DiaMedica Therapeutics to Report Third Quarter 2019 Financials and Provide a Business Update November 14, 2019

On November 6, 2019 DiaMedica Therapeutics Inc. (Nasdaq: DMAC) reported that its third quarter 2019 financial results will be released after the markets close on Wednesday, November 13th (Press release, DiaMedica, NOV 6, 2019, View Source [SID1234550643]). DiaMedica will host a live conference call on Thursday, November 14th at 7:00 AM Central Time to discuss its business update and financial results.

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Conference Call details:

Date:


Thursday, November 14, 2019

Time:


7:00 AM CT / 8:00 AM ET

Web access:


View Source

Dial In:


(844) 557-8483 (domestic)


(825) 312-2381 (international)

Conference ID:


4594493

Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on our website, under investor events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until November 21, 2019, by dialing (800) 585-8367 (US Toll Free), (416) 621-4642 (International), replay passcode 4594493.

Innate Pharma announces preclinical data presentations at SITC 2019

On November 6, 2019 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH; Nasdaq: IPHA) reported that it will provide an update on its preclinical pipeline at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Congress in National Harbor, Maryland, November 6-10, 2019 (Press release, Innate Pharma, NOV 6, 2019, View Source [SID1234550398]). Highlights will include:

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In vivo data on anti-CD39 IPH5201 supporting the rationale for assessing combination with PD-1/PD-L1 checkpoint inhibitors
Preclinical results of anti-CD73 IPH5301 targeting the adenosine immunosuppressive pathway
New generation trifunctional NK cell engagers (NKCEs), supporting its clinical development in immunotherapy
Innate will also present in vitro data on IPH5401, demonstrating that the molecule has the potential to block activation and migration of human neutrophils, a major mechanism to allow for the reactivation of effector cells. The Company believes this data supports its ongoing multi-center, open label, dose-escalation and dose expansion Phase I clinical trial (STELLAR-001), evaluating the safety and efficacy of IPH5401 in combination with durvalumab (anti-PD-L1) in patients with advanced solid tumors.

Eric Vivier, Chief Scientific Officer of Innate Pharma, will also give a presentation on harnessing innate imnunity in cancer, as part of the faculty session dedicated to NK cells.

"We are pleased to present data at SITC (Free SITC Whitepaper) 2019 on several of our preclinical and clinical assets, notably three antibodies targeting the tumor microenvironment, as well as on our new NKCEs technology," commented Eric Vivier, Chief Scientific Officer of Innate Pharma. "These data support the science and innovative technologies our scientists continue to develop, helping to further advance our multi-target strategy in immuno-oncology."

Oral presentation:

– Concurrent Session 312: NK Cells: From Basic Science to Clinical Application "Basic Science" presented by Eric Vivier, DVM, PhD, Innate Pharma
Saturday, November 9 | 5:15 pm

Poster presentations:

– IPH5301, a CD73 blocking antibody targeting the adenosine immunosuppressive pathway for cancer immunotherapy, Poster P323
Friday November 8 | 12:30 – 2 pm & 6:30 – 8 pm

– IPH5201, a blocking antibody targeting the CD39 immunosuppressive pathway, unleashes immune responses in combination with cancer therapies, Poster P488
Saturday November 9 | 12:35 – 2:05 pm & 7 – 8:30 pm

– IPH5401 anti-human C5aR antibody targets suppressive myeloid cells in the TME, Poster P268
Saturday November 9 | 12:35 – 2:05 pm & 7 – 8:30 pm

– Multifunctional natural killer cell engagers targeting NKp46 trigger protective tumor immunity, Poster P776
Saturday November 9 | 12:35 – 2:05 pm & 7 – 8:30 pm

AbbVie Announces Launch of Private Offering of Senior Unsecured Notes

On November 6, 2019 AbbVie Inc. (NYSE:ABBV) ("AbbVie") reported that it has launched a private offering (the "Offering") of senior unsecured notes (the "Notes") (Press release, AbbVie, NOV 6, 2019, View Source [SID1234550430]).

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The Offering is being conducted in connection with AbbVie’s previously announced acquisition (the "Acquisition") of Allergan plc ("Allergan"). AbbVie expects to use the net proceeds from the Offering to fund a portion of the aggregate cash consideration due to Allergan shareholders in connection with the Acquisition and to pay related fees and expenses, with any remaining net proceeds being used for general corporate purposes. Consummation of the Offering is subject to market and other conditions.

The Notes have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), any state securities laws or the securities laws of any other jurisdiction, and may not be offered or sold in the United States, or for the benefit of U.S. persons, except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities or blue sky laws. Accordingly, the Notes are being offered in the United States only to persons reasonably believed to be "qualified institutional buyers," as that term is defined under Rule 144A of the Securities Act, or outside the United States to non-"U.S. persons" in accordance with Regulation S under the Securities Act.

A confidential offering memorandum for the Offering of the Notes, dated as of today, is being made available to such eligible persons. The Offering is being conducted in accordance with the terms and subject to the conditions set forth in such confidential offering memorandum.

This news release does not constitute an offer to sell or purchase, or a solicitation of an offer to sell or purchase, the Notes or any other security. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such an offer, solicitation or sale would be unlawful.

Genmab Announces Data to be Presented at 2019 ASH Annual Meeting

On November 6, 2019 Genmab A/S (Nasdaq: GMAB) reported that 37 abstracts related to Genmab owned and partnered programs were accepted for presentation at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place December 7-10 in Orlando, Florida (Press release, Genmab, NOV 6, 2019, View Source [SID1234550464]). Abstracts accepted for presentation include preliminary dose-escalation data from the ongoing Phase I trial of DuoBody-CD3xCD20 (GEN3013) in B-cell non-Hodgkin lymphomas, which will be presented during an oral session of the conference. Accepted abstracts also include pre-clinical data from Genmab’s next generation CD38 antibody, HexaBody-CD38, and updates on multiple daratumumab clinical trials.

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All abstracts are available on the ASH (Free ASH Whitepaper) website at www.hematology.org. Details regarding the key abstracts to be presented are included below.

"2019 has been a banner year for Genmab as we advance our proprietary pipeline into the clinic, and we look forward to ending the year on a high note with two key firsts; the first presentation of dose-escalation data from DuoBody-CD3xCD20 and the first presentation of pre-clinical data from HexaBody-CD38," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We are also very pleased to see that, once again, a significant number of daratumumab abstracts were accepted for presentation at the prestigious ASH (Free ASH Whitepaper) conference, as this underscores our confidence in the wide potential of daratumumab."

Late breaking abstracts are not yet available.

On December 9 at 8:00 PM EST (2:00 AM CET / 1:00 AM GMT on 10 December) Genmab will hold its 2019 R&D Update and ASH (Free ASH Whitepaper) Data Review in Orlando, Florida. The event will be webcast live and details, including the webcast link, may be found on Genmab’s website in early December. This meeting is not an official program of the ASH (Free ASH Whitepaper) Annual Meeting.

Genmab Abstracts

First-in-Human, Phase 1/2 Trial to Assess the Safety and Clinical Activity of Subcutaneous GEN3013 (DuoBody-CD3×CD20) in B-cell Non-Hodgkin Lymphomas – Oral presentation, Monday, December 9

DuoBody-CD3xCD20 induces potent anti-tumor activity in malignant lymph node B cells from patients with DLBCL, FL and MCL ex vivo, irrespective of prior treatment with CD20 monoclonal antibodies – Poster presentation, Monday, December 9

Hexabody-CD38, a Novel CD38 Antibody with a Hexamerization Enhancing Mutation, Demonstrates Enhanced Complement-Dependent Cytotoxicity and Shows Potent Anti-Tumor Activity in Preclinical Models of Hematological Malignancies – Poster presentation, Sunday, December 8

Daratumumab Abstracts Sponsored by Janssen Biotech, Inc.

Oral Presentations:
Daratumumab Plus Bortezomib, Melphalan and Prednisone Versus Bortezomib, Melphalan and Prednisone in Patients with Transplant-ineligible Newly Diagnosed Multiple Myeloma: Overall Survival in ALCYONE– Oral presentation, Monday, December 9

Daratumumab Maintenance Therapy Improves Depth of Response and Results in Durable Progression-free Survival Following Daratumumab plus Cyclophosphamide, Bortezomib and Dexamethasone Induction Therapy in Multiple Myeloma: Update of the LYRA Study– Oral presentation, Monday, December 9

Depth of Response to Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone Improves Over Time in Patients with Transplant-eligible Newly Diagnosed Multiple Myeloma: GRIFFIN Study Update – Oral presentation, Monday, December 9

Evaluation of the Prognostic Value of Positron Emission Tomography-Computed Tomography at Diagnosis and Follow-up in Transplant-eligible Newly Diagnosed Multiple Myeloma Patients Treated in the Phase 3 CASSIOPEIA Study: Results of the CASSIOPET Companion Study – Oral presentation, Monday, December 9

Poster Presentations:
Randomized Phase 2 Study of Subcutaneous Daratumumab Plus Carfilzomib/Dexamethasone Versus Carfilzomib/Dexamethasone Alone in Patients with Multiple Myeloma who have been Previously Treated with Intravenous Daratumumab to Evaluate Retreatment (LYNX) – Poster presentation, Saturday, December 7

Daratumumab Plus Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma Ineligible for Transplant: Updated Analysis of MAIA – Poster presentation, Saturday, December 7

Final Analysis of a Phase 1b Study of Daratumumab in Combination with Carfilzomib and Dexamethasone for Relapsed or Refractory Multiple Myeloma – Poster presentation, Saturday, December 7

Daratumumab Monotherapy for Patients with Relapsed or Refractory Natural Killer/T-cell Lymphoma, Nasal Type: Updated Results from an Open-label, Single-arm, Multicenter Phase 2 Study – Poster presentation, Saturday, December 7

Four-Year Follow-up of the Phase 3 POLLUX Study of Daratumumab Plus Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone Alone in Relapsed or Refractory Multiple Myeloma – Poster presentation, Saturday, December 7

Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma after Frontline Autologous Stem Cell Transplant: Use of Minimal Residual Disease as a Novel Primary Endpoint in the Phase 3 AURIGA Study – Poster presentation, Saturday, December 7

Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: Body Weight Subgroup Analysis of COLUMBA – Poster presentation, Saturday, December 7

Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: COLUMBA Update – Poster presentation, Saturday, December 7

Daratumumab Subcutaneous Delivery in Relapsed or Refractory Multiple Myeloma: Population Pharmacokinetics and Exposure-response Analysis – Poster presentation, Sunday, December 8

Subcutaneous Daratumumab Plus Standard Treatment Regimens in Patients with Multiple Myeloma Across Lines of Therapy: PLEIADES Study Update – Poster presentation, Sunday, December 8

Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in First Relapse Patients with Multiple Myeloma: Four-Year Update of CASTOR – Poster presentation, Sunday, December 8

MorphoSys to Present Data on Tafasitamab at ASH 2019 Meeting

On November 6, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported presentation of so far unpublished data on tafasitamab, its proprietary key asset and investigational hemato-oncological drug candidate, at the upcoming 61th American Society of Hematology (ASH) (Free ASH Whitepaper) 2019 Annual Meeting, taking place from December 7-10, 2019 in Orlando, Florida (Press release, MorphoSys, NOV 6, 2019, View Source [SID1234550480]).

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This year, overall four abstracts feature the clinical development of tafasitamab in diffuse large B-cell lymphoma (DLBCL) as well as other blood cancer indications. In addition, three abstracts feature preclinical data.

Abstracts on the clinical development of tafasitamab in DLBCL:

Subgroup analysis from the L-MIND trial, a phase 2 study assessing tafasitamab in combination with lenalidomide in patients with relapsed or refractory DLBCL
Trial in progress update for the First-MIND trial, an open label, randomized study in patients with newly diagnosed DLBCL
Abstracts on the clinical development of tafasitamab in other blood cancer indications:

Results from the COSMOS trial, assessing tafasitamab in combination with idelalisib or venetoclax in patients with relapsed of refractory chronic lymphocytic leukemia (CLL)
Final analysis and long term follow-up of tafasitamab monotherapy in patients with relapsed or refractory B-Cell Non-Hodgkin’s Lymphoma (NHL)
Preclinical abstracts on in vitro studies:

Study investigating gamma delta T cells and allogeneic activated NK cells as effector cells for tafasitamab
Study investigating the influence of tafasitamab on CAR-T cell activity
Study investigating tumor-associated macrophages as effector cells for tafasitamab
"We are excited to present a number of important updates on our investigational compound tafasitamab at this year’s ASH (Free ASH Whitepaper)," said Dr. Malte Peters, Chief Development Officer of MorphoSys AG. "The seven accepted abstracts provide insights into our scientific and clinical activities to evaluate the efficacy and safety of tafasitamab. The data highlight our commitment to patients with high unmet medical needs."

MorphoSys will meet ASH (Free ASH Whitepaper) attendees at the Orange County Convention Center, at Booth #1261.

Details about MorphoSys’s abstracts accepted for presentation at ASH (Free ASH Whitepaper) 2019:

Subgroup analysis from L-MIND, a Phase II Study of Tafafsitamab (MOR208) Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Abstract publication number: 1582
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas) – Results from Prospective Clinical Trials: Poster I
Session date and time: Saturday, December 7th, 2019; 9:00am – 7:30pm ET
Poster presentation time: 5:30pm – 7:30pm ET

A Phase Ib, Open-label, Randomized Study to Assess Safety and Preliminary Efficacy of Tafasitamab (MOR208) or Tafasitamab + Lenalidomide in Addition to R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma: The First-MIND Trial

Abstract publication number: 2877
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas) – Results from Prospective Clinical Trials: Poster II
Session date and time: Sunday, December 8th, 2019; 9:00am – 8:00pm ET
Poster presentation time: 6:00 pm – 8:00 pm ET

Primary Analysis of Anti-CD19 Tafasitamab (MOR208) Treatment in Combination with Idelalisib or Venetoclax in R/R CLL Patients Who Failed Prior BTK Inhibitor Therapy (COSMOS Trial)

Abstract publication number: 1754
Session: 642. CLL: Therapy, excluding Transplantation: Poster I
Session date and time: Saturday, December 7th, 2019; 9:00am – 7:30pm ET
Poster presentation time: 5:30pm – 7:30pm ET

A Phase IIa, Open-label, Multicenter Study of Single-Agent Tafasitamab (MOR208), an Fc-Optimized Anti-CD19 Antibody, in Patients with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma: Long-term Follow-up, Final Analysis

Abstract publication number: 4078
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas) – Results from Prospective Clinical Trials: Poster III
Session date and time: Monday, December 9th, 2019; 10:00am – 8:00pm ET
Poster presentation time: 6:00 pm – 8:00 pm ET

Targeting of CD19 by Tafasitamab Does Not Impair CD19 Directed Chimeric Antigen Receptor T Cell Activity In Vitro

Abstract publication number: 2859
Session: 625. Lymphoma: Pre-Clinical-Chemotherapy and Biologic Agents: Poster II
Session date and time: Sunday, December 8th, 2019; 9:00am – 8:00pm ET
Poster presentation time: 6:00 pm – 8:00 pm ET

Functional Characterization of Gamma Delta T Cells and Allogeneic Activated NK Cells as Effector Cells for Tafasitamab (MOR208)

Abstract publication number: 3801
Session: 605. Molecular pharmacology drug resistance – lymphoid and other diseases: Poster III
Session date and time: Monday, December 9th, 2019; 10:00am – 8:00pm ET
Poster presentation time: 6:00 pm – 8:00 pm ET

Mechanistic Characterization of Tafasitamab-Mediated Antibody-Dependent Cellular Phagocytosis Alone or in Combination with Lenalidomide

Abstract publication number: 4064
Session: 625. Lymphoma: Pre-Clinical-Chemotherapy and Biologic Agents: Poster III
Session date and time: Monday, December 9th, 2019; 10:00am – 8:00pm ET
Poster presentation time: 6:00 pm – 8:00 pm ET

The abstracts will also be available online in a supplemental issue of Blood. Additional information, including the abstracts, can be found in the online meeting program of the American Society of Hematology (ASH) (Free ASH Whitepaper).