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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported that two abstracts from the Company’s lead innate cell engager AFM13 have been accepted for oral and poster presentation at the 15th International Conference on Malignant Lymphoma (ICML) being held June 18 to 22, 2019 in Lugano, Switzerland (Press release, Affimed, JUN 12, 2019, View Source [SID1234537043]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentations related to AFM13, Affimed’s lead CD30/CD16A bispecific ROCK antibody, include a data update of the completed clinical study of AFM13 in combination with Merck’s Keytruda (pembrolizumab) in patients with relapsed or refractory Hodgkin lymphoma and updated clinical and immunological data from Columbia University on AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation. Details for the ICML presentations are as follows:

Oral Presentation:

Abstract: Investigating safety and preliminary efficacy of AFM13 plus Pembrolizumab in Patients with Relapsed/Refractory Hodgkin Lymphoma after Brentuximab Vedotin Failure
Session: 11 – New Drugs Combination
Date and Time: Saturday, June 22, 8:30 – 10:00 am (CET)
Location: Room A (main hall of Palazzo dei Congressi)

Poster Presentation:

Abstract: Clinical and Biological Evaluation of the Novel CD30/CD16A Tetravalent Bispecific Antibody (AFM13) in Relapsed or Refractory CD30-Positive Lymphoma with Cutaneous Presentation: A Biomarker Phase Ib/IIa Study (NCT03192202)
Section: Immunotherapy
Poster sessions: Wednesday, June 19, 12:00 – 17:00 (CET), Thursday, June 20, 9:00 – 17:00 (CET) and Friday, June 21, 9:00 – 18:30 (CET)
Location: Marquee Parco Ciani

Full abstracts of the presentations are published in the supplement to "Hematological Oncology" (John Wiley and Sons, Inc.), available on the Wiley Online Library website.