On October 12, 2020 Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, reported that Jesse Trekker, Ph.D., Business Director, Strategic Partnerships, Catalent Cell & Gene Therapy, will present at the Allogeneic Cell Therapies Summit, which will take place virtually on 26 – 28 October, 2020 (Press release, Catalent, OCT 12, 2020, https://www.catalent.com/catalent-news/catalent-to-discuss-innovative-approaches-to-achieving-t-cell-commercial-readiness-at-upcoming-industry-conference/ [SID1234568331]).

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On Monday, 26 Oct., at 12:30 p.m. EST, Dr. Trekker will present "How to Commercially Scale T-cell Allogeneic Therapies", where he will consider ways to overcome scale up challenges to progress successful development programs. Dr. Trekker will also discuss Catalent’s custom manufacturing methodology, and approaches to accelerate T-cell therapies to commercial readiness, so that patients can benefit sooner from innovative new therapies.

Dr. Trekker joined Catalent through its acquisition of MaSTherCell in 2020. Prior to joining MaSTherCell, he worked as a valorization researcher at Imec. Dr. Trekker holds a master’s degree in biomedical sciences, and a doctorate in biomedical technology, both from the University of Leuven (KU Leuven), Belgium.

ABOUT CATALENT CELL & GENE THERAPY
With deep experience in viral vector scale-up and production, Catalent Cell & Gene Therapy is a full-service partner for adeno-associated virus (AAV) and lentiviral vectors, and CAR-T immunotherapies. When it acquired MaSTherCell, Catalent added expertise in autologous and allogeneic cell therapy development and manufacturing to position it as a premier technology, development and manufacturing partner for innovators across the entire field of advanced biotherapeutics. Catalent has a global cell and gene therapy network of dedicated, large-scale clinical and commercial manufacturing facilities, and fill-finish and packaging capabilities located in both the U.S. and Europe. An experienced partner, Catalent Cell & Gene Therapy has worked with industry leaders across 70+ clinical and commercial programs.

On October 12, 2020 Priothera Limited, a clinical stage company developing orally applied sphingosine 1 phosphate (S1P) receptor modulators for haematological malignancies, reported that it has successfully closed a Series A financing round of €30 million led by Fountain Healthcare Partners with participation from co-lead investor HealthCap and funds managed by Tekla Capital Management, LLC as well as EarlyBird Venture Capital (Press release, Priothera, OCT 12, 2020, View Source [SID1234568330]).

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Priothera will use the funds to progress the clinical development of mocravimod, a modulator of sphingosine 1 phosphate (S1P) receptors, to enhance the curative potential of allogenic hematopoietic stem cell transplantation (HSCT) for treating AML. Priothera expects to generate further randomized clinical data in high risk AML patients with this Series A funding round.

Mocravimod has already been extensively tested in multiple immunologic indications and has shown survival benefit in an early clinical study evaluating acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL) patients undergoing hematopoietic stem cell transplantation (HSCT). Priothera acquired mocravimod from KYORIN Pharmaceutical Co., Ltd.

Following the closing of the financing, Florent Gros (Priothera’s Co-Founder and CEO), Dr. Dhaval Patel (Priothera’s Co-Founder and CSO at UCB), Dr. Manus Rogan (Fountain Healthcare Partners Co-Founder and Managing Director), Dr. Mårten Steen (Partner at HealthCap), Dr. Henry Skinner (Senior Vice President at Tekla Capital Management, LLC) and Lionel Carnot (Partner at EarlyBird Venture Capital), have joined the Board of Directors.

On October 12, 2020 Exact Sciences Corp. (NASDAQ: EXAS) reported the introduction of the Oncotype MAP Pan-Cancer Tissue test for patients with advanced, metastatic, refractory, or recurrent cancer (Press release, Exact Sciences, OCT 12, 2020, View Source [SID1234568328]). The Oncotype MAP test, previously known as PCDx, provides clinically actionable information from genomic alterations in hundreds of cancer-related genes, allowing physicians to understand a patient’s tumor profile and effectively recommend targeted therapies or clinical trials.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Exact Sciences Introduces the Oncotype MAP Test to Help Guide Treatment for Patients with Advanced Cancer
"Exact Sciences is pursing life-changing answers that give people the clarity to take action earlier. Our growing Precision Oncology portfolio and the addition of the Oncotype MAP test allow us to do just that for patients fighting late-stage or metastatic cancer," said Kevin Conroy, chairman and CEO of Exact Sciences. "Patients with advanced cancer need answers fast, and providing them with actionable results in days, rather than weeks, is critical for improving their outcomes."

Key attributes and differentiators of the Oncotype MAP test include:

fast turnaround time of 3-5 business days1,2 to guide timely treatment decisions,
small sample requirements with as little as 3 mm2 of tissue or 2-3 slides3,
highly accurate1 and comprehensive results using next generation sequencing and immunohistochemistry, and,
based on a study from a previous generation of the test, a significantly increased rate of progression-free survival when compared to patients who did not utilize the test (43% vs. 5%)4.
The Oncotype MAP test report is easy to interpret with NCCN Compendium-based recommendations, along with potential evidence-based therapies and clinical trials. The report is currently tailored to support clinical decision making by showing actionable biomarkers associated with more than 100 evidence-based therapies, over 45 combination therapies, and more than 650 active clinical trial associations. By delivering insights into targeted therapy options, the Oncotype MAP test is designed to address the needs of more than 500,000 patients who face advanced cancer each year in the United States5.

"The systemic treatment of patients with advanced or metastatic cancer is challenging," said Rick Baehner, MD, chief medical officer of Precision Oncology at Exact Sciences. "Oncotype MAP is a tissue-based assay which delivers results regarding the underlying biology of a patient’s cancer and provides therapeutic and clinical trial options. Genomic results guide clinicians to individualize and optimize oncology therapy by targeting patient tumor biology with the most effective therapies."

The Oncotype MAP test is currently available for physicians in the U.S. to order at www.OncotypeMAP.com. Medicare covers the Oncotype MAP test for qualifying members and commercial coverage varies by insurance plan and patient benefit level.

On October 12, 2020 Aileron Therapeutics (Nasdaq: ALRN) reported that proof-of-concept data from the company’s Phase 1b study of ALRN-6924 will be featured in a late-breaking poster presentation during the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Annual (ENA 2020) Symposium on Molecular Targets and Cancer Therapeutics, being held virtually October 24 – 25, 2020 (Press release, Aileron Therapeutics, OCT 12, 2020, View Source [SID1234568326]).

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The abstract entitled, "Prevention of Chemotherapy-induced Myelosuppression in SCLC patients treated with the Dual MDM2/MDMX inhibitor ALRN-6924," (LBA96) will be presented starting Saturday, October 24, on the ENA 2020 website.

The data to be presented is from Aileron’s Phase 1b study, which is evaluating ALRN-6924 as a therapeutic agent administered ahead of chemotherapy to prevent chemotherapy-induced toxicities, such as severe anemia, neutropenia and thrombocytopenia, in patients with p53-mutated small cell lung cancer (SCLC) who are being treated with the chemotherapy topotecan. In June 2020, Aileron announced positive interim data from this study.

"Chemotherapy, which remains the backbone of treatment for millions of cancer patients, is associated with toxicities and side effects – ranging from unpleasant to life-threatening, and sometimes fatal. Current supportive care drugs try to manage these side effects, but often unsuccessfully and with associated toxicities of their own. Aileron has the potential to bring much-needed innovation to this area of cancer care, improving patients’ quality of life as well as their tolerance for chemotherapy," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron Therapeutics.

Dr. Aivado continued, "ALRN-6924 is the first and only chemoprotective agent to utilize a biomarker strategy by treating patients with p53-mutated cancers. In these patients, ALRN-6924 is designed to selectively shield healthy non-p53-mutated cells while chemotherapy can continue targeting p53-mutated cancer cells. We believe that our novel mechanism of action has the potential to introduce a transformative paradigm of proactive prevention of hematological and non-hematological chemotherapy-induced side effects. Importantly, our approach is designed to give oncologists access to a chemoprotective agent that will not reduce the efficacy of chemotherapy."

Aileron’s long-term vision is to bring chemoprotection to all patients with p53-mutated cancers, which represent at least 50% of cancer patients, regardless of cancer type or chemotherapy.

Aileron Investor Call

Aileron will host a virtual investor call and webcast to discuss the new data as well as the company’s clinical development strategy to expand chemoprotection to patients with p53-mutated cancers. The event will take place on Monday, October 26 at 8:30 a.m. ET. Details will be provided closer to the event at View Source

How ALRN-6924 Works to Protect Healthy Cells from Chemotherapy

ALRN-6924 is being developed by Aileron as a novel chemoprotective medicine to selectively protect healthy cells in patients with cancers that harbor p53-mutations to reduce or eliminate chemotherapy-induced side effects.

Chemotherapy preferentially acts on cells that are cycling, or undergoing the process of cell division. In cancer cells, the cell cycle is unchecked, which leads to uncontrolled cell proliferation, a hallmark of cancer. Certain types of healthy cells also naturally need to cycle, such as bone marrow cells, hair follicle cells, skin cells, and cells lining the oral cavity and the gastrointestinal tract. As a result, chemotherapy targets and kills both cycling healthy cells and cycling cancer cells. This, in turn, leads to a spectrum of chemotherapy-induced side effects, from unpleasant to life-threatening and fatal.

ALRN-6924, an investigational first-in-class MDM2/MDMX dual inhibitor, is administered prior to chemotherapy to patients with p53-mutant cancers. ALRN-6924 is designed to activate normal p53 protein in patients’ healthy cells, temporarily and reversibly pausing cell cycling to selectively shield the patients’ healthy cells from chemotherapy. The protection is limited to healthy cells, as ALRN-6924 cannot work in p53-mutated cancer cells given that p53 has lost its function in those cells. Therefore, cancer cells continue to cycle uninterrupted and remain fully susceptible to destruction by chemotherapy.

On October 12, 2020 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported a poster presentation at the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics to be held October 24-25, 2020 in a virtual format (Press release, Sunesis, OCT 12, 2020, View Source [SID1234568324]).

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The details for the poster presentation are as follows:

Date and Time: October 24, 2020, 9:00 a.m. ET
Abstract Title: PDK1 inhibitor SNS-510 shows synergy with standard cancer therapies in solid tumor and hematologic cancer models
Session Name: Molecular Targeted Agents
Publication Number: 163

The full abstract can be viewed here, and the poster will be made available on the Sunesis website at the time of the presentation.