On November 4, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that it expects the first clinical data from its Phase 1 trial evaluating IGM-2323 will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, which will be held virtually. IGM-2323 is a bispecific IgM antibody targeting the CD20 protein on the surface of lymphoma cells and the CD3 protein on(Press release, IGM Biosciences, NOV 4, 2020, View Source [SID1234569842]) the surface of T cells in order to kill lymphoma cells in patients with non-Hodgkin’s lymphoma (NHL). The Company’s multicenter, open-label Phase 1 clinical trial is intended to assess the safety, pharmacokinetics and preliminary efficacy of intravenous IGM-2323 in patients with relapsed/refractory B cell NHL.

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The preliminary results are expected to be presented on Saturday, December 5, 2020, at 7:00 a.m. PT, in an oral poster presentation titled "Preliminary Results of a Phase 1 Dose Escalation Study of the First-in-Class IgM Based Bispecific Antibody IGM-2323 (anti-CD20 x anti-CD3) in Patients with Advanced B-Cell Malignancies." At the time of the ASH (Free ASH Whitepaper) Annual Meeting, IGM plans to present additional safety, pharmacokinetic, biomarker and efficacy data from the eight patients described in the abstract released today (Budde et. al., abstract #134983) and from additional patients treated subsequent to the data cut-off for the abstract. IGM is currently enrolling patients for treatment with 300 mg, but data from this dose cohort will not be available by the time of the ASH (Free ASH Whitepaper) Annual Meeting.

As described in the abstract, as of June 12, 2020, eight patients had been treated at 4 dose levels (0.5, 2.5, 10, and 30 mg). The eight patients had received an average of four prior therapies before treatment with IGM-2323. Six of the eight patients remained on active treatment as of the data cut-off for the abstract. No dose limiting toxicities (DLTs) or drug related serious adverse events (SAEs) had been observed among the eight patients. Two patients had experienced low-grade transient fevers, but no grade 2 or higher cytokine release syndrome had been observed among the eight patients. When cytokines were detectable following dosing, they were transient and had returned to baseline at less than 6-12 hours. Interferon-gamma (IFNg) was the primary cytokine observed, with significant levels of IL-6 detected in only one patient. Preliminary results from this first-in-human T cell engaging antibody study show an improved safety and tolerability profile. There is also evidence of a novel mechanism of action based on repeatable T cell activation and preservation of T cell function compared with other T cell engaging antibodies.

"We are very pleased with the clinical data described in the abstract from the first-in-human clinical testing of an engineered IgM antibody," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We believe that these data provide an important initial validation of the IGM T cell engaging bispecific technology and the broader IGM antibody technology platform. We look forward to the continued development of IGM-2323, IGM-8444 and our extensive pipeline of IgM antibodies."

"It is very encouraging to see evidence of a repeatable immune activation of T cells," said Daniel Chen M.D., Ph.D., Chief Medical Officer of IGM Biosciences. "This is in contrast to the T cell activation profile of other T cell engagers and CAR-T cells and suggests that IGM-2323 is activating T cells in a manner which is different from IgG and fragment-based T cell engagers and which preserves T cell function and repeatable T cell activation. We look forward to presenting our initial clinical results at ASH (Free ASH Whitepaper), continuing the development of IGM-2323 and applying this novel T cell engager technology to additional hematologic and solid tumor targets and indications."

On November 4, 2020 Genmab reported to deliver on the promise of improving the lives of patients, with multiple regulatory milestones for Genmab-created products under development by our partners, including the exciting U.S. FDA’s approval of Kesimpta and the 8th U.S. FDA approval for DARZALEX," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab (Press release, Genmab, NOV 4, 2020, View Source [SID1234569841]). "During the first nine months of 2020, with our solid financial footing Genmab has continued its focused investment in advancing its proprietary antibody product pipeline and building its capabilities as we evolve into a fully integrated biotech."

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Financial Performance First Nine Months of 2020

Revenue was DKK 8,067 million in the first nine months of 2020 compared to DKK 2,405 million in the first nine months of 2019. The increase of DKK 5,662 million, or 235%, was primarily driven by the upfront payment from AbbVie pursuant to our new collaboration announced in June and higher DARZALEX royalties.
Net sales of DARZALEX by Janssen Biotech Inc. (Janssen) were USD 2,937 million in the first nine months of 2020 compared to USD 2,168 million in the first nine months of 2019, an increase of USD 769 million, or 35%.
Operating expenses were DKK 2,641 million in the first nine months of 2020 compared to DKK 1,943 million in the first nine months of 2019. The increase of DKK 698 million, or 36%, was driven by the advancement of epcoritamab (DuoBody-CD3xCD20) and DuoBody-PD-L1x4-1BB, additional investments in our product pipeline, and the increase in new employees to support the expansion of our product pipeline.
Operating income was DKK 5,426 million in the first nine months of 2020 compared to DKK 462 million in the first nine months of 2019. The increase of DKK 4,964 million was driven by higher revenue, which was partly offset by increased operating expenses.
Outlook
Genmab is maintaining its 2020 financial guidance published on August 20, 2020.

Conference Call
Genmab will hold a conference call in English to discuss the results for the first nine months of 2020 today, Wednesday, November 4, at 6:00 pm CET, 5:00 pm GMT or 12:00 pm EST. To join the call dial
+1 646 741 3167 (U.S. participants) or +44 2071 928338 (international participants) and provide conference code 7839599.

On November 4, 2020 Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, reported that data across the portfolio will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, to be held December 5-8, 2020 (Press release, Magenta Therapeutics, NOV 4, 2020, View Source [SID1234569840]).

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"These data demonstrate the progress of our clinical and preclinical pipeline to expand patient eligibility to safely and effectively benefit from a potentially curative stem cell transplant," said John Davis Jr., M.D., M.P.H., M.S., Head of Research & Development and Chief Medical Officer, Magenta Therapeutics. "Our ASH (Free ASH Whitepaper) presentations give insight into the significant impact our mobilization and conditioning programs stand to make for a broad range of patient populations. We look forward to advancing this pipeline further in 2021, with several anticipated data milestones ahead."

Oral Presentation Showcasing Clinical Data of MGTA-145 Stem Cell Mobilization Program:

Magenta is developing MGTA-145 to be the first-line therapy for same-day mobilization and collection of hematopoietic stem cells (HSCs) for transplant, to enable successful rebuilding of the blood and immune system. MGTA-145 has the potential to be used across a broad range of diseases, including genetic diseases, such as sickle cell disease, as well as blood cancers, and autoimmune diseases.

All primary and secondary endpoints were met in the MGTA-145 Phase 1 trial in healthy volunteers completed earlier this year. By the end of 2020, Magenta intends to initiate multiple Phase 2 clinical trials of MGTA-145. These trials, including both allogeneic and autologous transplant settings across multiple diseases, are intended to evaluate mobilization and collection of functional hematopoietic stem cells and engraftment of these cells in patients after transplant.

Title: MGTA-145, in Combination with Plerixafor in a Phase 1 Clinical Trial, Mobilizes Large Numbers of Human Hematopoietic Stem Cells and a Graft with Immunosuppressive Effects for Allogeneic Transplant (Oral Abstract #184)
Presenting Author: Steven M. Devine, MD, Center for International Blood and Marrow Transplant Research, National Marrow Donor Program / Be The Match
Date and Time of Oral Presentation: Saturday, December 5, 2020, 12:15pm PT

These clinical data provide further confirmation that MGTA-145, in combination with plerixafor, provides a rapid and reliable method to obtain large numbers of functional hematopoietic stem cells for both autologous and allogeneic stem cell transplantation with preclinical data demonstrating enhanced engraftment and reduced Graft-versus-Host disease (GvHD).

Preclinical Data from Magenta’s Antibody-Drug Conjugate Conditioning Programs

Pre-transplant patient conditioning is a critical component necessary to prepare a patient’s body to receive the edited cells, which carry the corrected gene and must engraft in the patient’s bone marrow to be effective. Targeted antibody-drug conjugates (ADCs) are designed to selectively and rapidly remove disease-causing cells in the body and enable immune and blood system reset and long-term engraftment, without the need for aggressive chemotherapy or radiation.

Magenta expects to generate initial clinical data in 2021 in MGTA-117, the Company’s clinical candidate for ADC-based conditioning for stem cell transplant and gene therapy and its most advanced conditioning program.

Title: A Single Dose of a Novel Anti-Human CD117-Amanitin Antibody Drug Conjugate (ADC) Engineered for a Short Half-life Provides Dual Conditioning and Anti-Leukemia Activity and Extends Survival Compared to Standard of Care in Multiple Preclinical Models of Acute Myeloid Leukemia (AML) (Abstract #1044)
Presenting Author: Leanne Lanieri, M.S., Magenta Therapeutics
Date and Time to View Poster Presentation: Saturday, December 5, 2020, 7:00am to 3:30pm PT

These preclinical data show that a single dose of MGTA-117, a targeted ADC, was effective as a conditioning agent for transplant, and significantly decreased peripheral tumor burden leading to delayed tumor growth and increase median survival rates. MGTA-117 has potential to serve as an effective, potent conditioning and anti-leukemia agent, improving HSCT outcomes in patients with acute myeloid leukemia (AML). MGTA-117 was well-tolerated in all three AML xenograft models, both as a single- and multi-dose regimen.

Title: Single Agent CD45-Targeted Antibody Drug Conjugate Enables Full Mismatch Allogeneic Hematopoietic Stem Cell Transplantation in a Murine HSCT Model (Abstract #2330)
Presenting Author: Bruce Blazar, M.D., Regents Professor of Pediatrics in the Division of Blood and Marrow Transplantation, University of Minnesota
Date and Time to View Poster Presentation: Sunday, December 6, 2020, 7:00am to 3:30pm PT

Magenta’s CD45-ADC program targets CD45, a protein expressed on immune cells and blood stem cells and is designed to remove the cells that cause autoimmune diseases to enable curative immune reset. Magenta has identified a lead antibody for its CD45-ADC program for blood and immune system reset and IND-enabling work continues to advance.

Preclinical data in this abstract show that a single dose of CD45-ADC for conditioning enabled complete chimerism in a fully mismatched allogeneic HSCT model, which may provide a reduced toxicity conditioning regimen for patients with malignant and non-malignant blood disorders, among other diseases.

Additional Posters:

Title: Reversing Clonal Hematopoiesis and Associated Atherosclerotic Disease by Targeted Antibody Drug Conjugate (ADC) Conditioning and Transplant (Abstract #1843)
Presenting Author: Karin Gustafsson, Ph.D., Massachusetts General Hospital and Harvard University
Date and Time to View Poster Presentation: Sunday, December 6, 2020, 7:00am to 3:30pm PT

Title: MGTA-145/Plerixafor-Mediated HSC Mobilization and Intravenous HDAd5/35++ Vector Injection into Mice Allows for Efficient in vivo HSC Transduction and Stable Gene Marking in Peripheral Blood Cells of CD46-Transgenic and Thalassemia Mice (Abstract #2602)
Presenting Author: Chang Li, Ph.D., Division of Medical Genetics, Department of Medicine, University of Washington
Date and Time to View Poster Presentation: Monday, December 7, 2020, 7:00am to 3:30pm PT

On November 4, 2020 Aptose Biosciences Inc. ("Aptose") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that early clinical data, along with certain preclinical data, for CG-806, an oral, first-in-class FLT3 and BTK cluster selective kinase inhibitor, and early clinical data for APTO-253, a first-in-class small molecule MYC inhibitor, will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held virtually Saturday, December 5 – Monday, December 7, 2020 (Press release, Aptose Biosciences, NOV 4, 2020, View Source [SID1234569839]).

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The abstracts accepted for presentation are listed below and can be viewed online at the ASH (Free ASH Whitepaper) conference website. Note that the presentations will include additional data not found in the abstracts.

Poster Presentation Details

Abstract #1042: A Phase 1a/b Dose Escalation Study of the MYC Repressor Apto-253 in Patients with Relapsed or Refractory AML or High-Risk MDS
Poster Session Date & Time: Saturday, December 5, 2020, 7:00 a.m. – 3:30 p.m. PT
Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster I

Abstract #1174: Pharmacologic Inhibition of B Cell-Receptor-Associated Kinases with CG-806 Induces Apoptosis and Metabolic Reprogramming in Aggressive Non-Hodgkin Lymphoma (NHL) Models
Poster Session Date & Time: Saturday, December 5, 2020, 7:00 a.m. – 3:30 p.m. PT
Session Name: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster I

Abstract #2228: A Phase 1 a/b Dose Escalation Study of the Mutation Agnostic BTK/FLT3 Inhibitor CG-806 in Patients with Relapsed or Refractory CLL/SLL or Non-Hodgkin’s Lymphomas
Poster Session Date & Time: Sunday, December 6, 2020, 7:00 a.m. – 3:30 p.m. PT
Session Name: 642. CLL: Therapy, excluding Transplantation: Poster II

The poster abstracts also will be published in the November supplemental issue of Blood, an ASH (Free ASH Whitepaper) journal, available online.

On November 4, 2020 Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a pharmaceutical company focusing on the development of targeted therapies for difficult-to-treat hematological diseases, reported that twelve abstracts, including one oral presentation, have been accepted for the upcoming virtual American Society of Hematology (ASH) (Free ASH Whitepaper) meeting on December 5-8, 2020 (Press release, Oncopeptides, NOV 4, 2020, View Source [SID1234569838]). Key clinical abstracts focus on data from the ongoing phase 1/2 ANCHOR combination study and the pivotal phase 2 HORIZON study. The preclinical abstracts further explore the mechanism of action of the proprietary peptide-drug conjugate platform in multidrug resistant models of multiple myeloma. The abstracts are published online today at View Source

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The updated analysis of the ongoing phase 1/2 ANCHOR study confirms the initial findings of encouraging activity as a triplet regimen with melflufen plus dexamethasone and either daratumumab or bortezomib in patients with relapsed refractory multiple myeloma and sets the foundation for the planned phase 3 LIGHTHOUSE daratumumab combination study.

Seven clinical abstracts are based on the HORIZON study, most notable are the subgroup analysis of patients exposed to and refractory to alkylators and the analysis of patients with extramedullary disease, that further verify the distinct mechanism of action of melflufen.

"We look forward to sharing a robust dataset from our clinical and pre-clinical programs in multiple myeloma which further validates the strength of our peptide-drug conjugate platform," says Klaas Bakker, MD, PhD, Chief Medical Officer of Oncopeptides. "These abstracts provide a comprehensive and multi-faceted analysis of the safety and efficacy of melflufen. Collectively, these results demonstrate our continued commitment to finding a novel therapeutic approach for heavily treated, high risk multiple myeloma patients, with a particularly poor prognosis and limited treatment options."

Below is a brief description of the abstracts that have been accepted by the American Society of Hematology (ASH) (Free ASH Whitepaper).

Clinical abstracts First Author Abstract Code Disposition
ANCHOR
ANCHOR (OP-104): Melflufen Plus Dexamethasone (dex) and Daratumumab (dara) or Bortezomib (BTZ) in Relapsed/Refractory Multiple Myeloma (RRMM) Refractory to an IMiD and/or a Proteasome Inhibitor (PI)—Updated Efficacy and Safety. Ocio E, et. al. 417 Oral
HORIZON
HORIZON (OP-106): Melflufen Plus Dexamethasone (dex) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM) Exposed to Prior Alkylator Therapy—Subgroup Analysis Roudriguez-Otero P, et.al 2321 Poster
HORIZON (OP-106): Melflufen Plus Dexamethasone (dex) in 55 Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM) with Extramedullary Disease (EMD)—Subgroup Analysis. Richardson, PG, et.al 3214 Poster
HORIZON (OP-106): Melflufen Plus Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma ith High-Risk Cytogenetics—Subgroup Analysis. Mateos MV, et.al 3237 Poster
HORIZON (OP-106): Melflufen Plus Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma—Age Subgroup Analysis of Elderly Patients. Larocca A et.al. 2293 Poster
HORIZON (OP-106): Melflufen Plus Dexamethasone (dex) in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM)—Health-related Quality of Life (HR QoL) Analysis. Oriol A, et.al. 3477 Poster
HORIZON (OP-106): Melflufen Plus Dexamethasone (dex) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM)—Analysis of Adverse Events Related to Hospitalizations. Nadeem O, et.al. 2564 Poster
HORIZON (OP-106) Versus MAMMOTH: An Indirect Comparison of Efficacy Outcomes for Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Refractory to Anti-CD38 Monoclonal Antibody Therapy Treated with Melflufen Plus Dexamethasone Versus Conventional Agents. Blade J, et.al. TBC Publication only
Pre-clinical abstracts
Effect of ABCB1 Multidrug Resistance Protein on Efficacy of Anti-Myeloma Drugs in Carfilzomib Resistant Myeloma Model. Byrgazov K, et.al. Poster
Melflufen Shows Efficacy Against Bortezomib-Resistant Multiple Myeloma Models Including Myeloma Stem Cells Byrgazov K, et.al. Poster
Anti-Myeloma Drug Melflufen Inhibits RANKL Osteoclastogenesis By Suppressing Proliferation of CD14+ Precursor Cells Byrgazov K, et.al. Poster
Novel Alkylating Agent Melflufen Displays Potent Efficacy in Samples from Patients with High Risk Subsets of Multiple Myeloma Including Plasma Cell Leukemia Idler B, et.al. Poster
Melflufen (INN Melphalan flufenamide) is an investigational first-in-class peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells. Melflufen is in late-stage clinical development for the treatment of patients with triple-class refractory multiple myeloma and has recently been granted a priority review by the U.S. Food and Drug Administration, FDA, for a New Drug Application based on the results from the phase 2 HORIZON study.

For more information, please contact:
Klaas Bakker, MD, PhD, Chief Medical Officer of Oncopeptides
E-mail: [email protected]
Cell: +44 7818 523903

Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: [email protected]
Cell phone: +46 70 853 72 92

This information was submitted for publication on November 4, 2020 at 16:30 (CET).

About melflufen
Melflufen (INN melphalan flufenamide) is a first in class peptide-drug conjugate (PDC) that targets aminopeptidases and releases alkylating agents into tumor cells. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and is immediately hydrolyzed by peptidases to release an entrapped hydrophilic alkylator payload. Aminopeptidases are overexpressed in tumor cells and are even more pronounced in advanced cancers and tumors with a high mutational burden. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the increased intracellular alkylator concentration. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies. In the pivotal phase 2 HORIZON study melflufen plus dexamethasone demonstrated encouraging efficacy and a clinically manageable safety profile in heavily pretreated patients with relapsed refractory multiple myeloma, with primarily hematologic Adverse Events (AE) and a low incidence of non-hematologic AEs.