On November 4, 2021 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a mission to deliver targeted therapies that treat rare forms of cancer, reported new retrospective analyses of the momelotinib Phase 3 SIMPLIFY studies will be presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held virtually and in Atlanta, GA December 11-14, 2021 (Press release, Sierra Oncology, NOV 4, 2021, View Source [SID1234594530]).

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Baseline Serum Ferritin Differentially Predicts W24 Transfusion Independence Response for Momelotinib and Ruxolitinib in Patients with Myelofibrosis

Myelofibrosis is characterized by the presentation of constitutional symptoms, splenomegaly and anemia, with the degree of anemia and transfusion dependence being among the most important predictors of overall survival. Prior analyses demonstrate patients randomized to momelotinib who achieve Week 24 Transfusion Independence Response (TI-R) have increased overall survival compared to non-TI responders. The new analyses to be presented by Stephen Oh, MD, PhD, Washington University School of Medicine in St. Louis and Siteman Cancer Center, expand on these findings, demonstrating that the TI-R treatment effect of momelotinib versus ruxolitinib was greater in patients with baseline serum ferritin >90ng/mL versus <90ng/mL in both JAK inhibitor-naïve and in ruxolitinib-experienced patients. These data suggest that pre-treatment serum ferritin level may be an important biomarker for the treatment effect of momelotinib versus ruxolitinib on the clinically important Week 24 TI-R endpoint.

Presentation Details

Abstract: 3638
Title: Baseline Serum Ferritin Differentially Predicts W24 Transfusion Independence Response for Momelotinib and Ruxolitinib in Patients with Myelofibrosis
Presenter: Stephen Oh, MD, PhD
Session Name: 634. Myeloproliferative Syndromes: Clinical and Epidemiological: Poster III
Date and Time: Monday, December 13, 2021, 6:00 pm – 8:00 pm ET
Location: Georgia World Congress Center, Hall B5

About Momelotinib
Momelotinib is a selective and orally bioavailable JAK1, JAK2 and ACVR1 / ALK2 inhibitor for the potential treatment of myelofibrosis. Myelofibrosis results from dysregulated JAK-STAT signaling and is characterized by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia.

Momelotinib is currently under investigation in the MOMENTUM clinical trial, a global, randomized, double-blind Phase 3 study for symptomatic and anemic myelofibrosis patients. Top-line data are anticipated by February 2022. Assuming positive results, Sierra Oncology plans to file a New Drug Application with the US Food & Drug Administration (FDA) in the second quarter of 2022. Momelotinib has been granted Fast Track Designation by the FDA.

On November 4, 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that three abstracts highlighting data and information from three oncology drug candidates in its pipeline will be presented at the upcoming 63rd Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 11 – 14, 2021 (Press release, MEI Pharma, NOV 4, 2021, View Source [SID1234594529]).

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Details on the poster presentations are included below:

Title: Coastal: A Phase 3 Study of the PI3Kδ Inhibitor Zandelisib with Rituximab (R) Versus Immunochemotherapy in Patients with Relapsed Indolent Non-Hodgkin’s Lymphoma (iNHL)
Authors: Wojciech Jurczak, M.D., Ph.D., et. al.
Date: Sunday, December 12, 2021, 6:00 PM – 8:00 PM ET
Abstract ID: 2430

Summary of study methods: the COASTAL study is a randomized, open-label, controlled multicenter phase 3 trial to investigate the safety and efficacy of zandelisib in combination with rituximab versus standard immunochemotherapy in patients with relapsed or refractory follicular or marginal zone lymphomas who received at least one prior line of therapy. Eligible patients must have received an anti-CD20 antibody in combination with chemotherapy or lenalidomide.

Title: A Novel Isoflavone, ME-344, Enhances Venetoclax Antileukemic Activity Against AML Via Suppression of Oxidative Phosphorylation and Purine Biosynthesis
Authors: Katie Hurrish, et. al.
Date: Sunday, December 12, 2021, 6:00 PM – 8:00 PM ET
Abstract ID: 2238

Summary of results: preclinical studies evaluating the combination of ME-344 with venetoclax in AML cell lines, including those with cytarabine resistance, and in an AML patient sample, suggest that ME-344 suppresses OXPHOS and the purine biosynthesis pathway to enhance the antileukemic activity of venetoclax against AML.

Title: A Phase 1 Dose-Escalation Study of the Oral CDK Inhibitor Voruciclib in Patients with Relapsed/Refractory B-Cell Malignancies or Acute Myeloid Leukemia (AML): Preliminary Results of the Completed Dose Escalation Stage in AML
Authors: Marina Konopleva, M.D., Ph.D., et. al.
Date: Monday, December 13, 2021, 6:00 PM – 8:00 PM ET
Abstract ID: 3423

Summary of conclusions: voruciclib administered on an optimized schedule of 14 consecutive days in a 28-day cycle was well tolerated. Further, no dose limiting toxicities were observed and no significant myelosuppression was seen in patients with B-cell malignancies, suggesting no overlapping toxicities with venetoclax. Disease stabilization was observed in heavily pretreated patients and differentiation syndrome was observed in AML patients indicating biologic activity. A protocol amendment is forthcoming to evaluate voruciclib in combination with venetoclax in patients with relapsed AML.

The abstracts are available on the ASH (Free ASH Whitepaper) annual meeting website. The e-poster presentations will be available on the MEI Pharma website on the morning each poster opens for viewing at ASH (Free ASH Whitepaper).

On November 4, 2021 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, reported four presentations at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held in Atlanta, Georgia or virtually from December 11-14, 2021 (Press release, Gamida Cell, NOV 4, 2021, View Source [SID1234594527]).

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New data on omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant, will be presented during an oral presentation showing that hematopoietic stem cell transplantation with omidubicel is associated with robust immune constitution and lower rates of severe infection compared to standard umbilical cord blood transplantation. Additionally, there will be three poster presentations and one e-publication highlighting additional clinical data from omidubicel and GDA-201, the company’s natural killer (NK) cell immunotherapy in development for the treatment of hematologic and solid tumors with standard of care antibody therapies. Together the data that will be presented at ASH (Free ASH Whitepaper) reflect the progress across Gamida Cell’s NAM-enabled pipeline of cell therapies being developed as potentially curative approaches for cancer patients in need of new and better therapeutic options.

Details about the ASH (Free ASH Whitepaper) presentations are as follows:

Title: Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel Is Associated with Robust Immune Reconstitution and Lower Rates of Severe Infection Compared to Standard Umbilical Cord Blood Transplantation (Oral)
Abstract Number: 333
Lead Author: Paul Szabolcs, M.D., Division of Blood and Marrow Transplantation and Cellular Therapy, UPMC Children’s Hospital of Pittsburgh, Pittsburg, PA
Time: Saturday, December 11, 2021, 4:00 p.m. – 5:30 p.m. EST (session time) and 4:30 p.m. EST (presentation)

Title: Allogeneic Stem Cell Transplantation with Omidubicel: Long-Term Follow-up from a Single Center (Poster)
Abstract Number: 1827
Lead Author: Chenyu Lin, M.D., Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University Medical Center, Durham, NC
Time: Saturday, December 11, 2021, 5:30 p.m. – 7:30 p.m. EST

Title: GDA-201, a Novel Metabolically Enhanced Allogeneic Natural Killer (NK) Cell Product Yields High Remission Rates in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (NHL): 2-Year Survival and Correlation with Cytokine IL7 (Poster)
Abstract Number: 3854
Lead Author: Veronika Bachanova, M.D., Ph.D., Division of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, MN
Time: Monday, December 13, 2021, 6:00 p.m. – 8:00 p.m. EST

Title: Hospitalization and Healthcare Resource Use of Omidubicel Vs Cord Blood Transplantation for Hematological Malignancies in a Global Randomized Phase III Clinical Trial (Poster)
Abstract Number: 4036
Lead Author: Navneet Majhail, M.D., Taussig Cancer Institute, Department of Hematology and Oncology, Cleveland Clinic, Cleveland, OH
Time: Monday, December 13, 2021, 6:00 p.m. – 8:00 p.m. EST

Title: Transcriptional and Metabolic Profiling of Nicotinamide-Enhanced Natural Killer (NAM-NK) Cells (GDA-201) (e-Publication)
Abstract Number: 4791
Lead Author: Dima Yackoubov, M.Sc., Gamida Cell, Jerusalem, Israel

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Status by the FDA. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results, as reported at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition1. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. For more information about GDA-201, please visit View Source

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

On November 4, 2021Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that updated clinical data from its Phase 1 dose-escalation study of plamotamab, a CD20 x CD3 bispecific antibody, in patients with B-cell malignancies will be presented in a poster session during the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Atlanta, Georgia on Sunday, December 12, 2021 (Press release, Xencor, NOV 4, 2021, View Source [SID1234594526]).

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"Plamotamab is generally well tolerated and demonstrates encouraging clinical activity at our recommended intravenous Phase 2 dose, 50 mg flat dosing every two weeks after step-up dosing. We believe the best outcomes for patients require our focus on studying unique combinations of plamotamab with chemotherapy-free partners, and we are initiating the first of these studies in patients with relapsed or refractory diffuse large B cell lymphoma in late 2021 or early 2022," said Allen Yang, M.D., Ph.D., senior vice president and chief medical officer at Xencor. "Additionally, our recently announced collaboration for advancing plamotamab development will close soon, and this will expand our strategy to develop multiple highly active chemotherapy-free regimens across B-cell cancers, importantly with tumor-selective, co-stimulatory CD28 bispecific antibodies."

Key Highlights from the Abstract

The accepted abstract with data from the study is available through the ASH (Free ASH Whitepaper) website. Updated results will be shared at the ASH (Free ASH Whitepaper) Annual Meeting.

At data cut off on July 1, 2021, 80 patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) had received doses of plamotamab. Patients had a median age of 62 years, a median of 4 prior therapies and had been diagnosed a median of 28 months prior to treatment. The study was originally designed in two parts: Part A to establish an initial priming dose with fixed, weight-based dosing regimens and Part B to escalate dosing on administrations subsequent to the priming dose. A third part, Part C, was added to establish a step-up dosing regimen with higher, flat and less frequent, every other week, dosing.

The most common treatment-related adverse event was cytokine release syndrome (CRS), which occurred in 62.5% (50/80) of patients, with 5.0% (4/80) experiencing Grade 3 or 4 events. CRS was generally manageable with premedication. No related neurotoxicity Grade 2 or higher was observed.

The efficacy analysis included 53 evaluable patients who were treated at doses between 80 and 360 mcg/kg (n=45) or at flat doses of 50 mg (n=8). The overall response rate (ORR) was 38.2% (13/34) in patients with diffuse large B-cell lymphoma. The ORR was 80% (8/10) for patients with follicular lymphoma. The median duration of response was 57 days.

After the implementation of higher doses in the flat-dosing regimen, the ORR among all patients with NHL had improved to 50% (4/8) from 42.2% (19/45) in prior weight-based dosing cohorts. At data cut off, the median duration of response was 19.5+ days, with three of four patients continuing to respond to plamotamab monotherapy.

The ORR for patients with prior CAR-T therapy was 25% (4/16).

Presentation Details

Abstract 2494, "Safety and Anti-Tumor Activity of Plamotamab (XmAb13676), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Subjects with Relapsed/Refractory Non-Hodgkin’s Lymphoma"
Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster II
Date & Time: Sunday, December 12, 2021. 6:00 – 8:00 p.m. EST
Location: Georgia World Congress Center, Hall B5
About Plamotamab

Plamotamab is an investigational tumor-targeted XmAb bispecific antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3). CD20 is highly expressed across a range of B-cell tumors, including non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Engagement of CD3 by plamotamab activates T cells for highly potent and targeted killing of CD20-expressing tumor cells.

Plamotamab is currently being evaluated in a Phase 1 clinical study for the treatment of patients with CD20-expressing hematologic malignancies, including NHL and CLL. Preliminary safety and anti-tumor activity from the Phase 1 study indicated that plamotamab was generally well tolerated and demonstrated encouraging clinical activity as a monotherapy.

On November 4, 2021 Catamaran Bio, Inc., a biotechnology company developing off-the-shelf CAR-NK cell therapies to treat cancer, reported that it has designated CAT-179, a HER2-targeted CAR-NK cell therapy, and CAT-248, a CD70-targeted CAR-NK cell therapy, as its first preclinical development programs (Press release, Catamaran Bio, NOV 4, 2021, View Source [SID1234594524]). The company also announced that data supporting the CAT-248 program will be presented during a poster session at the 63rd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) which will be held virtually and in person in Atlanta from December 11-14, 2021.

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At ASH (Free ASH Whitepaper), Catamaran will present data demonstrating the successful deployment of its proprietary TAILWIND platform to generate a CAR-NK cell therapy which demonstrates high levels of cytotoxicity against various tumor cell lines. Catamaran’s TAILWIND platform provides an integrated CAR-NK solution that includes technology to overcome the immunosuppressive tumor microenvironment, CAR architectures optimized for NK cells, and non-viral transposon engineering for efficient manufacturing of CAR-NK cell therapies. The ASH (Free ASH Whitepaper) presentation will focus on preclinical data supporting CAT‑248, Catamaran’s allogeneic CAR-NK cell therapy directed against CD70, a tumor antigen that is highly expressed on certain types of cancers, including renal cell carcinoma, pancreatic cancer, and acute myeloid leukemia. This work is a collaboration between Catamaran and the lab of Dr. Branden Moriarity, scientific co-founder of Catamaran and Associate Professor in the Department of Pediatrics, Division of Hematology/Oncology at the University of Minnesota Medical School.

"The unveiling of our initial two development programs demonstrates Catamaran’s rapid progress toward delivering off-the-shelf CAR‑NK cell therapies capable of reaching solid tumors," said Alvin Shih, MD, Chief Executive Officer of Catamaran Bio. "The new preclinical data we will be presenting at ASH (Free ASH Whitepaper) demonstrate the viability and potential of our TAILWIND platform to enable a leading-edge solution for skillfully designing and efficiently manufacturing CAR-NK cell therapies for the treatment of cancer. We are excited to continue advancing our lead programs toward the clinic, as we seek to extend the transformative potential of cell therapy to patients with solid tumors."

The details of Catamaran’s presentation at ASH (Free ASH Whitepaper) 2021 are as follows:

Title: Engineering CD70-Directed CAR-NK Cells for the Treatment of Hematological and Solid Malignancies
Poster session: Abstract 1691, Session 703, Cellular Immunotherapies: Basic and Translational
Date and time: Saturday, December 11, 2021, from 5:30 – 7:30 p.m. ET
Location: Hall B5 at Georgia World Congress Center and via virtual meeting registration
Presenters: Eugene Choi (Principal Scientist, Catamaran Bio) and Celeste Richardson (SVP Research, Catamaran Bio)