On December 4, 2019 Innovative Cellular Therapeutics (ICT), a biotechnology company developing a comprehensive platform of chimeric antigen receptor (CAR) T cell therapies for blood cancers and solid tumors, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ICTCAR014, a next generation CD19-targeting CAR-T cell therapy that expresses a dominant negative PD-1 protein to block immunosuppression by cancer cells (Press release, Innovative Cellular Therapeutics, DEC 4, 2019, View Source [SID1234551918]). ICT expects to initiate a U.S. clinical trial evaluating ICTCAR014 in patients with relapsed or refractory non-Hodgkin lymphoma (NHL), including patients whose tumors are PD-L1 positive, in the first part of 2020. Dr. David L. Porter of the Abramson Cancer Center of the University of Pennsylvania will be the Lead Principal Investigator for the clinical trial.

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"The clearance of our first U.S. IND is a significant step as we expand our U.S. activities," said Larry (Lei) Xiao, Ph.D., Chairman and Chief Executive Officer of ICT. "Building upon the encouraging data presented in November at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), which showed objective response rate of over 92%, the ICTCAR014 program highlights our accelerated and de-risked approach for developing novel immunotherapies. Our development strategy translates rapid clinical proof-of-concept trials in China into U.S. and global development programs with the goal of regulatory approval through expedited review pathways. We look forward to advancing ICTCAR014 into our first U.S. clinical trial."

About ICTCAR014
The U.S. Food and Drug Administration (FDA) has cleared ICT’s Investigational New Drug (IND) application for ICTCAR014, a next generation CD19-targeting CAR-T cell therapy that expresses a dominant negative PD-1 protein to block immunosuppression by cancer cells. ICT is moving ICTCAR014 into a U.S. clinical trial. ICTCAR014, referred to as an "armored" CAR-T cell therapy, has already demonstrated encouraging results in proof-of-concept human trials in China. As highlighted in ICT’s presentation at the November 2019 Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting, ICTCAR014 demonstrated a 92.3% objective response rate (53.8% complete remission; 38.5% partial remission) in 13 initial patients with relapsed or refractory non-Hodgkin lymphoma. Significant tumor shrinkage and limited toxicity were observed.

On December 4, 2019 Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with cardiorenal diseases, reported the pricing of an underwritten public offering of 20,000,000 shares of its common stock at a public offering price of $6.25 per share, before underwriting discounts and commissions, for gross proceeds of $125,000,000 (Press release, Ardelyx, DEC 4, 2019, View Source [SID1234551936]). In addition, Ardelyx has granted the underwriters of the offering the right for a period of 30 days to purchase up to an additional 3,000,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about December 9, 2019, subject to customary closing conditions.

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Ardelyx currently expects to use its existing cash, cash equivalents and short-term investments and the net proceeds from the offering to support its activities for the clinical development and potential commercialization of tenapanor for the treatment of hyperphosphatemia in patients with chronic kidney disease, or CKD, on dialysis, for regulatory activities to support the submission of a New Drug Application, in such indication, as well as for clinical trials and nonclinical studies for other product candidates, and for general corporate purposes and working capital.

Citigroup, Cowen, SVB Leerink and Piper Jaffray are acting as joint book-running managers for the offering.

A registration statement on Form S-3 (File No. 333-217441) relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on May 4, 2017. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement, copies of which may be obtained when available by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY,11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132 or by e-mail at [email protected]; or Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On December 4, 2019 Moffitt Cancer Center, a leader in the clinical care and research of blood malignancies, reported that it will present its top clinical research at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, Dec. 7-10 at the Orange County Convention Center in Orlando, Fla (Press release, Moffitt Cancer Ctr, DEC 4, 2019, View Source [SID1234551919]).

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Moffitt faculty are authors on more than 80 abstracts accepted for this year’s meeting, and will be presenting 37 including the four following oral presentations:

Date/Time: Saturday, Dec. 7, 3:00 p.m.

Abstract: 245

Title: Characteristics and Outcomes of Patients Receiving Bridging Therapy While Awaiting Manufacture of Standard of Care Axicabtagene Ciloleucel CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory Large B-Cell Lymphoma: Results from the US Lymphoma CAR-T Consortium

Presenter: Michael Jain, M.D., Ph.D., Assistant Member, Department of Blood and Marrow Transplant and Cellular Immunotherapy

Location: Hall E2, Level 2

Date/Time: Monday, Dec. 9, 8:00 a.m.

Abstract: 569

Title: The First-in-Class Anti-CD47 Antibody Magrolimab (5F9) in Combination with Azacitidine Is Effective in MDS and AML Patients: Ongoing Phase 1b Results

Presenter: David Sallman, M.D., Assistant Member, Department of Malignant Hematology

Location: W311EFGH, Level 3

Date/Time: Monday, Dec. 9, 11:15 a.m.

Abstract: 676

Title: Phase 2 Results of APR-246 and Azacitidine (AZA) in Patients with TP53 mutant Myelodysplastic Syndromes (MDS) and Oligoblastic Acute Myeloid Leukemia (AML)

Presenter: David Sallman, M.D., Assistant Member, Department of Malignant Hematology

Location: W311ABCD, Level 3 (Orange County Convention Center)

Date/Time: Monday, Dec. 9, 4:45 p.m.

Abstract: 842

Title: Combined Treatment with Lenalidomide and Epoetin Alfa Leads to Durable Responses in Patients with Epo-Refractory, Lower Risk Non-Deletion 5q [Del(5q)] MDS: Final Results of the E2905 Intergroup Phase III Study – an ECOG-ACRIN Cancer Research Group Study, Grant CA180820, and the National Cancer Institute of the National Institutes of Health

Presenter: Alan F. List, M.D., Senior Member, Department of Malignant Hematology

Location: W311ABCD, Level 3

If you’d like to schedule an interview with any Moffitt experts during the annual meeting, please contact Kim Polacek at [email protected].

You can also learn more about the cancer center by visiting booth no. 1464 on the exhibit floor during the meeting.

On December 4, 2019 Servier Group and Servier Pharmaceuticals, the U.S. subsidiary of the global French pharmaceutical company, reported that data from multiple studies will be presented at the 61st Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Orlando, from December 7-10, 2019 (Press release, Servier, DEC 4, 2019, View Source [SID1234551937]).

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"As a patient-centric, innovation-driven organization, we believe it is critical to foster scientific exchange and discussion around novel approaches to treating hematologic-oncologic conditions and addressing unmet needs," said Claude Bertrand, Executive Vice President of Research and Development, Servier Group. "Oncology is one of Servier’s strategic priorities, and these new data findings to be presented at ASH (Free ASH Whitepaper) 2019 demonstrate our expanding pipeline of drug candidates, including allogeneic CAR-T therapy.*"

A complete listing of this year’s Servier abstracts* are available on the ASH (Free ASH Whitepaper) website. Notable abstracts include:

Sunday, December 8, 6:00 PM; Orange County Convention Center, Hall B

Allogeneic Anti-CD19 CAR T Cells Manufactured from Healthy Donors Provide a Unique Cellular Product with Distinct Phenotypic Characteristics Compared to CAR T Cells Generated from Patients with Mature B Cell Malignancies
Poster presentation in collaboration with Allogene Therapeutics
Session: 703. Adoptive Immunotherapy: Mechanisms and New Approaches: Poster II
Abstract: 3228
Preclinical Activity of the MPS1 Inhibitor S81694 in Acute Lymphoblastic Leukemia (ALL)
Session: Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: Poster II
Abstract: 2631
Monday, December 9, 2019, 6:00 PM; Orange County Convention Center, Hall B

Initial findings of the Phase 1 Trial of PBCAR0191, a CD19 Targeted Allogeneic CAR-T Cell Therapy
Poster presentation in collaboration with Precision BioSciences
Session: 627. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas) – Results from Retrospective/Observational Studies: Poster III
Abstract: 4107
Additionally, on Friday, December 6, from 12:30 p.m. to 4:30 p.m., Medscape has a Continued Medical Education Program (CME) entitled "New Data and Paradigms in ALL: Insights and Applications." This CME event will take place at the Hyatt Regency Orlando Hotel, 9801 International Drive, Room Plaza International I-K. ASH (Free ASH Whitepaper) attendees can register here to attend. This CME event is supported by an independent educational grant from Servier, and all content discussed and presented is developed independently of commercial interests by Medscape’s Education staff.

"Since opening our U.S. headquarters in 2018, we have remained squarely focused on advancing and launching innovative treatment options for patients in need and are agnostic to where that innovation comes from," said David K. Lee, Chief Executive Officer, Servier Pharmaceuticals. "The presence of Servier Pharmaceuticals and our strategic partners at ASH (Free ASH Whitepaper) 2019 further exemplifies our commitment and dedication to developing new medicines in a way that’s most meaningful for patients."

More than 40 percent† of Servier Group’s investments in R&D are devoted to fighting cancer. Servier’s research in oncology focuses on therapies aimed at restoring programmed cell death (apoptosis) in cancer cells and at mobilizing the immune system against cancer cells (immuno-oncology).

To further accelerate the research and development of innovative treatments, Servier Group has instituted a policy of open innovation and has established more than 50 strategic partnerships. Partnership models are uniquely tailored to the engagement and span industry and academia.

In oncology, 13 drugs are currently being developed as an outgrowth of this collaborative research approach. These drugs target different types of lymphomas and leukemia, and other solid tumors, including gastrointestinal and lung. These drugs are investigational and have not yet been reviewed by the U.S. Food and Drug Administration (FDA) for safety and efficacy.

To learn more about Servier and their R&D efforts visit booth #955 in the Exhibition Hall.

About UCART19
UCART19 is being jointly developed under a clinical development collaboration between Servier and Allogene based on an exclusive license granted by Cellectis to Servier. UCART19 utilizes TALEN gene-editing technology pioneered and owned by Cellectis. Servier grants to Allogene exclusive rights to UCART19 in the U.S. while Servier retains exclusive rights for all other countries.

About PBCAR0191
In partnership with Servier, Precision BioSciences is responsible for early-stage research activities, manufacturing and Phase 1 execution for PBCAR0191. Servier has exclusive worldwide rights to opt-in for late-stage development and commercialization, and Precision has the right to participate in the development and commercialization of any licensed products resulting from the collaboration through a 50/50 co-development and co-promotion option in the U.S.

About Servier in the U.S.
Servier Pharmaceuticals LLC is a commercial-stage pharmaceuticals company with a passion for innovation and improving the lives of patients and their families and caregivers. With 13 additional oncology projects currently in clinical development, Servier is the partner of choice for leading academic institutions and a growing number of pharmaceutical companies. Servier BioInnovation is a joint initiative between Servier Group R&D and Global Business Development for external innovation. The initiative is focused on identifying new early-stage R&D opportunities and expediting business development and licensing activities in the U.S. Learn more at www.servier.us.

On December 4, 2019 Aptose Biosciences Inc. (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported the appointment of Rafael Bejar, M.D., Ph.D., to the position of Senior Vice President, Chief Medical Officer, effective January 1, 2020 (Press release, Aptose Biosciences, DEC 4, 2019, View Source [SID1234551957]). In his role as a member of the executive leadership team, Dr. Bejar will oversee global clinical development and regulatory initiatives for Aptose, as well as other research activities.

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"Rafael is a physician-scientist whose depth of experience both in the research setting and in treating patients with hematologic malignancies brings a unique and important perspective as we accelerate the clinical development of our hematologic product candidates," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "We are very fortunate and excited to have him join Aptose and welcome him as a senior member of the management team."

Dr. Bejar is trained in internal medicine and board certified in oncology and hematology, with a special interest in hematologic malignancies and myelodysplastic syndrome (MDS). Prior to joining Aptose, he served as Associate Professor of Clinical Medicine in the Division of Hematology and Oncology at University of California San Diego in the Moores Cancer Center, where he established an MDS Center of Excellence, which provides state of the art care, clinical trials and medical expertise in one center. Dr. Bejar has authored numerous research articles published in leading journals such as The New England Journal of Medicine, Journal of Clinical Oncology, Blood and more; has served as an invited speaker and chair at multiple scientific/clinical conferences; has served in teaching capacities and has been honored extensively.

Dr. Bejar completed his internal medicine residency at the Brigham and Women’s Hospital in Boston, where he later served as a Chief Medical Resident. He then received his fellowship training in hematology and oncology at the Dana-Farber Cancer Institute. He earned his medical degree and Ph.D. at UC San Diego School of Medicine, and his bachelor’s degree in Physics at the Massachusetts Institute of Technology.

"As a physician and researcher who has dedicated my professional life to understanding the development and progression of hematologic malignancies such as AML and MDS, I’m excited join Aptose at such a pivotal moment and to have the opportunity to bring CG-806 and APTO-253 to patients in need of new therapies," said Dr. Bejar. "Our goal is to translate these discoveries into clinically meaningful improvements for these patient populations and I very much look forward to being an integral part of that endeavor."