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TG Therapeutics Announces Data Presentations at the Upcoming XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL)

On August 30, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported the schedule of four data presentations at the upcoming XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL), being held virtually September 17 – 20, 2021 (Press release, TG Therapeutics, AUG 30, 2021, View Source [SID1234587007]). Details of the data presentations are included below.

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"We are excited to share data from four combination clinical trials at the upcoming iwCLL conference, all of which evaluated either U2, the combination of UKONIQ plus ublituximab, alone or as a backbone in a triple combination regimen. We believe these data further highlight the potential of the U2 combination, which currently has a PDUFA date of March 25, 2022, to treat patients with CLL." Mr Weiss continued, "We are particularly excited to be able to share, earlier than expected, the updated Phase 1 results from the triple combination of U2 plus venetoclax in patients with relapsed/refractory CLL. The data shown thus far from this phase 1/2 study has been highly encouraging and led to the commencement of our ULTRA-V Phase 2/3 trial, which is also evaluating the U2 plus venetoclax triple combination."

IwCLL 2021 PRESENTATION INFORMATION

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

Abstract Number: 1083667
Presentation Date/Time: Saturday September 18, 2021 at 1:30 PM EDT/ 19:30 CEST
Session: Session 6: Front-Line Therapy of CLL
Lead Author: Wojciech Jurczak, MD, PhD, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland
Oral Presentation Title: A Phase 1/2 Study of Umbralisib, Ublituximab, and Venetoclax in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Abstract Number: 1083987
Presentation Date/Time: Sunday September 19, 2021 at 10:50 AM EDT/ 16:50 CEST
Session: Session 8: New Agents in CLL Clinical Trials
Lead Author: Paul M. Barr, MD, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY
Oral Poster Presentation Title: TG-1701, a Selective Bruton Tyrosine Kinase (BTK) Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Patients with Chronic Lymphocytic Leukemia

Abstract Number: 1083634
Presentation Date/Time: Sunday September 19, 2021 at 2:00 PM EDT/ 20:00 CEST
Session: Poster Session
Lead Author: Chan Y. Cheah MBBS, DMSc, Linear Clinical Research, and Department of Haematology, Sir Charles Gairdner Hospital, Nedlands Western Australia, and Medical School, University of Western Australia, Crawley, Western Australia
Poster Presentation Title: Phase I/II Study of Umbralisib (TGR-1202), Ublituximab (TG-1101), and Pembrolizumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia and Richter’s Transformation: 5-Year Follow-up

Abstract Number: 1083523
Presentation Date/Time: Available on demand
Session: Virtual Poster Gallery
Lead Author: Lindsey E. Roeker, MD, CLL Program, Leukemia Service, Division of Hematologic Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY
Currently, the conference agenda, including abstract titles, is available via the iwCLL website at View Source Full text abstracts will be publicly available on September 13, 2021.

At the time of each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.

Rocket Pharmaceuticals Announces $26.4 Million Private Placement

On August 30, 2021 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a clinical-stage company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders, reported a securities purchase agreement with a fund affiliated with RTW Investments, LP, the Company’s largest shareholder, for the purchase of an aggregate of 812,516 shares of common stock, par value $0.01 per share, at a purchase price of $32.48 per share, the closing price on August 27, 2021, for aggregate gross proceeds of approximately $26.4 million to the Company before offering expenses (Press release, Rocket Pharmaceuticals, AUG 30, 2021, View Source [SID1234587006]). The private placement is expected to close on or about August 31, 2021, subject to the satisfaction of customary closing conditions. Rocket expects to use the net proceeds from the private placement to continue to advance and expand its pipeline of product candidates, for research and development expenses and for working capital.

The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the "SEC") registering the resale of the common shares issued in the private placement upon the purchasers’ request.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

Quest Diagnostics to Speak at the Morgan Stanley 19th Annual Global Healthcare Conference

On August 30, 2021 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it is scheduled to speak at the Morgan Stanley 19th Annual Global Healthcare Conference (Press release, Quest Diagnostics, AUG 30, 2021, View Source [SID1234587005]). Steve Rusckowski, Chairman, CEO and President and Jim Davis, Executive Vice President, General Diagnostics will discuss the company’s vision, goals and two-point strategy to accelerate growth and drive operational excellence, as well as the company’s current perspective on the impact of the COVID-19 pandemic. The presentation is scheduled for Thursday, September 9, 2021, at 9:30 a.m. Eastern Time.

The presentation will be webcast live during the conference and will be available on the company’s investor relations page which can be accessed at ir.QuestDiagnostics.com. In addition, the archived webcast will be available within 24 hours after the conclusion of the live event and will remain available until October 9, 2021.

OPKO Health to Participate in Two Upcoming Investment Conferences

On August 30, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported that management will be participating in two upcoming virtual investor conferences (Press release, Opko Health, AUG 30, 2021, View Source [SID1234587004]).

14th Annual Barrington Research Fall Conference, September 9, 2021. Management will be available for one-on-one and small-group virtual meetings with investors during the event.

H.C. Wainwright 23rd Annual Global Investment Conference, September 13-15, 2021. Management will participate in a fireside chat and will be available for one-on-one virtual meetings with investors. The recorded fireside chat will be available on demand beginning Monday, September 13th on the Investors section of OPKO Health’s website.

Novartis sabatolimab receives orphan drug designation from the European Commission for myelodysplastic syndromes

On August 30, 2021 Novartis reported that the European Commission (EC) has granted orphan drug designation to sabatolimab (MBG453) for the treatment of myelodysplastic syndromes (MDS), based on clinical data showing a high rate of responses in patients with high-risk MDS who were treated with sabatolimab in combination with hypomethylating agents (HMAs) (Press release, Novartis, AUG 30, 2021, View Source [SID1234587003]). The decision follows a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA)1.

MDS are a group of rare and often underdiagnosed blood cancers characterized by two major components, a dysfunctional immune system and leukemic stem cell proliferation, which limits the ability of current treatment options to achieve durable responses2-4.
Patients with MDS face the possibility of poor outcomes with a limited duration of response and a median overall survival rate of less than two years despite treatment with the current standard of care5,6.
Sabatolimab is an investigational, potential first-in-class immuno-myeloid therapy that binds to TIM-3, a novel target expressed on immune and leukemic cells, but not on normal hematopoietic stem cells. It is in development for the treatment of higher-risk MDS and acute myeloid leukemia (AML). Targeting TIM-3 reawakens the immune system to selectively attack leukemic stem cells, the source of MDS/AML, and has the potential to safely deliver a durable response7,8.
Orphan drug designation is reserved for medicines that treat, prevent or diagnose a life-threatening or chronically debilitating rare disease with a prevalence in the EU of below 5 in 10,000 and with either no currently approved method of diagnosis, prevention or treatment or with significant benefit to those affected by the disease9. At the time of the EMA’s evaluation of the marketing authorization application for sabatolimab, the COMP will determine whether the orphan designation can be maintained based on an analysis of available data1.

The EC decision follows the US Food and Drug Administration’s fast track designation for sabatolimab in May 2021, for the treatment of adult patients with MDS defined with an IPSS-R risk category of high- or very high-risk in combination with HMAs1.