On September 23, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that data from two Phase 1/2 trials were presented at the XVIII International Workshop on Chronic Lymphocytic Leukemia (iwCLL), currently being held in Edinburgh, Scotland (Press release, TG Therapeutics, SEP 23, 2019, View Source [SID1234539695]). These data were previously presented earlier this year at the 15th International Conference on Malignant Lymphoma (ICML), held in Lugano, Switzerland. Highlights from the presentations are included below.

Presentation Title: A Phase 2 Study to Assess the Safety and Efficacy of Umbralisib in Patients with Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K Delta Inhibitor Therapy

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This presentation includes data from patients with CLL who are intolerant to prior BTK or PI3K delta inhibitor therapy who were then treated with single agent umbralisib. To be eligible for the study patients had to have received prior treatment with a BTK inhibitor or a PI3K delta inhibitor and discontinued therapy due to intolerance and were in need of subsequent therapy. Fifty-one patients were evaluable for safety of which 50 were evaluable for Progression Free Survival (PFS).

Data highlights include:

Umbralisib demonstrated a favorable safety profile in patients intolerant to prior BTK (ibrutinib or acalabrutinib) or PI3K delta (idelalisib) therapy

Only 12% discontinued due to an umbralisib adverse event, of which only one patient discontinued due to a recurrent adverse event (AE) previously experienced with prior kinase inhibitor therapy (ibrutinib)

In this previously treated CLL population, 67% had a high-risk molecular / genetic marker and 6% had an ibrutinib resistance mutation, the estimated median progression free survival (PFS) was 23.5 months and overall survival (OS) not reached at a median follow-up of 15.7 months

As of the cut-off date, 58% of patients have been on umbralisib for a duration longer than their prior BTK or PI3k inhibitor

Presentation Title: Phase I/II Triple Therapy Study of Umbralisib and Ublituximab (U2) Combined with Checkpoint Inhibition in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Richter’s Transformation (RT)

This presentation includes data from patients with relapsed or refractory CLL or RT treated with the triple combination of ublituximab, umbralisib, and pembrolizumab. Patients with CLL received 2 cycles of the U2 regimen before pembrolizumab was added for an additional 4 cycles, followed by umbralisib maintenance. Patients with RT received U2 + pembrolizumab for the first 4 cycles, followed by U2 maintenance. Twenty patients were evaluable for safety (11 CLL patients and 9 RT patients) and 19 were evaluable for efficacy (11 CLL and 8 RT).

Data highlights include:

The triple combination was well tolerated, with immune mediated toxicities not appearing above what would be expected with either umbralisib or pembrolizumab alone

In this heavily pre-treated cohort with a median of 2 (1-9) prior lines of therapy:

91% (10 of 11) Overall Response Rate (ORR) in patients with relapsed/refractory CLL

83% (5 of 6) ORR in BTK refractory CLL patients, with 4 of 5 responders achieving a response to U2 alone at the patient’s first efficacy assessment, prior to the addition of pembrolizumab

38% (3 of 8) ORR in RT, with two durable complete responses; 1 subject relapsed post-CAR-T in CR for 12 months and 1 subject progressed post-transplant continuing on study in CR now 20+ months. Two additional subjects were in stable disease, one with a 49% reduction in tumor burden.

The data presentations are now available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.

On September 23, 2019 Onconova Therapeutics, Inc. (Nasdaq: ONTX), a Phase 3 stage biopharmaceutical company discovering and developing novel products to treat cancer, with a focus on Myelodysplastic Syndromes (MDS), reported that it has entered into securities purchase agreements with certain institutional and accredited investors to purchase an aggregate of 2,136,193 shares of its common stock, at a purchase price of $1.60 per share in a registered direct offering for aggregate gross proceeds of approximately $3.4 million (Press release, Onconova, SEP 23, 2019, View Source [SID1234539694]). The offering is expected to close on or about September 25, 2019, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

Onconova also has agreed that for each share of common stock purchased in the offering by an investor, a corresponding number of warrants of Onconova that were issued to such investor in February 2018 and/or April 2018, as applicable, will be amended to have a reduced exercise price of $1.60 per share and the term of exercise will be extended to December 31, 2022.

The shares of common stock are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-221684) previously declared effective by the Securities and Exchange Commission (the "SEC") on December 28, 2017. The shares of common stock may be offered only by means of a prospectus supplement that forms a part of the effective registration statement. A prospectus supplement and the accompanying prospectus relating to the offering will be filed with the SEC. Electronic copies of the prospectus supplement and the accompanying prospectus may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On September 23, 2019 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported that Brian M. Culley, Chief Executive Officer, will be presenting at the 2019 Cell & Gene Meeting on the Mesa on October 3rd, 2019 at 5:00pm Pacific Time at the Park Hyatt Aviara Resort in the BlueRock Therapeutics Ballroom in Carlsbad, CA (Press release, Lineage Cell Therapeutics, SEP 23, 2019, View Source [SID1234539693]).

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Organized by the Alliance for Regenerative Medicine, the Cell & Gene Meeting on the Mesa is a premier conference combining discussions between senior executives and top decision-makers in the industry. The program also includes presentations by the field’s most promising companies in the areas of cell therapy, gene therapy, gene editing, tissue engineering, and broader regenerative medicine technologies and extensive one-on-one partnering capabilities.

A live video webcast of all company presentations will be available at: View Source and will also be published on the conference website shortly after the event.

On September 23, 2019 Incyte (Nasdaq:INCY) reported that it will host a conference call and webcast Friday, September 27, 2019, at 11:00 a.m. EDT (5:00 p.m. CEST), to discuss updated pemigatinib data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress as well as potential future development opportunities for the product candidate (Press release, Incyte, SEP 23, 2019, View Source [SID1234539692]).

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Conference call information:

Date and Time: September 27, 2019, 11:00 a.m. EDT (5:00 p.m. CEST)

Domestic Dial-In Number: 877-407-3042

International Dial-In Number: +1 201-389-0864

Conference ID Number: 13694537

The live webcast and slides can be accessed via the Events and Presentations tab of the Investor section of www.incyte.com and will be available for replay for 30 days.

If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853 and the dial-in number for international callers is +1 201-612-7415. To access the replay you will need the conference ID number 13694537.

On September 23, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will participate in the 2019 Cantor Global Healthcare Conference in New York, NY. Dr. Helen Torley, president and chief executive officer, will represent the company in a question and answer session on Thursday, October 3 at 3:35 p.m. ET / 12:35 p.m. PT (Press release, Halozyme, SEP 23, 2019, View Source [SID1234539691]).

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A live webcast of the presentation can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 90 days following each event. To access a live webcast, please visit Halozyme’s website approximately 15 minutes prior to the presentation to register and download any necessary audio software.