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."

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 PharmaMar (MSE:PHM) has reported that the Independent Data Monitoring Committee (IDMC) has notified the Company of its recommendation that the Phase III (ATLANTIS) trial currently under way with Zepsyre (lurbinectedin, PM1183) in combination with doxorubicin in small-cell lung cancer patients should continue without any changes (Press release, PharmaMar, MAY 29, 2018, View Source [SID1234527441]).

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The IDMC’s recommendation came after an analysis of the safety data obtained with more than 500 patients treated in the trial. This pivotal randomized Phase III trial assesses the efficacy of PM1183 in combination compared with the standard treatment for this indication: investigator’s choice of either Topotecan or CAV (cyclophosphamide, doxorubicin, and vincristine).

About Zepsyre
Zepsyre (lurbinectedin, PM1183) is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.

About small-cell lung cancer
SCLC is a very aggressive cancer that usually presents with distant metastases and has already spread at the time of diagnosis, thus limiting the role of traditional approaches and posing a worse prognosis compared to other lung cancer types. The 5-year survival rate is about 5%i

About 18% of all the lung
cancer cases diagnosed are SCLC, and only in the US more than 34,000 new cases are recorded every year. This tumor is strongly associated with tobacco smoking, posing an important public health problemii.

After failure to treatment with a platinum-based therapy in first line, the therapeutic alternatives are very limited, and the approval of the last drug for this disease took place 20 years ago.