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MorphoSys to Present Data on Investigational Drugs MOR208 and MOR202 in Various Blood Cancer Indications at ASH 2018 Meeting

On November 1, 2018 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) reported the presentation of data on its investigational hemato-oncological drug candidates MOR208 and MOR202 at the upcoming 60th American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting, taking place from December 1-4, 2018 in San Diego, California (Press release, MorphoSys, NOV 1, 2018, View Source [SID1234530482]). All three abstracts submitted to ASH (Free ASH Whitepaper) 2018 were accepted, resulting in two oral and one poster presentation.

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"This year’s ASH (Free ASH Whitepaper) Meeting will see a number of important updates from our investigational compounds in various blood cancer indications," said Dr. Malte Peters, Chief Development Officer of MorphoSys AG. "We are particularly excited that we have been selected to present updated preliminary results on all 81 enrolled patients in the L-MIND study, in an oral presentation at ASH (Free ASH Whitepaper). This study is designed to evaluate efficacy and safety of our Fc-enhanced CD19 antibody MOR208 in combination with lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL). Based on the U.S. FDA breakthrough therapy designation received last year, we are committed to developing MOR208 plus lenalidomide as a new treatment option for patients with r/r DLBCL, where there is a particularly high unmet medical need."

Details about MorphoSys’s abstracts accepted for presentation at ASH (Free ASH Whitepaper) 2018:

Single-Arm Phase II Study of MOR208 Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma: L-Mind

The oral presentation will include clinical data from all 81 patients enrolled in the ongoing phase 2 L-MIND study of the investigational Fc-enhanced CD19 antibody MOR208 plus lenalidomide in adult patients with r/r DLBCL who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT).

Abstract publication number: 227
Session name: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)-Results from Prospective Clinical Trials"
Session date and time: Saturday, December 1, 2018, 4:00pm-5:30pm PST
Presentation time: 5:00pm PST
Room: Marriot Marquis San Diego Marina, Pacific Ballroom 20, San Diego, California.

Two-Cohort Phase II Study in R/R CLL (COSMOS): First Preliminary Safety and Efficacy Results of anti-CD19 MOR208 Treatment in Combination with Venetoclax in Patients Who Discontinued Prior BTK Inhibitor Therapy

The poster presentation will include preliminary safety and efficacy results from the phase 2 trial COSMOS of the investigational Fc-engineered CD19 antibody MOR208 in combination with venetoclax in patients with relapsed/refractory CLL/SLL who discontinued a prior BTK inhibitor therapy.

Abstract publication number: 4433
Session name: 642. CLL: Therapy, excluding Transplantation: Poster III
Presentation date and time: Monday, December 3, 2018, 6:00pm-8:00pm PST
Location: San Diego Convention Center, Hall GH, San Diego, California.

MOR202 with Low-Dose Dexamethasone (Dex) or Pomalidomide/Dex or Lenalidomide/Dex in Relapsed or Refractory Multiple Myeloma (RRMM): Primary Analysis of a Phase I/IIa, Multicenter, Dose-Escalation Study

The oral presentation will include results from the phase 1/2a trial of the investigational CD38 antibody MOR202 alone, MOR202 in combination with pomalidomide and MOR202 in combination with lenalidomide, each together with low-dose dexamethasone, in relapsed/refractory multiple myeloma (MM).

Abstract publication number: 153
Session name: 653. Myeloma: Therapy, excluding Transplantation: Novel Antibody Combinations in Myeloma
Session date and time: Saturday, December 1, 2018, 12:00pm-1:30pm PST
Presentation Time: 12:30 pm PST
Room: Marriot Marquis San Diego Marina, Pacific Ballroom 7, San Diego, California.

In addition to the presentations, the abstracts will also be published online in the November supplemental issue of Blood. Additional information, including the abstracts can be found in the online meeting program at www.hematology.org.

MorphoSys will hold an investor & analyst event after the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2018 on December 5, 2018, 10:00am EST (3:00pm GMT, 4:00pm CET) in New York. The presentation, a live webcast and a replay of the webcast will be made available at View Source

Roche announces EU approval of Venclyxto plus MabThera for people with previously treated chronic lymphocytic leukaemia

On November 1, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission has approved Venclyxto (venetoclax) in combination with MabThera (rituximab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy (Press release, Hoffmann-La Roche, NOV 1, 2018, View Source [SID1234530480]).

"There are approximately 30,000 people living with chronic lymphocytic leukaemia in Europe, an incurable blood cancer that becomes harder to treat with each relapse," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We are pleased that, thanks to this approval, Venclyxto plus MabThera will provide a new chemotherapy-free option for people with previously treated chronic lymphocytic leukaemia, helping them to live longer without their disease progressing compared to a standard-of-care therapy."

This approval is based on results from the randomised phase III MURANO study which showed that a fixed duration of treatment with Venclyxto plus MabThera significantly reduced the risk of disease progression or death (progression-free survival [PFS] as assessed by investigators [INV], primary endpoint of the study) by 83% compared with bendamustine plus MabThera (BR), a current standard of care (HR=0.17; 95% CI 0.11-0.25; p<0.0001). PFS assessed by independent review committee was consistent. In addition, minimal residual disease (MRD)-negativity in peripheral blood at the end of combination treatment was 62.4% with Venclyxto plus MabThera compared to 13.3% with BR. Being MRD-negative means no cancer can be detected in the blood and or bone marrow using a sensitive test. In Europe, MRD is used as an indicator of a patient achieving longer endpoints such as PFS and overall survival. The most commonly observed side effects of Venclyxto plus MabThera included low white blood cell count (neutropenia), diarrhoea and upper respiratory tract infection.

Venclyxto was previously granted conditional marketing authorisation in the EU in December 2016 as a single agent for the treatment of CLL in the presence of 17p deletion or TP53 mutation in people who are unsuitable for or have failed a B-cell receptor pathway inhibitor. Today’s EU approval follows the US Food and Drug Administration approval in June 2018 of Venclexta in combination with Rituxan for the treatment of people with CLL or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy. Additional submissions of the MURANO data to health authorities around the world are ongoing.

Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States, under the brand name Venclexta, and commercialised by AbbVie outside of the United States.

About the MURANO Study
MURANO (NCT02005471) is a phase III open-label, international, multicentre, randomised study evaluating the efficacy and safety of fixed duration Venclexta/Venclyxto (venetoclax) in combination with MabThera/Rituxan (rituximab) compared to standard of care bendamustine in combination with MabThera/Rituxan (BR) in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL). Patients on the Venclexta/Venclyxto plus MabThera/Rituxan arm received six cycles of Venclexta/Venclyxto plus MabThera/Rituxan followed by Venclexta/Venclyxto monotherapy for up to two years total. Patients on the BR arm received six cycles of BR. The study included 389 patients with CLL who had been previously treated with at least one line of therapy. Patients were randomly assigned in a 1:1 ratio to receive either Venclexta/Venclyxto plus MabThera/Rituxan or BR. The primary endpoint of the study was progression-free survival (PFS) as assessed by investigator (INV). Secondary endpoints included overall survival (OS), overall response rate (ORR), complete response rate (with or without complete blood count recovery, CR/CRi), minimal residual disease (MRD) and safety.

*Data at median follow-up of 24 months

The most common adverse reactions (≥20%) of any grade in patients receiving Venclyxto in the combination study with MabThera were neutropenia, diarrhoea, and upper respiratory tract infection. Death occurred in 11% of people who received Venclexta/Venclyxto plus MabThera/Rituxan compared to 16% for BR.

About Venclexta/Venclyxto (venetoclax)
Venclexta/Venclyxto is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumours, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta/Venclyxto blocks the BCL-2 protein and works to restore the process of apoptosis.

Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States and by AbbVie outside of the United States. Together, the companies are committed to research with Venclexta/Venclyxto, which is currently being studied in clinical trials across several types of blood and other cancers.

In the United States, Venclexta has been granted four Breakthrough Therapy Designations by the FDA: in combination with Rituxan for people with relapsed or refractory chronic lymphocytic leukaemia (CLL); as a monotherapy for people with relapsed or refractory CLL with 17p deletion; in combination with hypomethylating agents (azacitidine or decitabine) for people with untreated acute myeloid leukaemia (AML) ineligible for intensive chemotherapy; and in combination with low-dose cytarabine for people with untreated AML ineligible for intensive chemotherapy.

Venclexta/Venclyxto is approved in more than 50 countries. Roche and AbbVie are currently working with regulatory agencies around the world to bring this medicine to additional eligible patients in need.

About Chronic Lymphocytic Leukaemia
Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in the Western world.[1]
CLL mainly affects men and the median age at diagnosis is about 70 years.[2] In Europe, the incidence of all leukaemias is estimated to be almost 95,000[3] and CLL is estimated to affect around one-third of all people newly diagnosed with leukaemia.[1]

Syros to Present Initial Clinical Data from Combination Cohorts in Its Ongoing Phase 2 Trial of SY-1425 at ASH Annual Meeting

On November 1, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported that the Company will present initial clinical data from both combination cohorts in its ongoing Phase 2 trial of SY-1425, its first-in-class selective retinoic acid receptor alpha (RARα) agonist, in genomically defined subsets of patients with acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (MDS) at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 1-4 in San Diego (Press release, Syros Pharmaceuticals, NOV 1, 2018, View Source [SID1234530479]).

The data will include initial assessments of safety and efficacy of SY-1425 in combination with azacitidine in RARA and IRF8 biomarker-positive patients with newly diagnosed AML who are not suitable candidates for standard chemotherapy, and in combination with daratumumab in biomarker-positive patients with relapsed or refractory AML and higher-risk MDS. Additionally, for the daratumumab cohort, the presentation will include data on the level of CD38 induction observed in patients.

The abstract for the presentation is now available online on the ASH (Free ASH Whitepaper) conference website at View Source

Details on the presentation are as follows:

Presentation Title: Early Results from a Biomarker-Directed Phase 2 Trial of SY-1425 in Combination with Azacitidine or Daratumumab in Non-APL Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
Date & Time: Sunday, December 2, 6:00-8:00 p.m. PT (9:00-11:00 p.m. ET)
Session Title: Poster Session II
Session Category: 616. Acute Myeloid Leukemia: Novel Therapy Excluding Transplantation
Presenter: Rachel J. Cook, M.D., Oregon Health Science University
Abstract Number: 2735
Location: Hall GH, San Diego Convention Center

Alpine Immune Sciences Announces Scientific Presentations at 60th American Society of Hematology Annual Meeting and Exposition

On November 1, 2018 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading immunotherapy company focused on developing innovative treatments for cancer, autoimmune/inflammatory, and other diseases, reported two upcoming poster presentations at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held December 1-4, 2018 in San Diego, CA (Press release, Alpine Immune Sciences, NOV 1, 2018, View Source [SID1234530478]).

60th ASH (Free ASH Whitepaper) Annual Meeting and Exposition

Abstract Title: Therapeutic Candidate ALPN-101, a Dual ICOS/CD28 Antagonist, Potently Suppresses Human/NSG Mouse Xenograft Graft Vs. Host Disease (GvHD) in a Dose Ranging Study and Reduces Disease Activity in a Mouse Model of Hemophagocytic Lymphohistiocytosis (HLH)
Session Name: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster I
Publication Number: 2037
Abstract Title: "Switch" Transmembrane Immunomodulatory Proteins (TIPs) Consisting of High-Affinity PD-1 Extracellular Domains (PD-1 vIgDs) and Costimulatory Intracellular Domains Potently Enhance the Activity of TCR-Engineered T Cells
Session Name: 703. Adoptive Immunotherapy: Poster I
Publication Number: 2052
Both posters will be available in Hall GH of the San Diego Convention Center on Saturday, December 1, 2018 from 6:15 p.m. PT – 8:15 p.m. PT.

MannKind Corporation Reports 2018 Third Quarter Financial Results

On November 1, 2018 MannKind Corporation (NASDAQ:MNKD) reported financial results for the third quarter ended September 30, 2018 (Press release, Mannkind, NOV 1, 2018, View Source [SID1234530468]).

"In 3Q 2018, we executed on both of our corporate value drivers, Afrezza and Technosphere Platform, by signing a global licensing and collaboration agreement for Treprostinil Technosphere and a research agreement for an undisclosed Technosphere formulation with upfront payments from these deals received in the last two months. Our sales and marketing efforts continue to show progress in growing Afrezza sales as the 3Q revenues have more than doubled from 3Q 2017," said Michael Castagna, Chief Executive Officer of MannKind Corporation.

Third Quarter Results

For the third quarter of 2018, Afrezza net revenue was $4.4 million, an increase of 121% compared to $2.0 million for the third quarter of 2017, reflecting increased product demand and pricing as well as a more favorable mix of cartridges.

Cost of goods sold was $5.3 million for the third quarter of 2018, an increase of 16% compared to $4.6 million for the same period in 2017, which was driven by an increased write-off of expiring inventory in the amount of $0.7 million.

Research and development (R&D) expenses for the third quarter of 2018 were $2.0 million compared to $4.4 million for the third quarter of 2017, a decrease of $2.4 million or 53%, reflecting $1.0 million in lower salary related expenses (for personnel who were engaged in research and development activities in 2017 but who have transitioned to Afrezza commercial support activities), lower clinical trial expense of $0.9 million, a decrease in headcount of $0.4 million and lower research and development supply costs of $0.2 million. These decreases were offset by increases in stock compensation expense and in travel expenses of $0.2 million.

Selling, general and administrative (SG&A) expenses were $19.4 million for the third quarter of 2018 compared to $17.7 million for the third quarter of 2017. The $1.7 million or 9% increase was primarily due to a marketing and advertising cost increase of $1.2 million, an increase in commercial operations headcount of $0.9 million, an increase in sample spending of $0.3 million which were offset by lower facility costs of $0.5 million and a decrease in general and administrative personnel severance costs of $0.4 million.

Interest expense on notes was $1.0 million for the third quarter of 2018 compared to $2.3 million for the third quarter of 2017. The $1.3 million or 57% decrease was primarily due to a reduction in the principal debt balances.

The net loss for the third quarter of 2018 was $24.2 million, or $0.16 per share, compared to the $32.9 million net loss in the third quarter of 2017 or $0.31 per share. The lower loss per share is attributable to an increase in revenues, lower expenses and an increase in shares used to compute the basic and diluted net loss per share.

Nine Months Ended Results

For the nine months ended September 30, 2018, Afrezza net revenue was $11.5 million, an increase of 144% compared to $4.7 million for the same period in 2017, reflecting increased product demand and pricing as well as a more favorable mix of cartridges.

Cost of goods sold for the nine months ended September 30, 2018 was $14.4 million compared to $12.2 million for the nine months ended September 30, 2017. This increase of $2.2 million or 18% was primarily attributable to a $1.2 million increase resulting from higher Afrezza sales, an increase of $0.9 million of excess capacity costs and a $0.4 million realized currency loss from insulin purchases which were offset by a $0.3 million settlement of a credit related to a purchase of insulin. Inventory write-offs of $1.8 million for the nine months ended September 30, 2018 remained flat compared to 2017.

R&D expenses for the nine months ended September 30, 2018 were $7.7 million compared to $10.6 million for the same period in 2017. This $3.0 million or 28% decrease was primarily attributable to a $2.2 million decrease in salary-related expenses (for personnel who were engaged in research and development activities in 2017 but who have transitioned to Afrezza commercial support activities), a decrease in headcount of $0.7 million, a decrease in research and development supply costs of $0.5 million, and a decrease in salary related expenses for personnel supporting manufacturing and production activities of $0.4 million. These decreases were offset by an increase in relocation and recruiting fees of $0.6 million plus an increase in consulting services costs of $0.4 million in connection with international regulatory activities.

SG&A expenses were $61.7 million for the nine months ended September 30, 2018 compared to $51.7 million for the same period in 2017. The $10.0 million or 19% increase was primarily due to an increase in headcount-related expenses associated with commercial operations of $3.5 million and general and administration personnel of $2.5 million, a $2.2 million increase in salary-related expenses (for personnel who were engaged in research and development activities in 2017 but who have transitioned to Afrezza commercial support activities), an increase in stock-based compensation expense of $1.9 million, a $1.1 million increase in the cost of transitioning corporate support functions from Connecticut to our headquarters in California and an increase in consulting fees in connection with corporate strategies of $0.9 million, which were offset by lower marketing expenses of $1.6 million and a decrease in facility expenses of $0.7 million.

Interest expense on notes was $4.5 million for the nine months ended September 30, 2018 compared to $7.4 million for the same period in 2017. The $2.9 million or 40% decrease was primarily due to a reduction in the principal debt balances.

The net loss for the nine months ended September 30, 2018 was $77.2 million, or $0.56 per share, compared to $84.5 million for the nine months ended September 30, 2017, or $0.84 per share. The lower net loss per share is attributable to an increase in revenues, a decrease in expenses and an increase in shares used to compute basic and diluted net loss per share.

Cash and Cash Equivalents

Cash, cash equivalents and restricted cash at September 30, 2018 was $11.0 million compared to $48.4 million at December 31, 2017, primarily due to net cash used in operating activities of $62.7 million, inclusive of $10.0 million received from United Therapeutics in September 2018, primarily offset by $26.4 million of net proceeds from a registered direct offering of 14 million shares of common stock and warrants at a purchase price of $2.00 per share and accompanying warrant.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 9:00 a.m. Eastern Time. To view and listen to the earnings call webcast live via the Internet, visit the Company’s website at www.mannkindcorp.com and click on the "Q3 2018 MannKind Earnings Conference Call" link in the Webcasts section of News & Events. To participate in the live call by telephone, please dial (888) 394-8218 toll-free or (323) 701-0225 toll/international and use the conference passcode: 5666425.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 toll-free or (412) 317-6671 toll/international and use the replay passcode: 5666425. A replay will also be available on MannKind’s website for 14 days.