On December 11, 2018 Athenex, Inc., a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, reported that its global Phase 1b clinical trial of Oraxol (oral paclitaxel plus HM30181A) plus ramucirumab (monoclonal antibody to VEGF-R2) in gastric cancer patients who failed previous chemotherapies has completed the study of the second cohort of patients (Press release, Athenex, DEC 11, 2018, View Source;p=RssLanding&cat=news&id=2380209 [SID1234532013]). The results indicated strong positive signals of efficacy and the treatment was well tolerated.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

In the first cohort of six patients treated with a 200 mg/kg dose of Oraxol, partial responses were observed in 2/6 patients (33.3%) and stable disease observed in 1/6 patient (16.7%). There was one severe adverse event (SAE) of grade-4 neutropenia in one patient who had complete recovery from this event.

Athenex now reports that for the second cohort of six patients on an escalated Oraxol dose of 250 mg/kg, partial response, according to RECIST criteria, occurred in 3 patients (50%). There was one SAE of grade-3 vomiting in one patient, who elected to withdraw from the study and subsequently had complete recovery. The Oraxol dose is currently being further escalated to 300 mg/kg in the third cohort of patients and the study is ongoing.

"We are pleased by the strong positive signals of efficacy together with a good safety profile in this Phase 1b clinical trial of Oraxol plus ramucirumab in the second-line treatment of gastric cancer patients so far and look forward to further results from the continuation of this study. The results also echoed the strong positive signal that we have observed in other clinical studies of Oraxol as monotherapy for the treatment of metastatic breast cancer," stated Dr. Rudolf Kwan, Athenex’s Chief Medical Officer.

Oraxol is a novel oral formulation of paclitaxel currently in Phase 3 clinical trial in metastatic breast cancer.

Ramucirumab, as a single agent or in combination with paclitaxel, is FDA-approved for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab is manufactured and marketed by Eli Lilly and Company under the name CYRAMZA.

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

PharmaEssentia Corp. licensed the Taiwan, Singapore and Vietnam rights of Oraxol from Athenex and is a partner in the development of Oraxol in the territory

On December 11, 2018 INmune Bio, Inc., an immunotherapy company developing treatments to reprogram the innate immune system, reported that its lead drug candidate for treatment-resistant cancers, INB03, successfully inhibited the proliferation of tumor growth in pre-clinical models of trastuzumab treatment-resistant breast cancer (Press release, INmune Bio, DEC 11, 2018, View Source [SID1234531998]). The study was conducted by Roxana Schillaci, PhD., Researcher at the Institute of Biology and Experimental Medicine (IBYME-CONICET). Dr. Schillaci presented the data during a poster presentation at the San Antonio Breast Cancer Symposium in San Antonio, Texas, on December 8th.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

In the United States, one out of eight women will develop invasive ductal carcinoma (IDC) breast cancer in their lifetime. Two of those eight will have human epidermal growth factor receptor 2 (HER2) positive breast cancer that is treated with trastuzumab, an immunotherapy targeting HER2. Primary or secondary treatment resistance is a significant clinical problem that occurs in up to half of patients receiving trastuzumab for treatment of their HER2 positive breast cancer.

"Today, the definition of trastuzumab resistant breast cancer is the progression of breast cancer while the patient is on trastuzumab therapy," said Dr. Schillaci. "Our work shows that mucin 4 (MUC4) proteins, that block trastuzumab from binding with HER2 receptors, can be used as a biomarker to predict treatment-resistance. Additionally, the data shows that trastuzumab resistance can be reversed by eliminating soluble tumor necrosis factor (sTNF) in the tumor microenvironment".

Dr. Schillaci’s work showed that expression of MUC4 protein on cancer cells predicts trastuzumab resistance. The expression of MUC4 is caused by sTNF. Dr. Schillaci used INB03 to inhibit sTNF in mice to decrease MUC4 expression and reverse trastuzumab resistance. In further work, Dr. Schillaci’s team demonstrated that women resistant to trastuzumab express MUC4 on tumor while patients sensitive to trastuzumab do not.

"The results of this study suggest a possible solution for an ongoing problem in the treatment of women with HER2 positive breast cancer – predicting and treating trastuzumab resistance", said RJ Tesi, M.D., CEO and Co-Founder of INmune Bio. "If this work is confirmed in the clinic, the addition of therapy targeting sTNF, such as INB03, may improve the treatment options for a group of women previously unable to benefit from immunotherapy with trastuzumab."

INmune Bio initiated a Phase I clinical trial of INB03 on May 23. The company’s other drug candidate, INKmune, will enter clinical trials in early 2019.

On December 11, 2018 Abbott (NYSE: ABT) reported that it will present at the 37th Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 8, 2019. Brian Yoor, executive vice president of finance and Chief Financial Officer, will present at the conference at 11 a.m. Central time (Press release, Abbott, DEC 11, 2018, View Source [SID1234532014]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

A live audio webcast of the presentation will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the presentation will be available the next day.

On December 1, 2018 BiomX Ltd., a microbiome company developing customized phage therapies, reported that it has appointed Dr. Sailaja Puttagunta, M.D., as its Chief Medical Officer (CMO) (Press release, BiomX, DEC 11, 2018, View Source [SID1234532001]). With her extensive experience in conducting Phase I to IV clinical trials, contributing to NDA submissions in anti-microbial disease areas and product launch preparations, Dr. Puttagunta will oversee BiomX’s clinical development and strategy as the company prepares to enter the clinic with its Acne and Irritable Bowel Disease (IBD) programs. The company’s Acne program is expected to enter the clinic in mid 2019, and the IBD program is expected to commence clinical trials in 2020. Dr. Puttagunta will be based in United States’ East Coast and will work closely with BiomX’s Israeli management.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Sailaja’s broad experience and knowledge of the U.S. and global drug development field will accelerate our phage therapeutics advancement toward the clinic," stated Jonathan Solomon, CEO of BiomX. "BiomX is also establishing a presence in the U.S. with Sailaja’s appointment. Her clinical expertise and extensive contacts in the medical community will help build a strong foundation for our global footprint."

"BiomX’s novel approach to targeting harmful bacteria in our microbiome, harnessing bacteria’s natural enemies, bacteriophages, bodes great promise not only due to the phages’ lethality, but also due to their high specificity, which enables not harming the beneficial bacteria," added Dr. Puttagunta. "I am looking forward to bringing this technology to the clinic where it has the potential to help patients with chronic and sometimes life-threatening diseases."

Dr. Sailaja Puttagunta, M.D., was most recently Vice President, Development at Iterum Therapeutics, a clinical-stage pharmaceutical company developing antibiotics against multi-drug resistant pathogens. Prior to Iterum, Dr. Puttagunta served as VP, Medical Affairs for Anti-infectives at Allergan from early 2015 and was the VP of Development and Medical Affairs at Durata Therapeutics, Inc. prior to its acquisition by Actavis plc. From 2006 to 2012, Dr. Puttagunta led teams within clinical development and medical affairs on various antibiotic compounds at Pfizer Inc. Dr. Puttagunta has 20 years of clinical, academic and research experience in medicine and in the sub-specialty of infectious diseases. She graduated from Gandhi Medical College in Hyderabad, India and completed her residency in Internal Medicine and a fellowship in Infectious Diseases at Yale University School of Medicine. She also holds an M.S. in Biochemistry from the New York University School of Medicine.

On December 10, 2018 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its Board of Directors has named Daniel O’Day Chairman of the Board and Chief Executive Officer, effective March 1, 2019. Mr. O’Day is currently the CEO of Roche Pharmaceuticals (Press release, Gilead Sciences, DEC 10, 2018, View Source;p=irol-newsArticle&ID=2380022 [SID1234531986]). He has held the position since 2012, and prior to that led Roche Diagnostics. His career spans three decades of diverse leadership roles across North America, Asia Pacific and Europe.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The Board has also appointed Gregg Alton as interim Chief Executive Officer for the period of January 1, 2019 until Mr. O’Day’s start date of March 1, 2019. Mr. Alton has held a number of executive positions at Gilead over the past 20 years, with experience in legal, medical affairs, policy and commercial. He previously served as general counsel and in August of this year, was appointed Chief Patient Officer.

"Following a comprehensive search, the Board became convinced that Dan is the right leader to bring Gilead into the future," said John C. Martin, PhD, Chairman, Gilead Sciences Board of Directors. "He is uniquely qualified to take on this role given his track record of success in highly scientific and competitive therapeutic areas, deep understanding of the evolving healthcare environment around the world, and unwavering commitment to driving innovation across all aspects of a business, which will serve Gilead and our stakeholders well. Additionally, Dan brings expertise and values that are aligned with our organization, and I, along with Gilead’s entire Board, am confident in his ability to work alongside our talented leadership team and deliver on our ambitious goals."

After joining Roche Pharmaceuticals in 1987, Mr. O’Day held various positions in the United States before moving to Roche headquarters in Switzerland in 1998. During his time in Switzerland, he held leadership roles in Global Marketing and Lifecycle Management. In 2001, he moved to Tokyo to become Head of Corporate Planning for Roche Pharmaceuticals in Japan and later moved to Denmark to serve as General Manager. He became President of Roche Molecular Diagnostics in California in 2006 and subsequently returned to Roche headquarters to lead the Diagnostics Division before assuming his current position. He is a member of the corporate executive committee of F. Hoffmann La Roche AG and a member of the boards of Shanghai Roche Pharmaceuticals Ltd., Roche (China) Holding, Roche Pharma Schweiz AG, Genentech, Inc., Chugai Pharmaceuticals Co., Ltd., Flatiron Health, Inc., and Foundation Medicine, Inc. Additionally, he has served as a member of the board of the European Federation of Pharmaceutical Industries and Associations. Mr. O’Day holds a Bachelor of Science in Biology from Georgetown University in Washington, D.C. and an MBA from the Columbia Business School at Columbia University in New York.

"I have long admired Gilead for its work to develop medicines that have fundamentally changed the way HIV and viral hepatitis are treated. The company has successfully grown into a global organization, providing access to people around the world, while maintaining its focus on innovative science," said Mr. O’Day. "Together with the Board, leadership team and Gilead’s 11,000 employees, I look forward to building on this in ways that I believe will – in keeping with Gilead’s mission – transform the lives of millions of individuals."

As previously announced, Dr. Martin will step down from the company’s Board of Directors, effective March 1, 2019, Mr. O’Day’s first day of employment. Also as previously announced, John F. Milligan, PhD, will step down from his role as President and Chief Executive Officer and as a member of the Board at the end of 2018.