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."

On May 29, 2018 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported that the company will participate at the upcoming 2018 BIO International Convention(Press release, Avid Bioservices, MAY 29, 2018, View Source [SID1234526916]). The company’s activities will include hosting of a corporate booth (#1073) in the conference’s exhibit hall, delivering a presentation on single-use manufacturing of biopharmaceuticals, participating in a roundtable discussion on the topic of capacity strategies for the utilization of single-use systems vs. traditional stainless steel technology, and taking part in the conference’s one-on-one partnering meetings. The company will also hold a reception at its booth on the evening of Tuesday, June 5th as part of the exhibit hall activities taking place on opening day. BIO 2018 is being held June 4-7, 2018 in Boston, MA.

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Details of Avid’s activities at BIO 2018 are as follows:
Avid will host corporate booth #1073 showcasing the company’s comprehensive range of process development, high quality cGMP clinical and commercial manufacturing services. Company representatives will provide a virtual tour of Avid’s 42,000 square foot state-of-the-art commercial biomanufacturing suite (Myford facility), which is in the unique position of being a validated facility with immediately available 2,000-liter scale bioreactor capacity. The company will also discuss the ongoing expansion of its process development capabilities and laboratories.

The Myford facility, located in Tustin, California, incorporates a variety of cutting-edge, single-use equipment with the goal of ultimately accommodating a fully disposable biomanufacturing process. A wide range of innovative features are incorporated into the facility including monolithic modular clean rooms, dedicated support utilities for each key processing area, and the industry’s most advanced single-use production systems and flexible solutions. Uni-directional process flows separate personnel and materials and provide assurance that the design meets the most stringent regulatory requirements for commercial biologics drug substance manufacturing.

Additionally, Avid will dedicate a portion of its booth to celebrating the company’s 25 years of experience in biopharmaceutical development and manufacturing, which dates back to 1993. This anniversary coincides with the 25-year anniversary of the Biotechnology Innovation Organization (BIO), which is also being celebrated this year.
Joining the Avid team at BIO 2018 will be Sandra C. Carbonneau, the company’s newly appointed director of business development for the East Coast. Mrs. Carbonneau has more than 26 years of relevant industry experience, including a 22-year tenure with Lonza, a global integrated solutions provider to the pharmaceutical and biotechnology industries. During her time with Lonza, she held positions of increasing responsibility spanning areas of manufacturing, quality assurance, compliance and contract management, culminating in her overseeing the company’s global commercial development for its mammalian business unit. Mrs. Carbonneau most recently served as director of business development in the New England region at Integrated Project Services (IPS), a leading consulting firm for technically complex facilities worldwide. At Avid, she will play a key role in the company’s new customer acquisition efforts on the east coast of the US, while supporting all its existing clients in the eastern half of the country.

Roger Lias, Ph.D., Avid’s president and chief executive officer, will participate in a roundtable discussion titled, "Capacity Strategies – The Strategy Behind the Large Scale SUS vs. Stainless Steel Investment." The roundtable discussion will take place from 1:00 – 2:00 p.m. Eastern on Wednesday, June 6th at booth #375 within the BioProcess Zone’s BPI Theatre. It will be part of the BPI Theatre’s "Emerging Techniques, Technologies and Strategies" track.

Sun Ra Bullins, director of manufacturing at Avid, will make a presentation titled, "The Perks and Pitfalls of a Single-Use Biopharmaceutical Facility." The presentation will take place from 3:40 – 4:00 p.m. Eastern on Wednesday, June 6th at booth #375 within the BioProcess Zone’s BPI Theatre. It will be part of the BPI Theatre’s "Emerging Techniques, Technologies and Strategies" track.