long-term benefit of Imfinzi across different types of lung cancer. These include a presentation of four-year OS data in patients with unresectable Stage III NSCLC who had not progressed following concurrent chemoradiation therapy and a presentation of updated data in ES-SCLC.

Progressing the pipeline – pushing boundaries, advancing combinations

Exploratory data from the DESTINY-Gastric01 Phase II trial will show the results of Enhertu (trastuzumab deruxtecan) in patients with metastatic gastric cancer and low expression of HER2.

The DANUBE Phase III trial will be presented in an oral presentation showing the results for Imfinzi with and without tremelimumab in patients with advanced bladder cancer, including analyses of patients with high PD-L1 expression. The trial did not meet its primary endpoints.

AstraZeneca will also present data from several trials of the early and mid-stage pipeline, including:

A Phase II trial of Lynparza plus Imfinzi and bevacizumab (MEDIOLA): initial results in patients with non-germline BRCA-mutated platinum sensitive relapsed ovarian cancer
A Phase lb expansion trial of adavosertib plus Lynparza in patients with ES or relapsed SCLC
Collaboration in the scientific community is critical to improving outcomes for patients. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. in the US and Canada). AstraZeneca is collaborating with Daiichi Sankyo Company, Limited (Daiichi Sankyo) to develop and commercialise Enhertu.

Key AstraZeneca presentations during the ESMO (Free ESMO Whitepaper) Virtual Congress 20201

Key AstraZeneca presentations ESMO (Free ESMO Whitepaper) 2020
1 114 abstracts at ESMO (Free ESMO Whitepaper) 2020 include AstraZeneca medicines and pipeline molecules, of which 75 are company sponsored or supported.

AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of six scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

Imago BioSciences to Participate in Upcoming Investor Conferences

On September 8, 2020 Imago BioSciences, Inc. ("Imago"), a private clinical stage biopharmaceutical company developing innovative treatments for myeloid diseases, reported that Hugh Young Rienhoff, Jr. M.D., chief executive officer, will present a corporate overview at two upcoming investor conferences (Press release, Imago BioSciences, SEP 8, 2020, View Source [SID1234564710]).

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Citi’s 15th Annual BioPharma Virtual Conference
Date: Tuesday, September 8th 2020
Time: 2:20 p.m. ET
Logistics: If you’d like to register and attend the company presentation, click here to learn more.
H.C. Wainwright 22nd Annual Global Investment Virtual Conference
Date: Monday, September 14th 2020
Time: 10:00 a.m. ET
Logistics: If you’d like to register and attend the company presentation, click here to learn more.

Amplia Receives Human Research Ethics Committee Clearance to Conduct Phase 1 Clinical Trial

On September 8, 2020 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported that it has received clearance from the Alfred Hospital Human Research Ethics Committee (HREC) to conduct a Phase 1 clinical trial of its Focal Adhesion Kinase (FAK) inhibitor, AMP945, in healthy volunteers (Press release, Amplia Therapeutics, SEP 8, 2020, View Source;[email protected] [SID1234564702]). With this clearance in hand, Amplia expects to initiate its Phase 1 trial in the coming weeks with the first subject likely to be dosed by early October.

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The double blind, placebo-controlled Phase 1 trial is designed to establish the safety profile of oral doses of AMP945 in up to 64 healthy adult volunteers as well as provide data on the pharmacodynamics and pharmacokinetics of the drug in human subjects. The trial protocol that has been approved by the HREC includes an initial single ascending dose (SAD) study, followed by a multiple ascending dose (MAD) study. With the HREC clearance now in hand, Amplia is on track to complete dosing of subjects for the SAD component of the Phase 1 trial by the end of the year and have data from the completed trial in the first half of 2021. Recruitment for the trial is not expected to be impacted by the current COVID-19 pandemic.

Data from this trial will be used to support Phase 2 clinical trials of AMP945 for the treatment of patients with specific, hard-to-treat cancers or with certain fibrotic diseases. Earlier this year, Amplia secured Orphan Drug Designations (ODDs) from the US Food and Drug Administration (FDA) covering the use of AMP945 in the treatment of both pancreatic cancer and idiopathic pulmonary fibrosis (IPF). As the Phase 1 trial is being conducted in healthy volunteers rather than in patients, data from the trial is expected to support the progression of AMP945 into Phase 2 trials for a range of different diseases (indications). Amplia is also continuing with the conduct of a program of non-clinical studies to further define and enhance the next stage of the clinical development program for AMP945.

"We are very excited to receive ethics approval for Amplia’s first clinical trial and to deliver on our commitment to advance AMP945 into human clinical trials during 2020" said Chief Executive Officer, Dr John Lambert. "Despite the challenges thrown up by the current COVID-19 pandemic, in the past few months we have managed to secure two Orphan Drug Designations, complete the preclinical studies required to support the Phase 1 trial, secure funding to conduct the trial, and now receive the approval required to initiate the trial. We are extremely grateful for the support we have received from our partners, providers and shareholders that has allowed us get to this stage and initiate the first-in-human study for AMP945."

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics

AnHeart Licenses Two Clinical Stage Oncology Candidates from Daiichi Sankyo

September 7, 2020 AnHeart Therapeutics reported that AnHeart has entered into license agreements with Daiichi Sankyo to acquire rights to two novel clinical stage oncology candidates (previously Daiichi Sankyo codes DS-1001 and DS-1205, now AnHeart codes AB-218 and AB-329, respectively) (Press release, AnHeart Therapeutics, SEP 7, 2020, https://anhearttherapeutics.com/en/2020/09/08/anheart-licenses-two-clinical-stage-oncology-candidates-from-daiichi-sankyo/ [SID1234574254]). Under the terms of the agreements, Daiichi Sankyo is eligible to receive upfront payments, as well as development, regulatory and commercial milestone payments and royalties on net sales following market approval of the products.

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AB-218 is a novel, potent, highly selective mutant IDH-1 inhibitor, which has high permeability of the blood-brain barrier and has demonstrated encouraging safety and efficacy signals in a Phase 1 trial of glioma patients. AnHeart will develop this compound for glioma and potentially other indications including acute myeloid leukemia (AML) and cholangiocarcinoma globally, except in Japan where Daiichi Sankyo will retain exclusive rights.

AB-329 is a novel, potent, highly selective AXL inhibitor, which AnHeart plans to test in combination with checkpoint inhibitors or third generation EGFR inhibitors in non-small cell lung cancer (NSCLC) as well as other solid tumors and hematological malignancies. AnHeart has global rights to the compound.

"We are extremely pleased with our highly productive relationship with Daiichi Sankyo," said Junyuan (Jerry) Wang, PhD, Chief Executive Officer of AnHeart. "These two clinical stage assets represent the expansion of our initial taletrectinib agreement, and are both differentiated and promising with multiple potential therapeutic applications for the global markets. These new license agreements highlight AnHeart’s progress towards our strategic goal of building a pipeline of targeted oncology therapeutics to help serve patients with unmet needs all over the world."

September 15th, Gerard Soula, Adocia CEO, to Present at H.C. Wainwright Global Investment Conference

On September 7, 2020 Adocia (Euronext Paris: FR0011184241 – ADOC), a clinical stage biopharmaceutical company focused on the treatment of diabetes and other metabolic diseases with innovative formulations of proteins and peptides, reported that CEO, Gérard Soula, will present a company overview at the H.C. Wainwright 22nd Annual Global Investment Conference, held virtually this year, September 14-16, 2020 (Press release, Adocia, SEP 7, 2020, https://www.adocia.com/september-15th-adocia-to-present-at-h-c-wainwright-global-investment-conference/ [SID1234565004]).

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Presentation details:

Presenter: Gérard Soula, CEO
Presentation Day: September 15, 2020

Time: 1:00 PM (EDT) / 7:00 PM (CEST)
Link to the online presentation (live and archived for 90 days)