On September 16, 2019 Rgenix, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, reported that Robert Wasserman, MD, has joined the Rgenix management team as its new Chief Medical Officer (Press release, Rgenix, SEP 16, 2019, View Source [SID1234539567]). Dr. Wasserman takes on his new role after a 20-year career that includes senior positions at large pharma companies including Roche, Novartis and Merck.

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In his new role, Dr. Wasserman will have oversight of clinical development for Rgenix’s two lead clinical programs, RGX-104 and RGX-202. In particular, he will oversee the imminent launch of a Phase 1b/2 trial of Rgenix’s lead therapy, RGX-104, a first-in-class oral LXR agonist that has demonstrated anti-tumor activity as a single agent and in combination with other therapies – including chemotherapy and checkpoint blockade – in patients with refractory cancers.

For the Phase 1b/2 trial, RGX-104 will be tested in combination with the standard-of-care regimen consisting of chemotherapy (carboplatin/pemetrexed) plus the checkpoint inhibitor immunotherapy pembrolizumab as a first-line treatment in non-small cell lung cancer (NSCLC) patients whose tumors lack expression of the PD-L1 protein (<1% expression). NSCLC patients whose tumors lack PD-L1 expression have significantly lower response rates to standard-of-care in the first line setting, and thus represent a patient population of high unmet need. Resistance to standard-of-care immunotherapy has been associated with the presence of high levels of immunosuppressive myeloid cells known as MDSCs. RGX-104 has demonstrated broad-spectrum depletion of MDSCs in refractory cancer patients – including NSCLC patients – and therefore represents a novel approach to overcome drug resistance. As part of the Phase 1b/2 trial, RGX-104 will also be tested in patients with small cell lung cancer (SCLC/HG-NET) in combination with docetaxel chemotherapy as a second line treatment.

"Bob’s vast experience in oncology and clinical research is a perfect fit for Rgenix given our expanding clinical programs and pending milestones," said Masoud Tavazoie, MD, PhD, Chief Executive Officer and co-founder of Rgenix. "As we prepare to launch Phase 1b/2 studies for our first-in-class compounds RGX-104 and RGX-202, we are eager to leverage his knowledge and expertise to help expand our efforts for patients with cancers considered to have high unmet need."

"I look forward to working with the team at Rgenix to develop novel treatments for these patients by applying the company’s unique platform technology and methodology to discover drivers of cancer growth. With its roots in strong science and its dedication to a novel approach, Rgenix’s reputation as a premier innovator in the oncology space is growing and I’m excited to be a part of such a dynamic effort at this key stage for the company," said Dr. Wasserman.

Dr. Wasserman started his career in the industry working with major pharmaceutical companies. His last large pharma appointment was at Roche, where he ended a six-year period at the company as the Chairman of the Clinical Biomarker Leadership Team and where he also served for a time as the Global Head of Oncology Translational Medicine (Early Clinical Development) for Roche Pharma Research/Early Development. Prior to Roche, he was the Deputy Global Head of Oncology Biomarkers at Novartis and, before that at Merck.

His most recent biotech role was as the Chief Medical Officer at Northern Biologics, a Canadian company developing first-in-class immuno-oncology products. He currently maintains a position as an Advisory Board Member of Sectoral Asset Management out of Montreal.

Dr. Wasserman earned his B.A. from the University of Pennsylvania and his MD from the Johns Hopkins University School of Medicine. He completed his pediatric residency and pediatric hematology-oncology fellowship training at The Children’s Hospital of Philadelphia, at the University of Pennsylvania and then was on faculty as an Assistant Professor

On September 16, 2019 AstraZeneca reported that it will unveil a series of breakthrough data across multiple cancer types in its mission to one day eliminate cancer as a cause of death at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Barcelona, Spain, 27 September to 1 October 2019 (Press release, AstraZeneca, SEP 16, 2019, View Source [SID1234539503]).

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With 63 abstracts, including 7 oral presentations, the Company will demonstrate its leadership in precision medicine and immunotherapy. Highlights include results of three Phase III clinical trials featured in the ESMO (Free ESMO Whitepaper) Presidential Symposia across three cancer types:

In lung cancer, new data from the Phase III FLAURA trial will highlight the superior overall survival (OS) benefit of Tagrisso (osimertinib) compared with previous standard-of-care (SoC) treatments erlotinib or gefitinib for patients with epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC) (Abstract #LBA5_PR). FLAURA is the first and only global Phase III trial to demonstrate a statistically-significant OS benefit in this setting.
In ovarian cancer, progression-free survival (PFS) results from the Phase III PAOLA-1 trial, including key subgroup analysis, will illustrate the benefit of adding Lynparza (olaparib) to SoC bevacizumab in the 1st-line maintenance treatment of women with advanced ovarian cancer (Abstract #LBA2_PR). PAOLA-1 is the second positive Phase III trial for Lynparza in 1st-line advanced ovarian cancer.
In metastatic castration-resistant prostate cancer (mCRPC), results from the Phase III PROfound trial will detail the improvements in radiographic PFS observed with Lynparza. Patients in the trial had progressed on prior treatment with new hormonal anticancer treatments and had mutations in homologous recombination repair (HRR) genes, such as BRCA1/2 and ATM, which are a common trait in cancer cells that can interfere with normal cell DNA repair mechanisms (Abstract #LBA12_PR). These data show the value of genomic testing beyond just BRCAm and make Lynparza the first PARP inhibitor to achieve positive Phase III results in four different cancer types (breast, ovarian, pancreatic and prostate).
Dave Fredrickson, Executive Vice President, Oncology, said: "The practice-changing data we are presenting at ESMO (Free ESMO Whitepaper) 2019 demonstrates our commitment to make prolonged survival a realistic outcome. By using biomarkers to define optimal treatment and match innovative precision medicines to the patients who can best benefit from them, our dynamic Oncology pipeline and pioneering research continue to deliver new potential medicines across multiple deadly cancers."

José Baselga, Executive Vice President, Oncology R&D, said: "At ESMO (Free ESMO Whitepaper) 2019 we will see key components of our next-generation Oncology pipeline, including innovative platform studies and early data for the next wave of therapies designed to preferentially kill cancer cells and regulate the immune response to cancer."

Improving overall survival across lung cancers

In addition to the FLAURA OS results, key presentations include:

Results from the Phase III CASPIAN trial showing improved OS with better quality of life for patients taking Imfinzi (durvalumab) in combination with SoC chemotherapy vs. SoC (Abstract #LBA89).
New data from the Phase III PACIFIC trial demonstrating that treatment benefit with Imfinzi vs. placebo was maintained regardless of the occurrence of pneumonitis (Abstract #1459PD).
An oral presentation of data from the Phase I/II 1108 study in patients with solid tumours, including NSCLC, showing that reinitiating treatment with Imfinzi restored antitumour efficacy without disease progression in previously-treated patients who had progressed after a planned treatment interruption (Abstract #1175O).
Results from the real-world ASTRIS study of EGFR T790M mutation positive advanced NSCLC patients with central nervous system (CNS) metastases (Abstract #1521P).

Breaking treatment boundaries in ovarian cancer

In addition to the PAOLA-1 results, key presentations include:

Subanalyses from the Phase III SOLO-1 trial of Lynparza in newly-diagnosed advanced ovarian cancer patients, assessing time to second subsequent therapy (Abstract #995PD), patient-reported outcomes (Abstract #996PD) and health-related quality of life (HRQoL) (Abstract #998PD).
Updated results from the Phase II MEDIOLA trial of Lynparza and Imfinzi in germline BRCAm platinum-sensitive relapsed ovarian cancer (Abstract #1191PD).
Data from the Phase II BAROCCO trial of Lynparza and cediranib with a continuous or intermittent schedule in advanced platinum-resistant ovarian cancer (Abstract #LBA58).

Establishing new therapeutic landmarks in multiple tumour types

Presentations beyond the PROfound trial results include:

Subanalyses from the Phase III POLO trial of Lynparza in germline BRCAm metastatic pancreatic cancer patients, including HRQoL (Abstract #675PD) as well as time to treatment discontinuation and time to subsequent therapies (Abstract #693P).
An oral presentation of data from the Phase Ib BISCAY trial, an adaptive, biomarker-directed platform study of Imfinzi in combination with multiple targeted therapies in metastatic bladder cancer (Abstract #902O).
Preliminary results from the Phase I PATRIOT study of ATR inhibitor AZD6738 as monotherapy in advanced solid tumours (Abstract #450PD).
Safety data from a Phase I/II trial of Imfinzi plus monalizumab, bevacizumab and SoC combination chemotherapy in patients with metastatic microsatellite-stable colorectal cancer (Abstract #1201P).
Updated results from the MEDIOLA Phase II study of Lynparza and Imfinzi in germline BRCAm metastatic breast cancer (MBC) (Abstract #1191O).

On September 16, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported that it will present at the Sachs 19th Annual Biotech in Europe Forum for Global Partnering & Investment (Press release, Actinium Pharmaceuticals, SEP 16, 2019, View Source [SID1234539551]). The forum is being held at the Congress Center Basel in Basel, Switzerland on September 25-26, 2019. The event is expected to attract more than 700 delegates from across the globe. Details of Actinium’s presentation are as follows:

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(PRNewsfoto/Actinium Pharmaceuticals, Inc.)

Date: Wednesday, September 25, 2019
Time: 4:50 PM CEST
Venue: Congress Center Basel in Basel, Switzerland
Track: F

Members of Actinium’s Executive team will be available for one-on-one meetings with conference attendees. Those interested in scheduling a meeting with Actinium may do so by contacting David Gould, MD, Senior Vice President, Corporate Development and Affairs via email at [email protected].

About the Sachs 19th Annual Biotech in Europe Forum

The 19th Annual Biotech in Europe Forum is recognized as a leading international stage for those interested in investing and partnering in the biotech and life science industry. The event draws together a cross-section of early-stage/pre-IPO, late-stage and public companies with leading investors, analysts, money managers and pharma licensing executives. Supported and designed by leading figures within Europe’s pharmaceutical and biotech industry, the event is expected to attract more than 700 delegates and over 100 presenting companies. To learn more about the event, please click here: View Source

On September 16, 2019 LIPAC Oncology LLC and Huons Co., Ltd reported that they have entered into an exclusive licensing agreement to develop, manufacture and commercialize TSD-001 for all indications in Korea (Press release, Lipac Oncology, SEP 16, 2019, View Source [SID1234539568]). Huons is making an upfront payment and future milestone payments to LIPAC based on specific development, regulatory and commercial milestones. Huons will also make double-digit royalty payments based on sales.

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TSD-001 is a proliposomal intravesical paclitaxel formulation (PLIP), currently in development for intravesical administration in the treatment of non-muscle invasive bladder cancer (NMIBC). NMIBC is a common and highly recurrent disease that can often be difficult to treat. If approved, TSD-001 would be the first chemotherapeutic agent approved by the U.S. Food and Drug Administration for this indication in almost two decades. Additional indications covered by the agreement include upper tract urothelial carcinoma, stage II/III ovarian cancer and peritoneal carcinoma.

"We are excited to potentially bring TSD-001 to patients living with bladder cancer in Korea," said Michael Oefelein, M.D., Chief Medical Officer of LIPAC. "Having treated bladder cancer for more than 23 years, it is very clear that new treatment options and more effective delivery systems could help improve both clinical outcomes and quality of life."

"This collaboration is the first of many we envisage under our global development strategy," said Will Robberts, President of LIPAC. "We believe that regional partnerships with strong companies such as Huons are essential to navigate the local subtleties of commercialization in countries outside of the United States."

The parties will form a Joint Development Committee to collaborate on the clinical development of TSD-001 in Korea and other partnering opportunities.

"We look forward to collaborating closely with LIPAC given their deep experience with TSD-001 and their proprietary proliposomal delivery platform," said Keyan UM, President and CEO of Huons. "We believe patients in Korea will benefit from a chemotherapy that targets the site of their disease."

On September 16, 2019 Varian (NYSE: VAR) has named Francis R. Facchini, M.D., FSIR, as the new chief medical officer, Interventional Oncology, reporting to Dee Khuntia, Varian chief medical officer (Press release, Varian Medical Systems, SEP 16, 2019, View Source [SID1234539552]). Effective September 3, 2019, Dr. Facchini has global responsibility for overseeing all aspects of this area including ongoing development of Varian’s innovative IO treatment offerings, clinical strategy, and helping advance the field of interventional oncology as an important pillar of patient care.

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Dr. Facchini was most recently chief medical officer and head of medical affairs for BTG Plc. where he had responsibility for developing and commercializing products targeting critical care, cancer, vascular and other disorders. Facchini previously had served as global director of Medical and Clinical Affairs for Angiodynamics, Inc. and was chief medical officer of Navilyst Medical, Inc.

"Frank will be a great addition to the Varian Medical Affairs team," said Khuntia. "He is a strategic thinker with strong business acumen and a deep understanding of this ever-changing industry. As a key opinion leader in the field of Interventional Oncology, Frank has a proven track record delivering highly creative, impactful solutions that will benefit Varian in our fight against cancer."

"Varian is known for keeping patients at the center of its thinking and developing the most advanced technologies to fight cancer," said Facchini. "Varian excels at bringing together the greatest scientists, clinicians and researchers to do great things to advance oncology treatment. This is the most ideal time in my career path to be joining this team."

Among his many academic achievements, Dr. Facchini received a Doctor of Medicine from Loyola University, Stritch School of Medicine and a BA in Philosophy from DePauw University.