On May 29, 2018 Oncoceutics, Inc. reported that two abstracts will be presented at the 2018 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) that will highlight clinical success of the company’s lead compound in treating high-grade gliomas (HGG), including those that harbor the H3 K27M mutation (Press release, Oncoceutics, MAY 29, 2018, View Source [SID1234558368]).

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The first abstract, entitled "Integrated clinical experience with ONC201 in H3 K27M glioma," describes preliminary clinical data indicating ONC201 induces durable radiographic regressions and clinical benefit in patients with HGG that harbor the H3 K27M mutation. This mutation is prevalent among certain types of brain tumors that develop in children and young adults and is known to confer one of the most dismal and uniformly lethal prognoses amongst HGG. There is no proven medical therapy for these patients. The integrated cohort of H3 K27M-mutant glioma patients who have received ONC201 that will be reported at the meeting include children and adults with different tumor locations. The durability of regressions and clinical benefit will be reported, which is an important measure of efficacy in this disease that is consistent with the immunostimulatory activity of ONC201 that was recently reported in the Journal of Clinical Investigation. ONC201 is currently being evaluated in pediatric and adult H3 K27M-mutant gliomas in three ongoing clinical trials at several institutions around the United States: NCT03416530, NCT03295396, NCT02525692.

The second abstract, entitled "Intratumoral activity of ONC201 in adult recurrent glioblastoma patients" describes the concentrations, targeted signaling pathways, and apoptosis associated with ONC201 directly within tumors that have been surgically removed from adult recurrent glioblastoma patients who have received two doses ONC201. These results serve as an important complement to macroscopic clinical imaging by enabling microscopic studies that demonstrate the drug is inducing the intended therapeutic impact that causes tumor cells to undergo cell death.

In addition to the two abstracts focused on HGG, there is another abstract that reports the safety and pharmacodynamics of ONC201 in advanced solid tumor patients. Additional results support the conclusion that weekly, oral ONC201 is well-tolerated and results in prolonged stable disease, intratumoral apoptotic signaling and immunomodulatory activity.

The abstracts are listed below.

2059. Integrated clinical experience with ONC201 in H3 K27M glioma. Presented Saturday, June 2, 2018.

E14034. Intratumoral activity of ONC201 in adult recurrent glioblastoma patients.

2595. Safety and pharmacodynamics of the DRD2 antagonist ONC201 in advanced solid tumor patients with weekly oral administration. Presented Monday, June 4, 2018,

On May 29, 2018 Laminar Pharma, a pioneering clinical stage biopharmaceutical company developing a new generation of products modulating metabolism of membrane lipids based on the groundbreaking MLT platform, reported that the FDA has approved an IND for a paediatric trial entitled "a phase I study of 2-hydroxyoleic acid (2OHOA) in pediatric patients with malignant glioma and other advanced solid tumors (Press release, Laminar Pharma, MAY 29, 2018, View Source [SID1234562094])"

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This will be the first clinical study with 2OHOA in children with advanced malignant cancer and will be conducted in collaboration with two leading US paediatric clinical research institutions: Hackensack University Medical Center, in New Jersey and Dana-Farber Cancer Institute in Boston. The main objectives of this study are to determine the safety and tolerability of 2OHOA in paediatric population (under 18 years), to characterize the pharmacokinetic profiles in this population and to assess the preliminary anti-tumour efficacy of the product. The trial follows a standard 3+3 design in the dose escalation phase, where 9 to 18 patients will be recruited in three cohorts, and that will be followed by an expansion cohort with 10 additional patients.

High-grade gliomas (HGG) are relatively rare forms of paediatric brain tumours, constituting only 8–12% of primary central nervous system (CNS) tumours in children. The management of these tumours involves surgical resection to the extent feasible, as well as adjuvant radiation and chemotherapy. Even with these interventions, the prognosis for patients with these tumours is poor, with most patients succumbing to their disease within 12–18 months. The incidence rate of primary malignant and non-malignant brain and CNS tumours in the US in paediatric and adolescent population (0-19 years) is 5.42 cases per 100,000 for a total count of around 23,000 incident tumours per year, of which over 2.500 cases correspond to HGG.

Laminar Pharma is committed to advance the clinical development of this promising product and is excited about the prospect of providing a potential therapeutic alternative for children and adult patients with brain and other aggressive cancers.

The approval by the FDA of the Investigational New Drug (IND) application for this paediatric trial in the US is a significant regulatory milestone for 2OHOA, (re)validating the extensive preclinical and clinical development that Laminar Pharma is carrying out with this innovative product.

A PIIb trial in adult patients with newly-diagnosed glioblastoma (CLINGLIO) with 2OHOA added to the current chemoradiation standard of care for this type of tumours is also planned to open within this year in leading Hospitals in Europe and Israel, following the award of an important H2020 grant by the European Commission to an international consortium lead by Laminar Pharma.

On May 29, 2018 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing innovative gene therapy products for patients living with serious, life-threatening rare diseases, reported that Matthew R. Patterson, Chief Executive Officer, will present at the Jefferies 2018 Global Healthcare Conference in New York, NY (Press release, Audentes Therapeutics, MAY 29, 2018, View Source;p=RssLanding&cat=news&id=2351012 [SID1234526915]). The presentation is scheduled for Tuesday, June 5, 2018, at 8:30 am ET.

To access a live webcast of the presentation, please visit the Events & Presentations page within the Investors + Media section of the Audentes website. A replay of the live webcast will be available on the Audentes website for approximately 30 days following the conference.

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On May 29, 2018 Heron Therapeutics, Inc. (NASDAQ: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry D. Quart, Pharm.D., Chief Executive Officer of Heron Therapeutics, will present at the Jefferies 2018 Healthcare Conference on Tuesday, June 5, 2018, at 2:00 p.m. EDT at the Grand Hyatt New York Hotel (Press release, Heron Therapeutics, MAY 29, 2018, View Source [SID1234526934]).

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A live webcast of this presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for 60 days.

On May 29, 2018 BioNTech AG, a fully-integrated biotechnology company pioneering individualized cancer immunotherapy, reported the appointment of Özlem Türeci, M.D., as Chief Medical Officer, effective June 1, 2018 (Press release, BioNTech, MAY 29, 2018, View Source [SID1234527060]). Dr. Türeci has chaired BioNTech´s Scientific and Clinical Advisory Board since the inception of the Company.

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"We are delighted that Özlem has joined BioNTech as Chief Medical Officer," said Helmut Jeggle, Chairman of BioNTech. "She has an exceptional track record both as a physician scientist and as an entrepreneur and brings invaluable expertise to BioNTech."

Dr. Türeci has over 25 years of experience in cancer research and immuno-oncology, specifically in the identification of immunotherapeutic drug targets and the development of antibodies, as well as vaccinebased therapies. In 2001, Dr. Türeci co-founded Ganymed Pharmaceuticals as Chief Scientific Officer and became its Chief Executive Officer in 2008. Ganymed Pharmaceuticals, which focused on developing a new generation of first-in-class antibodies in solid cancers, was sold to Astellas Pharma, Inc. for EUR 422 million in 2016. Dr. Türeci is chairman and co-initiator of Ci3, the German Cluster Initiative of Individualized ImmunIntervention (Ci3) e.V., based in Mainz, Germany. She is also an executive board member of the Association for Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper). She authored over 110 peer-reviewed publications and is an inventor on more than 80 patents and patent applications.

"I very much look forward to working with the team at BioNTech," commented Dr. Türeci. "The Company has an incredibly strong foundation in the science of immunotherapy, and I am excited to help lead its efforts to develop individualized treatments for patients with cancer and other critical diseases."

"BioNTech has grown significantly since its foundation in 2008 and has matured to a clinical-stage company with encouraging early clinical results," added Prof. Ugur Sahin, co-founder and CEO of BioNTech. "As we move forward with more advanced clinical studies in patients, we need a leader with significant experience in translational and advanced clinical development to complement our existing expertise. The appointment of Özlem will allow us to further broaden and accelerate our development activities."