On November 6, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune diseases, asthma and allergic diseases, reported that initial data from its ongoing Phase 1 dose-escalation study of XmAb13676, a CD20 x CD3 bispecific antibody, in patients with B-cell malignancies will be presented in a poster session during the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Orlando, Florida on Monday, December 9, 2019 (Press release, Xencor, NOV 6, 2019, View Source [SID1234550532]).

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"Initial results from dose-escalation cohorts demonstrate encouraging clinical activity in heavily pretreated patients with several subtypes of non-Hodgkin lymphoma, as well as chronic lymphocytic leukemia. The most common treatment-related adverse event has been fever. Cytokine release syndrome, the second most common adverse event, has been generally manageable with premedication," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor.

Key Highlights from the Abstract

The abstract with accepted data from the study are 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 June 28, 2019, 36 patients with relapsed/refractory non-Hodgkin’s lymphoma (r/r NHL) and 8 patients with relapsed/refractory chronic lymphocytic leukemia (r/r CLL) had received XmAb13676. The study was designed in two parts: Part A to establish an initial priming dose and Part B to escalate dosing on subsequent administration. Prophylactic treatment for cytokine release syndrome (CRS) was mandated prior to each administration of XmAb13676.
Patients with r/r NHL (n=36) had a median age of 61.5 years, a median of 3.5 prior therapies and had been diagnosed a median of 24.6 months prior to treatment. In the efficacy evaluable population and at doses ranging from 80 to 125 mcg/kg, objective responses were observed in 33% of patients (n=6/18), including 42% of DLBCL patients (n=5/12). CRS occurred in 42% of patients (n=15/36), and one patient receiving an initial dose of 125 mcg/kg experienced Grade 4 CRS. A priming dose of 45 mcg/kg was chosen for Part B.
Patients with r/r CLL (n=8) had a median age of 76 years, a median of 4.5 prior therapies and had been diagnosed a median of 76.1 months prior to treatment. There was one complete response (Richter transformation) in five patients treated at the 20 mcg/kg dose level, the highest dose administered in the ongoing Part A of the study. CRS occurred in 25% of patients (n=2/8), and one patient experienced Grade 3 CRS.
Presentation Details

Abstract: 4079
Title: Preliminary Safety and Anti-tumor Activity of XmAb13676, an Anti-CD20 x Anti-CD3 Bispecific Antibody in Patients with Relapsed/Refractory Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia
Presenter: Krish Patel, M.D., Director of the Lymphoma Program at Swedish Cancer Institute
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster III
Date & Time: Monday, December 9, 2019, 6:00 p.m. – 8:00 p.m. EST
Location: Orange County Convention Center, Hall B
About XmAb13676

XmAb13676 is a tumor-targeted antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3) in a Phase 1 clinical trial for the treatment of B-cell malignancies. An XmAb bispecific Fc domain serves as the scaffold for these two antigen binding domains and confers long circulating half-life, stability and ease of manufacture on XmAb13676. CD20 is highly expressed on B-cell tumors, including in chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). Engagement of CD3 by XmAb13676 activates T cells for highly potent and targeted killing of CD20-expressing tumor cells.

On November 6, 2019 MaaT Pharma reported that a poster will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting with initial data on it’s lead microbiome restoration biotherapeutic, MaaT013, as a treatment in patients with gastrointestinal-predominant, Steroid-Refractory and Steroid-Dependent acute Graft-versus-Host-Disease (GI aGvHD) following allogeneic Hematopoietic Stem-Cell Transplantation (allo-HSCT) (Press release, MaaT Pharma, NOV 6, 2019, View Source [SID1234550531]). MaaT Pharma provided the product as a pharmaceutical preparation to hospitals as part of its compassionate use program for patients who had previously received and failed up to five previous systemic treatments for GvHD. MaaT013 is an enema formulation of a microbiota biotherapeutic characterized by a high diversity and consistent richness of microbial species derived from pooled healthy donors. The product is manufactured at the company’s centralized European cGMP production facility using its proprietary microbiome restoration biotherapeutic platform. The poster will be presented during the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Orlando, Florida from December 7 – 10, 2019. The poster abstract was published in the online meeting program on November 6, 2019 at 9:00 AM EDT and also in the online November supplemental issue of the journal Blood.

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Poster Presentation details:

Title: Successful and Safe Treatment of Intestinal Graft-Versus-Host Disease (GvHD) with Pooled-Donor Full Ecosystem Microbiota Biotherapeutics
Abstract No: 1993
Session Name: 722. Clinical Allogeneic Transplantation: Acute and Chronic GvHD, Immune Reconstitution: Poster I
Date/Time: Saturday, December 7, 2019 / 5:30 PM – 7:30 PM EDT
Location: Orange County Convention Center, Hall B

MaaT Pharma will announce the results through a press release following the presentation and will further make the poster available on the company website under "News".

In addition to the compassionate use program, MaaT Pharma is currently investigating MaaT013 in a Phase II clinical trial in acute SR GI GvHD patients (NCT03359980). The study, named HERACLES, is a multi-center, single-arm, open-label study, enrolling 32 patients to evaluate the safety and efficacy of MaaT013 in steroid-resistant, gastrointestinal-predominant aGvHD (SR GI aGvHD) patients. Acute GvHD is a serious, often fatal syndrome typically involving the gut, skin and liver. MaaT Pharma has established the most complete approach to restoring patient-microbiome symbiosis in the gut to improve efficacy of cancer treatments and survival outcomes in life-threatening diseases. The company announced in June this year the completion of a third positive safety assessment of MaaT013 in the Phase II trial by an independent Data and Safety Monitoring Board (DSMB). MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

On November 6, 2019 Celularity, Inc., a clinical-stage cell therapeutics company developing allogeneic cellular therapies harnessed from human placentas, reported it will present data supporting its allogeneic, off-the-shelf, placental derived cell therapy programs at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, taking place December 7-10 at the Orange County Convention Center in Orlando, Florida (Press release, Celularity, NOV 6, 2019, View Source [SID1234550530]).

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"We believe the placenta is nature’s cell factory, and the data being presented at ASH (Free ASH Whitepaper) will illustrate the potential of our investigational placental derived NK- and T cell-based allogeneic cell therapy programs in oncology," said Robert J. Hariri, M.D., Ph.D., Founder, Chairman and CEO at Celularity. "We look forward to advancing Celularity’s leading-edge technologies that harness the placenta’s unique immunologic and pro-regenerative biology to produce therapeutic solutions targeting unmet healthcare needs globally."

ASH abstracts are now available at View Source

Details for the 2019 ASH (Free ASH Whitepaper) poster presentations are as follows:

Title: Development of CD38 CAR Engineered Human Placental Hematopoietic Stem Cell Derived Natural Killer Cells (PNK-CAR38) As Allogeneic Cancer Immunotherapy
Date: Saturday, December 7, 2019

Title: Engineering High Affinity and Cleavage Resistant CD16 to Augment ADCC of Placental Hematopoietic Stem Cells-Derived Natural Killer Cells
Date: Saturday, December 7, 2019

Title: Preclinical Evaluation of Human Placental-Derived Allogeneic CD19 CAR-T Cells Against B Cell Malignancies
Date: Sunday, December 8, 2019

Title: Results of a Phase I Study of PNK-007, Allogeneic, Off the Shelf NK Cell, Post Autologous Transplant in Multiple Myeloma (NCT02955550)
Date: Monday, December 9, 2019

Title: Immune Monitoring of CD34+ Placental Cell Derived Natural Killer Cell Therapy (PNK-007) in Phase I Study of Multiple Myeloma
Date: Monday, December 9, 2019

About PNK-007
PNK‐007 is the only allogeneic, off-the-shelf NK cell therapy being developed from placental hematopoietic stem cells as a potential treatment option for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. When derived from the placenta, these cells offer intrinsic safety and versatility, allowing potential use across a range of organs and tissues. PNK cells are currently being investigated as a treatment for acute myeloid leukemia (AML) and multiple myeloma (MM).

About CYNK-001
CYNK-001, a cryopreserved formulation of PNK-007 cells, is the only cryopreserved, off-the-shelf NK cell therapy being developed from placental hematopoietic stem cells as a potential treatment option for various hematologic cancers and solid tumors.

On November 6, 2019 Promega Corporation reported it has entered into a global collaboration with Merck, known as MSD outside the United States and Canada, to develop Promega’s microsatellite instability (MSI) technology as an on-label, solid tumor companion diagnostic (CDx) for use with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) (Press release, Promega, NOV 6, 2019, View Source [SID1234550529]). The global collaboration will initially seek regulatory approval for the Promega MSI CDx in the United States and China. Plans to seek approvals in additional territories may follow.

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"It is gratifying to see our MSI technology have such meaning within the oncology community," said Bill Linton, president and CEO, Promega Corporation. "Promega developed this technology well over a decade ago and our long-term commitment to R&D helped evolve its use."

Promega MSI technology has been validated in labs around the world to characterize solid tumor MSI status. MSI testing functionally measures the genomic accumulation of insertion or deletion (INDEL) errors caused by a deficient mismatch-repair system (dMMR) that occurs in certain types of solid tumors, and this screening may be used to better characterize tumors and guide therapeutic choices for MSI-High cancer types. Tumors with MSI-High status have been shown to respond to immune checkpoint inhibitor (ICI) therapies. This outcome may be explained by MSI-driven tumor expression of mutation-associated neoantigens (MANA) that are believed to cause immune cell infiltration into the tumor microenvironment. Tumor induced inhibition of immune cell activity can be overcome with ICI therapies, allowing for tumor cell destruction by the immune cells.

"Unlike other DNA-based molecular screening options, Promega MSI technology uses five monomorphic mononucleotides, which is recommended by the National Cancer Institute," said Jeff Bacher, Ph.D., senior research scientist, Promega Corporation. "Our test uses a sensitive and specific panel of markers for detection of MSI status and offers valuable insight to help inform physicians on how best to treat patients with cancer including those likely to benefit from immune checkpoint inhibitor treatment."

Promega MSI technology is one of the leading standard tests for MSI status detection in research laboratories and recently achieved innovation status and priority review by the National Medical Products Administration (NMPA) in China. It has been used extensively in clinical research for more than 15 years and is supported by more than 140 peer-reviewed publications. Promega continues to advance the promise of MSI technology globally. In addition to the Merck collaboration announcement, Promega intends to seek regulatory clearance for an MSI in vitro diagnostic (IVD) test in the United States, China and Europe. These products are intended to launch in the first half of 2020 in the United States, China and Europe.

To learn more about microsatellite instability, visit: www.promega.com/ExploreMSI.

To request more information regarding the details of the announcement, visit: www.promega.com/msiCDx.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About Promega MSI Technology

The Promega technology is a PCR-based method for detecting MSI, a form of genomic instability caused by insertion or deletion of additional bases into DNA microsatellites, regions of repeating bases distributed throughout the human genome. During DNA replication, failure of the mismatch repair system to correct these errors causes MSI. MSI status is a measure of dMMR found in certain solid tumors, providing oncologists, pathologists and patients with information that characterizes tumors and can guide care and treatment. The current Promega Research Use Only MSI assay has been available and used in the market as part of Lab-Developed Tests since 2004.

On November 6, 2019 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported financial results for the three and nine months ended September 30, 2019 (Press release, Odonate Therapeutics, NOV 6, 2019, View Source [SID1234550528]).

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As of September 30, 2019, Odonate had $204.2 million in cash, compared to $139.1 million as of December 31, 2018. This increase in cash resulted primarily from the receipt of $135.1 million of net proceeds from Odonate’s June 2019 underwritten public offering, less net cash used in operating activities of $72.1 million. Odonate’s net loss for the three and nine months ended September 30, 2019 was $26.6 million and $84.0 million, or $0.88 and $3.15 per share, respectively, compared to $23.9 million and $60.2 million, or $0.98 and $2.47 per share, respectively, for the same periods in 2018.

"We are pleased to have recently announced the completion of enrollment in CONTESSA, Odonate’s Phase 3 study investigating tesetaxel as a potential treatment for patients with metastatic breast cancer," said Kevin Tang, Chief Executive Officer of Odonate. "We expect to report top-line results from CONTESSA in the third quarter of 2020."

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. Tesetaxel currently is the subject of three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with metastatic breast cancer, known as CONTESSA.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). CONTESSA’s secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC.

About CONTESSA 2

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA 2 is investigating tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 125 patients with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC not previously treated with a taxane. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are duration of response (DoR) as assessed by the IRC, progression-free survival (PFS) as assessed by the IRC, disease control rate (DCR) as assessed by the IRC and overall survival (OS).

About CONTESSA TRIO

CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). In Cohort 1, approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus either: (1) nivolumab at 360 mg by intravenous infusion on the first day of each 21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by intravenous infusion on the first day of each 21-day cycle. Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. One of these agents, atezolizumab, in combination with the intravenously delivered taxane, nab-paclitaxel, was recently approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with metastatic TNBC. The dual primary endpoints for Cohort 1 are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include duration of response (DoR) and overall survival (OS). Efficacy results for each of the three PD-(L)1 inhibitor combinations will be assessed for correlation with the results of each of the three approved PD-L1 diagnostic assays. In Cohort 2, approximately 40 elderly patients (with potential expansion to up to 60 patients) with human epidermal growth factor receptor 2 (HER2) negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m2 on the first day of each 21-day cycle. The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS. Patients with central nervous system (CNS) metastases are eligible for both cohorts.