On December 1, 2020 Aptose Biosciences Inc. ("Aptose") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that the company management team will provide a corporate update on Sunday, December 6th, at 2:00 PM PT, in conjunction with participation at the 2020 ASH (Free ASH Whitepaper) Annual Meeting (Press release, Aptose Biosciences, DEC 1, 2020, View Source [SID1234573620]). The event will include the current clinical status of CG-806, Aptose’s oral, first-in-class FLT3 and BTK cluster selective kinase inhibitor currently in two Phase 1 a/b trials, one in patients with relapsed or refractory acute myeloid leukemia (AML) and another in patients with relapsed or refractory B cell malignancies, as well as a review of APTO-253, a first-in-class small molecule MYC inhibitor in a Phase 1 a/b trial in patients with relapsed or refractory AML or high risk myelodysplastic syndrome (MDS).

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Aptose Corporate Update Details

Date & Time: Sunday, December 6, 2020, 2:00 PM PT

Participant Webcast Link: View Source

The slides will be available on Aptose’s website here and a recording of the presentation will be archived shortly after the conclusion of the event.

As announced previously, early clinical data, along with certain preclinical data for CG-806 and APTO-253, will be presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held virtually Saturday, December 5 – Monday, December 7, 2020. The posters will be available on the presentations page of Aptose website here.

Poster Presentation Details

Abstract #1042: A Phase 1a/b Dose Escalation Study of the MYC Repressor Apto-253 in Patients with Relapsed or Refractory AML or High-Risk MDS
Poster Session Date & Time: Saturday, December 5, 2020, 7:00 AM – 3:30 PM PT
Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster I

Abstract #1174: Pharmacologic Inhibition of B Cell-Receptor-Associated Kinases with CG-806 Induces Apoptosis and Metabolic Reprogramming in Aggressive Non-Hodgkin Lymphoma (NHL) Models
Poster Session Date & Time: Saturday, December 5, 2020, 7:00 AM – 3:30 PM PT
Session Name: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster I

Abstract #2228: A Phase 1 a/b Dose Escalation Study of the Mutation Agnostic BTK/FLT3 Inhibitor CG-806 in Patients with Relapsed or Refractory CLL/SLL or Non-Hodgkin’s Lymphomas
Poster Session Date & Time: Sunday, December 6, 2020, 7:00 AM – 3:30 PM PT
Session Name: 642. CLL: Therapy, excluding Transplantation: Poster II

On December 1, 2020 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 development and manufacturing 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 1, 2020, View Source [SID1234572028]).

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The quarterly dividend on the Series E Preferred Stock is payable on January 4, 2021 to holders of record at the close of business on December 14, 2020.

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, 2020 through December 31, 2020. The Series E Preferred Stock is listed on the NASDAQ Capital Market and trades under the ticker symbol "CDMOP".

On December 1, 2020 Proscia, a leading provider of digital and computational pathology solutions, reported that it has secured $23 million in Series B funding led by Scale Venture Partners, with participation from Hitachi Ventures, the strategic corporate venture capital arm of Hitachi, Ltd., bringing its funding total to $35 million (Press release, Proscia, DEC 1, 2020, View Source [SID1234572044]). The company will use the investment to accelerate its global growth and strengthen its position of leadership in transforming cancer research and diagnosis at a time when demand for modernizing pathology is higher than ever.

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The practice of pathology sits at the core of biomedical research and cancer diagnosis. Until recently, this practice has remained largely unchanged in its 150-year history, depending solely on the human eye recognizing patterns in tissue under the microscope. With its Concentriq software platform, Proscia is accelerating the transformation to digital pathology, which centers around high-resolution images of tissue biopsies, as the new standard of care. Concentriq combines enterprise scalability with powerful AI applications to help laboratories, health systems, and life sciences companies unlock new insights, accelerate breakthroughs, and improve patient outcomes.

"Digitization has swept through almost every domain of healthcare, and we are now seeing its revolutionary impact on pathology," said Alexander Niehenke, Partner at Scale Venture Partners. "Proscia is a high-growth company with a unique platform-plus-AI approach that is enabling it to capitalize on a multi-billion-dollar market opportunity. We’re excited to be a part of Proscia’s success as it expands its leadership position in pathology’s shift from analog to digital."

The infusion of capital will enable Proscia to continue to meet growing demand for digital pathology across research and diagnostics. The company will use the funds to accelerate commercial expansion, ramping up its global sales, marketing, and support teams. Proscia will also further drive pathology’s data-driven future by expanding its data assets and AI application portfolio, building off of the initial success of its DermAI application. The investment will additionally advance Proscia’s regulatory strategy to secure FDA clearance, drawing on the foundation that the company has established with its CE Mark and MDSAP certification.

Since closing its Series A round in 2018, Proscia has amassed a customer base of laboratory titans and digital pathology pioneers as well as 10 of the top 20 pharmaceutical companies. This includes Johns Hopkins School of Medicine and the Joint Pathology Center (JPC), the premiere pathology reference center for the U.S. government. JPC selected Concentriq to drive a complete modernization of its pathology practice and digitize the world’s largest human tissue repository of over 55 million slides, unleashing a transformative wave of biomedical research. Proscia also recently established a Computational Pathology Center of Excellence with University Medical Center (UMC) Utrecht, one of the first organizations in the world to implement digital pathology. As part of this collaboration, UMC Utrecht will deploy Proscia’s AI applications into its high-throughput workflows leveraging Concentriq.

"We are excited for this next milestone in our journey," said David West, CEO of Proscia. "Over the past few years, we have battle tested Concentriq at leading organizations and demonstrated the unprecedented potential of AI. In welcoming Scale Venture Partners and Hitachi Ventures to the Proscia team, we are better positioned than ever before to drive a transformation that will impact millions of cancer patients and their families."

Proscia’s commercial traction comes amid a surge in digital pathology adoption. Laboratories have increasingly shifted to digital to overcome the manual and subjective nature of the traditional standard of care and keep pace with the rising cancer burden. In the U.S. alone, pathologists have faced a 42% rise in diagnostic workload over the last decade, a challenge that will continue to intensify as the total number of cancer cases is projected to increase by 55% by 2030. Recently, laboratories have been implementing digital pathology to maintain operations during the COVID-19 pandemic, as digitization is the only means by which they can continue to serve patients.

"Digital pathology is quickly becoming the expected standard of diagnosis," said Steve Holloway, Company Director & Principal Analyst at Signify Research. "The global pandemic has exacerbated longstanding pressures, accelerating adoption. This market has now crossed an inflection point, with a critical mass of digital laboratories creating the momentum for more widespread implementation of digital pathology and augmentation by artificial intelligence."

On December 1, 2020 Dragonfly Therapeutics, Inc. ("Dragonfly"), reported that Merck, known as MSD outside the United States and Canada, has licensed its first TriNKET immunotherapy candidate from Dragonfly (Press release, Dragonfly Therapeutics, DEC 1, 2020, View Source [SID1234572060]). Merck and Dragonfly’s collaboration, initially focused on a number of solid tumor targets, began in October 2018. Earlier this year, the companies expanded their collaboration with a multi-target agreement to develop and commercialize additional natural killer ("NK") cell engager immunotherapies in oncology, infectious disease and immune disorders.

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"Merck is a powerful world leader in drug development across a wide number of therapeutic areas and continues to be a strong scientific collaborator," said Bill Haney, co-founder and CEO of Dragonfly Therapeutics. "We are delighted that Merck has exercised its option for this first immunotherapy candidate from our collaboration, and excited by the progress we are making together on bringing Dragonfly’s TriNKET technology to targets across a broader set of diseases."

Under the agreement Merck has exercised its option to license exclusive worldwide intellectual property rights on its first immunotherapy candidate developed using the TriNKET technology platform and Dragonfly has received an undisclosed payment associated with this milestone.

On December 1, 2020 BridgeBio Pharma, Inc. (NASDAQ: BBIO), a clinical-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, and affiliate QED Therapeutics reported that the U.S. Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for infigratinib, an oral FGFR1-3 selective inhibitor, for individuals with cholangiocarcinoma, or cancer of the bile ducts (Press release, BridgeBio, DEC 1, 2020, View Source [SID1234576220]).

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The NDA has been granted Priority Review designation and is being reviewed under the Real-Time Oncology Review (RTOR) pilot program, an initiative of the FDA’s Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients. Additionally, BridgeBio will submit for review in Australia and Canada under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among participating international regulatory agencies.

Cholangiocarcinoma, a cancer of the bile ducts of the liver, is a serious and often fatal disease which affects approximately 20,000 people in the United States and European Union each year. FGFR2 genetic aberrations are present in approximately 15% to 20% of people who have this disease. Currently, treatment options are limited, and the five-year survival rate is only 9%.

"We want to thank the patients, families, scientists, physicians and all others involved who helped us move this NDA forward. At BridgeBio we believe that every minute counts for patients and their families, and we are eager to help as many people suffering from cholangiocarcinoma as possible – as quickly as possible," said BridgeBio CEO and Founder Neil Kumar, Ph.D.

This is BridgeBio’s second NDA acceptance following the acceptance of its NDA for fosdenopterin in molybdenum cofactor deficiency (MoCD) Type A in September 2020.

About Infigratinib

Infigratinib is an orally administered, ATP-competitive, FGFR1-3 tyrosine kinase inhibitor in development for the treatment of individuals with FGFR-driven conditions, including cholangiocarcinoma (bile duct cancer), urothelial carcinoma (bladder cancer) and achondroplasia, a bone growth condition in children.