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TG Therapeutics Announces Data Presentations at the Upcoming 62nd American Society of Hematology Annual Meeting and Exposition

On November 2, 2020 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that four abstracts have been accepted for presentation at the upcoming 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting and exposition, to be held virtually December 5 – 8, 2020 (Press release, TG Therapeutics, NOV 2, 2020, View Source [SID1234569661]). Abstracts will be made publicly available online on November 5, 2020 at 9:00 AM ET via the ASH (Free ASH Whitepaper) meeting website at www.hematology.org. The Company will also host a zoom conference call with leading investigators from the UNITY-NHL and UNITY-CLL trials on Thursday, November 5, 2020, beginning at 8:45 AM ET. Details about the ASH (Free ASH Whitepaper) presentations and the conference call are outlined below.

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Michael S. Weiss, Executive Chairman and Chief Executive Officer, stated, "We are excited to have four abstracts accepted for presentation at the upcoming ASH (Free ASH Whitepaper) conference highlighting data from two registration directed trials, the UNITY-CLL Phase 3 trial of ublituximab in combination with umbralisib (U2) in CLL, and the UNITY-NHL MZL and FL/SLL umbralisib monotherapy cohorts. Our NDA for umbralisib monotherapy for previously treated MZL and FL is currently under review, and we are actively preparing a BLA/NDA submission for the U2 combination for CLL to be submitted in the coming months based on the results of the UNITY-CLL Phase 3 study. Demonstrating the potential to build upon these backbone regimens, there will also be two triple therapy datasets presented, one with U2 plus TG-1701, our BTK inhibitor; and one with U2 plus venetoclax in CLL. We look forward to the abstracts being released publicly on November 5 at 9 AM ET and to reviewing the exciting data on a conference call that morning."

ASH 2020 PRESENTATION DETAILS:

Oral Presentation Title: Umbralisib Plus Ublituximab (U2) Is Superior to Obinutuzumab Plus Chlorambucil (O+Chl) in Patients with Treatment Naïve (TN) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 UNITY-CLL Study
° Publication Number: 543
° Oral Session: 642. CLL: Therapy, excluding Transplantation
° Session Date and Time: Monday, December 7, 2020; 7:00 AM – 8:30 AM (Pacific Time)
– Presentation Time: 7:15 AM (Pacific Time)
° Presenter: John G. Gribben, D.Sc., F.R.C.P., F.R.C.Path., F.Med.Sci., North East London Cancer Research Network Centre, Barts and the London Cancer Center, UK
Poster Presentation Title: Umbralisib, the Once Daily Dual Inhibitor of PI3Kδ and Casein Kinase-1ε Demonstrates Clinical Activity in Patients with Relapsed or Refractory Indolent Non-Hodgkin Lymphoma: Results from the Phase 2 Global UNITY-NHL Trial
° Publication Number: 2934
° Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III
° Date and Time: Monday, December 7, 2020; 7:00 AM – 3:30 PM (Pacific Time)
° Presenter: Pier Luigi Zinzani, MD, Institute of Hematology, "L. e A. Seràgnoli", University of Bologna, Italy
Poster Presentation Title: A Phase 1/2 Study of Umbralisib, Ublituximab, and Venetoclax (U2-Ven) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) ° Publication Number: 3137
° Session: 642. CLL: Therapy, excluding Transplantation: Poster III
° Date and Time: Monday, December 7, 2020; 7:00 AM – 3:30 PM (Pacific Time)
° Presenter: Paul M. Barr, MD, Wilmot Cancer Institute, University of Rochester Medical Center, NY
Poster Presentation Title: Clinical Activity of TG-1701, As Monotherapy and in Combination with Ublituximab and Umbralisib (U2), in Patients with B-Cell Malignancies
° Publication Number: 1130
° Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster I
° Date and Time: Saturday, December 5, 2020; 7:00 AM – 3:30 PM (Pacific Time)
° Presenter: Chan Cheah, MD, Sir Charles Gairdner Hospital, Hollywood Private Hospital, University of Western Australia, Blood Cancer Research Western Australia
Abstracts will be made publicly available online on November 5, 2020 at 9:00 AM ET via the ASH (Free ASH Whitepaper) meeting website at www.hematology.org and will also be accessible via the publications page of TG corporate website at View Source Following each presentation during ASH (Free ASH Whitepaper), the data presented will also be available on TG’s website.

ZOOM CONFERENCE CALL INFORMATION
The Company will host a zoom conference call November 5, 2020, at 8:45 AM ET.

In order to participate in the call, please join via the zoom webinar link: https://bit.ly/37XZai1, which will also be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source Attendees may also join via phone by dialing 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics ASH (Free ASH Whitepaper) Abstract Review Call. A recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

LabCorp Is Scheduled to Present at the 29th Annual Credit Suisse Virtual Healthcare Conference

On November 2, 2020 LabCorp (NYSE: LH) reported that members of the executive management team will participate in a virtual fireside chat at the 29th Annual Credit Suisse Virtual Healthcare Conference on Monday, Nov. 9 at 8:00 a.m. ET (Press release, LabCorp, NOV 2, 2020, View Source [SID1234569660]).

A live audio webcast of the presentation will be available via the company website at www.LabCorp.com and archived for replay.

Trained Therapeutix Discovery Inc.’s Exclusively Licensed Technology Shown to Suppress Cancer Growth

On November 2, 2020 Trained Therapeutix Discovery, Inc. ("TTxD"), an immunotherapy biotech company founded by Jean Boulle Therapeutics, reported that the results of a preclinical Study ("the Study") published in Cell showing how nanobiologic immunotherapy promotes trained immunity and elicits a durable anti-tumor response either as a monotherapy or in combination with other checkpoint inhibitor drugs (Press release, Trained Therapeutix Discovery, NOV 2, 2020, View Source [SID1234569659]).

TTxD’s scientific founders Willem Mulder, Zahi Fayad, Jordi Ochando, Leo Joosten and Mihai Netea were all co-authors of the Study which involved scientists from 23 research institutions around the world. The Study shows for the first time how trained immunity can be therapeutically exploited to help fight cancers.

In the Study, the researchers developed a library of nanobiologics (nanomaterials bioengineered from molecules that exist naturally within the body) designed specifically to induce trained immunity in bone marrow cells. Through extensive screening, involving in vitro training assays and in vivo mouse biodistribution experiments, the Study identified a bone marrow-avid nanobiologic lead candidate, named MTP10-HDL.

MTP10-HDL was shown to have potent anti-tumor capabilities in a B16F10 mouse melanoma model. These capabilities resulted from changes to the way in which the bone marrow produced infection fighting cells (myelopoiesis) that were induced by trained immunity. The Study also showed MTP10-HDL’s favorable biodistribution and safety profile in non-human primates. This technology has been exclusively licensed to Trained Therapeutix Discovery, Inc.

TTxD applies advanced bioengineering methods to develop nanobiologic therapeutics that regulate the innate immune system with materials that are inherently well tolerated by the body. This pioneering approach has potential applications in the treatment of cancer, respiratory infections, autoimmune disorders, and organ transplant rejection.

Commenting on the paper, Willem Mulder, PhD scientific founder of TTxD said:
"This Study is further evidence of the huge potential that trained immunity has to fight a wide range of serious conditions. The identification of a nanobiologic material that can induce a durable anti-tumor response has the potential to open up a new horizon in cancer therapy."

Leighton Durham, Director of Jean Boulle Medtech and Co-CEO of TTxD, said:
"This study, although early stage, provides further support for TTxD’s approach and shows the potential power of trained immunity. The TTxD team is focused on further developing its revolutionary nanobiologic technologies and saving lives across a spectrum of illnesses."

Further information is available from the Eindhoven University of Technology.
Full paper: B. Priem et al., "Trained immunity-promoting nanobiologic therapy suppresses tumor growth and potentiates checkpoint inhibition", CELL, (2020).

Regulus Therapeutics Announces Achievement of Interim Enrollment Milestone Under Collaboration with Sanofi

On November 2, 2020 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, reported that it has achieved the remaining $5 million milestone associated with interim enrollment under its Collaboration and License Agreement (the "Milestone") with Sanofi for its development of miR-21 programs (Press release, Regulus, NOV 2, 2020, View Source [SID1234569658]). The Milestone was triggered upon achievement of an enrollment metric by Sanofi in its Phase 2 clinical study evaluating RG-012 for the treatment of patients with Alport Syndrome. The proceeds from this Milestone will be used to pay down the Company’s term loan with Oxford LLC. The payment to Oxford will reduce the remaining principal due under the term loan to approximately $4.7 million and enable the Company to receive an extension of interest-only payments through 2021, an extension of seven months from the previous terms.

"We are very pleased with the commitment of our partner, Sanofi, to this important program," stated Jay Hagan, CEO of Regulus. "This is an important step in advancing a potential treatment for patients with Alport Syndrome, a rare genetic condition affecting the kidneys with no approved therapies."

Previously, the Company announced completion of the Phase 1b renal biopsy study, where patients with Alport Syndrome were dosed every other week for one year. Results from that study demonstrated kidney tissue concentrations that would be predictive of therapeutic benefit based on animal disease models as well as engagement of the target, miR-21. Over the course of the one year open-label study, promising trends in disease markers were observed and RG-012 was generally well tolerated with no serious adverse events. RG-012 has received orphan designation in both the U.S. and Europe.

Under the terms of the Collaboration and License Agreement, the Company is also eligible to receive an additional $25.0 million upon the successful achievement of a development milestone anticipated in 2023 related to the ongoing Phase 2 HERA study.

Seagen to Host Virtual R&D Day on November 16, 2020

On November 2, 2020 Seagen Inc. (Nasdaq: SGEN) reported that it will host a virtual R&D day for investors and analysts on Monday, November 16, 2020 beginning at 10:00 a.m. Eastern Time (Press release, Seagen, NOV 2, 2020, View Source [SID1234569657]). The program will include a presentation by members of Seagen leadership on the broad clinical development of the Company’s marketed products, ADCETRIS (brentuximab vedotin), PADCEV (enfortumab vedotin-ejfv) and TUKYSA (tucatinib), and its deep pipeline of innovative therapies for cancer.

Access to the event will be available at the Company’s website www.seagen.com in the Investors section. A replay will be archived on the Company’s website following the live presentation.