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TG Therapeutics Recaps Schedule of Triple Therapy Data Presentations at the Upcoming 61st American Society of Hematology Annual Meeting and Exposition

On December 6, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported the schedule of triple therapy data presentations, at the upcoming 61stAmerican Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting and exposition, to be held December 7 – 10, 2019, at the Orange County Convention Center in Orlando, FL (Press release, TG Therapeutics, DEC 6, 2019, View Source [SID1234552004]).

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Presentations at the ASH (Free ASH Whitepaper) 2019 meeting include the following:

Oral Presentation Details:

Title: A Phase 1/2 Study of Umbralisib Ublituximab and Venetoclax in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Publication Number: 360
Oral Session: 642. CLL: Therapy, excluding Transplantation: Combination and Novel Treatment
Session Date and Time: Sunday, December 8, 2019; 7:30 AM – 9:00 AM ET
Presentation Time: 8:45 AM ET
Location: Orange County Convention Center, Hall E1
Presenter: Paul M. Barr, MD, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY

Poster Presentation Details:

Title: Phase 1 Study of TG-1701, a Selective Irreversible Inhibitor of Bruton’s Tyrosine Kinase (BTK), in Patients with Relapsed/Refractory B-Cell Malignancies
Publication Number: 4001
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III
Date and Time: Monday, December 9, 2019; 6:00 PM – 8:00 PM ET
Location: Orange County Convention Center, Hall B
Presenter: Chan Cheah, MD, Sir Charles Gairdner Hospital, Hollywood Private Hospital, University of Western Australia, Blood Cancer Research Western Australia

Oncopeptides will host a webcast on Tuesday, December 10[th] at 13:00 (CET) to provide an update regarding data presented at the ASH annual meeting

On December 6, 2019 Oncopeptides AB (Nasdaq Stockholm: ONCO), reported that the company will host a webcast on Tuesday, December 10th, 2019, at 13:00 (CET) to provide an update regarding the data presented December 7-8 at the American Society Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2019 (Press release, Oncopeptides, DEC 6, 2019, View Source [SID1234552003]). The webcast will be hosted by CEO Jakob Lindberg.

Inceptua Medicines Access and Onconova Therapeutics Announce Pre-approval Access Collaboration for Rigosertib in Selected Countries Outside the US

On December 6, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), and Inceptua Medicines Access (a business unit of the Inceptua Group), a global pharmaceutical company and service partner, reported that they have entered into a collaboration to make available intravenous rigosertib via a Pre-approval Access Program in selected countries around the world (Press release, Onconova, DEC 6, 2019, View Source [SID1234552002]).

Pre-approval Access Programs (also known as expanded access, early access, compassionate use, named patient supply) are regulatory-compliant processes permitting experimental agents in development to be made available upon the request of a physician or a patient for appropriate patients for whom no alternative treatment option exists in their country. Rigosertib is a small molecule that inhibits cellular signaling in cancer cells by acting as a RAS mimetic. Current clinical development of rigosertib is centered upon the therapeutic management of MDS, a heterogeneous group of bone marrow disorders characterized by ineffective hematopoiesis that often develop into acute myeloid leukemia (AML). Rigosertib, in its intravenous formulation, is currently in Phase 3 clinical development for the treatment of higher-risk MDS.

The rigosertib Pre-approval Access Program is expected to launch in first half of 2020 and will allow Inceptua to supply intravenous rigosertib within designated countries, primarily and initially concentrated in selected countries in Europe, in response to physician requests for patients with higher- risk MDS who have exhausted all available treatment options, and are not eligible for or have no access to the INSPIRE study. Under the terms of this agreement, Inceptua will support Onconova through the pre-approval provision of intravenous rigosertib initially into a number of countries including: Australia, Denmark, Finland, France, Ireland, Italy, the Netherlands, Portugal, South Africa, Spain, and the UK.

"Inceptua Medicines Access is delighted to be selected as Onconova’s partner for the Pre-approval Access Program for rigosertib. Higher-risk MDS is a disease with significant unmet need, and we are pleased to be able to support healthcare professionals seeking access to rigosertib, ahead of its commercial launch," said Mark Corbett, EVP, Inceptua Medicines Access.

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, said, "The rigosertib Pre-approval Access Program is a key strategic initiative for Onconova. We are pleased that intravenous rigosertib will be made compliantly available to suitable patients with higher-risk MDS through their physcians in designated countries. The program will run alongside our ongoing Phase 3 INSPIRE Trial, and is expected to continue until commercial launch in such countries. We are pleased to work with Inceptua, given their strong record of administering such programs successfully."

Navidea Biopharmaceuticals Announces $1.9 Million Private Placement

On December 6, 2019 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that they have executed agreements with five investors, including an existing investor, John K. Scott, Jr. (collectively, the "Investors"), to purchase approximately 2.1 million shares of the Company’s common stock, par value $0.001 per share, in a private placement for aggregate gross proceeds to Navidea of approximately $1.9 million (Press release, Navidea Biopharmaceuticals, DEC 6, 2019, View Source [SID1234552001]). The securities to be issued to the Investors will represent approximately 9.3% of the Company’s outstanding common stock after such issuance.

Navidea intends to use the net proceeds from the private placement to fund its research and development programs, including continuing to advance its Phase 2b and Phase 3 clinical trials of Tc99m tilmanocept in patients with rheumatoid arthritis, and for general working capital purposes and other operating expenses.

"This additional investment in Navidea demonstrates our family’s continued commitment to Navidea and our confidence in the long-term vision of its current board and management. It is very encouraging to us as shareholders to have these additional long-term investors co-investing and supporting the Company. This private placement will help Navidea to continue on the path towards obtaining approval for its rheumatoid arthritis diagnostic product," stated John K. Scott, Jr.

"We are very happy that a group of existing long-term shareholders continues to show faith in the potential of Navidea as well as the continued success of its ongoing RA trials," commented Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "The ability to quickly raise $1.9 million without having to pay any fees, give any warrants and at market price was an opportunity that the Company could not pass up. It also gives the Company additional runway to allow for several key milestones that we anticipate in the next few months."

A resale registration statement relating to any future resales of the newly issued shares will be filed with the Securities and Exchange Commission. While the Company expects to close the private placement of approximately 1.2 million shares within the next week, the closing of approximately 900,000 of the private placement shares is conditioned upon and will occur shortly after the U.S. Securities and Exchange Commission informs the Company of its willingness to declare the resale registration statement effective. These securities may not be sold nor may offers to buy be accepted prior to the time that the registration statement becomes effective.

IntelGenx Announces Issuance of Shares in Payment of Interest on Outstanding Debentures

On December 6, 2019 IntelGenx Technologies Corp. (TSXV: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") reported that it intends to issue 415,178 common shares of the Corporation (the "Common Shares") at a deemed price of CAD $0.73 per Common Share in payment of an aggregate of $303,080 in interest owing on the Corporation’s 8.00% convertible unsecured subordinated debentures due June 30, 2020 (the "Debentures") (Press release, IntelGenx, DEC 6, 2019, View Source [SID1234552000]).

Under the terms of the trust indenture governing the Debentures (the "Indenture"), the Corporation has the option to pay the semi-annual interest on the Debentures in either cash or Common Shares, subject to customary conditions set forth in the Indenture. The issuance of the Common Shares in payment of interest on the Debentures is subject to the acceptance by the TSX Venture Exchange Inc. The Common Shares issued in payment of interest on the Debentures will be issued pursuant to exemptions from the prospectus requirements of applicable securities laws.