Actinium Pharmaceuticals to Present at the Sachs 19th Annual Biotech in Europe Forum for Global Partnering & Investment

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

LIPAC Oncology and Huons Co. Announce Exclusive Licensing Agreement for TSD-001 in Korea

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."

Varian Names Chief Medical Officer for Interventional Oncology

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.

Glenmark Receives Orphan Drug Designation for GBR 1342, a Bispecific Antibody Candidate Under Evaluation for the Treatment of Multiple Myeloma

On September 16, 2019 Glenmark Pharmaceuticals (Glenmark), a research-led, integrated global pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its bispecific antibody candidate GBR 1342 for the treatment of patients with multiple myeloma who have received prior therapies (Press release, Glenmark, SEP 16, 2019, View Source [SID1234539569]). Derived from the company’s proprietary BEAT (Bispecific Engagement by Antibodies based on the T cell receptor) technology, GBR 1342 is being investigated for the treatment of multiple myeloma. The candidate is one of five clinical-stage assets in the pipeline of Glenmark’s new innovation company.

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GBR 1342 is designed to bind to both CD3 on T cells and CD38, an antigen known to be implicated in hematological malignancies, on target cells. This activates T cells and redirects them toward CD38+ tumor cells found in multiple myeloma. Once directed at the right target, the T cells help destroy the tumor cells.

A first-in-human, open-label, Phase 1 trial of GBR 1342 in multiple myeloma, is ongoing to assess the safety and tolerability of increasing doses of GBR 1342, and will also evaluate biomarkers, immunogenicity, and additional measures of disease activity.

"Patients who are struggling with diseases like multiple myeloma are seeking new treatment options and innovative approaches. We believe the focus of our new company is essential to these patients and to the healthcare system," said Alessandro Riva, MD, CEO of the new company. "As one of our first important pipeline milestones, we are excited that the FDA has recognized the potential for GBR 1342 to offer a significant advancement for patients with multiple myeloma."

Multiple myeloma is a rare blood disorder in which plasma cells in the bone marrow become malignant and replicate unchecked.1 The malignant plasma cells can displace normal blood cells in the body, leading to anemia and uncontrolled bleeding.1 It can also cause issues with bone density and strength, as well as lead to an increased risk of infection by lowering the body’s immune response.1

More than 32,000 new cases of multiple myeloma are expected to be diagnosed in 2019 in the U.S.2 During that same time, about 13,000 people are expected to die from the disease.2

The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.

Pfenex to Present at the Cantor Healthcare Conference

On September 16, 2019 Pfenex Inc. (NYSE American: PFNX), a clinical-stage development and licensing biotechnology company focused on leveraging its Pfēnex Expression Technology to improve protein therapies for unmet patient needs, reported that Eef Schimmelpennink, President and Chief Executive Officer, will be presenting at the Cantor Healthcare Conference on Thursday, October 3rd, taking place at the Intercontinental Hotel in New York City, October 2nd through 4th (Press release, Pfenex, SEP 16, 2019, View Source [SID1234539602]).

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Cantor Healthcare Conference

Date: Thursday, October 3, 2019

Time: 10:05 a.m. Eastern Time

Interested parties can access the live audio webcast and archive from the Investors Section of Pfenex’s website at www.pfenex.com.