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Exicure to Present at Upcoming Investor Conferences

On September 3, 2019 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported presentations at the following investor conferences during the months of September and early October (Press release, Exicure, SEP 3, 2019, View Source [SID1234539232]):

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H.C. Wainwright 21st Annual Global Investment Conference
Corporate update
Presented by: CEO David Giljohann
Monday, September 9, 2019 at 10:25am ET
Location: New York, NY
Ladenburg Thalmann 2019 Healthcare Conference
Corporate update
Presented by: CEO David Giljohann
Tuesday, September 24, 2019 at 1:30pm ET
Location: New York, NY
Chardan’s 3rd Annual Genetic Medicines Conference
Corporate update
Presented by: Dr. David Giljohann
Monday, October 7, 2019 at 2:00pm ET
Location: New York, NY

The Next Big Thing in Genetic Medicines
Panelist: Dr. David Giljohann
Tuesday, October 8, 2019 at 9:30am ET
Location: New York, NY
An audio webcast will be available on the Investors section of Exicure’s website: www.exicuretx.com. The webcast will be archived for approximately 30 days following the event.

Macrophage Pharma Appoints Dr Søren Bregenholt as Chief Executive Officer

On September 3, 2019 Macrophage Pharma Limited (‘MPL’), a company focused on the discovery and development of next-generation immunomodulatory small molecules inducing transcriptional reprofiling of macrophages to combat cancer and other diseases, reported that it has appointed Dr Soren Bregenholt as Chief Executive Officer (Press release, Macrophage Pharma, SEP 3, 2019, View Source [SID1234539231]).

Commenting on the appointment, Dr Michael Moore, Chairman of Macrophage Pharma, said: "The Board is delighted to have attracted Søren to Macrophage Pharma. Soren’s outstanding track record from executive positions in both biotech and pharma, as well as his extensive expertise and insight in immunology, will be invaluable as we further develop and commercialise our proprietary Esterase Sensitive Motif (ESM) platform and evolve Macrophage Pharma into a leading biotech company."

Dr Søren Bregenholt, CEO of Macrophage Pharma, said: "I am excited to join Macrophage Pharma as CEO. The Company’s unique and proprietary ESM technology platform is a compelling strategy for inducing transcriptional reprofiling of monocytes and macrophages and represents a differentiated approach to modulation of a centrally important regulator of the immune response across a variety of human diseases. I look forward to working with management and Board to unlock the full therapeutic and commercial potential of the technology in both cancer and non-cancer fields."

Søren Bregenholt PhD is a Danish national with an extensive operational and strategic track record from the biotech and pharmaceutical industries. He previously held senior executive roles including COO and CBO at Danish biotech companies Symphogen and IO Biotech, respectively. As part of the global R&D Management at Novo Nordisk, Søren was responsible for the global R&D Strategy and External Innovation efforts. Currently, Søren serves as Chairman of the Board at the Danish-Swedish life science organization Medicon Valley Alliance. His academic career, at the University of Copenhagen and Institute Pasteur, Paris, has focussed on immunoregulation and immunopathology in cancer and other diseases.

Selvita to Present at Upcoming Conferences in September

On September 3, 2019 Selvita (WSE: SLV) reported that Pawel Przewiezlikowski, Chief Executive Officer, will present at the following conferences in New York (Press release, Selvita, SEP 3, 2019, View Source [SID1234539230]):

Event: H.C. Wainwright 21st Annual Global Investment Conference, Sept. 8-10, 2019
Location: Lotte New York Palace Hotel
Date/Time: Monday, Sept. 9, at 5:30 p.m. EDT
Webcast: A live and archived webcast of this presentation will also be made available at View Source

Event: Rambam Foundation Life Sciences Symposium, Sept. 10, 2019
Location: The YJP Mansion
Date/Time: Tuesday, Sept. 10, at 9:15 a.m. EDT

OBI Pharma Announces U.S. FDA Clearance of IND Application for a Phase 1/2 Study of its Antibody-Drug Conjugate (ADC) targeted cancer therapy, OBI-999

On September 3, 2019 OBI Pharma, a Taiwan biopharma company (TPEx: 4174), reported that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for OBI-999 to conduct a Phase 1/2 study of its antibody drug conjugate (ADC) cancer therapy targeting Globo H, a glycolipid antigen (Press release, OBI Pharma, SEP 3, 2019, View Source [SID1234539229]).

OBI plans to enroll patients with advanced solid tumors including pancreatic, gastric, colorectal and esophageal cancers. OBI Pharma’s Chief Medical Advisor, Tillman Pearce, M.D. noted, "This clinical trial intends to verify the safety and preliminary efficacy profile of OBI-999, a novel first-in-class antibody-drug conjugate that selectively targets Globo H. We are delighted to conduct this first-in-human clinical trial at the University of Texas M.D. Anderson Cancer Center, one of America’s leading academic oncology research institutions."

Michael Chang, Ph.D., OBI Pharma Chairman and CEO, added, "OBI Pharma is excited to commence the Phase 1/2 safety and efficacy study of OBI-999, our unique anti-Globo H ADC glycolipid cancer therapy. We strive to develop and validate our novel anti-Globo H immuno-oncology pipeline to fulfill unmet medical needs of cancer patients."

About OBI-999

OBI-999 is a novel first-in-class Antibody Drug Conjugate (ADC) with a proprietary linker technology that provides a consistent Drug-to-Antibody ratio (DAR) for cancer treatment that is based on Globo H, an antigen expressed in up to 15 epithelial cancers. OBI-999 uses a Globo H antibody to target cancer cells of high Globo H expression. By releasing a small molecule chemotherapeutic drug through the specificity of the antibody, it directly deploys cytotoxic therapy at the targeted cancer cells. This Globo H targeting antibody, OBI-888, is currently in a Phase ½ clinical trial (ClinicalTrials.gov Identifier: NCT03573544) to test its safety and efficacy as an immune-oncology therapy. In pre-clinical xenograft animal models in multiple tumor types (pancreatic, lung, gastric, and breast), OBI-999 has demonstrated profound tumor shrinkage at various doses. In pre-clinical single and repeated dose toxicology studies, OBI-999 was well-tolerated, and achieved a favorable safety margin which warrants further clinical development. OBI Pharma owns global rights to OBI-999.

Debiopharm Successfully Completes Randomized Phase II Study For IAP Antagonist Debio 1143 in High Risk Head & Neck Cancer Patients

On September 3, 2019 Debiopharm (www.debiopharm.com), a Swiss biopharmaceutical company, announced positive topline results across clinical endpoints following the completion of the two-year follow-up period of its double-blind, randomized Phase II study of Debio 1143 in high-risk, previously untreated patients with locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) (Press release, Debiopharm, SEP 3, 2019, View Source;neck-cancer-patients-300910586.html [SID1234539228]). These significant results, including the primary endpoint LRC (locoregional control) being met along with prolonged PFS (progression-free survival), will be presented at the forthcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress in Barcelona in September 2019 by the lead investigator, Professor Jean Bourhis, Head of the Radio-Oncology department at the University Hospital of Lausanne, Switzerland.

This robust Phase II trial, which included 96 patients, was designed to demonstrate the efficacy and safety of this IAP antagonist, first in its class to be Phase III ready. The results support future clinical assessments of the compound in stage III-IV LA-SCCHN patients as a frontline treatment in combination with CRT.

"We initiated the Debio 1143 clinical development program to address the high unmet medical need in LA-SCCHN patients who have a poor prognosis, including those who are HPV-negative and heavy smokers. This new data strongly suggests that our product may enhance efficacy of the current standard of care for patients suffering from this particularly debilitating type of tumor."
– Angela Zubel, Chief Development Officer, Debiopharm.

In parallel with the design and initiation of a registration Phase III study, Debiopharm is actively considering potential partnerships with pharmaceutical industry leaders in order to deliver a new therapeutic option to LA-SCCHN patients as soon as possible.

Head and neck cancer is the 6th most common cancer worldwide, with a complex management strategy including the standard administration of CRT along with surgery when possible. The two main pathological causes for SCCHN are tobacco/alcohol consumption and human papillomavirus (HPV) infection. Although the standard of care improves survival and quality of life for many patients, more than half of high-risk patients, notably heavy smokers (>10 pack-years) and those with HPV-negative tumors, will relapse.

About Debio 1143
Debio 1143 is an antagonist of IAPs (inhibitor of apoptosis proteins), acting as chemo-radio-sensitizer to enhance treatment efficacy with a dual mode of action, promoting programmed cell death and fostering anti-tumor immunity. Currently in clinical development in a broad range of cancer types, the compound is being developed in combination with chemo-radiotherapy or with ICIs (PD-1/PD-L1), with reported data consistently showing a favorable safety profile. Over 200 patients have been treated so far with Debio 1143 in various indications and lines of treatment.

Trial information:

Head & neck cancers: patients.debiopharm.com/head-and-neck-cancer/
Small cell lung cancers: patients.debiopharm.com/small-cell-lung-cancer-sclc/
Gastrointestinal cancers: patients.debiopharm.com/gastrointestinal-cancers/
Gynecologic cancers: patients.debiopharm.com/gynecologic-cancer/
Debiopharm’s commitment to cancer patients
Debiopharm aims to develop innovative therapies that target high unmet medical needs in oncology. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

Visit us www.debiopharm.com/

Debiopharm Contact
Dawn Haughton – Communication Manager
[email protected]
Tel: +41 (0)21 321 01 11