Zymeworks to Present at Raymond James Life Sciences and MedTech Conference

On June 12, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will present at the upcoming Raymond James Life Sciences and MedTech Conference taking place June 18-19, 2019 in New York, NY (Press release, Zymeworks, JUN 12, 2019, View Source [SID1234537050]).

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The Company’s presentation will be on Wednesday, June 19, 2019 at 11:30 a.m. ET.

OnKure and CU Cancer Center Announce First Patient Enrolled in Clinical Trial of OKI-179, a Potent and Selective HDAC Inhibitor

On June 12, 2019 OnKure, Inc. and the University of Colorado Cancer Center reported enrollment of the first patient in a first-in-human phase 1 clinical trial testing investigational anti-cancer agent OKI-179, a novel and Class-selective HDAC inhibitor, in patients with advanced solid tumors (Press release, OnKure, JUN 12, 2019, View Source [SID1234537049]). The study represents a milestone in the ongoing partnership between OnKure and the University of Colorado system, with the drug discovery and development company built around basic research from CU Boulder and the clinical trial taking place in partnership with CU Cancer Center on the Anschutz Medical Campus.

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"This CU homegrown, clinical-stage drug is the result of a multi-year collaboration, so our team is very excited. We’re happy to report that we successfully dosed the first patient and the patient is doing well," says Jennifer Diamond, MD, Medical Director of the CU Cancer Center Cancer Clinical Trials Office, Co-director of the Women’s Cancer Developmental Therapeutics Program, and principal investigator of the OKI-179 phase 1 clinical trial.

OKI-179 is a potent and selective inhibitor of a family of enzymes known as histone deacetylases (HDACs), specifically inhibiting Class 1 HDACs, which are implicated in the development and growth of a range of solid and hematologic cancers. While previous HDAC inhibitors have shown promise in preclinical studies, clinical benefit has generally been limited by toxicity.

"We’re very optimistic that OKI-179 will fill a hole in what is currently available," says Anthony D. Piscopio, PhD, President and Chief Executive Officer of OnKure. "It also stands out from FDA-approved HDAC inhibitors based on its unique potency and selectivity profile."

The compound is an analog of the naturally occurring chemical largazole, named for Key Largo, Florida, where largazole is bio-manufactured by a type of coral-colonizing bacteria indigenous to the region. After its structure and anti-proliferative effects were described in 2008, work by Xuedong Liu, PhD, Professor of Chemistry and Biochemistry at CU Boulder, showed that largazole and the chemical analog that would become OKI-179 achieve their anti-proliferative effects through the mechanism of HDAC inhibition. Dr. Liu also serves as Chief Science Officer of OnKure.

"Basically, HDAC enzymes remove a kind of speed limiter from cells, allowing them to proliferate more readily and HDAC inhibitors like OKI-179 block this effect," Dr. Diamond says.

The phase 1 clinical trial (NCT03931681) is offered exclusively at CU Cancer Center to patients with solid tumors for whom no standard therapy exists, and is meant to explore drug safety, tolerability, and dosing. Additional research, including a 2017 study by CU Cancer Center investigators published in the Journal of Clinical Oncology, shows that in addition to possible single-agent use, OKI-179 may sensitize tumor tissue to targeting via immunotherapies including anti-PD1 checkpoint inhibitors.

"This drug is a compelling part of our portfolio of innovative clinical trials in the CU Cancer Center Women’s Cancer Developmental Therapeutics Program," Dr. Diamond says.

Prelude Therapeutics Secures $60 Million and Expands Management Team to Develop Drugs Targeting Novel Molecular Mechanisms in Cancer

On June 12, 2019 Prelude Therapeutics, a privately held, clinical-stage biopharmaceutical company focused on the discovery and development of small molecule drugs that target key drivers of cancer cell growth, survival and resistance, secured $60 million in Series B financing; taking its total investments to date to $95 million (Press release, Prelude Therapeutics, JUN 12, 2019, View Source [SID1234537048]). The financing was co-led by Prelude’s two existing institutional investors, including OrbiMed Advisors LLC.

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Since its launch in July 2016, Prelude has made rapid progress in its first discovery program targeting Protein Arginine Methyltransferase 5 (PRMT5), a member of the arginine methyltransferase family. PRMT5 plays an important role in several cellular processes that drive cancer cell proliferation, cell cycle progression and resistance to apoptosis in hematological malignancies and solid tumors.

Proceeds from the Series B financing will be used to advance Prelude’s proprietary PRMT5 inhibitor, PRT543, through proof of concept clinical studies. PRT543 is in a parallel dose escalation Phase 1 clinical trial for solid tumors, myeloid malignancies and lymphomas.

Series B funding will also be used to advance additional differentiated compounds from the PRMT5 program and strengthen Prelude’s discovery, preclinical and clinical development infrastructure to support a rapidly advancing pipeline beyond PRMT5. Prelude has established several drug discovery programs and compounds from these early-stage programs are also expected to enter preclinical development in the second half of 2019 with a potential IND-filing in 2020.

"We are very appreciative of the continued support of our current investors, who have been integral to the founding of Prelude and the creation of our growing pipeline," said Kris Vaddi, PhD, Founder and CEO of Prelude Therapeutics. "We believe PRMT5 inhibitors represent a promising new class of drugs to treat cancers, including ones that have developed resistance to existing targeted therapies. We are also pleased to have assembled such a talented, experienced and proven leadership team to address some of the most pressing gaps in cancer treatment."

Prelude Management Team

Dr. Vaddi founded Prelude in July 2016 and serves as CEO and a member of the Board of Directors. Prior to Prelude, Dr. Vaddi was a member of the founding team of Incyte Corporation in 2002 and most recently served as a group vice president. He initiated and championed JAK research programs at Incyte that led to the discovery, development and approval of Jakafi (ruxolotinib) for Myelofibrosis and Polycythemia Vera and Olumiant (Baricitinib) for rheumatoid arthritis. Dr. Vaddi received his Doctorate in Veterinary Medicine from APAU in India and his PhD from the University of Florida.

On May 1, 2019, David Mauro, MD, PhD, was named Chief Medical Officer. Dr. Mauro comes to Prelude with strong drug development experience in positions of increasing responsibility at Bristol-Myers Squibb, Merck and most recently Checkmate Pharmaceuticals as its Chief Medical Officer. Dr. Mauro earned his MD and PhD from Temple University School of Medicine.

Beginning July 1, 2019, Brian Piper, MBA will join Prelude as Chief Financial Officer. Mr. Piper most recently served as Chief Financial Officer at Aevi Genomic Medicine, where he was responsible for leadership and management of corporate financing and reporting, corporate fundraising efforts and investor relations. Prior to that, Mr. Piper held roles of increasing responsibility in finance, program and alliance management and investor relations at Shire Pharmaceuticals.

Epizyme Announces Conference Call to Discuss Phase 2 Tazemetostat Follicular Lymphoma Data

On June 12, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported that management will host a conference call on Friday, June 21, 2019 at 8:30 a.m. ET to discuss updated data from an ongoing Phase 2 study of its lead candidate, tazemetostat, as a monotherapy for patients with relapsed or refractory follicular lymphoma (Press release, Epizyme, JUN 12, 2019, View Source [SID1234537047]). The data, which will be from a recent June 2019 data cutoff date, will be reported in an oral presentation by Franck Morschhauser, M.D., Ph.D., Centre Hospitalier Régional Universitaire and study investigator, at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland.

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The details of the presentation and the company’s conference call are listed below:

ICML Oral Presentation
Title: Interim update from a Phase 2 multicenter study of tazemetostat, an EZH2 inhibitor, in patients with relapsed or refractory follicular lymphoma
Presenter: Franck Morschhauser, M.D., Ph.D., Centre Hospitalier Régional Universitaire de Lille, France
Abstract No.: 105
Date: Friday, June 21, 2019; 2:45 – 3:00 p.m. CEST
Location: Room A

Conference Call Details
To participate in the call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 7765222. A live webcast will be available in the investor section of the company’s website at www.epizyme.com. The webcast will be archived on the website for 60 days.

Harbour BioMed and Erasmus MC Sign MoU to Advance Next-Generation Immuno-oncology, and Immunology Drug Discovery and Clinical Development

On June 12, 2019 Harbour BioMed (HBM) and Erasmus MC, University Medical Center Rotterdam reported that they have signed a 10-year Memorandum of Understanding (MOU) to enable a broad range of joint basic, translational and clinical research activities aimed at developing next generation biotherapeutics for the treatment of cancer and immunological diseases (Press release, Harbour BioMed, JUN 12, 2019, View Source [SID1234537046]). The MoU was signed during the official, 40th anniversary celebration ceremony of the Shanghai-Rotterdam Sister City Relationship.

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Under the MoU, HBM expects to establish laboratory space in Rotterdam to facilitate scientific collaborations with Erasmus MC investigators across multiple departments. The company and Erasmus MC have established an umbrella CDA to expedite collaboration discussions. In addition, HBM plans to run its Phase I and II clinical trials at Erasmus MC, which will also serve as the base for larger clinical trials across Europe of its growing therapeutic portfolio.

"This MoU will advance the company’s vision of growing its footprint in Europe and provide a foundation for strengthening our scientific and business collaborations with Erasmus MC," said Dr. Jingsong Wang, Founder, Chairman and CEO of HBM. "Working under the broader umbrella of the MoU will allow a broad range of collaborations between our two organizations to discover breakthrough therapies that can be rapidly developed and tested in clinical trials."

Professor Ernest J. Kuipers, CEO of Erasmus MC, stated, "This expanded partnership, which builds on the strong, longstanding relationship we have established with HBM, provides a framework for discovering and advancing innovative drugs into clinical trials to address unmet needs of patients with cancer and immunological diseases. Such collaborations between industry and academic institutions like Erasmus MC provide an important avenue for scientists and clinicians to advance basic and clinical science."

The Mayor of Rotterdam, Mr. Ahmed Aboutaleb, also commented in support of the MoU, "The collaboration between Harbour BioMed and Erasmus MC offers diverse opportunities for the city of Rotterdam as well as for Shanghai: employability, knowledge and a chance of realizing better treatments of certain types of cancers and immune-mediated diseases."

Harbour BioMed has collaborated with Erasmus MC since its inception in 2016, when the company acquired Harbour Antibodies, an Erasmus MC spin-out commercializing two transgenic mouse platforms for producing fully human antibodies. Since that time, HBM and Erasmus MC have worked closely apply these powerful platform technologies for the discovery of novel therapeutics.