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]).

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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.

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.

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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/

Follow us @DebiopharmNews at View Source

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

On September 3, 2019 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing IPI-549, a potentially first-in-class immuno-oncology product candidate that selectively inhibits phosphoinositide-3-kinase gamma (PI3K-gamma), reported that management will be participating in the following two upcoming conferences this month (Press release, Infinity Pharmaceuticals, SEP 3, 2019, View Source [SID1234539227]):

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Wells Fargo 2019 Healthcare Conference: Adelene Perkins, Infinity’s Chief Executive Officer, will present at Wells Fargo Securities14th Annual Healthcare Conference on Wednesday, September 4, 2019, at 1:50 p.m. ET at the Westin Copley Place in Boston, MA. A live webcast of the presentation will be available on the Investors/Media section of Infinity’s website at www.infi.com and will be available for 30 days following the event.

Morgan Stanley 17th Annual Global Healthcare Conference: Infinity’s management team will participate in the Morgan Stanley 17th Annual Global Healthcare Conference on Wednesday, September 11, 2019, at the Grand Hyatt New York, New York.

On September 3, 2019 Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, reported that the company will present at three conferences in New York in the first half of September 2019 (Press release, Oramed Pharmaceuticals, SEP 3, 2019, View Source [SID1234539226]).

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RHK Capital 4th Annual Disruptive Growth Conference
Date: September 4, 2019
Time: 2:00 p.m.
Location: 599 Lexington Avenue, New York, NY
Presenter: Estee Yaari, Director, Corporate Communications

H. C. Wainwright 21st Annual Global Investment Conference
Date: September 9, 2019
Time: 9:10 a.m.
Location: Lotte New York Palace Hotel, New York
Presenter: Nadav Kidron, CEO

The Future of Healthcare Panel Discussion
Date: September 12, 2019
Time: 6:00 p.m.
Location: SOSA NYC
Presenter: Nadav Kidron, CEO

On September 3, 2019 Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") reported that Company management will participate at the following upcoming investment conferences in September (Press release, Intech Pharmaceuticals, SEP 3, 2019, https://www.prnewswire.com/news-releases/intec-pharma-to-participate-in-september-investment-conferences-300910451.html [SID1234539225]).

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HC Wainwright 21st Annual Global Investment Conference
Date: September 8-10, 2019
Company Presentation: Monday, September 9, 2019 at 4:40 pm (Eastern time)

Location: Lotte New York Palace Hotel, New York City
Presenter: Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma
Format: Corporate presentation and One-on-One Investor Meetings

Ladenburg Thalmann 2019 Healthcare Conference
Date: September 24, 2019

Company Presentation: September 24, 2019 at 11:30 am (Eastern time)
Location: Sofitel, New York City
Presenter: Walt Linscott, Chief Business Officer
Format: Corporate presentation and One-on-One Investor Meetings

Both presentations will be webcast live and will be accessible through the Events section of Intec Pharma’s website at www.intecpharma.com, where they will also be archived for a period of time.