On June 13, 2019 Oncopeptides AB (Nasdaq Stockholm: ONCO), reported that the company will make a review and update on the presented data from the European Hematology Meeting (EHA) (Free EHA Whitepaper) on Monday, June 17, 2019, at. 09:00 (CET) (Press release, Oncopeptides, JUN 13, 2019, View Source [SID1234537055]).

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It will be presented by CEO Jakob Lindberg and members of the Oncopeptide management team.

The conference call can also be followed via the link: View Source

Phone numbers for participants from:
Sweden: +46 8 566 427 06
Europe: +44 3333 009 030
USA: +1 833 526 8384

For further information, please contact:
Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: [email protected]
Cell phone: +46 70 853 72 92

This information was submitted for publication at 09:00 CET, 13 June 2019

On June 13, 2019 Intrexon Corporation (NASDAQ: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, and its wholly-owned Intrexon Health subsidiary Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, reported their presentation at the JMP Securities Life Sciences Conference in New York. Helen Sabzevari, PhD, President of Precigen, will highlight Intrexon Health and Precigen in the presentation on Thursday, June 20, 2019 at 12:30 pm Eastern Time (Press release, Intrexon, JUN 13, 2019, View Source [SID1234537053]).

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A live webcast of the presentation will be available on the Investors section of Intrexon’s website under ‘Events’ at investors.dna.com/events and on Precigen’s website under ‘Presentations’ at www.precigen.com/media/#id-presentations. The presentation will be archived on the Intrexon and Precigen websites for 30 days following the event.

On June 12, 2019 CutisPharma, Inc. reported its acquisition of Silvergate Pharmaceuticals and the unveiling of its new corporate brand for the unified company: Azurity Pharmaceuticals (Press release, Azurity Pharmaceuticals, JUN 12, 2019, View Source [SID1234625386]).

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"I am thrilled to announce the combination of two strong companies with a rich legacy meeting the needs of underserved patients, such as children and the elderly," said Neal I. Muni, MD, MSPH, Azurity Pharmaceuticals’ Chief Executive Officer. "Azurity’s mission, to make safe, high-quality treatments for patients requiring customized formulations for their care, is significantly bolstered by our combined resources and capabilities."

NovaQuest Capital Management, LLC, the majority owner of Azurity Pharmaceuticals, supported CutisPharma and its management team in the transaction. Goldman Sachs Specialty Lending Group continues to support the company as a lender and arranged the debt financing for the transaction.

Azurity’s management team will be comprised of leaders from both the legacy CutisPharma and Silvergate teams. Azurity’s Corporate Headquarters and Manufacturing Facility will be located in the Greater Boston area (Woburn, MAand Wilmington, MA, respectively); its R&D Campus will be located outside Kansas City, MO and the Corporate Satellite Campus will be located outside Denver, CO.

Both companies have achieved several key milestones over the past year, including CutisPharma’s FDA approval and launch of FIRVANQ (vancomycin hydrochloride) for oral solution for the treatment of Clostridium difficile-associated diarrhea in early 2018, and Silvergate’s submission of a New Drug Application (NDA) for its lead pipeline drug, SG-05, to the FDA, currently under review. Together as one company, Azurity will offer its valued customers a comprehensive portfolio across 12 products that serve multiple therapeutic areas.

On June 12, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of antibody drug conjugates (ADCs), reported that data on ADCT-402 (loncastuximab tesirine) and ADCT-301 (camidanlumab tesirine) have been selected for four presentations at the 15th International Conference on Malignant Lymphoma (15-ICML), which is being held June 18-22, 2019, in Lugano, Switzerland (Press release, ADC Therapeutics, JUN 12, 2019, View Source [SID1234596062]).

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Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, "We are pleased to be presenting compelling data at 15-ICML from our 183-patient Phase I clinical trial of ADCT-402 in relapsed or refractory B-cell lymphoma (including 139 patients with diffuse large B-cell lymphoma), as well as our 128-patient Phase I clinical trial of ADCT-301 in relapsed or refractory Hodgkin and non-Hodgkin lymphoma (including 77 patients with Hodgkin lymphoma). Based on these data, ADCT-402 is now in an ongoing pivotal Phase II trial and we plan to commence a pivotal Phase II trial of ADCT-301 later this summer. In addition, new preclinical studies highlight the potential of these novel ADCs for the treatment of lymphomas as both single agents and in combination with other targeted drugs. The data reinforce our position as a leader in the development of next generation PBD-based ADCs and the strength of our hematology franchise, which now also includes ADCT-602 in a Phase I clinical trial for acute lymphoblastic leukemia."

Oral Presentations

Title: Analysis of Efficacy and Safety of Loncastuximab Tesirine (ADCT-402) by Demographic and Clinical Characteristics in Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Abstract Number: 054
Session: Session 4 – Treatment with Novel Antibodies
Date/Time: Thursday, June 20, 16:25 CEST
Location: Room A, Cinema Corso Auditorium and Aula Magna
Presenter: John Radford MD, FRCP, Department of Medical Oncology, The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK

Title: Analysis of Clinical Determinants Driving Safety and Efficacy of Camidanlumab Tesirine (ADCT-301, Cami) in Relapsed/Refractory (R/R) Classical Hodgkin Lymphoma (cHL)

Abstract Number: 055
Session: Session 4 – Treatment with Novel Antibodies
Date/Time: Thursday, June 20, 16:40 CEST
Location: Room A, Cinema Corso Auditorium and Aula Magna
Presenter: Graham Collins, MB, BS, DPhil, Department of Clinical Haematology, Oxford University Hospitals, NHS Foundation Trust, Oxford, UK

Title: The Antibody-Drug Conjugate (ADC) Loncastuximab Tesirine (ADCT-402) Targeting CD19 Shows Strong In Vitro Anti-Lymphoma Activity Both as Single Agents and In Combination

Abstract Number: 084
Session: Focus On Non-Clinical New Drugs
Date/Time: Thursday, June 20, 17:55 CEST
Location: Auditorium (USI Universitá)
Presenter: Chiara Tarantelli, PhD, Università della Svizzera italiana, Institute of Oncology Research

Poster Presentation

Title: The Anti-CD25 Antibody-Drug Conjugate Camidanlumab Tesirine (ADCT-301) Presents a Strong Preclinical Activity Both as Single Agent and In Combination in Lymphoma Cell Lines

Poster Number: 270
Session: Poster Session
Date/Time: Wednesday, June 19, 12:00-17:00 CEST; Thursday, June 20, 9:00-17:00 CEST; Friday, June 21, 9:00-18:30 CEST
Location: Marquee
Presenter: Filippo Spriano, PhD, Institute of Oncology Research

Abstracts are available on the 15-ICML web site: www.lymphcon.ch.

About ADCT-402
ADCT-402 (loncastuximab tesirine) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD19-expressing cell, ADCT-402 is internalized into the cell where enzymes release the PBD-based warhead. CD19 is a clinically validated target for the treatment of B-cell malignancies. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and resulting in cell death. ADCT-402 is being evaluated in a pivotal Phase II clinical trial in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (NCT03589469), a Phase Ib trial in combination with ibrutinib in patients with R/R DLBCL or mantle cell lymphoma (MCL) (NCT03684694) and a Phase Ib trial in combination with durvalumab in patients with R/R DLBCL, MCL or follicular lymphoma (NCT03685344). The U.S. Food and Drug Administration granted orphan drug designation to ADCT-402 for the treatment of relapsed or refractory DLBCL and MCL.

About ADCT-301
ADCT-301 (camidanlumab tesirine) is an antibody drug conjugate (ADC) composed of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload tesirine. Once bound to a CD25-expressing cell, ADCT-301 is internalized into the cell where enzymes release the PBD-based warhead. The intra-tumor release of its PBD warhead may cause bystander killing of neighboring tumor cells. In addition, the PBD warhead will trigger immunogenic cell death, which in turn will strengthen the immune response against tumor cells. ADCT-301 is being evaluated in ongoing Phase Ia/Ib clinical trials in patients with relapsed or refractory Hodgkin lymphoma and non-Hodgkin lymphoma (NCT02432235), as well as a Phase Ib clinical trial in solid tumors (NCT03621982).

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, reported that 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 [SID1234539637]). 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.