On September 3, 2019 Exelixis, Inc. (Nasdaq: EXEL) reported that Michael M. Morrissey, Ph.D., the company’s President and Chief Executive Officer, will provide a corporate overview at the Morgan Stanley 17th Annual Global Healthcare Conference, which is being held next week in New York (Press release, Exelixis, SEP 3, 2019, View Source [SID1234539243]). Exelixis’ presentation has been scheduled for Tuesday, September 10, 2019 at 4:40 PM EDT / 1:40 PM PDT.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for 14 days.

On September 3, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that it has initiated an international Phase I/Ib study of HMPL-689, its novel, highly selective and potent small molecule phosphoinositide-3 kinase delta isoform ("PI3Kδ") inhibitor, in patients with relapsed or refractory lymphoma (Press release, Hutchison China MediTech, SEP 3, 2019, View Source [SID1234539194]). The first patient was dosed on August 26, 2019 in the U.S.

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The international clinical study, with sites in the U.S. and Europe, is a multi-center, open-label, two-stage study, including dose escalation and expansion, investigating the effects of HMPL-689 administered orally to patients with relapsed or refractory lymphoma. The primary outcome measures are safety and tolerability. Secondary outcomes include pharmacokinetic ("PK") measurements and preliminary efficacy such as objective response rate (ORR). The co-lead investigators of the study are Dr. Nilanjan Ghosh (Lymphoma Program Director, Levine Cancer Institute-Morehead, Charlotte, NC), and Dr. Jonathan B. Cohen (Associate Professor, Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA). Additional details may be found at clinicaltrials.gov, using identifier NCT03786926.

This study complements the ongoing Phase I/Ib dose escalation and expansion study of HMPL-689 in China (clinicaltrials.gov identifier: NCT03128164) addressing a broad range of hematological cancers. A Phase I dose escalation study in Australia in healthy adult volunteers to evaluate HMPL-689’s PK and safety profile following single oral dosing was completed in 2016 (clinicaltrials.gov identifier: NCT02631642).

About HMPL-689

HMPL-689 is a novel, potential best-in-class, highly selective and potent small molecule inhibitor targeting the isoform PI3Kδ. In preclinical PK studies, HMPL-689’s PK properties have been found to be favorable with expected good oral absorption, moderate tissue distribution and low clearance. HMPL-689 is also expected to have low risk of drug accumulation and drug-to-drug interaction and is highly potent, particularly at the whole blood level.

On September 3, 2019 TRACON Pharmaceuticals (Nasdaq:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, wet age-related macular degeneration through our license to Santen Pharmaceutical Co. Ltd., and utilizing our product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that Charles Theuer, M.D., Ph.D., President and CEO, will present at the Rodman & Renshaw 21st Annual Global Investment Conference sponsored by H.C. Wainwright in New York on Monday, September 9th, at 3:50pm EDT (Press release, Tracon Pharmaceuticals, SEP 3, 2019, View Source [SID1234539211]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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To access a live webcast of the presentation, please visit the "Events and Presentations" page within the "Investors" section of the TRACON Pharmaceuticals website at www.traconpharma.com. A replay of the webcast will be available on the website for 60 days following the event.

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 Puma Biotechnology, Inc. (Nasdaq: PBYI) reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NERLYNX (neratinib) for the treatment of breast cancer patients with brain metastases (Press release, Puma Biotechnology, SEP 3, 2019, View Source [SID1234539244]).

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"Receiving Orphan Drug Designation from the FDA signifies our continued progress and commitment to developing treatments for patients with HER2-positive breast cancer," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "Despite expanded treatment options for HER2-positive breast cancer, brain metastases in these patients represent a significant clinical challenge, as well as sources of morbidity and mortality for most of these patients. The blood-tumor penetrability of NERLYNX represents a potential treatment option for these underserved patients."

The FDA Orphan Drug Designation program grants orphan designation to investigational drugs designed to treat, prevent, or diagnose rare medical diseases or conditions that affect fewer than 200,000 individuals in the United States. Orphan designation qualifies sponsors for several key benefits and incentives, including opportunities for grant funding towards clinical trial costs, tax credits, user fee waivers, and the potential for a seven-year period of marketing exclusivity upon FDA approval of the investigational drug for the indication for which it has orphan designation.

About HER2-Positive Breast Cancer

Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.