On February 20, 2019 ADC Therapeutics, an oncology drug discovery and development company that specializes in the development of proprietary antibody drug conjugates (ADCs), reported that the first patient has been dosed in a Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumor activity of ADCT-402 (loncastuximab tesirine) in combination with Pharmacyclics LLC’s ibrutinib in patients with advanced diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) (Press release, ADC Therapeutics, FEB 20, 2019, View Source [SID1234596064]).

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ADCT-402, an ADC designed to target and kill CD19-expressing malignant B-cells, is also being evaluated in an ongoing pivotal Phase II clinical trial in patients with relapsed or refractory (R/R) DLBCL and a Phase I clinical trial in combination with IMFINZI (durvalumab) in patients with multiple types of R/R non-Hodgkin lymphoma. Ibrutinib, a small-molecule inhibitor of Bruton’s tyrosine kinase that is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc., is a mediator of the B-cell-receptor signaling pathway implicated in the pathogenesis of B-cell cancers. Ibrutinib is approved for use in patients with R/R MCL and has shown some activity in R/R DLBCL.

Jay Feingold, MD, PhD, Chief Medical Officer and Senior Vice President of Clinical Development at ADC Therapeutics, said, "At the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, the data we presented from our 183-patient first-in-human clinical trial of ADCT-402 demonstrated its encouraging safety profile and anti-tumor activity as a single agent against relapsed or refractory diffuse large B-cell lymphoma and mantle cell lymphoma. Now, in our second combination trial of ADCT-402, we look forward to exploring whether ADCT-402 and ibrutinib, both of which target B-cell cancers with different mechanisms of action, may increase the response rate and durability of response compared to the effects of these compounds as single agents."

Julien Depaus, MD, an investigator for the trial at CHU UCL Namur, Yvoir, Belgium, said, "Unfortunately, a significant number of patients with B-cell malignancies will relapse after initial treatment. As the prognosis for these patients is poor, it is important to evaluate potential viable new treatments for relapsed or refractory diffuse large B-cell lymphoma and mantle cell lymphoma, such as the combination of ADCT-402 and ibrutinib we are studying in this Phase I trial."

The open-label, single-arm trial will include a dose-escalation part, followed by a dose-expansion part. The dose-expansion part may have up to two cohorts, one for DLBCL and one for MCL, in order to obtain additional safety and preliminary anti-tumor activity information at the maximum tolerated dose. Approximately 60 patients will be enrolled in the trial. For more information, please visit www.clinicaltrials.gov (identifier NCT03684694).

ADCT-402 Interim First-in-Human Data

Updated data from the ongoing 183-patient Phase I clinical trial of ADCT-402 were presented at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. In a subpopulation of 139 evaluable patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who had failed or were intolerant to established therapies, ADCT-402 demonstrated manageable toxicity. At doses >120 μg/kg, the overall response rate (ORR) was 43.3 percent (55/127 patients with DLBCL), comprising 23.6 percent complete responses and 19.7 percent partial responses. In a subgroup of 15 patients with mantle cell lymphoma (MCL), ADCT-402 demonstrated manageable toxicity, and ORR was 46.7 percent (7/15) and median duration of response was not reached after a median follow-up time of 8.7 months.

About ADCT-402

ADCT-402 (loncastuximab tesirine) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody that binds to human CD19, conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer toxin. Once bound to a CD19-expressing cell, ADCT-402 is internalized into the cell where enzymes release the PBD-based warhead. CD19 is a clinically validated target for the treatment of B-cell malignancies. The PBD-based warhead has the ability to form highly cytotoxic DNA interstrand cross-links, blocking cell division and resulting in cell death. ADCT-402 is being evaluated in a pivotal Phase II clinical trial in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (NCT03589469), a Phase I clinical trial in combination with IMFINZI (durvalumab) in patients with R/R DLBCL, mantle cell lymphoma or follicular lymphoma (NCT03685344) and a Phase I clinical trial in combination with ibrutinib in patients with R/R DLBCL or mantle cell lymphoma (NCT03684694). The U.S. Food and Drug Administration granted orphan drug designation to ADCT-402 for the treatment of DLBCL and MCL.

On February 20, 2019 Sunstar, a multi-national healthcare company based on oral care reported the acquisition from BMG Pharma S.p.A. of the innovative cancer supportive care product, GelX (Press release, SUNSTAR Americas, FEB 20, 2019, View Source [SID1234553908]). Through this acquisition Sunstar gains global distribution of this product line, expanding its position as a global leader in the development and commercialisation of oral healthcare products, mainly marketed under the GUM brand.

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BMG Pharma S.p.A, an innovative specialty pharmaceutical company, will invest the proceeds from this transaction into the rapid development completion of a number of new patent protected products with topical, subcutaneous dermatology, osteoarthritis and oral care applications, which it will be able to offer to its network of global marketing partners.

Takeshi Kamigouchi, CEO of Sunstar Suisse SA, commented– "We are proud and excited to distribute the superior product GelX to make the difference in cancer patients’ oral conditions globally. Our purpose is to develop and provide products and services that promote mouth & body concept to extend people’s healthy lifespan and improve their quality of life. GelX is truly expected as a product that plays a key role that demonstrates we are the purpose driven company."

Marco Mastrodonato, CEO of BMG Pharma S.p.A., commented– "I have been partnering with Sunstar since 2002 with a win-win partnership in the oral care segment and at BMG are very proud to be the development and provider partner to a global oral care market leader. This is an important step for the company, bringing a strategic investment which represents a significant growth opportunity by allowing focus on the rapid completion of a number of products in our pipeline with unique propositions.

On February 20, 2019 Torque, a clinical-stage immuno-oncology company developing first-in-class Deep Primed T Cell Therapeutics to direct immune power deep within the tumor microenvironment, reported that it has entered into a clinical trial collaboration agreement with Merck (known as MSD outside of the U.S. and Canada) (Press release, Torque Therapeutics, FEB 20, 2019, View Source [SID1234553880]). The collaboration will evaluate Torque’s Deep IL-15 Primed T Cells (TRQ-1501) both as a single agent and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in a Phase 1/2 study in multiple solid tumor indications.

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"We are very excited about this clinical collaboration with Merck to evaluate the combination of KEYTRUDA with our Deep IL-15 Primed T cells," said Bart Henderson, Chief Executive Officer of Torque. "Torque’s new class of cellular immunotherapy is designed to harness the full biology of natural T cells for treating multiple solid tumors, and we believe the combination with anti-PD-1 therapy will further enhance the function of these cells by protecting them against immunosuppression in the tumor microenvironment. This combination has the potential to improve treatment outcomes for patients with solid tumors that are relapsed or refractory to currently available treatments and broaden the applications of cellular immunotherapy."

The Phase 1/2 trial will evaluate the safety, tolerability, immune biomarkers, and overall response rates achieved with TRQ-1501 in combination with KEYTRUDA in two groups of patients:

Patients with melanoma, non-small cell lung cancer, bladder cancer, renal cell carcinoma, and head and neck cancer who are relapsed or refractory to checkpoint inhibitor therapy (anti PD-1/PD-L1 inhibitor treatment)
Patients with advanced or metastatic ovarian cancer or sarcoma who are relapsed or refractory to standard-of-care treatments
Torque will conduct the trial at multiple clinical sites in the U.S. and expects to commence the combination arm of the study with KEYTRUDA later this year.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA.

About TRQ-1501
Torque is developing a new class of Deep-Primed cellular immunotherapy designed to overcome the key challenges limiting broad use of cellular therapy in oncology, including the capability to target tumors that express multiple heterogeneous antigens, the ability to overcome the immunosuppressive microenvironment that shuts down T cell function, and the need for outpatient treatment with a high margin of safety. Torque uses its Deep-Priming technology to develop multi-targeted, antigen-primed T cells that carry surface-anchored immune-stimulatory drugs to drive a full immune response within the tumor microenvironment against tumors with heterogenous antigens. TRQ-1501 is an investigational immune cell therapy produced from a patient’s own T cells, which are primed to be active against multiple tumor-associated antigens and loaded with Deep IL-15 (a multimer of IL-15 cytokine) anchored to the T cells’ surface.

About Torque’s Deep-Primed Immune Cell Therapy Platform
Torque’s Deep-Priming platform uses advanced cell process engineering to:

prime and activate T cells to target multiple tumor antigens and
tether immune-stimulatory drugs to the surface of these multi-target T cells to direct immune activation in the tumor microenvironment
using a proprietary technology platform, without genetic engineering, for a high margin of safety.
Deep-Primed T cells both target multiple tumor antigens and pharmacologically activate an immune response with anchored cytokines. This process does not require genetic engineering of the T cells and so preserves the natural T cell receptor for delivering a regulated immune response, with the potential for a high margin of safety. In addition to antigen priming, immunomodulators are tethered to the surface of Deep-Primed T cells—initially IL-15 and IL-12 cytokines, and TLR agonists—that activate both innate and adaptive immunity. Administering these immunomodulators systemically to a patient can cause lethal toxicity by activating immune cells throughout the body. By loading precise doses of cytokines onto the surface of T cells, Deep Priming focuses the immune response to target the tumor, without systemic exposure.

In hematologic cancers, this new class of immune cell therapeutics has the potential to improve on the initial success of single-target CAR T therapeutics with expanded efficacy and also move cell therapy treatment out of the hospital with a high margin of safety. For solid tumors, Deep-Primed T cells have the potential to enable efficacy against tumors with heterogeneous antigens protected by hostile microenvironments, which are not readily addressable with the first generation of immune cell therapies.

On February 20, 2019 Nordic Nanovector ASA (OSE: NANO) reported that it will report its fourth quarter and full year 2018 results on Wednesday, 27 February 2019 (Press release, Nordic Nanovector, FEB 20, 2019, View Source [SID1234553482]).

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A presentation by Nordic Nanovector’s senior management team will take place at 8:30 am CET at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: AKER

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2018 from 7:00 am CET the same day.

On February 20, 2019 Sapreme Technologies, a privately-held biotech company developing a technology platform to enable the cytosolic delivery of macromolecule therapeutics, reported that it has been awarded a 6.8 M€ grant together with a multidisciplinary consortium including 11 other academic and industrial parties (Press release, Sapreme Technologies, FEB 20, 2019, View Source com/201902201890/sapremetechnologies-in-a-6-8-m-eu-alliance-to-develop-an oligonucleotide-delivery-platform-based-on-its-proprietary-endosomal-escape-enhancers.html [SID1234538878]). The grant was provided by the European Union (EU) through Horizon 2020 to develop a non-viral based gene therapy using Sapreme’s proprietary endosomal escape enhancers.

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Ruben Postel, CSO of Sapreme Technologies, "We are pleased to see that the EU has recognized the great potential of the ENDOSCAPE project and the expert multi-disciplinary consortium developing a novel oligonucleotide delivery technology for treatment of cancer and haemophilia patients"

Ernst Geutjes, acting Managing Director, "The fact that the EU awarded the proposal with the maximum score demonstrates the potential of Sapreme’s proprietary endosomal escape enhancement technology as well as the exceptional quality of the proposal and the consortium spearheaded by Sapreme and Charité – Universitätsmedizin Berlin"