On November 7, 2019 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, is reported it has been accepted for a poster presentation at the 61st Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting, which takes place from 7-10 December 2019 in Orlando, Florida (Press release, BerGenBio, NOV 7, 2019, View Source [SID1234550702]).

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The poster will provide an update on its phase II study of bemcentinib (BGB324) in combination with Low-dose Cytarabine in elderly AML patients.

Abstract titles have been announced online. Details of the presentation are below.

Title: Durable responses observed in elderly AML patients unfit for intensive chemotherapy with first-in class selective AXL inhibitor bemcentinib (BGB324) in combination with LDAC: Phase II open-label study

Date: Monday 9th December 2019

Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III

Time, Location: 6:00 PM – 8:00 PM, Orange County Convention Center, Hall B

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.

About bemcentinib

Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.

On November 7, 2019 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results for the third quarter ended September 30, 2019 and provided a corporate update (Press release, Jounce Therapeutics, NOV 7, 2019, View Source [SID1234550718]).

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"We have continued to work diligently on advancing our pipeline and further executing on our clinical development plans through our Translational Science Platform and reverse translational analysis. Both of our clinical-stage programs, vopratelimab and JTX-4014, continue to progress well. We are pleased to be presenting both new data from JTX-4014, as well as the dosing and sequencing strategy for vopratelimab in our ongoing EMERGE Phase 2 trial, at the SITC (Free SITC Whitepaper) 2019 Annual Meeting this weekend," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We continue to focus on the underlying mechanistic science of our immunotherapies as we work towards bringing meaningful and long-lasting benefits to cancer patients. We look forward to executing on several key milestones in 2020 across our robust pipeline."

Clinical Programs:
Vopratelimab

Two development paths established for vopratelimab program: The reverse translational analysis from the ICONIC trial established the correlation between ICOS hi CD4 T cells, which emerged due to vopratelimab, and clinical benefit. The first development path focuses on the biology of optimizing the induction of ICOS hi CD4 T cells prior to vopratelimab administration. The second path focuses on the use of a predictive biomarker to identify and select patients who may be more likely to benefit from a combination of vopratelimab and a PD-1 inhibitor. The first of the induction studies, EMERGE, is underway.
Dosing and sequencing strategy for EMERGE Phase 2 trial to be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper): On November 9, 2019, Jounce will present a Trials in Progress poster on the EMERGE trial, which will include the combination dosing and sequencing strategy based on its understanding of the kinetics of induction of ICOS hi CD4 T effector cells by ipilimumab and their expansion and sustained activation by vopratelimab. The EMERGE Phase 2 clinical trial began enrollment in mid-June 2019. Jounce expects to report EMERGE data including preliminary efficacy and biomarker relationships to clinical outcomes for up to 80 patients in 2020.
Predictive biomarker approach: In the second development path, Jounce will focus on the use of a predictive biomarker. In the analysis of ICONIC patients, Jounce was able to identify a biomarker from baseline samples that correlated with the emergence of ICOS hi CD4 T cells, ORR, PFS and OS, in patients treated with vopratelimab alone or in combination with nivolumab. Jounce plans to use this potential predictive biomarker to select patients in a new trial with vopratelimab and JTX-4014. Jounce will provide more details in the next few months on this clinical trial.
JTX-4014

New safety and preliminary efficacy data from JTX-4014 Phase 1 trial to be presented at SITC (Free SITC Whitepaper): On November 8, 2019, Jounce will present new safety and preliminary efficacy data from the Phase 1 trial of JTX-4014 during a poster session at the SITC (Free SITC Whitepaper) 2019 Annual Meeting.
JTX-4014 identified as combination agent: Based on the encouraging safety and preliminary efficacy data, Jounce plans to use JTX-4014 as the PD-1 inhibitor in combination with its other product candidates, including in the new predictive biomarker trial with vopratelimab.
Discovery Pipeline:

On track to announce next development candidate: Jounce continues to advance and develop its broad discovery pipeline, which includes multiple programs targeting T-regulatory cells, macrophages and stromal cells. Jounce expects to move its next novel program into IND-enabling studies by the end of the year.
Corporate Highlights:

Senior appointments: During the third quarter of 2019, Jounce announced the addition of Jacqui Fahey Sandell to its management team as Chief Legal Officer and Corporate Secretary. In October, Haley Laken, Ph.D., VP of Program and Portfolio Strategy, who has been with Jounce since early 2018, also joined the management team.
Third Quarter 2019 Financial Results:

Cash position: As of September 30, 2019, cash, cash equivalents and investments were $185.1 million, compared to $195.9 million as of December 31, 2018. The decrease in cash, cash equivalents and investments was primarily due to operating costs incurred during the period, offset by the $50.0 million license fee received in July 2019 pursuant to Jounce’s new license agreement with Celgene.
License and collaboration revenue: License and collaboration revenue was $119.4 million for the third quarter of 2019, compared to $14.5 million for the same period in 2018. License and collaboration revenue recognized during the third quarter of 2019 was comprised of $50.0 million of cash revenue related to Jounce’s new license agreement with Celgene and $69.4 million of non-cash revenue recognition relating to the $225.0 million upfront payment received in July 2016 upon the execution of Jounce’s original strategic collaboration with Celgene. In connection with the termination of the original strategic collaboration, Jounce recognized the remaining deferred revenue relating to this agreement in the third quarter of 2019. License and collaboration revenue recognized during the third quarter of 2018 was comprised solely of non-cash revenue recognition related to the $225.0 million upfront payment.
Research and development expenses: Research and development expenses were $15.1 million for the third quarter of 2019, compared to $16.8 million for the same period in 2018. The decrease in research and development expenses was primarily due to $2.2 million of decreased external research and development costs attributable to vopratelimab manufacturing expenses and JTX-4014 IND-enabling expenses incurred during the third quarter of 2018. This decrease was partially offset by $0.9 million of increased employee compensation costs.
General and administrative expenses: General and administrative expenses were $6.5 million for both the third quarter of 2019 and the same period in 2018.
Net income (loss): Net income was $98.9 million for the third quarter of 2019, resulting in basic net income per share of $2.99 and diluted net income per share of $2.90. This increase in net income was primarily attributable to $119.4 million of license and collaboration revenue recognized under Jounce’s agreements with Celgene. Net loss was $7.6 million for the same period in 2018, or a basic and diluted net loss per share of $0.23.
Financial Guidance:

Based on its operating and development plans for the remainder of 2019, Jounce now expects gross cash burn on operating expenses and capital expenditures for the full year 2019 to be approximately $75.0 million to $85.0 million, a decrease from its previously announced guidance of approximately $80.0 million to $95.0 million for the full year 2019.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 3379867. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. The webcast will be archived and made available for replay on Jounce’s website approximately two hours after the call and will be available for 30 days.

On November 7, 2019 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported financial results for the third quarter ended September 30, 2019 (Press release, Arena Pharmaceuticals, NOV 7, 2019, View Source [SID1234550782]).

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"Arena continues to have a strong 2019 and we remain highly focused on achieving several key clinical and regulatory goals. This year we have initiated multiple important trials, including the etrasimod Phase 3 ELEVATE UC 52 trial, the olorinab Phase 2 CAPTIVATE trial, and the etrasimod Phase 2 ADVISE trial. We remain on track to initiate the etrasimod Ph 2/3 program in Crohn’s disease and to file an IND for APD418 this year," said Amit D. Munshi, President and CEO of Arena. "We look forward to delivering on our exciting milestones and will continue to be bold and creative as we scale our enterprise to advance our pipeline."

Pipeline Update

Etrasimod – Next generation, once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of multiple immune-mediated inflammatory diseases

Ulcerative colitis (UC): The global Phase 3 ELEVATE UC registrational program will consist of two key trials to evaluate etrasimod 2 mg in subjects with moderately to severely active UC
ELEVATE UC 52 Phase 3 trial ongoing
ELEVATE UC 12 Phase 3 trial expected to initiate at a later date to optimize speed to market
Crohn’s disease (CD):
Phase 2b/3 program planning ongoing, on track to initiate this year
Atopic dermatitis (AD):
ADVISE Phase 2b trial initiated
Olorinab – Oral, peripherally acting, highly selective, full agonist of cannabinoid receptor 2 (CB2) in development for the treatment of visceral pain associated with gastrointestinal (GI) diseases

Abdominal pain associated with irritable bowel syndrome (IBS): CAPTIVATE Phase 2b trial ongoing
APD418 – First-in-Class Beta-3 AdrR Antagonist and Cardiac Myotrope in preclinical development for the treatment of decompensated heart failure (DHF)

Preclinical program advancing, on track to file IND this year
Etrasimod, olorinab and APD418 are investigational compounds that are not approved for any use in any country.

Financial Update

Third Quarter 2019 Financial Results

Revenues totaled $1.4 million, primarily consisting of $0.8 million of royalty revenue
Research and development expenses totaled $60.3 million, including $6.7 million related to non-cash share-based compensation
General and administrative expenses totaled $20.4 million, including $6.6 million related to non-cash share-based compensation
Net loss was $72.9 million or $1.46 per share
At September 30, 2019, Arena’s cash, cash equivalents and investments balance was approximately $1.2 billion and approximately 50.0 million shares of Arena common stock were outstanding.

Conference Call & Webcast Information
Arena will host a conference call and live webcast with the investment community today, Thursday, November 7, 2019, at 4:30 PM EST to discuss the financial results and provide a corporate update.

When: Thursday, November 7, 2019, at 4:30 PM EST
Dial-in: (877) 643-7155 (United States) or (914) 495-8552 (International)
Conference ID: 2598434

Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of Arena’s website at: www.arenapharm.com. A replay of the conference call will be archived under the investor relations section of Arena’s website for 30 days shortly after the call.

On November 4, 2019, Abeona Therapeutics Inc. (the "Company") reported that it entered into the First Amendment to License Agreement (the "First Amendment") with REGENXBIO Inc. (the "Licensor"), which amends the license agreement between the Company and the Licensor entered into on November 4, 2018 (the "Original Agreement," and as amended by the First Amendment, the "Agreement") (Filing, 8-K, Abeona Therapeutics, NOV 7, 2019, View Source [SID1234550638]). As disclosed previously, the Agreement grants the Company an exclusive, worldwide commercial license, with rights to sublicense, to the NAV AAV9 vector for the treatment of the certain indications in humans by in vivo gene therapy. The First Amendment amends the Original Agreement solely to replace the $10 million payment due to the Licensor within one year of the Original Agreement with a provision stating that the Licensor shall receive $3 million within one year of the Original Agreement and another $8 million no later than April 1, 2020.

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On November 7, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported data from its ADCETRIS (brentuximab vedotin) clinical development program at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 7-10 in Orlando, Fla (Press release, Seattle Genetics, NOV 7, 2019, View Source [SID1234550654]). 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. ADCETRIS is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 corporate- and investigator-sponsored clinical trials.

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"At this year’s ASH (Free ASH Whitepaper) meeting, ADCETRIS will be featured in 15 data presentations, including updated analyses from ECHELON-1 and ECHELON-2 phase 3 frontline trials," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "We are encouraged by the ECHELON-1 update supporting a sustained progression-free survival benefit for ADCETRIS in combination with AVD when compared to ABVD in advanced classical Hodgkin lymphoma and additional analyses from trials evaluating ADCETRIS in combination with nivolumab. We continue to invest in our ADCETRIS clinical development program with the goal of improving outcomes for patients."

Details of oral presentations featured at ASH (Free ASH Whitepaper) include:

Safety and Efficacy of Brentuximab Vedotin in Combination with AVD in Stage II-IV HIV-Associated Classical Hodgkin Lymphoma: Results of the Phase 2 Study, AMC 085
Abstract: 130
Presenter: P. Rubinstein, Rush University Medical Center, Chicago, Ill.
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Combination Chemotherapy and Biomarkers of Response in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 10:15 a.m. ET
Location: Tangerine 2 (WF2)

Brentuximab Vedotin in First Refractory/Relapsed Classical Hodgkin Lymphoma Patients Treated By Chemotherapy (ICE) before Autologous Transplantation. Final Analysis of Phase II Study
Abstract: 132
Presenter: A. Stamatoullas, Departement d’Hematologie, Centre Henry Becquerel, Rouen, France
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Combination Chemotherapy and Biomarkers of Response in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 10:45 a.m. ET
Location: Tangerine (WF2)

Phase 2 Study of Frontline Brentuximab Vedotin Plus Nivolumab in Patients with Hodgkin Lymphoma Aged ≥ 60 Years
Abstract: 237
Presenter: C. Yasenchak, Willamette Valley Cancer Institute and Research Center/US Oncology Research, Eugene, Ore.
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Immunotherapy Approaches in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 2:30 p.m. ET
Location: W224

Brentuximab Vedotin and Nivolumab for Relapsed or Refractory Classical Hodgkin Lymphoma: Long-term Follow-up Results from the Single-arm Phase 1/2 Study
Abstract: 238
Presenter: A. Moskowitz, Memorial Sloan Kettering Cancer Center, New York, N.Y.
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Immunotherapy Approaches in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 2:45 p.m. ET
Location: W224

A Phase I/II Trial of Brentuximab Vedotin (BV) Plus Rituximab (R) as Frontline Therapy for Patients with Immunosuppression-Associated CD30+ and/or EBV+ Lymphomas
Abstract: 351
Presenter: W. Pearse, Loyola University Medical Center, Maywood, Ill.
Session: Oral presentation Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas) – Results from Prospective Clinical Trials: Optimizing Frontline Chemotherapy
Date and Time: Sunday, December 8, 8:00 a.m. ET
Location: Hall E2

An Exploratory Analysis of Brentuximab Vedotin plus CHP (A+CHP) in the Frontline Treatment of Patients with CD30+ Peripheral T-cell Lymphomas (ECHELON-2): Impact of Consolidative Stem Cell Transplant
Abstract: 464
Presenter: K. Savage, British Columbia Cancer Centre for Lymphoid Cancer, University of British Columbia and the Department of Medical Oncology, Vancouver, B.C., Canada
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Novel Therapies in Peripheral T-cell Lymphomas
Date and Time: Sunday, December 8, 12:15 p.m. ET
Location: Valencia D (W415D)

Details of company-sponsored presentations are as follows:

Patterns of Care and Clinical Outcomes in Peripheral T-Cell Lymphoma Patients Receiving First-Line Treatment in Routine Clinical Practice in France and the United Kingdom
Abstract: 3482
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Real-World Treatment Patterns and Overall Survival Among Medicare Fee-for-Service Beneficiaries Newly Diagnosed with Peripheral T-Cell Lymphoma (PTCL)
Abstract: 3492
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Brentuximab Vedotin with Chemotherapy for Stage III/IV Classical Hodgkin Lymphoma (cHL): Four-Year Update of the ECHELON-1 Study
Abstract: 4026
Session: Poster Presentation
Date and Time: Monday, December 9, 6:00-8:00 p.m. ET
Location: Hall B

Details of select investigator-sponsored presentations are as follows:

Long-Term Follow-up Confirms Durability of Single-Agent Brentuximab Vedotin as Pre-Transplant Salvage for Hodgkin Lymphoma
Abstract: 1555
Session: Poster Presentation
Date and Time: Saturday, December 7, 5:30-7:30 p.m. ET
Location: Hall B

A Pilot Study of Brentuximab Vedotin Combined with AVD Chemotherapy and Radiotherapy in Patients with Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
Abstract: 2834
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Preliminary Results from a Phase 2 Trial of Brentuximab Vedotin Plus Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (CHEP-BV) Followed by BV Consolidation in Patients with CD30-Expressing Peripheral T-cell Lymphomas
Abstract: 4023
Session: Poster Presentation
Date and Time: Monday, December 9, 6:00-8:00 p.m. ET
Location: Hall B

Details of company-sponsored trials in progress are as follows:

Brentuximab Vedotin in Combination with Nivolumab, Doxorubucin, and Dacarbazine in Newly Diagnosed Patients with Advanced Stage Hodgkin Lymphoma
Abstract: 2836
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Brentuximab Vedotin in Front-Line Therapy of Hodgkin Lymphoma (HL) and CD30-Expressing Peripheral T-Cell Lymphoma (PTCL) in Adults Age 60 and Above
Abstract: 2852
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

A Phase 2 Study of Retreatment with Brentuximab Vedotin in Patients with cHL, sALCL or other CD30 Expressing PTCL
Abstract: 4054
Session: Poster Presentation
Date and Time: Monday, December 9, 6:00-8:00 p.m. ET
Location: Hall B