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.

On June 12, 2019 Debiopharm (Debiopharm – www.debiopharm.com) and Ipsen (www.ipsen.com) reported renewal of their Decapeptyl agreement, which extends and strengthens their strategic partnership through 2034 for the development, manufacturing and distribution of Decapeptyl across Europe and certain Asian and African markets (Press release, Ipsen, JUN 12, 2019, View Source [SID1234537019]). Having established their collaboration in the 1980s, this extension represents a long-term commitment to patients, offering the benefits of Decapeptyl in the treatment of metastatic and non-metastatic patients with locally advanced prostate cancer, endometriosis, uterine fibroids, central precocious puberty and endocrine-responsive early-stage breast cancer.

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Under the renewed agreement, both parties will co-develop novel formulations and explore additional indications for other patient populations with high unmet needs.

"Our continued partnership remains critical to ensure that patients maintain access to Decapeptyl therapy for their various conditions. Furthermore, this renewed agreement represents an opportunity to refine and refocus our collaboration by further exploring our co-development capacity to potentially identify how Decapeptyl can respond to more unmet patient needs."

Thierry Mauvernay, President & Delegate of the Board Group, Debiopharm

"We are delighted to renew and extend this partnership with Debiopharm. This collaboration has been – and continues to be – a testament to our commitment to patients and our shared passion with strategic partners."

Ivana Magovčević-Liebisch, Executive Vice-President, Chief Business Officer

About Decapeptyl

Decapeptyl (triptorelin pamoate) is an agonist analogue of the natural gonadotropin-releasing hormone (GnRH), currently available in three sustained-release formulations (1, 3 and 6 months). First registered in France in 1986, triptorelin is currently marketed in more than 80 countries, being the market leader in many territories worldwide. The alliance between Debiopharm and Ipsen for Decapeptyl has successfully delivered sustained market growth with €372.6 million total sales in 2018, representing 8.1% annual growth.

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.

On June 12, 2019 Alkermes plc (Nasdaq: ALKS) reported the initiation of the monotherapy expansion stage of its ARTISTRY-1 clinical trial to evaluate the efficacy, safety and tolerability of ALKS 4230 in treating patients with renal cell carcinoma or melanoma (Press release, Alkermes, JUN 12, 2019, View Source;p=RssLanding&cat=news&id=2401218 [SID1234537031]). Initiation of this portion of the ongoing study follows the identification of 6 µg/kg/day administered intravenously as the recommended monotherapy dose of ALKS 4230 to evaluate in these select tumor types. The maximum tolerated dose of ALKS 4230 has not yet been reached, and the dose-escalation stage of the ARTISTRY-1 study is continuing. ALKS 4230 is a novel, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex.

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"At the 6 µg/kg/day dose, data from the dose-escalation stage of ARTISTRY-1 demonstrated the tolerability profile we set out to achieve for ALKS 4230, along with desired lymphocyte cell expansion without corresponding Treg activation. This validates our design rationale for ALKS 4230, and we now look forward to progressing into the expansion stage to evaluate ALKS 4230 as monotherapy in select tumor types," said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. "We plan to present the first efficacy data from across the ALKS 4230 development program at a medical meeting later this year, pending conference acceptance."

Selection of the recommended phase 2 dose of ALKS 4230 as monotherapy was made following the completion of five dose-escalation cohorts, spanning a dose range of 0.1 µg/kg/day to 6 µg/kg/day, in 36 patients who were refractory to prior administered therapies known to demonstrate clinical benefit. Data from the completed cohorts demonstrated dose-dependent pharmacodynamic effects on circulating natural killer (NK) cells and CD8+ T cells, and minimal and non-dose dependent effects on immunosuppressive regulatory T cells (Tregs). The newly initiated monotherapy expansion stage will assess objective efficacy measures of ALKS 4230 administered intravenously daily for five consecutive days in up to 105 patients refractory to prior administered therapies with renal cell carcinoma or melanoma, two tumor types for which high-dose IL-2 has demonstrated durable anti-tumor responses as a monotherapy treatment.1

Data from the initial four cohorts of the dose-escalation stage of ARTISTRY-1 were presented at the 2018 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. Treatment with ALKS 4230 at 3 µg/kg/day resulted in a dose-dependent increase in circulating NK cells and CD8+ T cells with a near 4-fold and 2-fold expansion, respectively, and minimal, non-dose-dependent change in Tregs. Further effector-cell expansion was observed in cohort 5 at the 6 µg/kg/day dose, with minimal increase in circulating Tregs. No dose-limiting toxicities were observed in cohort 5. Fever and chills were the most common treatment-related adverse events (AEs) for ALKS 4230 across all cohorts, and the safety profile observed with ALKS 4230 was consistent with the known profile of cytokine therapy.

About ALKS 4230
ALKS 4230 is a novel, engineered fusion protein designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity interleukin-2 (IL-2) receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Program
ARTISTRY is an Alkermes-sponsored clinical program evaluating ALKS 4230 in patients with advanced solid tumors. ARTISTRY-1 is an ongoing phase 1/2 study in which ALKS 4230 is administered as an intravenous infusion daily for five consecutive days. ARTISTRY-1 has three distinct stages: an ongoing monotherapy dose-escalation stage, the newly initiated monotherapy expansion stage and an ongoing combination therapy stage with the PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with select advanced solid tumors.

ARTISTRY-2 is an ongoing phase 1/2 study of ALKS 4230 administered subcutaneously as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. ARTISTRY-2 is designed to explore the safety, tolerability and efficacy of ALKS 4230 administered subcutaneously and assess once-weekly and once-every-three-week dosing schedules.