On December 4, 2019 Civetta Therapeutics, LLC reported a $53 million Series A financing to advance select programs and a proprietary platform focused on beta-propeller proteins (Press release, Civetta Therapeutics, DEC 4, 2019, View Source [SID1234551920]). Deerfield Management established the new Company in early 2019 with Civetta scientific founders William Sellers, MD, and Eric Fischer, PhD. Bruce Goldsmith, PhD serves as the interim CEO. Dr. Goldsmith, who is Venture Partner at Deerfield, has recruited industry innovators in biology, chemistry, and lead discovery in an effort to advance the Company’s research initiatives.

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Beta-propeller proteins are structural scaffolds that mediate important protein-protein interactions. These propeller proteins are found ubiquitously across cell types and have diverse functions in the pathogenesis of serious disease such as cancer, neurodegeneration and metabolic disorders. Civetta will take a comprehensive approach to identify critical propeller protein targets underlying disease and advance therapeutics by creating selective inhibitors or activators.

"Civetta’s vision is to develop a broad range of expertise in drugging the propeller domains, spanning from biochemistry to biology to medicinal chemistry. These efforts could lead to both the creation of nearer-term therapeutics and longer-term value in becoming a leader in this space," said Dr. Fischer.

"While the initial focus will be in oncology, other disease areas will be targeted as well. Similar to the synergies that have benefited kinase drug discovery, it is envisioned that the insights gained through our platform could potentially be leveraged to apply more broadly to many propeller targets," said Dr. Sellers.

Utilizing Deerfield seed funding and operational support since the first quarter of 2019, Civetta has established its initial operations at Ipsen Innovation Center BioLabs. The Series A funding will position Civetta to further validate its platform, advance lead programs, secure permanent facilities, and expand the research team. As part of Civetta’s formation, the Company has gained scientific insights from the Broad Institute through a know-how license as well as from the Dana-Farber Cancer Institute.

"We are excited to announce the funding and advancement of Civetta, which has created a platform to explore diverse and structurally unique proteins and the role these play in serious diseases. The team we have recruited has an outstanding track record and we look forward to developing transformative therapeutics," said Cameron Wheeler, PhD, Director at Civetta and Partner at Deerfield Management.

"Civetta’s research teams are truly thrilled to be on the cutting edge of exploration of propeller proteins in order to identify novel therapeutics," said Bruce Goldsmith. "We believe that the Company is well positioned to potentially identify new therapeutics that could transform patients’ lives."

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 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 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality services to biotechnology and pharmaceutical companies, reported that its Board of Directors has declared a quarterly cash dividend payment on the Company’s 10.50% Series E Convertible Preferred Stock (the "Series E Preferred Stock") (Press release, Avid Bioservices, DEC 4, 2019, View Source [SID1234551915]).

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The quarterly dividend on the Series E Preferred Stock is payable on January 2, 2020 to holders of record at the close of business on December 16, 2019.

The quarterly dividend payment on the Series E Preferred Stock will be $0.65625 per share, which is equivalent to an annualized 10.50% per share, based on the $25.00 per share stated liquidation preference, accruing from October 1, 2019 through December 31, 2019. The Series E Preferred Stock is listed on the NASDAQ Capital Market and trades under the ticker symbol "CDMOP".

On December 4, 2019 Alector, Inc. (Nasdaq: ALEC), a clinical stage biotechnology company pioneering immuno-neurology, reported that it will host an R&D Day for analysts and investors on Friday, December 13, 2019 at 8:00 a.m. ET in New York City (Press release, Alector, DEC 4, 2019, View Source [SID1234551914]).

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The event agenda will include a discussion of the Company’s therapeutic approach to neurodegeneration and Alector’s pipeline of novel, genetically validated therapeutics including: Phase 1b data for AL001 for frontotemporal dementia; Phase 1 data for AL002 for Alzheimer’s disease; a Phase 1 study update on AL003 for Alzheimer’s disease; and, an introduction to a new product candidate from the Company’s discovery platform, AL014.

The program will also feature presentations from leading key opinion leaders focused on the human genetics of neurodegeneration, including:

Mario Masellis, MSc (Pharm), M.D., Ph.D., FRCPC
Assistant Professor, Department of Medicine, Institute of Medical Sciences
Co-director, Cognitive Neurology Research Unit, Sunnybrook Health Sciences Centre
Elizabeth M. Bradshaw, Ph.D.
Adler Assistant Professor of Neurology, the Taub Institute for Research on Alzheimer’s Disease and the Aging Brain and the Institute for Genomic Medicine, Colombia University
Carlos Cruchaga, Ph.D.
Professor of Psychiatry and Neurology, Director of NeuroGenomics and Informatics Washington University in St. Louis
A live webcast of the event will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 90 days following the event. For further information, please contact [email protected]