On November 2, 2023 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported that data from the Phase 3 MANIFEST-2 trial of pelabresib, an investigational BET inhibitor, in combination with the JAK inhibitor ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis will be presented during an oral presentation on Sunday, December 10, at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, MorphoSys, NOV 2, 2023, View Source [SID1234636777]). The conference is being held in San Diego, California, from December 9 to 12, 2023.

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"Pelabresib represents an opportunity to meaningfully improve the standard of care for patients with myelofibrosis, a community in dire need of more effective and well-tolerated treatment options," said Tim Demuth, M.D., Ph.D., MorphoSys Chief Research and Development Officer. "We will be sharing topline results from our pivotal MANIFEST-2 study in the coming weeks and look forward to presenting detailed findings at ASH (Free ASH Whitepaper) 2023 shortly thereafter. We are very excited about the potential of pelabresib and grateful for the efforts of everyone who is contributing to this research – the investigators, clinical trial staff members, our employees and, most importantly, every patient and caregiver."

MANIFEST-2 is a global, multicenter, double-blind, Phase 3 study investigating pelabresib in combination with ruxolitinib versus placebo plus ruxolitinib in JAK inhibitor-naïve patients with myelofibrosis (those who have not been previously treated with a JAK inhibitor). A total of 431 patients were randomized in the study, making it one of the largest myelofibrosis studies conducted to date.

The primary endpoint of the study is the proportion of patients who achieve a 35% or greater reduction in spleen volume (SVR35) from baseline at 24 weeks. A key secondary endpoint is the proportion of patients achieving a 50% or greater improvement in total symptom score (TSS50), as measured by the Myelofibrosis Symptom Assessment Form v4.0, from baseline at 24 weeks. The study is also assessing the absolute change in total symptom score (TSS) from baseline at week 24, percentage change in TSS from baseline at week 24, progression-free survival, overall survival, duration of the splenic and total symptom score responses, and improvement in bone marrow fibrosis, among other endpoints.

One additional abstract on pelabresib and six abstracts on tafasitamab, marketed in the U.S. as Monjuvi and outside the U.S. by Incyte as Minjuvi, were accepted for presentation and publication at ASH (Free ASH Whitepaper) 2023.

ASH 2023 Accepted Abstracts
Abstracts listed below include both MorphoSys-led and partner abstracts.

Abstract Title Abstract Number Date/Time
Pelabresib
ORAL
Pelabresib in Combination with Ruxolitinib for Janus Kinase Inhibitor Treatment-Naïve Patients with Myelofibrosis: Results of the MANIFEST-2 Randomized, Double-Blind, Phase 3 Study
#628
Sunday, December 10, 4:30 p.m. – 6:00 p.m. PST / Monday, December 11, 1:30 a.m. – 3:00 a.m. CET

Presentation Time: 5:15 p.m. PST
POSTER
Assessment of Minimal Clinically Important Difference in Patient-Reported Myelofibrosis-Associated Symptoms Using an Anchor-Based Analysis Based on MANIFEST Arm 3 Data
#3195
Sunday, December 10,
6:00 p.m. – 8:00 p.m. PST / Monday, December 11, 3:00 a.m. – 5:00 a.m. CET
Tafasitamab
ORAL
Tafasitamab for the Treatment of Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) in the US Real-World Setting
#265
Saturday, December 9,
2:00 p.m. – 3:30 p.m. PST / 11:00 p.m. – 12:30 a.m. CET

Presentation Time: 2:00 p.m. PST
POSTER
Real-World Use of Tafasitamab (tafa) for Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) Among Racial and Ethnic Minorities in the United States
#2415 Saturday, December 9, 5:30 p.m. – 7:30 p.m. PST / Sunday, December 10, 2:30 a.m. – 4:30 a.m. CET
POSTER
Tafasitamab in Combination with a CD20xCD3 Bispecific T-cell Engager Significantly Prolongs Survival in Preclinical Lymphoma Models
#2813 Sunday, December 10, 6:00 p.m. – 8:00 p.m. PST / Monday, December 11, 3:00 a.m. – 5:00 a.m. CET
PUBLICATION
realMIND: A Prospective and Retrospective Study to Characterize Real-World Use of Tafasitamab Plus Lenalidomide in US Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma, With a Focus on Patients from Minority Groups
N/A N/A
PUBLICATION
Estimates of Survival and Life Expectancy with Tafasitamab plus Lenalidomide in the L-MIND Study Compared with Real-World Standard-of-Care for Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma
N/A N/A
PUBLICATION
A Multicenter, Open-label, Phase 1b/2 Study to Evaluate the Effects of Maplirpacept in Combination with Tafasitamab and Lenalidomide in People with Relapsed or Refractory Diffuse Large B-cell Lymphoma
N/A N/A

On November 2, 2023 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, will present preliminary data from its ongoing Phase 1/2a trial of MP0533, a novel tetra-specific T cell engager at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held from December 9–12 in San Diego, California (Press release, Molecular Partners, NOV 2, 2023, View Source [SID1234636776]). MP0533 is in development for the treatment of patients with relapsed/refractory acute myeloid leukemia (r/r AML) and myelodysplastic syndrome (AML/MDS).

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As of data cut-off (20 July 2023) of the abstract published today, five patients across three dosing regimens had been treated. The preliminary data reported indicate an acceptable safety profile, with no dose-limiting toxicity or Grade ≥3 adverse reactions. Grade 1/2 events considered related to MP0533 included infusion-related reactions and cytokine release syndromes. One of the two patients evaluable for MP0533 antitumor activity in the third treatment cohort achieved a response. The study is currently enrolling its fifth cohort with up to seven dose-escalating cohorts planned and a total enrollment of up to 45 patients. The Company anticipates to present data including from the fourth dose cohort at the ASH (Free ASH Whitepaper) Annual Meeting and Exposition in December this year.

"The data from the ASH (Free ASH Whitepaper) abstract represent the beginning of an exciting and encouraging clinical journey for the MP0533 program. We are now able to show initial clinical activity of the first tetra-specific, non-antibody-based T cell engager, MP0533, in patients with r/r AML and MDS/AML," said Patrick Amstutz, Ph.D., Molecular Partners’ CEO. "We see both an acceptable tolerability profile at initial doses, as well as the emergence of single-agent anti-tumor activity at relatively low dose levels and we look forward to presenting additional data on MP0533’s potential to treat this particularly intractable blood cancer at the ASH (Free ASH Whitepaper) Annual Meeting in December."

The clonal heterogeneity and lack of single AML-specific target antigens represent major challenges for the development of targeted immune therapies for AML. To overcome these hurdles, Molecular Partners designed MP0533, a novel tetra-specific T cell-engaging, half-life extended DARPin, which simultaneously targets CD33, CD123 and CD70, as well as CD3 on T cells. This unique mode of action is designed to enable avidity-driven, T cell-mediated killing of leukemic stem cells and malignant blast cells, which commonly co-express at least two of the three target antigens, while preserving a therapeutic window that minimizes damage to healthy cells.

The ongoing single-arm, open-label, multicenter Phase 1/2a study of MP0533 is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics, as well as assess preliminary antileukemic activity of MP0533 as a monotherapy for patients with r/r AML and AML/MDS.

The presentation details are as follows:

Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster 2
Publication Number: 2921
Title: MP0533, a CD3-Engaging DARPin Targeting CD33, CD123, and CD70 in Patients with Relapsed/Refractory AML or MDS/AML: Preliminary Results of a Phase 1/2a Study
Session Location & Date: San Diego Convention Center, Halls G-H; Sunday, December 10, 2023
Presentation Time: 6:00–8:00 pm PT

The abstract will become available today on the ASH (Free ASH Whitepaper) website at 9:00 am ET.

On November 2, 2023 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [("Merrimack" or the "Company")] reported its third quarter 2023 financial results for the period ended September 30, 2023 (Press release, Merrimack, NOV 2, 2023, View Source [SID1234636775]).

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"During the third quarter we saw interest income on our cash and short term investments offset a significant portion of our operating expenses" said Gary Crocker, Chairman of Merrimack’s Board of Directors. "We continue to monitor developments in Ipsen’s Onivyde (irinotecan liposomal injection) program and Elevation’s seribantumab program."

Third Quarter 2023 Financial Results

Merrimack reported a net loss of $279 thousand for the third quarter ended September 30, 2023, or $0.02 per basic and diluted share on a fully diluted basis, compared to a net loss of $442 thousand, or $0.03 per basic and diluted share on a fully diluted basis, for the same period in 2022.

General and administrative expenses for the third quarter ended September 30, 2023, were $531 thousand, compared to $504 thousand for the same period in 2022.

As of September 30, 2023, Merrimack had short term investments and cash and cash equivalents of $18.9 million, compared to $19.4 million as of December 31, 2022.

As of September 30, 2023, Merrimack had 14.3 million shares of common stock outstanding.

Updates on Programs Underlying Potential Milestone Payments

Ipsen

-
In June 2023, Ipsen announced that the U.S. Food and Drug Administration (FDA) had accepted its supplemental new drug application (sNDA) Onivyde (irinotecan liposome injection) plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX

regimen) as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC) and that the FDA had provided a Prescription Drug User Fee Act goal date of 13 February 2024 for review of the application. This guidance was reiterated in Ipsen’s September 2023 investor presentation.
Elevation Oncology

In January 2023, Elevation announced it is pausing further investment in the clinical development of seribantumab and intends to pursue further development only in collaboration with a partner.

On November 2, 2023 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported that the Company’s management will participate in the following upcoming investor conferences (Press release, MacroGenics, NOV 2, 2023, View Source [SID1234636774]):

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BMO Biopharma Spotlight Series: Oncology Day
Date: Wednesday, November 8, 2023
Fireside Chat: 10:30 am ET
Location: Virtual

Stifel 2023 Healthcare Conference
Date: Tuesday, November 14, 2023
Fireside Chat: 3:00 pm ET
Location: New York

6th Annual Evercore ISI HealthCONx Conference
Date: Tuesday, November 28, 2023
Fireside Chat: 7:55 am ET
Location: Miami
Webcasts of the above presentations may be accessed under "Events & Presentations" in the Investor Relations section of MacroGenics’ website at View Source The Company will maintain archived replays of these webcasts on its website for 30 days.

On November 2, 2023 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported that extended results from its Early Access Program of MaaT013 in 111 patients (additional 30 patients included in the Program compared to last year) with aGvHD and the design of its Phase 2b study evaluating MaaT033 in improving overall survival in patients undergoing allogenic hematopoietic cell transplantation (allo-HSCT) have been selected for poster presentations at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting held from December 9-12, 2023, in San Diego, California, USA (Press release, MaaT Pharma, NOV 2, 2023, View Source [SID1234636773]). This is the seventh year in a row that the Company’s clinical data and activities have been selected for a presentation at the ASH (Free ASH Whitepaper) Annual Meeting, the world-leading event in malignant and non-malignant hematology, demonstrating the ongoing interest from clinicians for microbiome modulation approaches in the hemato-oncology field.

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In line with the conference embargo policy, MaaT Pharma will detail the presented results through a press release on Monday, December 11th, 2023. The Company will also host an investor webcast on Monday, December 18th, 2023, at 6:00pm CET (further details to follow).

The EAP results include data from 111 patients with steroid-resistant or steroid-dependent aGvHD treated with MaaT013, previously unresponsive to 1-6 lines of therapy. MaaT013 is currently being evaluated in a pivotal Phase 3 trial (n=75) for corticosteroid- and ruxolitinib-refractory gastrointestinal aGvHD. The Company shared the positive review by DSMB in October 2023 for this Phase 3 trial, including a favorable benefit/risk ratio, with a good safety profile and positive preliminary efficacy results. As of today, over 170 patients have been safely treated with MaaT013 in Europe in clinical trials and the EAP.

The Company provides an update on MaaT033, an oral ecosystem microbiome capsule for adjunctive therapy, and will share the design of the Phase 2b trial, the largest randomized clinical trial (RCT) study for a microbiome therapy in hemato-oncology to date with the enrollment of 387 patients, investigating the efficacy of MaaT033 in improving overall survival for patients receiving allo-HSCT.

Poster Presentations:

MaaT013

Title: Pooled Fecal Allogenic Microbiotherapy for Refractory Gastrointestinal Acute Graft-Versus-Host Disease: Results from Early Access Program in Europe
Poster number: 3553
Presenter: Professor Florent Malard, hematology professor at the Saint-Antoine Hospital and Sorbonne University
Session: Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster II
Session Date/Time: Sunday, December 10, 2023: 6:00pm -8:00pm EST
Location: San Diego Convention Center, Halls G-H
MaaT033

Title: A Multicentre, Randomized, Double-Blinded, Phase 2b Study Evaluating the Efficacy and Safety of MaaT033, an Oral, Pooled Microbiome Ecosystem Therapy in Patients Undergoing Allogenic Hematopoietic Cell Transplantation to Improve Overall Survival: The Phoebus Trial
Poster number: 4947
Presenter: Professor Florent Malard, hematology professor at the Saint-Antoine Hospital and Sorbonne University
Session: Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster III
Session Date/Time: Monday, December 11, 2023: 6:00pm -8:00pm EST
Location: San Diego Convention Center, Halls G-H
Upcoming scientific conference participations

November 1-5, 2023 – 38th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting – Posters presentations
November 15-17, 2023 – 22nd Société Francophone de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC) Congress – Booth #12
December 9-12, 2023 – 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting- Posters presentations