On November 1, 2017 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that data from two Phase 1 clinical trials of REGN1979 and cemiplimab (REGN2810) in patients with different forms of B-cell lymphoma will be presented at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, December 9-12, 2017, in Atlanta, GA(Press release, Regeneron, NOV 1, 2017, View Source [SID1234521403]).

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Regeneron’s clinical presentations will include new safety and activity results from a Phase 1 study of cemiplimab alone or in combination with REGN1979, as well as updated results from a Phase 1 study of REGN1979 monotherapy. Collectively, the two studies enrolled patients with B-cell non-Hodgkin lymphoma (B-NHL) or Hodgkin lymphoma (HL) previously treated with at least one prior therapy and for whom no standard-of-care options exist.

REGN1979 is an investigational bispecific monoclonal antibody that binds to CD3 on immune system T-cells and to CD20 on B-cell malignancies to help trigger tumor killing. Cemiplimab is an investigational human, monoclonal antibody targeting PD-1 (programmed cell death protein 1).

The studies will be presented as posters during the 2017 ASH (Free ASH Whitepaper) Annual Meeting as follows:

Safety and Preliminary Antitumor Activity of the Anti-PD-1 Monoclonal Antibody REGN2810 Alone or in Combination with REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Patients with B-Lymphoid Malignancies
Abstract # 1495
Saturday, December 9, 5:30 – 7:30 p.m. ET

Safety and Preliminary Clinical Activity of REGN1979, an Anti-CD20 x Anti- CD3 Bispecific Antibody, in Patients with B-NHL Previously Treated with CD20-Directed Antibody Therapy
Abstract # 1550
Saturday, December 9, 5:30 – 7:30 p.m. ET

The FDA granted orphan drug designation to REGN1979 for diffuse large B-cell lymphoma (DLBCL) and breakthrough therapy designation status to cemiplimab for metastatic or locally advanced and unresectable cutaneous squamous cell carcinoma (CSCC) earlier in 2017. Cemiplimab is being developed jointly with Sanofi under a global collaboration agreement.

REGN1979 and cemiplimab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

On November 1, 2017 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that oral and poster presentations will be given with regard to emicizumab at The American Society of Hematology (ASH) (Free ASH Whitepaper) 2017 in Atlanta, Georgia, United States. Emicizumab is a bispecific antibody under development for hemophilia A (Press release, Chugai, NOV 1, 2017, View Source [SID1234521451]).

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Data from additional six-month follow-up of global Phase lll studies in hemophilia A with inhibitors to factor VIII, HAVEN 1 study (NCT02622321) and HAVEN 2 study (NCT02795767), will be shown at the conference. The HAVEN 2 will be presented at 7:30 EST on December 9 as part of the official Press Program at ASH (Free ASH Whitepaper). Both studies have been conducted in collaboration with Roche and Genentech, while HAVEN 1 is for adults and adolescents and HAVEN 2 is for children.

In addition, preliminary data from HAVEN 4 study (NCT03020160), a Phase lll study with hemophilia A patients with or without inhibitors which examines emicizumab prophylaxis administered subcutaneously once every four weeks, and real-world data from a non-interventional trial in children under 12 years of ages with hemophilia A with inhibitors will be presented.

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On November 1, 2017 Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, reported financial results for the quarter and nine months ended September 30, 2017, and provided updates on its development programs (Press release, Conatus Pharmaceuticals, NOV 1, 2017, View Source [SID1234521422]).

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Program Updates
In collaboration with Novartis under terms of the company’s Option, Collaboration and License Agreement with Novartis, which was executed in December 2016, Conatus is conducting four randomized, double-blind, placebo-controlled Phase 2b clinical trials designed to evaluate emricasan treatment in various patient populations, including three EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) clinical trials in patients with fibrosis or cirrhosis caused by nonalcoholic steatohepatitis (NASH), and a fourth clinical trial in POLT-HCV-SVR patients:

POLT-HCV-SVR, initiated in the second quarter of 2014, in approximately 60 post-orthotopic liver transplant (POLT) recipients with liver fibrosis or cirrhosis post-transplant as a result of recurrent hepatitis C virus (HCV) infection who have successfully achieved a sustained viral response (SVR) following HCV antiviral therapy, with top-line results expected in the second quarter of 2018;

ENCORE-PH (for Portal Hypertension), initiated in the fourth quarter of 2016, in approximately 240 patients with compensated or early decompensated NASH cirrhosis and severe portal hypertension, with top-line results expected in the second half of 2018 followed by an integrated treatment extension period for clinical outcomes;

ENCORE-NF (for NASH Fibrosis), initiated in the first quarter of 2016, in approximately 330 patients with NASH fibrosis, with top-line results expected in the first half of 2019; and

ENCORE-LF (for Liver Function), initiated in the second quarter of 2017, in approximately 210 patients with decompensated NASH cirrhosis, with top-line results expected in the second half of 2019.
Results from the four ongoing emricasan clinical trials are expected to support the design of Phase 3 clinical efficacy and safety trials.

Pipeline Expansion Plans

In October 2017, the European Medicines Agency (EMA) granted Orphan Drug Designation in the European Union to the company’s pan-caspase inhibitor IDN-7314 for the treatment of primary sclerosing cholangitis (PSC), a disease affecting bile ducts in the liver, which can lead to cirrhosis and liver failure. In June 2017, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation in the United States to IDN-7314 for the treatment of PSC.

These orphan drug designations were based on previously reported data with IDN-7314 demonstrating reduction of relevant biomarkers in two preclinical models of PSC. New results, showing that IDN-7314 markedly diminished inflammasome activation and reduced liver injury in a preclinical model of PSC, were presented in October 2017 at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases (AASLD). In a separate study, IDN-7314 reduced biochemical markers in a new acute preclinical model of PSC.

Conatus believes the orphan drug designations, along with the growing body of preclinical data, warrant further evaluation of IDN-7314 as a potential product candidate in PSC as a component of its initial pipeline expansion plans. The company’s ongoing pipeline expansion activities also include:

internal development of new preclinical product candidates leveraging its expertise with the caspase inhibition technology platform, and

evaluation for potential in-licensing or acquisition of external clinical-stage product candidates consistent with its product development and regulatory expertise.
Conatus may pursue the development of product candidates in liver disease and in other related disease areas.

Financial Results
The net loss for the third quarter of 2017 was $4.0 million compared with $6.9 million for the third quarter of 2016. The net loss for the first nine months of 2017 was $13.0 million compared with $20.6 million for the first nine months of 2016.

Total revenues were $9.6 million for the third quarter of 2017 and $26.6 million for the first nine months of 2017, compared with $0.0 million for the comparable periods in 2016. Total revenues for both periods in 2017 consisted of collaboration revenue related to the Option, Collaboration and License Agreement with Novartis.

Research and development expenses were $11.2 million for the third quarter of 2017 compared with $4.8 million for the third quarter of 2016. Research and development expenses were $32.3 million for the first nine months of 2017 compared with $13.8 million for the first nine months of 2016. The increases in research and development expenses were primarily due to the ramp up of our ENCORE-NF, ENCORE-PH and ENCORE-LF clinical trials.

General and administrative expenses were $2.4 million for the third quarter of 2017 compared with $2.1 million for the third quarter of 2016. General and administrative expenses were $7.4 million for the first nine months of 2017 compared with $6.9 million for the first nine months of 2016. The increases in general and administrative expenses were primarily due to higher personnel costs and professional fees.

Cash, cash equivalents and marketable securities were $85.2 million at September 30, 2017, compared with $77.0 million at December 31, 2016. Based primarily on lower than expected spending on in-licensing and internal pipeline development, the company is now projecting a year-end 2017 balance of between $70 million and $75 million. The company believes its current and forecasted financial resources are sufficient to maintain operations and ongoing emricasan clinical development activities through the end of 2019, as well as to fund anticipated pipeline expansion activities.

Conference Call and Audio Webcast
Conatus will host a conference call and audio webcast at 4:30 p.m. Eastern Time today to discuss the financial results and provide a corporate update. To access the conference call, please dial 877-312-5857 (domestic) or 970-315-0455 (international) at least five minutes prior to the start time and refer to conference ID 99505370. A live and archived audio webcast of the call will also be available in the Investors section of the Conatus website at www.conatuspharma.com.

On November 1, 2017 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that 18 abstracts featuring data from the broad ADCETRIS (brentuximab vedotin) development program have been accepted for presentation, including a plenary presentation, at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place from December 9-12, 2017 in Atlanta, Georgia (Press release, Seattle Genetics, NOV 1, 2017, View Source [SID1234521404]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of Hodgkin lymphoma cells and several types of non-Hodgkin lymphoma. 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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Data accepted for presentation at the ASH (Free ASH Whitepaper) Annual Meeting include the following:

Data from the phase 3 ECHELON-1 clinical trial evaluating ADCETRIS in combination with chemotherapy in frontline advanced classical Hodgkin lymphoma patients will be featured in the Plenary Scientific Session on Sunday, December 10, 2017 from 2:00 – 4:00 p.m. ET. Based on the positive results from the ECHELON-1 trial, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to ADCETRIS in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. Seattle Genetics expects to submit in the fourth quarter of 2017 a supplemental Biologics License Application (BLA) to the FDA for approval of ADCETRIS in frontline advanced classical Hodgkin lymphoma.
Numerous oral and poster presentations highlighting additional progress within the ADCETRIS development program including:
Updated durability results from the phase 3 ALCANZA clinical trial in patients with CD30-expressing mycosis fungoides and primary cutaneous anaplastic large cell lymphoma, the most common subtypes of cutaneous T-cell lymphoma (CTCL). Based on the positive results from the ALCANZA trial, a supplemental BLA for ADCETRIS in CTCL was accepted for filing by the FDA. The FDA granted Priority Review for the application and the Prescription Drug User Fee Act (PDUFA) target action date is December 16, 2017. ADCETRIS previously received FDA Breakthrough Therapy Designation in this setting.
Updated results from a phase 1/2 study of ADCETRIS in combination with Opdivo (nivolumab) among patients with relapsed or refractory Hodgkin lymphoma
Final five-year survival and durability results in patients with CD30-expressing peripheral T-cell lymphomas who received ADCETRIS with cyclophosphamide, hydroxydaunorubicin, and prednisone (CHP) as frontline therapy
“At this year’s ASH (Free ASH Whitepaper) Annual Meeting, we will present data from 18 abstracts, highlighting several ADCETRIS clinical program advancements that support our plans to establish ADCETRIS as the foundation of care for CD30-expressing lymphomas,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Importantly, the results of the phase 3 ECHELON-1 clinical trial evaluating ADCETRIS combination therapy in frontline advanced Hodgkin lymphoma patients was selected from over 6,000 abstracts submitted to be featured in the Plenary Scientific Session. These data are the basis for our planned supplemental biologics license application to the FDA requesting approval of ADCETRIS in this setting. The breadth of data being presented with ADCETRIS in CD30-expressing lymphomas demonstrates the power of antibody-drug conjugates with a goal of improving patient outcomes.”

ADCETRIS is currently not approved for the treatment of frontline Hodgkin lymphoma, CTCL, or as combination therapy for Hodgkin lymphoma or non-Hodgkin lymphoma.

Multiple corporate and investigator presentations will be featured at ASH (Free ASH Whitepaper). Abstracts can be found at www.hematology.org and include the following:

Saturday, December 9, 2017

Updated analyses of the international, open-label, randomized, phase 3 ALCANZA study: longer-term evidence for superiority of brentuximab vedotin versus methotrexate or bexarotene for CD30-positive cutaneous T-cell lymphoma (Abstract #1509, poster presentation)
A pilot study of weekly brentuximab vedotin in patients with CD30+ malignancies resistant to every 3 week brentuximab vedotin (Abstract #1528, poster presentation)
Brentuximab vedotin with R-CHP chemotherapy as frontline treatment for patients with CD30 positive primary mediastinal large B-cell, diffuse large B-cell, and grey zone lymphomas: results of a phase I/II multisite trial (Abstract #191, oral presentation at 3:00 p.m. ET)
Patient-reported distress in Hodgkin lymphoma patients on active therapy vs. long-term survivors (Abstract #2173, poster presentation)
Real world clinical and economic burden of patients with Hodgkin lymphoma who fail frontline therapy in the US (Abstract #2128, poster presentation)
Sunday, December 10, 2017

Brentuximab vedotin plus doxorubicin, vinblastine, dacarbazine (A+AVD) as frontline therapy demonstrates superior modified progression-free survival versus ABVD in patients with previously untreated stage III or IV Hodgkin lymphoma (HL): the phase 3 ECHELON-1 study (Plenary Scientific Session presentation from 2:00 – 4:00 p.m. ET)
Five-year survival results: frontline brentuximab vedotin in combination with CHP in patients with CD30-expressing peripheral T-cell lymphomas (Abstract #2790, poster presentation)
Radiographic and high-throughput sequencing (HTS)-based response assessment after brentuximab vedotin plus ifosfamide, carboplatin, and etoposide (ICE) for relapsed/refractory classical Hodgkin lymphoma: updated results of a phase I/II trial (Abstract #2806, poster presentation)
Patient and physician preferences for front-line treatment of advanced stage Hodgkin lymphoma (Abstract #4082, poster presentation)
Changes in serum TARC predict PET response among pediatric patients with relapsed or refractory Hodgkin lymphoma treated with brentuximab vedotin and gemcitabine: a report from the Children’s Oncology Group (Abstract #2798, poster presentation)
Phase 2 Study of Brentuximab Vedotin in Patients with Advanced Systemic Mastocytosis (Abstract #2909, poster presentation)
Monday, December 11, 2017

Results from a phase 1/2 study of brentuximab vedotin in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma (Abstract #649, oral presentation at 10:30 a.m. ET)
Sequential brentuximab vedotin before and after adriamycin, vinblastine, and dacarbazine (A-VAD-A) for older patients with untreated Hodgkin lymphoma: final results from a multicenter phase II study (Abstract #733, oral presentation at 2:45 p.m. ET)
About ADCETRIS

ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30 and is being evaluated broadly in more than 70 clinical trials, including four phase 3 studies: the ECHELON-1 trial in frontline classical Hodgkin lymphoma from which positive top-line results were recently reported and the FDA granted Breakthrough Therapy Designation in this setting, the ongoing ECHELON-2 trial in frontline mature T-cell lymphomas, the completed ALCANZA trial in cutaneous T-cell lymphoma that supported the supplemental BLA with a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2017, and the recently initiated CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS for intravenous injection has received FDA approval for three indications: (1) regular approval for the treatment of patients with classical Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (2) regular approval for the treatment of classical Hodgkin lymphoma patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (3) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-ASCT consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.

ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. The European Commission extended the current conditional marketing authorization of ADCETRIS and approved ADCETRIS for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT.

ADCETRIS has received marketing authorization by regulatory authorities in 68 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See important safety information below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.