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Shasqi to Present Data Updates at Upcoming SITC and CTOS Meetings

On November 4, 2021 Shasqi, a clinical-stage biotechnology company developing precision activated oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPAC) platform, reported upcoming presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting, taking place virtually and in person in Washington, DC, on November 10–14, 2021, and at the Connective Tissue Oncology Society’s (CTOS) Annual Meeting, being held virtually on November 10–13, 2021 (Press release, Shasqi, NOV 4, 2021, View Source [SID1234594531]). Shasqi will present updated data from its Phase 1 clinical study of SQ3370 in patients with advanced solid tumors, and nonclinical data on SQ3370 in combination with cancer immunotherapies.

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"We look forward to these upcoming presentations where we will share the progress of our Phase 1 study, present data on the compatibility of SQ3370 treatment with a local immune response and increases in certain circulating immune cells, and review nonclinical evidence that our click-chemistry approach has additional potential when combined with other cancer therapies," said José M. Mejía Oneto, M.D., Ph.D., Founder and CEO of Shasqi.

SITC Meeting:

Title: Pharmacokinetic and immunologic data from a Phase I study of the click chemistry-based therapy SQ3370 in advanced solid tumors and soft-tissue sarcoma provides proof-of-concept for the CAPAC platform
Presentation number: 367
Date and time: Friday, Nov. 12, 2021, 7 AM – 8:30 PM EST
Presenter: Vivek A. Bhadri, M.D., Ph.D., Medical Oncologist at Chris O’Brien Lifehouse in Australia
Title: Combination of click chemistry-based SQ3370 with immunotherapies enhances antitumor effect in murine tumors with minimized systemic toxicity
Presentation number: 695
Date and time: Friday, Nov. 12, 2021, 7 AM – 8:30 PM EST
Presenter: Amir Mahmoodi, Scientist at Shasqi
CTOS Meeting:

Title: First-in-human trial of SQ3370 in relapsed or refractory soft tissue sarcoma and other solid tumors: proof-of-concept for the click chemistry-based CAPAC platform
Presentation number: P 182
Date and time: Friday, Nov. 12, 2021, 2:30 – 3:15 PM EST
Presenter: Alexander Guminski, M.D., Ph.D., Medical Oncologist at Royal North Shore Hospital in Australia
Title: Click Activated Protodrugs Against Cancer (CAPAC) Platform Enhances Antitumor Efficacy, Safety and Pharmacokinetics of Cancer Therapeutics
Presentation number: P 019
Date and time: Thursday, Nov. 11, 2021, 2:30 – 3:15 PM EST
Presenter: Sangeetha Srinivasan, Ph.D., Associate Director at Shasqi
CAPAC and SQ3370:
SQ3370 utilizes Shasqi’s proprietary CAPAC platform, a click chemistry-based approach that activates cancer drugs at the site of a tumor with decreased systemic toxicity. The investigational product is based on the chemical reaction between an attenuated trans-cyclooctene-modified protodrug and a tetrazine-modified biopolymer. The biopolymer is injected into the target tumor lesion, where it precisely activates an intravenously infused protodrug. Unlike traditional targeted therapies, the CAPAC platform is agnostic to tumor characteristics that can vary from patient to patient, such as biomarker expression and enzymatic activity.

Sierra Oncology Announces Momelotinib Poster Accepted for Presentation at ASH

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]).

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.

MEI Pharma Announces Acceptance of Three Abstracts for Presentation at the 63rd Annual American Society of Hematology Annual Meeting

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]).

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).

Gamida Cell Announces Data to Be Presented at 63rd ASH Annual Meeting

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]).

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.

Xencor to Present Data from the Phase 1 Study of Plamotamab in B-Cell Malignancies at the American Society of Hematology Annual Meeting

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]).

"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.