On November 1, 2018 Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, reported that new translational data for NiCord, an investigational cell therapy in Phase 3 clinical development for allogeneic stem cell, or bone marrow, transplant, will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting, which is being held December 1-4 in San Diego, CA (Press release, Gamida Cell, NOV 1, 2018, View Source [SID1234530653]).

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Details about the poster presentation are as follows:
Presentation Time: Saturday, December 1, 2014, 6:15 p.m. – 8:15 p.m. PT
Title: Rapid and Robust CD4+ and CD8+ T-, NK-, B- and Monocyte Cell Reconstitution after Nicotinamide-Expanded Cord Blood Transplantation
Abstract Number: 2123
Lead Author: Jaap Jan Boelens, M.D., Ph.D., Pediatric Blood and Marrow Transplantation Program, University Medical Center Utrecht, Utrecht, Netherlands
Location: San Diego Convention Center, Hall GH

About NiCord
NiCord, the company’s lead clinical program, is under development as a universal bone marrow transplant solution for patients with high-risk hematologic malignancies. NiCord has demonstrated improved efficacy over standard cord blood, including fewer bacterial and fungal infections and a reduction in duration of hospital stays. NiCord has been granted breakthrough status by the U.S. Food and Drug Administration, making it the first bone marrow transplant alternative to receive this designation. It has also received U.S. and EU orphan drug designation. A Phase 3 study evaluating NiCord in patients with leukemia and lymphoma is ongoing in the United States, Europe and Asia (NCT02730299). For more information on NiCord clinical trials, please visit www.clinicaltrials.gov.

On November 1, 2018 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported that it will present data supporting its allogeneic pipeline program during the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, taking place December 1-4 at the San Diego Convention Center (Press release, Allogene, NOV 1, 2018, View Source [SID1234530652]).

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"ASH is the first significant medical meeting where we will present data on programs led by Allogene," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "Our teams have spent years doing extensive preclinical research across our pipeline and the development of UCART19 with our partner Servier continues to provide insights that inform and accelerate the strategy for ALLO-501 (anti-CD19) in non-Hodgkin lymphoma. This work is important as we look ahead to our first Investigational New Drug (IND) applications for ALLO-501 and ALLO-715 (anti-BCMA) in multiple myeloma in 2019."

The ASH (Free ASH Whitepaper) abstracts are now available at www.hematology.org. The oral and poster presentations will include additional data not available in the abstracts. Details are as follows.

Allogene Oral Presentation

Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Development of Novel Immunotherapeutic Approaches in Multiple Myeloma
Abstract #591
Title: ALLO-715, an Allogeneic BCMA CAR T Therapy Possessing an Off-Switch for the Treatment of Multiple Myeloma
Presenter: Cesar Sommer, Ph.D., Allogene Therapeutics
Session Date & Time: Monday, December 3, 7:00-8:30 a.m. PT
Presentation Time: 7:30 a.m. PT
Location: Ballroom 20D

Allogene Poster Presentation

Session: 703. Adoptive Immunotherapy: Poster II
Abstract #3335
Title: ALLO-819, an Allogeneic Flt3 CAR T Therapy Possessing an Off-Switch for the Treatment of Acute Myeloid Leukemia
Presenter: Cesar Sommer, Ph.D., Allogene Therapeutics
Session Date & Time: Sunday, December 2, 6:00-8:00 p.m. PT
Location: Hall GH

Oral Presentation in Collaboration with Development Partner
UCART19, sponsored by Servier1, is in Phase 1 development for the treatment of relapsed/refractory acute lymphoblastic leukemia (ALL).

Session: 612. Acute Lymphoblastic Leukemia: Clinical
Abstract #896
Title: Preliminary Data on Safety, Cellular Kinetics and Anti-Leukemic Activity of UCART19, an Allogeneic Anti-CD19 CAR T-Cell Product, in a Pool of Adult and Pediatric Patients with High-Risk CD19+ Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
Presenter: Reuben Benjamin, MBBS, MRCP, FRCPath, Ph.D., King’s College Hospital, London
Session Date & Time: Monday, December 3, 4:30-6:00 p.m. PT
Presentation time: 4:45 p.m. PT
Location: Room 6A

UCART19, ALLO-715 and ALLO-819 utilize the TALEN gene-editing technology pioneered and owned by Cellectis.

UCART19, initially developed by Cellectis, is now exclusively licensed to Servier and is under joint clinical development between Servier and Allogene.

ALLO-715 and ALLO-819 were progressed under a joint research collaboration with Cellectis, and are directed at targets that were licensed exclusively from Cellectis. Allogene holds the exclusive global development and commercial rights for these product candidates.

On November 1, 2018 4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 antagonist drugs to improve immune cell trafficking to treat rare disease and cancer, reported that an abstract highlighting X4P-001-RD, the company’s CXCR4 antagonist, has been selected for poster presentation at the 60th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) meeting, taking place Dec. 1-4 in San Diego (Press release, X4 Pharmaceuticals, NOV 1, 2018, View Source [SID1234530651]). The presentation will describe Phase 2 results used to determine the Phase 3 dose in the ongoing Phase 2/3 study of X4P-001-RD in patients with WHIM syndrome, a rare genetic, primary immunodeficiency disease.

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At ASH (Free ASH Whitepaper): X4 Pharmaceuticals to present clinical data used to determine Phase 3 Dose from Phase 2/3 Study of X4P-001-RD in WHIM Syndrome.

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Details of the presentation on X4P-001-RD in WHIM syndrome are as follows:

Title: Determination of Phase 3 Dose for X4P-001 in Patients with WHIM Syndrome

Date & Time: Saturday, December 1, 6:15 PM – 8:15 PM

Location: San Diego Convention Center, Hall GH

Publication #: 1102

Poster Session: 201. Granulocytes, Monocytes, and Macrophages: Poster I

About WHIM Syndrome
WHIM syndrome is a primary immunodeficiency disease caused by genetic mutations in the CXCR4 receptor gene resulting in susceptibility to certain types of infections. WHIM is an abbreviation for the characteristic clinical symptoms of the syndrome: Warts, Hypogammaglobulinemia, Infections, and Myelokathexis. Within the overall category of primary immunodeficiencies, there are between 15,000 and 100,000 patients in the U.S. that are classified with primary immunodeficiency disease of unknown origin – of which WHIM is one.1,2,3 WHIM syndrome is a rare disorder and the precise prevalence or incidence of patients that have the genetic mutation responsible for WHIM syndrome is unknown. Individuals with WHIM syndrome are more susceptible to potentially life-threatening bacterial infections4. Additionally, WHIM syndrome is associated with significant morbidity beginning in early childhood and continuing throughout life. Current therapy is limited to treatment of acute infections with antibiotics or prevention through the use of intravenous immunoglobulin or G-CSF. There is no approved therapy for the treatment of WHIM syndrome.

On November 1, 2018 Bio-Thera Solutions, reported the initiation of a Phase III clinical trial evaluating the efficacy and safety of its investigational HER2 Antibody-Drug Conjugate (ADC), BAT8001, in patients with HER-2 positive metastatic breast cancer who previously received trastuzumab separately or in combination with taxanes (Press release, BioThera Solutions, NOV 1, 2018, View Source [SID1234530650]). The trial is designed to compare BAT8001 versus lapatinib combined with capecitabine which is 2nd-line standard of care for metastatic breast cancer patients in China.

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"Metastatic breast cancer is a difficult to treat cancer that impacts hundreds of thousands of patients around the world. Patients with metastatic breast cancer need more treatment options that provide an improved survival benefit," said Shengfeng Li, CEO of Bio-Thera Solutions. "This Phase III trial is an important step in the development of BAT8001, potentially providing patients with metastatic breast cancer a new treatment option."

This Phase III, multicenter, randomized, open-label, controlled trial will recruit approximately 410 patients in China. The primary efficacy outcome of the trial is progression-free survival (PFS). Other pre-specified outcome measures include overall survival (OS), and objective response rate (ORR). The safety and immunogenicity of BAT8001 will also be evaluated in the trial.

More information on the trial is available at View Source
(CTR20180157).

About BAT8001

BAT8001 is an investigational HER2-ADC being evaluated in multiple tumor types. HER2 is a naturally occurring receptor that is overexpressed in many types of cancer, including breast cancer and gastric cancer. BAT8001 is being developed for use as a single agent and in combination with other agents for the treatment of multiple cancers. The BAT8001 clinical study program will be expanded beyond metastatic cancer to other HER2-positive cancers, including gastric cancer, over the next 12 months.

About Antibody-Drug Conjugates

Antibody-drug Conjugates or ADCs are designed to harness the targeting ability of monoclonal antibodies (mAbs) to deliver cytotoxic agents selectively to tumor cells by linking the monoclonal antibody and cytotoxic agent through a chemical linker. An ideal ADC consists of: 1) a highly selective mAb for a tumor-associated antigen that has little or no expression on normal cells, 2) a potent cytotoxic agent designed to induce target cell death after being internalized in the tumor cell and released and 3) a chemical linker that is stable in circulation but releases the cytotoxic agent in target cells. By selectively delivering a cytotoxic agent directly inside a tumor cell, ADCs increase the safety and tolerability of the cytotoxic agent relative to giving the cytotoxic agent systemically to the patient.

About Metastatic Breast Cancer

Metastatic breast cancer is not a specific type of breast cancer, it is breast cancer that has spread beyond the breast to other organs in the body. Metastatic breast cancer is most often found in the bones, lungs, liver or brain but can be found in other locations in the body. Although metastatic breast cancer has spread to another part of the body, it is still considered and treated as breast cancer. Typically, metastatic breast cancer arises months or years after a person has completed treatment for early or locally advanced breast cancer. This is sometimes called a distant recurrence. Some patients are first diagnosed with metastatic breast cancer. This is called de novo metastatic breast cancer. The risk of metastasis after breast cancer treatment varies from person to person and depends greatly on the biology of the tumor, the stage at the time of the original diagnosis and the treatments for the original cancer.

On November 1, 2018 Alliance for Cancer Gene Therapy (ACGT), the nation’s only public charity exclusively funding cancer cell and gene therapy research, reported that Kevin Honeycutt will be joining ACGT as its new CEO and President, effective December 3, 2018 (Press release, Alliance Pharma, NOV 1, 2018, View Source [SID1234530649]). Mr. Honeycutt was most recently the President and CEO of the Avon Breast Cancer Crusade (ABCC) since 2015. At ACGT, his principal role will be to enhance the vision of ACGT, begun in 2001 by its co-founders, Barbara Netter and her late husband Edward, to spearhead ACGT’s current focus on funding the next generation of challenges brought by metastatic cancers and solid tumors, and to continue to build our alliances and joint ventures.

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Mrs. Netter stated that, "We are delighted to have Kevin as ACGT’s new CEO and President at this momentous time in the field of cancer cell and gene therapy. His experience at ABCC, in which he led several highly successful fundraising campaigns, positions him to hit the ground running to oversee ACGT‘s fundraising and grants program. Kevin brings a depth of knowledge and experience in the oncology space and strategic thinking which perfectly fits within the ACGT model."

Mr. Honeycutt said that, "ACGT’s outstanding Board of Directors and pre-eminent Scientific Advisory Council, together with the leadership of Barbara Netter, the ACGT staff, and ACGT’s current and past grant recipients, were key to my enthusiasm in joining ACGT. Given the remarkable advances being made in the field of cancer cell and gene therapy, it is an opportune time to be working in cancer research with significant opportunities to advance the understanding of how to treat the disease and give patients the best chances for successful long-term favorable outcomes."

Prior to his years at ABCC, Mr. Honeycutt served as Executive Director of the Avon Foundation for Women for five years, and in cause marketing. He previously led projects for, among others, the American Diabetes Association, DaVita, Inc. / The Kidney Trust, the Entertainment Industry Foundation and the Jane Goodall Institute