Orion Biotechnology Reports Additional Positive Preclinical Data for OB-002 in the Treatment of Colorectal Cancer

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."

Onxeo Expands its Pipeline with New Optimized Lead OX401 Entering Proof-of-Concept Preclinical Phase

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.

Arvinas to Present at the BMO Prescriptions for Success Healthcare Conference

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.

Actinium’s Portfolio of Antibody Radiation-Conjugates to be Highlighted in Two Oral and Two Poster Presentations at the 2019 Society of Nuclear Medicine and Molecular Imaging Annual Meeting

On June 20, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported its presence at the upcoming SNMMI or Society of Nuclear Medicine and Molecular Imaging 2019 Annual Meeting being held June 22nd – 25th in Anaheim, California (Press release, Actinium Pharmaceuticals, JUN 20, 2019, View Source [SID1234537190]). In total, two oral and two poster presentations highlighting Actinium’s programs will be presented at SNMMI. In addition, Actinium’s Chief Scientific Officer, Dr. Dale Ludwig, will participate in a panel at the Ac-225 User Group at SNMMI to discuss the use of the radioisotope Ac-225 or Actinium-225 produced by the of U.S. Department of Energy via a high-energy linear accelerator. Actinium has demonstrated feasibility in generating ARC’s or Antibody Radiation-Conjugates with linear accelerator produced Ac-225.

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Actinium’s lead program, Iomab-B, which is being studied in the pivotal Phase 3 SIERRA trial, will be highlighted in two oral presentations at SNMMI. The two oral presentations will focus on the dosimetry of Iomab-B, which is used to tailor personalized doses for each patient in the SIERRA trial. Dosimetry allows for high levels of the isotope I-131 or Iodine-131 to be delivered in a patient specific doses, which has facilitated engraftment in all patients that received Iomab-B and a BMT or Bone Marrow Transplant in the first 25% of patients enrolled in the SIERRA trial. In addition, findings from a multi-center team suggest that dosimetry imaging optimization may be possible with Iomab-B, which could result in benefits for patients and treatment centers including a reduction in the number and time required for imaging.

The two poster presentations will highlight Actinium’s AWE or Antibody Warhead Enabling Technology Platform that Actinium utilizes to empower its pipeline of ARC’s. A poster will highlight the ARC comprised of the anti-CD38 antibody daratumumab, which is marketed as Darzalex by Johnson & Johnson for patients with Multiple Myeloma, labeled with the radioisotope actinium-225. In addition, a poster presentation will highlight Actinium’s expansion of its Iomab-ACT for lymphodepletion prior to CAR-T and other adoptive cell therapies. Actinium’s Iomab-ACT program, which is a lower dose of Iomab-B, is intended to eliminate chemotherapy based conditioning agents such as Flu/Cy or Fludarabine and Cyclophosphamide. The poster will highlight the use of the radioisotope Lu-177 or Lutetium-177 with an anti-CD45 antibody, which has the potential to expand the radioisotope warheads that Actinium can utilize to achieve lymphodepletion prior to CAR-T and other adoptive cell therapies with its ARC’s. The poster at SNMMI will be the first time that Actinium is presenting data on the use of Lu-177 with a CD45 targeting moiety.

Details of the SNMMI presentations are as follows:

Oral Presentations:

Session Title: SS51: Other Solid Tumors/ Hematologic Malignancies (Clinical) I
Date & Time: Tuesday, June 25th, 8:00 AM – 9:30 AM
Location: Room 202AB, Anaheim Convention Center

Publication 433
Presenter: Neeta Pandit-Taskar MD, Memorial Sloan Kettering Cancer Center
Time: 9:10-9:20 AM
Title: Optimizing Dosimetry Imaging in High dose Radioimmunotherapy Using the Novel, AntiCD45 Reinduction and Targeted Conditioning Agent Iodine (131I) Apamistamab [IomabB] in Patients 55 Years or Older with Active, Relapsed or Refractory Acute Myeloid Leukemia (SIERRA Phase III Trial)

Publication 434
Presenter: Neeta Pandit-Taskar MD, Memorial Sloan Kettering Cancer Center (on behalf of first author Landis Griffeth MD, Baylor University Medical Center)
Time: 9:20-9:30 AM
Title: Personalized Dosimetry using 131I-anti-CD45-Apamistamab (Iomab-B) Prior to High-dose Myeloablative Radioimmunotherapy for Hematopoietic Stem Cell Transplant (HCT) in Active, Relapsed, or Refractory Acute Myelogenous Leukemia: Novel Re-induction and Targeted Conditioning Feasibility and Engraftment Results from the SIERRA Trial

Poster Presentations:

Session Title: MTA I: Oncology, Basic and Translational (Basic Science) Posters
Date & Time: Monday, June 24th, 3:00 PM – 4:30 PM
Location: Poster Hall, Exhibit Hall, Anaheim Convention Center

Poster 1410
Presenter: Dr. Ekaterina Dadachova, University of Saskatchewan
225Ac-CD38 antibody targeting is effective and well tolerated in experimental models of lymphoma and multiple myeloma

Poster 1420
Presenter: Dr. Dale Ludwig, Actinium Pharmaceuticals, Inc.
Modeling targeted lymphodepletion with 177Lu-radiolabeled CD45 antibody as a preparative regimen prior to adoptive cell therapy

Ac-225 User Group at SNMMI
Date and Time: Sunday, June 23rd 4:00 – 5:00 PM PT
Location: Platinum Ballroom Salon 3 in Anaheim Marriott

AbbVie Declares Quarterly Dividend

On June 20, 2019 The board of directors of AbbVie Inc. (NYSE: ABBV) reported a quarterly cash dividend of $1.07 per share (Press release, AbbVie, JUN 20, 2019, View Source [SID1234537189]).

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The cash dividend is payable August 15, 2019 to stockholders of record at the close of business on July 15, 2019.

Since the company’s inception in 2013, AbbVie has increased its dividend by 168 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.