On September 28, 2020 AQILION AB and Immunscape AB reported that it initiated a joint early project in oncology and autoimmune diseases in the spring of 2019 (Press release, Aqilion, SEP 28, 2020, View Source [SID1234567662]). The point of departure was to create a drug candidate that the parties would develop and test further in a joint feasibility study. The parties have now agreed to discontinue the project.

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"Collaborating with Immunscape has been highly rewarding and we continue to appreciate their expertise, from which we have gained great professional benefit. The feasibility study produced good technical results and new intangible assets, but external factors have led to declining interest in the continued commercial development of the project. We have therefore agreed to terminate our collaborative effort. It is extremely important for us to have the courage to start innovative projects, but also to have the courage to close those in which Aqilion cannot continue to create value, even if it is disappointing not to reach all the way to our goal," says Sarah Fredriksson, CEO of AQILION AB.

"We have appreciated the interactions with Aqilion and would like to thank them for their commitment to the project. Our collaboration with Aqilion has allowed us to advance our understanding of the drug targets in the project, which helps us to explore new uses of the compounds as potential treatments for certain cancers," says Lars Öhman, CEO of Immunscape AB.

On September 28, 2020 3 EORTC reported that abstracts were selected for the 12th European Breast Cancer Conference (EBCC-12) that will take place virtually on 2-3 October 2020 (Press release, EORTC, SEP 28, 2020, View Source [SID1234567660]).

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Plenary Session

Keynote Lecture, Best and Late Breaking Abstract Presentations

Clinical Utility of MammaPrint testing in Invasive Lobular Carcinoma: Results from the MINDACT phase III trial

Presentation number: ORAL-007
Date: 2 October 2020, 13:50-14:00
Speaker: Otto Metzger (USA)
Proffered Papers Session

Updated results of the MINDACT trial: 70-gene signature to guide de-escalation of chemotherapy in early breast cancer

Presentation number: ORAL-021
Date: 3 October 2020, 13:00-13:10
Speaker: Emiel Rutgers (The Netherlands)
Screen-detected breast cancers have different tumor biology and better prognosis compared to interval breast cancers

Presentation number: ORAL-011
Date: 3 October 2020, 12:50-13:00
Speaker: Josephine Lopez Cardozo (The Netherlands)
EBCC-12 is a breast cancer conference where the very latest practice-changing research is presented. It aims to provide a unique multidisciplinary setting for all professionals with a common interest in breast cancer to discuss, debate, inform and educate themselves about this evolving disease.

To view the full two day programme, visit the EBCC-12 searchable programme.

On September 28, 2020 EORTC Melanoma group reported that it has presented and published new data that has shown improved outcomes for cancer patients. First of all, EORTC 1325/Keynote 054 study (adjuvant pembrolizumab vs. placebo after complete resection of high-risk stage III melanoma) which was presented at ASCO (Free ASCO Whitepaper) 2020, showed new recurrence free survival (RFS) data with median 3-year follow-up, confirming that the positive effect of pembrolizumab is durable with longer follow-up (Press release, EORTC, SEP 28, 2020, View Source [SID1234567658]).

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In addition, EORTC 1325 study presented, at the ESMO (Free ESMO Whitepaper) virtual Congress, the reduced risk of Distant Metastasis Free Survival (DMFS) or death with adjuvant immunotherapy.

EORTC MG has, also, published a number of papers, Alexander van Akkooi, group chair, highlights the importance of these papers:

Evaluating the potential of relapse-free survival as a surrogate for overall survival in the adjuvant therapy of melanoma with checkpoint inhibitors (EJC)
This is an important paper, as it shows that RFS is a surrogate for OS in case of adjuvant immunotherapy for melanoma. This is an important methodological study, since RFS is not always a proxy for durable and meaningful benefit in OS.
Prognosis of Patients With Stage III Melanoma According to American Joint Committee on Cancer Version 8: A Reassessment on the Basis of 3 Independent Stage III Melanoma Cohorts (JCO)
This paper shows that the new AJCC 8th edition staging prognosis seems to be too positive, which does not seem realistic. In this independent European cohort ofall substages of melanoma, the prognosis seems slightly worse compared to AJCC, which is important information when counselling patients about their risks and the need for adjuvant treatment or participation into trials.
Adjuvant therapy with pegylated interferon-alfa2b vs observation in stage II B/C patients with ulcerated primary: Results of the European Organisation for Research and Treatment of Cancer 18081 randomised trial (EJC)
Although one might think that this prospective randomized trial with an ‘old’ therapy would not be worth reporting, it still confirms that patients with non-metastatic, but thick and ulcerated primary melanomas can benefit from PEG-IFN treatment. Might not be very relevant anymore in Europe, but certainly important findings for developing countries.
The EORTC-DeCOG nomogram adequately predicts outcomes of patients with sentinel node-positive melanoma without the need for completion lymph node dissection (EJC)
This study is relevant as it gives a prognostic risk assessment of melanoma patients with a positive Sentinel Node, without the need to perform extensive surgery (CLND). The latter clearly benefits patients’ Quality of life. This study was conducted by an early career investigator, who defended her PhD thesis in recent months.

On September 27, 2020 Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, reported APL-106 (uproleselan) has received Investigational New Drug (IND) approval from the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) (Press release, Apollomics, SEP 28, 2020, View Source [SID1234567657]). This approval enables the initiation of a Phase 1 pharmacokinetic (PK) and tolerability study and includes acceptance of a Phase 3 bridging study of APL-106 in combination with chemotherapy in relapsed/refractory acute myeloid leukemia (AML).

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"Our team has worked diligently since licensing APL-106 earlier this year, and receiving China IND approval for our Phase 3 bridging study is a major milestone for Apollomics," said Guo-Liang Yu, PhD, Co-Founder, Chairman and Chief Executive Officer. "AML is one of the most common leukemias in adults, and there is a strong demand for an effective breakthrough treatment for relapsed/refractory AML. We are pleased that the CDE recognized the need to improve treatment outcomes in this patient population and accepted our Phase 3 bridging study while the Global Phase 3 trial sponsored by GlycoMimetics, our partner, is ongoing. We look forward to initiating our clinical trials in China as we strive to offer a new and effective treatment option for AML patients."

A comprehensive Phase 3 development program in AML is currently ongoing with uproleselan in the United States by GlycoMimetics. Uproleselan has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as well as Breakthrough Therapy Designation for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan has also been granted Orphan Drug Designation in AML from the FDA and European Union.

About Uproleselan (APL-106)

Discovered and developed by GlycoMimetics, uproleselan (APL-106) is a late clinical stage, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an) is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. Apollomics licensed APL-106 from Glycomimetics in January 2020. Under the terms of the agreement, Apollomics has the rights and responsibility to develop and commercialize APL-106 in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China.

About Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow. It is an aggressive disease that causes the bone marrow to produce immature cells that are unable to carry out their normal function and develop into leukemic white blood cells called myeloblasts. In the U.S., there are approximately 20,000 new cases of AML each year and a 5-year survival rate of 28.7%.1 The annual incidence of new cases of AML in China is 21,600, and relapsed/refractory AML has an extremely poor prognosis.2

On September 28, 2020 Ona Therapeutics, which is focused on the discovery and development of therapeutic biologics to treat metastatic cancer, reported that it has been named by Fierce Biotech as one of 2020’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotechnology companies in the industry (Press release, Ona Therapeutics, SEP 28, 2020, View Source;utm_medium=rss&utm_campaign=ona-therapeutics-is-named-as-one-of-fierce-biotechs-fierce-15-biotech-companies-of-2020 [SID1234567656]).

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Valerie Vanhooren, CEO and co-founder of Ona Therapeutics, commented: "It is a great honor to be selected from hundreds of companies around the world as a Fierce 15 company. It has been a transformational year for Ona Therapeutics. Following one of the biggest Series A in Europe this year, this award validates our scientific approach and our commitment to developing first-in-class treatments for metastatic cancer patients. I would like to thank our team for their exceptional work, and we look forward to taking Ona Therapeutics to the next stage of development."

Ona Therapeutics was founded in 2019 by research scientists Salvador Aznar-Benitah and Valerie Vanhooren as an IRB Barcelona and ICREA spin-off. Its approach is based on pioneering work from Dr Aznar-Benitah published in Nature in 2017 that validates Metastasis-Initiating Cells as therapeutic targets in metastatic cancer. In June 2020, Ona Therapeutics raised €30 million in Series A financing to complete the pre-clinical development in a variety of tumor types and to move its lead candidate into first clinical studies in patients with metastatic cancer. The company’s investors include Asabys Partners, Alta Life Sciences, Bpifrance – InnoBio 2, Fund+ and Ysios Capital.

Now in its 18th edition, Fierce 15 celebrates the next generation of healthcare companies championing innovation and creativity in the face of intense competition. Every year Fierce Biotech evaluates hundreds of private companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position.