On June 20, 2019 DURECT Corporation ("DURECT" or the "Company") (Nasdaq: DRRX) reported that it has entered into a securities purchase agreement with certain investors pursuant to which, subject to the terms and conditions expressed therein, the Company agreed to sell and the investors agreed to purchase 29,000,000 shares of common stock of the Company at a price per share of $0.52 (Press release, DURECT, JUN 20, 2019, View Source [SID1234537195]). The net proceeds, after estimated expenses of the offering payable by the Company, will be approximately $15.0 million. No placement agent or broker dealer was used or participated in the offering. The offering is expected to close on or about June 24, 2019, subject to customary closing conditions.

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A registration statement on Form S-3 (File No. 333-226518) relating to the shares of common stock to be issued in this offering was declared effective by the Securities and Exchange Commission on October 9, 2018. The offering of these securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement, copies of which can be obtained on the SEC’s website at www.sec.gov.

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

About DURECT Corporation

DURECT is a biopharmaceutical company actively developing therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. DUR-928, a new chemical entity in Phase 2 development, is the lead candidate in DURECT’s Epigenetic Regulator Program. An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival. Human applications may include acute organ injury such as Alcoholic

On June 20, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported data from four presentations, including three oral presentations and one poster presentation, at the 15thInternational Conference on Malignant Lymphoma (ICML), being held in Lugano, Switzerland (Press release, TG Therapeutics, JUN 20, 2019, View Source [SID1234537194]). Highlights from all presentations are included below.

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "We are excited by the data presented today evaluating umbralisib in patients intolerant to currently approved BTK or PI3K therapies. We believe the data presented continue to show that there are many patients in need of alternative treatment options for whom umbralisib can provide meaningful benefit." Mr. Weiss continued, "We are also pleased to present data from the combination of ublituximab + umbralisib ("U2") plus pembrolizumab in patients with relapsed/refractory CLL and Richter’s transformation. It was encouraging to see that 5 of 6 BTK refractory patients responded to therapy, with 4 of those responders achieving a rapid response to U2 alone at the patient’s first efficacy assessment prior to the addition of pembrolizumab. We are eager to initiate our clinical study of U2 plus TG-1501, our PDL1 inhibitor, in the same patient population and believe the triplet may offer the opportunity for time limited therapy in CLL."

Highlights from the oral presentations include:

Oral 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

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. Fifty-one patients were evaluable for safety of which 50 were evaluable for Progression Free Survival (PFS).

Highlights:

Umbralisib demonstrated a favorable safety profile in patients intolerant to prior BTK or PI3K delta 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
In this relapsed/refractory 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
Median overall survival (OS) has not been reached with a median follow-up of 14 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
Oral Presentation Title: Phase I/II Study of Umbralisib (TGR-1202) in Combination with Ublituximab (TG-1101) and Pembrolizumab in Patients with Relapsed/Refractory CLL and Richter’s Transformation (RT)

This oral 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 relapsed post-transplant continuing on study in CR now 20+ months
Additionally, data from the UNITY-NHL MZL cohort and data from TG-1801, the Company’s first-in-class anti-CD47-CD19 bispecific antibody, will be presented during ICML. These presentations were recaps and have been previously presented. Links to full data presentations included below.

Oral Presentation Title: Umbralisib Monotherapy Demonstrates Efficacy and Safety in Patients with Relapsed/Refractory Marginal Zone Lymphoma: A Multicenter, Open-Label, Registration Directed Phase 2 Study

Poster Presentation Title: The novel bispecific CD47-CD19 antibody TG-1801 potentiates the activity of ublituximab-umbralisib (U2) drug combination in preclinical models of B-NHL

Full schedule of data being presented at ICML:

Oral Presentation: 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
— Session Date & Time: Thursday, June 20, 2019 13:45 – 15:15 CEST
– Presentation Time: 15:00 CEST
— Session Title: Session 3 – CLL
— Location: Palazzo dei Congressi, Room A – Main Hall
— Lead Author: Anthony R. Mato, MD, Memorial Sloan Kettering Cancer Center

Oral Presentation: Phase I/II Study of Umbralisib (TGR-1202) in Combination with Ublituximab (TG-1101) and Pembrolizumab in Patients with Rel/Ref CLL and Richter’s Transformation
— Session Date & Time: Thursday, June 20, 2019 17:05 – 18:05 CEST
– Presentation Time: 17:05 CEST
— Session Title: Focus on Non-Clinical and Early Clinical Data with New Combinations
— Location: Palazzo dei Congressi, Cinema Corso
— Lead Author: Anthony R. Mato, MD, Memorial Sloan Kettering Cancer Center

Oral Presentation: Umbralisib Monotherapy Demonstrates Efficacy and Safety in Patients with Relapsed/Refractory Marginal Zone Lymphoma: A Multicenter, Open-Label, Registration Directed Phase 2 Study
— Session Date & Time: Saturday, June 22, 2019 10:15 – 11:15 CEST
– Presentation Time: 10:45 CEST
— Session Title: Focus on Indolent Non-Follicular Lymphoma
— Location: Palazzo dei Congressi, Room A and B
— Lead Author: Pierre-Luigi Zinzani, MD, University of Bologna, Institute of Hematology "L. e A. Seràgnoli"

Poster Presentation: The novel bispecific CD47-CD19 antibody TG-1801 potentiates the activity of ublituximab-umbralisib (U2) drug combination in preclinical models of B-NHL
— Session Date & Time: Wednesday, June 19 (12:00-17:00 CEST), Thursday, 20 (9:00-17:00 CEST) and Friday, June 21 (9:00-18:30 CEST)
— Location: Palazzo dei Congressi, Marquee Parco Ciani
— Lead Author: Marcelo Lima Ribeiro, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Autonomous University of Barcelona, Barcelona, Spain
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 June 20, 2019 Orion Biotechnology Canada Ltd., reported new preclinical data evaluating the efficacy of OB-002 (5P12-RANTES) in colorectal cancer (Press release, Orion Biotechnology, JUN 20, 2019, View Source [SID1234537193]). BALB/c mice were inoculated subcutaneously with the CT-26 colorectal cancer cell line. Seven days after inoculation, the mice were randomized to receive intraperitoneal treatment with OB-002, a murine anti-PD-1 antibody, an anti-CTLA-4 antibody, OB-002 + an anti-PD-1, OB-002 + an anti-CTLA-4, or OB-002 + an anti-PD-1 + an anti-CTLA-4, or a saline placebo. The OB-002 and the saline placebo were administered five times per week, and the anti-PD-1 and anti-CTLA-4 antibodies were given every third day. Treatment with OB-0020 or the anti-PD-1 antibody alone led to equivalent delayed tumor growth at multiple time-points. An even more profound effect on the decrease in mean tumor volume was observed when animals received combinations of OB-0020 and the anti-PD-1 or anti-CTLA-4 antibodies.

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"These data confirm and build upon previous experiments conducted in the CT-26 model. This is impressive, as treatment was only started seven days after implantation of the tumour cells. This new study clearly demonstrates that OB-002 has activity alone, or in combination with other immunotherapy agents, in the treatment of colorectal cancer and provides guidance as to how future clinical trials should be designed," said Dr. Ian McGowan, Chief Medical Officer for Orion Biotechnology.

Mark Groper, President and CEO of Orion Biotechnology, added, "We are delighted by these new data that confirm and extend our initial observations on the activity of OB-002 in colorectal cancer and provide a compelling rationale for moving this unique product into clinical trials as quickly as possible."

On June 20, 2019 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR) in oncology, in particular against rare or resistant cancers, reported that its new optimized drug candidate, OX401, has started its proof-of-concept preclinical phase (Press release, Onxeo, JUN 20, 2019, View Source [SID1234537192]). Results of these studies are expected by early Q4 2019.

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OX401 was designed by capitalizing on Onxeo’s expertise of oligonucleotides acting as decoy agonists and exhibits very original properties. During optimization, OX401 has demonstrated that it inhibited the DNA Damage Response by acting on PARP proteins. In parallel, OX401 activated the STING pathway, a recent and promising field of research in immuno-oncology, which makes it amenable to combinations with immuno- oncology agents such as checkpoint inhibitors.

A comprehensive patent has been filed for OX401 to protect Onxeo’s intellectual property rights on this product, alone and in combination with cancer immunotherapies, until 2039.

Françoise BONO, scientific director, commented: "This new development program represents a significant milestone for Onxeo, as it expands our R&D pipeline and prominently positions the Company at the crossroads of two of the most active fields in oncology, DNA damage response and cancer immunotherapy. Based on the experience and insights gained during the development of AsiDNA, our first-in-class DNA repair inhibitor, we have developed and optimized OX401 to maintain its unique mechanism of action, while targeting other DNA-binding proteins and other mechanisms of tumor growth, such as the immune response. OX401 could represent a new generation of PARP inhibitors that do not have the limitations of current products, such as the induction of resistance, while providing improved biological properties, especially the activation of innate immunity within tumors."

While the clinical relevance of PARP inhibitors is now well-established, this class still has a number of limiting factors, particularly the relatively rapid onset of resistance. Its decoy agonist mechanism of action positions OX401 as a next-generation PARP inhibitor that should not present these limitations and instead offer a lack of acquired resistance and more specificity to cancer cells.

OX401 was also developed to induce a strong immune response through the activation of the STING pathway, an area of significant interest in immuno-oncology. However, current molecules have experienced challenges, notably in terms of toxicity. OX401 is based on the same decoy agonist mechanism as AsiDNA , Onxeo’s first-in-class DNA repair inhibitor, which showed good tolerance in the DRIIV-1 Phase 1 study, and should trigger a rapid and significant inducing effect of innate immunity against tumor cells.

Preclinical proof-of-concept results showing OX401 efficacy, alone and in combination with immunotherapy treatments, are expected early Q4 2019.

On June 20, 2019 Arvinas Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on protein degradation, reported that Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the BMO Prescriptions for Success Healthcare Conference on Tuesday, June 25 at 2:00 p.m. ET in New York, NY (Press release, Arvinas, JUN 20, 2019, View Source [SID1234537191]).

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A live audio webcast of the presentation will be available here and at www.arvinas.com on the Events page. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation.