On December 4, 2018 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported updated interim results from the Company’s ongoing Phase 2a study of cerdulatinib, an investigational, oral Syk/JAK inhibitor, in patients with specific subtypes of T-cell Non-Hodgkin Lymphoma, including relapsed/refractory peripheral T-cell lymphoma (PTCL); angioimmunoblastic T-cell lymphoma (AITL), a subset of PTCL; and cutaneous T-cell lymphoma (CTCL) (Press release, Portola Pharmaceuticals, DEC 4, 2018, View Source;p=RssLanding&cat=news&id=2379193 [SID1234531875]). The data will be presented today during an oral session at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego (December 1-4).

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As of the November 1, 2018 cut-off date, 41 PTCL patients and 27 CTCL patients were evaluable for response. The objective response rate (ORR) was 34 percent in the PTCL cohort and 26 percent in the CTCL cohort. Among the subset of patients in the PTCL cohort with AITL, the ORR was 57 percent.

PTCL Cohort Data

Eleven of 41 patients (27 percent) achieved a complete response (CR), and three patients (7 percent) achieved a partial response (PR).
In the subgroup of 14 patients with AITL, seven patients (50 percent) achieved a CR and one patient (7 percent) achieved a PR.
One patient who achieved a CR went on to transplant.
Eight responding patients have remained on drug for three to more than 12 months and five patients have had a duration of response of six months or greater. Follow-up is ongoing.
CTCL Cohort Data

In the CTCL cohort, two patients (7 percent) achieved a CR and five patients (19 percent) achieved a PR. Responses have been seen in patients with Mycosis Fungoides and Sezary Syndrome.
Eleven of 23 patients (48 percent) achieved a ≥ 50 percent reduction in skin lesions, based on the Modified Severity Weighted Assessment Tool (mSWAT).
Rapid improvements in pruritus, or severe itching – a common and often serious condition associated with CTCL – have been observed, as measured by the Likert scale.
The CTCL cohort continues to enroll and data analysis is ongoing.
Cerdulatinib has demonstrated tolerability in both PTCL and CTCL. The most common grade 3 or greater adverse events across the PTCL and CTCL cohorts with a frequency > 5 percent were lipase increase (23 percent), amylase increase (18 percent), sepsis/bacteremia (8 percent), and neutropenia, pneumonia/lung infection and diarrhea (7 percent each). These events are manageable and further accrual is ongoing.

"The ongoing Phase 2a cerdulatinib data continue to demonstrate meaningful clinical activity, with particularly compelling complete response rates among AITL patients and the potential for durable response among patients with PTCL and CTCL," said Steven M. Horwitz, M.D., Memorial Sloan Kettering Center, and study investigator. "Like many others with T-cell malignancies, the patients in this study have failed prior therapies and are in need of additional treatment options. It is encouraging to see such a strong early signal in both disease response and quality-of-life measures, such as itching."

"While still early, the continuing and durable response rates in PTCL and the encouraging responses in CTCL underscore the potential of cerdulatinib to control relapsed/refractory T-cell malignancies," said John Curnutte, M.D., Ph.D., executive vice president and head of research and development at Portola. "We will apply our learnings from this study to inform the design of a pivotal trial, and look forward to continuing discussions with the U.S. Food and Drug Administration about the potential for an accelerated approval pathway for cerdulatinib in PTCL."

ASH Oral Session Details – Monday, December 3, 2018 at 7:15 p.m. PST

Title: 1001. The Novel Syk/JAK Inhibitor Cerdulatinib Demonstrates Good Tolerability
and Clinical Response in a Phase 2a Study in Relapsed/Refractory Peripheral
T-Cell Lymphoma and Cutaneous T-Cell Lymphoma

Session: 624 (Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: T Cell
Lymphoma: Chemotherapy and Targeted Approaches)

Presenter: Steven M. Horwitz, M.D., Memorial Sloan-Kettering Cancer Center

Session Time: 6:15 – 7:45 p.m. PST; Room 6F

About Cerdulatinib
Cerdulatinib is an investigational oral, dual spleen tyrosine kinase (Syk) and janus kinase (JAK) inhibitor that uniquely inhibits two key cell signaling pathways implicated in certain hematologic malignancies and autoimmune diseases. There is a strong rationale for inhibiting both Syk (B-cell receptor pathway) and JAK (cytokine receptors) in B-cell malignancies where both targets have been shown to promote cancer cell growth and survival. In addition, pre-clinical data suggest an important role for Syk and JAK in PTCL tumor survival.

The U.S. Food and Drug Administration granted cerdulatinib Orphan Drug Designation for the treatment of PTCL in September 2018.

On December 4, 2018 Amgen (NASDAQ:AMGN) reported the first clinical results from studies evaluating investigational novel bispecific T cell engager (BiTE) immunotherapies AMG 420 and AMG 330 (Press release, Amgen, DEC 4, 2018, View Source;p=RssLanding&cat=news&id=2379192 [SID1234531859]). In two separate Phase 1 dose escalation studies, AMG 420, which targets B-cell maturation antigen (BCMA), and AMG 330, which targets CD33, provided early evidence of tolerability and anti-tumor activity in patients with relapsed and/or refractory multiple myeloma and relapsed or refractory acute myeloid leukemia (AML), respectively. These data were highlighted during oral presentations at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in San Diego.

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BiTE antibody construct technology, pioneered by Amgen, is an innovative treatment approach that helps the body’s immune system attack cancer cells without the removal of immune cells from the patient. Amgen is studying a number of "off-the-shelf" investigational BiTE immunotherapies, with distinct targets, across a range of hematologic and solid tumors.

"Building on our success with the only approved BiTE immunotherapy available for patients, Amgen is emphasizing our commitment to the potential of this platform by advancing the development of approximately a dozen novel molecules across hematologic and solid tumor targets in hopes of continuing to offer meaningful advances to patients in need," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We’re encouraged by the early results of investigational BiTE immunotherapies AMG 420 and AMG 330, especially when considered in the context of these heavily pre-treated patients, many of whom have run out of available options. We look forward to sharing more results from our BiTE pipeline at future medical meetings."

ASH Abstract #1010: Treatment with AMG 420, an anti-B-Cell Maturation Antigen (BCMA) Bispecific T-cell Engager (BiTE) Antibody Construct, Induces Minimal Residual Disease (MRD) Negative Complete Responses in Relapsed and/or Refractory (R/R) Multiple Myeloma (MM) Patients: Results of a First-in-Human (FIH) Phase 1 Dose Escalation Study

The data shared at ASH (Free ASH Whitepaper) were the first presentation of all endpoints from this Phase 1 dose-escalation trial of AMG 420 in patients with relapsed and/or refractory multiple myeloma. The objectives of the study included assessment of safety, tolerability and anti-tumor activity of AMG 420 per International Myeloma Working Group 2006 Uniform Response Criteria for Multiple Myeloma.

In the study, 42 patients with relapsed and/or refractory multiple myeloma who had progression after at least two prior lines of treatment (including a proteasome inhibitor and an immunomodulatory imide drug) received AMG 420 at varying doses [0.2 to 800 µg/day (d)]. AMG 420 induced clinical responses in 13 patients, including complete responses (CR) in seven patients. Four patients treated at the 400 µg/d dose achieved minimal residual disease (MRD) negative complete responses, meaning that no cancer cells were detectable in the bone marrow. The objective response rate at 400 µg/d was 70 percent (seven of 10 patients), with six patients still responding up to 7.5 months. One dose-limiting toxicity was observed up to the 400 µg/d dose (peripheral polyneuropathy, which improved to baseline after intravenous immunoglobulin and corticosteroid treatment).

Of those patients with serious adverse events (AEs) (n=20, 48 percent), 17 required hospitalization and four had prolonged hospitalization. Serious AEs included infections (n=12), peripheral polyneuropathy (n=2), and one each of liver failure, cardiac failure, edema, biliary obstruction, spinal cord compression, renal failure and weight loss. Treatment-related serious AEs included polyneuropathy (n=2, both grade 3) and edema (n=1, grade 3). Cytokine release syndrome (CRS) was seen in 16 patients (grade 1, n=13; grade 2, n=2; grade 3, n=1). In this study, 800 µg/d was determined to not be tolerable, as two out of the three patients treated at this dose experienced dose-limiting toxicities.

Two patients died during the course of the study from AEs not considered treatment-related. One patient died after the first cycle of treatment from acute respiratory distress due to concurrent flu and aspergillosis. The second patient died from liver failure secondary to a viral infection during the course of treatment.

"These first-in-human data of a BCMA-targeting BiTE immunotherapy showed encouraging evidence of AMG 420 activity, with no major toxicities up to the 400 µg/d dose in patients with relapsed and/or refractory multiple myeloma who received a median of four prior therapies," said Max S. Topp, M.D., professor, Hospital of Wuerzburg, Germany and AMG 420 clinical study investigator. "Despite recent treatment advances, multiple myeloma continues to be a disease characterized by cycles of relapse and recurrence requiring additional therapies to help control the disease."

Additionally, AMG 420 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.

ASH Abstract #25: A Phase 1 First-in-Human Study of AMG 330, an Anti-CD33 Bispecific T-cell Engager (BiTE) Antibody Construct, in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

In a separate first-in-human Phase 1 dose escalation study, 40 patients with relapsed or refractory AML were enrolled to receive AMG 330 in 12 dose cohorts with a target dose range of 0.5 to 480 µg/d. The study objectives were to evaluate the safety, pharmacokinetics and pharmacodynamics of AMG 330 and to estimate the maximum tolerated dose. Results showed that two patients in the trial achieved a CR at the 240 µg/d dose and two patients achieved a CR with incomplete blood count recovery, one at the 240 µg/d dose and one at the 120 μg/d dose. The CRs were not sustained beyond one cycle of treatment.

Patients in the trial received a median of one (range: 1-6) cycle with AMG 330; the majority of patients discontinued treatment for disease progression. Other reasons for study discontinuation included AEs (n=6, 2 treatment-related) and patient request (n=2).

Serious AEs were seen in 73 percent of patients (treatment-related in 17 patients). The most common serious AEs seen in more than one patient included CRS (n=11), febrile neutropenia (n=7), pneumonia (n=4), leukopenia (n=4), pyrexia (n=3), thrombocytopenia (n=3) and subdural hematoma (n=2). One patient died on study due to AML progression and one due to intracranial hemorrhage (neither treatment-related). There were dose-limiting toxicities of grade 2 CRS and grade 4 ventricular fibrillation with a target dose of 480 μg/d administered as a single-step regimen.

"The majority of adult AML patients will not be cured with standard chemotherapy, underscoring the need for innovative treatment options for those who have relapsed or are refractory to currently available treatments1," said Farhad Ravandi, M.D., Janiece and Stephen A. Lasher professor of medicine and chief of section of Developmental Therapeutics in the Department of Leukemia at the University of Texas – MD Anderson Cancer Center and AMG 330 clinical study investigator. "These early data are encouraging as they indicate AMG 330 may have anti-leukemic activity in heavily pretreated patients with relapsed or refractory AML, validating the need for continued evaluation of the BiTE platform in targeting CD33."

About BiTE Technology
Bispecific T cell engager (BiTE) antibody construct is an innovative technology that can be engineered to target any tumor antigen expressed by any type of cancer. The protein molecules are designed to kill malignant cells using the patient’s own immune system by bridging T cells to tumor cells. BiTE antibody construct helps connect the T cells to the targeted cell, with the intent of causing T cells to inject toxins which trigger cancer cell death (apoptosis). Amgen is developing BiTE antibody constructs to uniquely (or specifically) target numerous hematologic malignancies and solid tumors.

On December 4, 2018 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported new preclinical data on the Company’s induced pluripotent stem cell (iPSC) product platform and its iPSC-derived, off-the-shelf cell-based cancer immunotherapy pipeline at the 60thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Fate Therapeutics, DEC 4, 2018, View Source [SID1234531876]). Last week, the Company announced that the U.S. Food and Drug Administration (FDA) allowed its Investigational New Drug (IND) Application for FT500, the Company’s universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master iPSC line. The clinical trial of FT500 is expected to be the first-ever clinical investigation in the U.S. of an iPSC-derived cell product.

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"Fate Therapeutics is at the forefront in developing off-the-shelf, cell-based cancer immunotherapies, and is rapidly progressing multiple iPSC-derived CAR T- and NK cell product candidates that have the potential to disrupt autologous and allogeneic approaches to cell therapy," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "The clearance of our FT500 IND by the FDA is a landmark achievement and serves as a roadmap for advancement of our iPSC-derived cell product pipeline into clinical development. We believe the use of clonal master iPSC lines uniquely enables the production of multi-functional, cell-based cancer immunotherapies that are uniformly engineered, are available for off-the-shelf administration to patients and can be effectively combined in multi-dose, multi-cycle regimens with well-established immune-oncology agents, such as checkpoint inhibitor blockade and monoclonal antibody therapy, including in earlier lines of therapy."

Several of the Company’s iPSC-derived cell product candidates undergoing development were discussed during an investor event at ASH (Free ASH Whitepaper) by its collaborating experts in the field of cell-based cancer immunotherapy including:

Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering & Gene Transfer and Gene Expression Laboratory, Memorial Sloan Kettering Cancer Center;

Jeffrey S. Miller, M.D., Deputy Director, Masonic Cancer Center, University of Minnesota; and

Dan S. Kaufman, M.D., Ph.D., Professor of Medicine, Division of Regenerative Medicine, Director of Cell Therapy, University of California – San Diego.
FT500
The clinical trial of FT500 is intended to evaluate the safety and tolerability of multiple doses of FT500, in multiple dosing cycles with nivolumab, pembrolizumab or atezolizumab, in subjects that have progressed or failed on immune checkpoint blockade (CPB) therapy. Although CPB therapy can lead to prolonged responses, refractory disease and progression after initial response remain major causes of mortality. In patients receiving CPB therapy, mutations in beta-2-microglobulin (B2M), an essential component for the stable presentation of antigens by tumor cells, have been identified in approximately 30% of patients with progressing disease and are associated with poor overall survival. Investigators have demonstrated in various tumor model systems that NK cells have the potential to rescue CPB therapy by recognizing and killing B2M-deficient target cells. An oral presentation at ASH (Free ASH Whitepaper) by Dr. Miller showed that FT500 synergizes with T cells and anti-PD1 antibody to produce pro-inflammatory cytokines and completely clear target cancer cells in an in vitro three-dimensional tumor spheroid model.

FT516
FT516 is a universal, off-the-shelf NK cell product candidate manufactured from a clonal master iPSC line engineered to uniformly express a high-affinity, non-cleavable CD16 (hnCD16) Fc receptor. Since CD16 binds the Fc region of tumor-bound antibodies, FT516 can be combined with FDA-approved monoclonal antibody therapies to target a broad spectrum of tumor-associated antigens. In preclinical studies, FT516 exhibits potent and persistent anti-tumor activity in vitro and in vivo against multiple tumor types, including in combination with monoclonal antibody therapies that target CD20, HER2 and EGFR. The Company plans to submit an IND to the FDA by the end of 2018 to evaluate the safety and tolerability of multiple doses of FT516 in multiple dosing cycles in combination with FDA-approved monoclonal antibody therapy.

FT596
FT596 is a universal, off-the-shelf chimeric antigen receptor (CAR) NK cell product candidate that expresses a proprietary CAR targeting CD19, a novel IL-15 receptor fusion for cytokine-independent persistence, and a hnCD16 Fc receptor for augmented antibody-dependent cellular-cytotoxicity (ADCC). A poster presentation at ASH (Free ASH Whitepaper) by scientists from the Company and the University of California – San Diego highlighted new in vivo data demonstrating that FT596 displays long-term persistence without systemic cytokine support. Additionally, FT596 prevents tumor progression and promotes sustained long-term survival in a B-cell leukemia xenograft model. Moreover, as proof-of-concept for the mitigation of antigen escape, FT596 in combination with rituximab completely eliminates CD19+ and CD19- B-cell tumor cells in a co-culture cytotoxicity assay.

FT538
FT538 is a universal, off-the-shelf NK cell product candidate that expresses both a novel IL-15 receptor fusion for cytokine-independent persistence and a hnCD16 Fc receptor for augmented ADCC, and additionally lacks CD38 expression to eliminate fratricide when combined with CD38-targeting monoclonal antibody therapy. A poster presentation at ASH (Free ASH Whitepaper) by scientists from the Company and the University of Minnesota highlighted new in vitro data showing that FT538 in combination with daratumumab is resistant to fratricide and eliminates multiple myeloma cancer cells in a serial re-challenge assay. The Company is investigating the additional therapeutic benefit of including a novel humanized CAR targeting B-cell Maturation Antigen (BCMA) as a dual-targeting mechanism to address multiple myeloma and other BCMA-positive malignancies.

FT819
FT819 is an off-the-shelf, TCR-less CD19 CAR T-cell product candidate manufactured from a clonal master iPSC line that is undergoing preclinical development under a collaboration with Memorial Sloan Kettering Cancer Center (MSK) led by Dr. Sadelain. FT819 is engineered to completely eliminate expression of the T-cell receptor and to insert a next-generation CAR receptor into the T-cell receptor alpha locus, a strategy which is intended to convey enhanced safety and efficacy while eliminating the possibility of graft-versus-host disease. A poster presentation at ASH (Free ASH Whitepaper) by scientists from the Company and MSK showcased new in vivo data demonstrating that FT819, when thawed and directly infused, effectively controls tumor progression comparable to peripheral blood CAR T cells in a preclinical mouse model of acute lymphoblastic leukemia.

A copy of the Company’s presentation from its ASH (Free ASH Whitepaper) investor event can be accessed under "Events & Presentations" in the Investors & Media section of the Company’s website at www.fatetherapeutics.com.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary iPSC product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered in repeat doses to mediate more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event, and selecting a single iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf to treat many patients. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 100 issued patents and 100 pending patent applications.

On December 4, 2018 Cofactor Genomics, a clinical RNA sequencing and translational assay developer, reported a pilot study to evaluate use of Cofactor’s ImmunoPrismTM assay in Genocea Biosciences’ Phase 1/2a clinical trial testing the safety and efficacy of its lead personalized cancer vaccine candidate, GEN-009, in adult cancer patients with a variety of solid tumors (Press release, Cofactor Genomics, DEC 4, 2018, View Source [SID1234531892]).

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The pilot study is designed to enable Genocea to comprehensively characterize the immune responses that patients enrolled in the clinical trial generate in response to vaccination. The RNA-based assay developed by Cofactor should enable Genocea to compare the immune cell composition for 8 major immune types within and between patients, including expression reporting for key immune escape genes.

"We are working to develop truly effective personalized neoantigen vaccines with which to treat cancer patients. Through exploration of advanced technologies like Cofactor’s ImmunoPrism assay, we aim to better understand the intratumoral immune responses we are eliciting in response to our vaccine," said Jessica Baker Flechtner, Ph.D., Chief Scientific Officer at Genocea.

"Pilot studies such as this one, where our technology is implemented in the field to empower drug developers to find the most robust markers of therapeutic success, are extremely important in validating our cutting-edge technology," noted David Messina, Chief Operating Officer at Cofactor Genomics. "Demonstrating the utility of a new approach to immune profiling is best accomplished with partners like Genocea, who are eager to gain access to the most innovative and advanced assays."

Cofactor Genomics recently announced the release of their ImmunoPrism Immune Profiling Kit, which enables access to their proprietary molecular and machine-learning informatics for RNA analysis of the tumor microenvironment. The ImmunoPrism kit offers laboratories the ability to validate the assay, as Cofactor has done through their CAP-accredited laboratory.

Cofactor will present the results of this clinical validation work during an upcoming webinar titled, "Clinical Validation of a Multidimensional Pan-Cancer Immune Assay" on Thursday, December 13 at 11 AM EST: View Source

On December 4, 2018 GlycoMimetics, Inc. (NASDAQ: GLYC) reported at the 60thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting yesterday two posters with preclinical data presentations: on GMI-1687, the company’s highly potent E-selectin antagonist that is bioavailable via subcutaneous administration, and GMI-1757, the company’s dual-function E-selectin/galectin-3 antagonist (Press release, GlycoMimetics, DEC 4, 2018, View Source [SID1234531877]).

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"The new preclinical data presented at ASH (Free ASH Whitepaper) underscore GlycoMimetics’ commitment to pioneering advances in the field of glycobiology and to rationally designing innovative drug candidates that address areas of significant unmet medical need," said John Magnani, Ph.D., Senior Vice President and Chief Scientific Officer. "The two compounds, debuted in posters, are currently in preclinical testing. The GMI-1687 poster points to the potential for a life-cycle extension for uproleselan, which is more highly-potent and is subcutaneously bioavailable in animal models. The poster on GMI-1757, a novel galectin-3/E-selectin antagonist, suggests the compound may be able to play a role in the treatment of a variety of cancers and fibrotic conditions."

Details for the two poster presentations on GlycoMimetics’ wholly owned drug candidates follow:

Publication Number: 4678
TITLE: A Novel and Potent Inhibitor of E-Selectin, GMI-1687, Attenuates Thrombus Formation and Augments Chemotherapeutic Intervention of AML in Preclinical Models Following Subcutaneous Administration
Publication Number: 2211
TITLE: A Novel Glycomimetic Compound (GMI-1757) with Dual Functional Antagonism to E-Selectin and Galectin-3 Demonstrates Inhibition of Thrombus Formation in an Inferior Vena Cava Model