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 BioInvent International AB (BINV) reported the publication of the first data from two parallel Phase l/lla clinical trials of its lead product candidate BI-1206 as single agent and/or in combination with rituximab, currently being conducting in the UK and the US/EU respectively (Press release, BioInvent, JUN 12, 2019, View Source [SID1234537044]).

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In the UK trial, 10 patients have received single agent therapy with up to 100 mg BI-1206 once weekly for a period of 4 weeks. In the US/EU study, five patients have received up to 100 mg BI-1206 in combination with rituximab. The data are published in the Abstract Book from the 15-ICML International Conference on Malignant Lymphoma, available online as of today (View Source).

Receptor occupancy is dose proportionate and anticipated to yield high levels of receptor blockade at clinically relevant doses of BI-1206. While target-mediated drug disposition has not yet been overcome, as the optimal dose has still not been reached, pharmacodynamic analysis at the current doses showed depletion of peripheral B cells, including circulating mantle cell lymphoma cells during the first week of induction therapy.

"These are exciting results that further support the development of BI-1206 as a potential first-in-class therapeutic with a unique mechanism of action. Circumventing rituximab internalization by FcγRIIB blocking means it will potentially enhance rituximab’s efficacy," says BioInvent’s CEO Martin Welschof.

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.

On June 12, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported data from its ADCETRIS (brentuximab vedotin) clinical development program at the 24th Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place June 13-16 in Amsterdam; and the International Conference on Malignant Lymphoma (ICML) from June 18-22 in Lugano (Press release, Seattle Genetics, JUN 12, 2019, View Source [SID1234537045]). Updated analyses from clinical trials evaluating ADCETRIS in combination with Opdivo (nivolumab), as well as encore analyses from the phase 3 ECHELON-1, ECHELON-2 and ALCANZA clinical trials, will be highlighted in 12 presentations at EHA (Free EHA Whitepaper) and ICML. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma (HL) and expressed on the surface of several types of peripheral T-cell lymphomas. Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to harness the body’s own immune system to help restore anti-tumor immune response. ADCETRIS and Opdivo are not approved in combination for the treatment of relapsed or refractory primary mediastinal large B-cell lymphoma (PMBL), HL, pediatric HL or for other indications. ADCETRIS in combination with bendamustine is not approved for HL.

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"This year at the EHA (Free EHA Whitepaper) and ICML meetings, key ADCETRIS data will be featured that continue to support our goal of further expanding our clinical development program beyond the six ADCETRIS approved indications," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "We are excited about several ADCETRIS-related presentations including encore oral presentations from the ECHELON-1 and ECHELON-2 phase 3 trials, as well as clinical research updates on ADCETRIS combination treatment strategies."

Details of oral and poster presentations featured at EHA (Free EHA Whitepaper) include:

Abstract Title: Frontline Brentuximab Vedotin with Chemotherapy for Stage 3/4 Classical Hodgkin Lymphoma: 3-Year Update of the ECHELON-1 Study (Abstract #S820)
Oral Presentation Date and Time: Saturday, June 15, 12:00-12:15 p.m. CEST
Location: Hall 5

Abstract Title: Nivolumab and Brentuximab Vedotin-based, Response-adapted Treatment in Primary Refractory and in Pediatric Patients with Relapsed/Refractory Classical Hodgkin Lymphoma in Checkmate 744 (Abstract #S822)
Oral Presentation Date and Time: Saturday, June 15, 12:30-12:45 p.m. CEST
Location: Hall 5

Abstract Title: The ECHELON-2 Trial: Results of a Randomized, Double-blind Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) versus CHOP in Frontline Treatment of Patients with CD30+ Peripheral T-cell Lymphomas (Abstract #PS1070)
Poster Presentation Date and Time: Saturday, June 15, 5:30-7:00 p.m. CEST
Location: Poster Area

Abstract Title: Nivolumab Combined with Brentuximab Vedotin for Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma: Efficacy and Safety Results from the Phase 2 Checkmate 436 Study (Abstract #S1601)
Oral Presentation Date and Time: Sunday, June 16, 9:00-9:15 a.m. CEST
Location: Hall 5

Details of oral and poster presentations featured at ICML include:

Abstract Title: Safety and Response after 2 Cycles of Brentuximab Vedotin Substituting Vincristine in the OEPA/COPDAC Regimen for High Risk Pediatric Hodgkin Lymphoma (HL) (Abstract #025)
Oral Presentation Date and Time: Wednesday, June 19, 5:25 p.m. CEST
Location: Cinema Corso

Abstract Title: Response-Adapted Treatment with Nivolumab and Brentuximab Vedotin in Young Patients with Relapsed/Refractory Classical Hodgkin Lymphoma: Checkmate 744 Subgroup Analyses (Abstract #026)
Oral Presentation Date and Time: Wednesday, June 19, 5:35 p.m. CEST
Location: Cinema Corso

Abstract Title: Extended Follow-up a Phase 1 Study of Ipilimumab, Nivolumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma: A Trial of the ECOG-ACRIN Research Group (E4412: Arms A-I) (Abstract #077)
Oral Presentation Date and Time: Thursday, June 20, 5:45 p.m. CEST
Location: Cinema Corso

Abstract Title: Nivolumab Combined with Brentuximab Vedotin for Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma: Efficacy and Safety Results from the Phase 2 Checkmate 436 Study (Abstract #108)
Oral Presentation Date and Time: Friday, June 21, 2:15 p.m. CEST
Location: Room B, Palazzo dei Congressi

Abstract Title: Response to A+CHP by CD30 Expression in the ECHELON-2 Trial (Abstract #228)
Poster Presentation Date and Time: Wednesday-Friday, June 19-21, 12:00-5:00 p.m., 9:00 a.m.-5:00 p.m. and 9:00 a.m.-6:30 p.m. respectively, CEST
Location: Marquee Parco Ciani

Abstract Title: Exploratory Biomarker Analysis in the Phase 3 ECHELON-1 Study: Worse Outcome with ABVD in Patients with Elevated Baseline Levels of sCD30 and TARC (Abstract #235)
Poster Presentation Date and Time: Wednesday-Friday, June 19-21, 12:00-5:00 p.m., 9:00 a.m.-5:00 p.m. and 9:00 a.m.-6:30 p.m. respectively, CEST
Location: Marquee Parco Ciani

Abstract Title: Brentuximab Vedotin and Bendamustine is a Feasible and Effective Drug Combination as First-line Treatment of Hodgkin Lymphoma in the Elderly (HALO trial) (Abstract #237)
Poster Presentation Date and Time: Wednesday-Friday, June 19-21, 12:00-5:00 p.m., 9:00 a.m.-5:00 p.m. and 9:00 a.m.-6:30 p.m. respectively, CEST
Location: Marquee Parco Ciani

Abstract Title: Final Data from the Phase 3 ALCANZA Study: Brentuximab Vedotin (BV) vs Physician’s Choice (PC) in Patients (pts) with CD30-positive (CD30+) Cutaneous T-cell Lymphoma (CTCL) (Abstract #232)
Poster Presentation Date and Time: Wednesday-Friday, June 19-21, 12:00-5:00 p.m., 9:00 a.m.-5:00 p.m. and 9:00 a.m.-6:30 p.m. respectively, CEST
Location: Marquee Parco Ciani

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.