On September 12, 2018 Surefire Medical, Inc. (Surefire) reported the company is changing its name to TriSalus Life Sciences to better reflect the company’s contribution to patient care (Press release, Surefire Medical, SEPT 12, 2018, View Source [SID1234529409]). TriSalus is focused on developing drug delivery technology for use in solid tumors and improving the administration of immuno-oncology (IO) therapies.

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"The re-naming of our company to TriSalus Life Sciences reflects an important step in our journey to build a leading oncology drug delivery company," said TriSalus CEO Mary Szela. "As researchers identify more ways to fight cancer, successful outcomes for patients are increasingly being defined by three strategic pillars for oncology treatment: the administration of the right therapeutic, the stimulation of the immune system, and equally important: a targeted delivery system to augment the therapeutic index."

TriSalus derives from the Roman goddess Salus, who represents health, prosperity, safety and welfare, while tri, represents the three strategic pillars of integrated cancer treatment. "The new name inspires our organization to make a meaningful difference for patients undergoing cancer treatment," added Szela.

The name change is one of many milestones supporting the transformation of the company. In 2018, the company:

Advanced its pipeline of drug delivery therapies with plans to launch its next-generation platform in 2019
Presented interim data from a national patient registry showing high tumor response rates among hepatocellular carcinoma patients treated with the company’s Pressure-Enabled Drug Delivery (PEDD) technology
Published a paper in the Journal of Vascular and Interventional Radiology indicating that further development of chimeric antigen receptor T cells (CAR-T) therapy should be done in combination with novel devices to allow for regional delivery of therapy into solid tumors
Closed a $5 million convertible note and initiated plans for Series E funding of $25 million to support investment in the company’s technology in combination with immuno-oncology therapy
About Pressure-enabled Drug Delivery (PEDD)

The high intratumoral pressure created by the tumor microenvironment limits the flow and accumulation of therapy in solid tumors. Pressure-Enabled Drug DeliveryTM (PEDD) can improve drug delivery to the tumor by creating a favorable pressure gradient that penetrates the hostile tumor microenvironment and increases drug concentration in the tumor without increasing systemic toxicity. Locoregional infusion with the company’s patented technology has been used in nearly 8,000 procedures worldwide for liver cancer and can be applied to a variety of other high-pressure solid tumors.

On September 12, 2018 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing Pentarins as a new class of potent and selective medicines to treat a wide range of cancers, reported the appointment of Jeffrey D. Bloss, M.D., as Chief Medical Officer (Press release, Tarveda Therapeutics, SEPT 12, 2018, View Source [SID1234529408]). In addition, the company strengthened its clinical leadership team with the appointment of Steven A. Hamburger, Ph.D. as Vice President, Regulatory Affairs and Laura Mei as Vice President, Clinical Operations.

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"We are very pleased to have Jeff join Tarveda at this exciting time for our Company. Jeff brings deep expertise and over two decades of experience leading the clinical development and medical affairs of oncology programs at both biotech and pharmaceutical companies. His track record of success, including taking numerous oncology drug programs through development and approval, will be invaluable to Tarveda as we continue to advance our two clinical stage drug programs and pipeline," said Drew Fromkin, President and Chief Executive Officer of Tarveda. "Further, with the additions of Laura and Steve leading Clinical Operations and Regulatory Affairs, respectively, we have greatly strengthened our ability to optimize and execute the development of our two current clinical programs as well as future pipeline opportunities."

In the second quarter of 2018, Tarveda announced the initiation of the Phase 2a expansion portion of its Phase 1/2a trial for PEN-221 in patients with somatostatin receptor 2-expressing neuroendocrine tumors and small cell lung cancer. In the same quarter, Tarveda also announced the commencement of the dose escalation portion of its Phase 1/2a trial for PEN-866 in patients with solid malignancies.

"I am pleased to join Tarveda and am impressed with the novel approach of our new class of selective and potent miniature conjugates as well as by the clinical data from our two clinical stage drug programs," said Dr. Jeffrey Bloss. "Both PEN-221 and PEN-866 have the potential to dramatically improve the treatment of patients with solid tumors by leveraging the small size of the conjugates to rapidly penetrate deep into solid tumors while leading to the prolonged accumulation of their potent therapeutic payloads in the tumor versus healthy tissues. I am eager to advance the clinical development of both clinical stage drug programs and look forward to working side by side with Laura, Steve and the entire team to fully explore the potential of our drugs in treating patients with cancer."

Jeffrey D. Bloss, M.D., Chief Medical Officer
During his career encompassing more than 25 years in oncology, Dr. Bloss has held many leadership roles and has been responsible for the development, approval and commercialization of over ten successful oncology drugs including Gemzar, Tarceva, Sorafenib, Tykerb, Xtandi and others. Prior to joining Tarveda, Dr. Bloss served as Chief Medical Officer and Senior Vice President, Medical Affairs at Aegerion. He has also held senior level positions at Astellas, GlaxoSmithKline, Xencor, Onyx, Genentech, and Eli Lilly. Before joining the biotech industry, Dr. Bloss held a series of roles of increasing responsibility at the University of Missouri, Ellis Fischel Cancer Center and at the USAF Medical Corps. He holds an M.D. from Thomas Jefferson University Medical College and a B.S. from Juniata College. Dr. Bloss completed his Residency in Obstetrics & Gynecology at Wilford Hall USAF Medical Center and his Fellowship in Gynecologic Oncology at the University of California, Irvine.

Steven A. Hamburger, Ph.D., Vice President, Regulatory Affairs
Prior to joining Tarveda, Dr. Hamburger served as Vice President, Regulatory Affairs and Quality Assurance at BERG. He has led global regulatory efforts for both biotech and large pharmaceutical companies including Castle Creek Pharmaceuticals, Baxalta and Immunomedics. Dr. Hamburger has also held senior regulatory positions at Millennium/Takeda, Johnson & Johnson, Eli Lilly, and Zeneca Pharmaceuticals. He has had significant involvement in the development and/or global registration of many drugs including Krystexxa, Onivyde, Oncaspar, Velcade, Alimta, DOXIL and Accolate. Dr. Hamburger holds a Ph.D. in Pharmacology and Toxicology from Indiana University School of Medicine, an M.S. from Butler University and a B.S. from the University of Iowa.

Laura Mei, Vice President, Clinical Operations
Prior to joining Tarveda, Ms. Mei served as Executive Director, Global Clinical Operations and Metabolic Franchise Head at Alexion Pharmaceuticals. She has also held management positions at several biotech and pharmaceutical companies including Senior Director, Clinical Operations at Synageva Biopharma, Senior Director, Clinical Operations and GCP Compliance at Alexza Pharmaceuticals and Associate Director, R&D Compliance at Biogen. Ms. Mei holds a B.A. in physics and zoology from Connecticut College.

About Pentarins
Tarveda is developing Pentarins, potent and selective miniature drug conjugates with high affinity for specific cell surface and intracellular targets. Pentarins are engineered to bind to their tumor cell targets and provide sustained release of their potent therapeutic payloads deep into solid tumor tissue. Comprised of a targeting ligand conjugated to a potent cancer cell killing agent through a tuned chemical linker, Pentarins are designed to overcome the deficits of both larger antibody drug conjugates and small molecules that limit their therapeutic effectiveness against solid tumors. Together, the components of Tarveda’s Pentarins have distinct, yet synergistic, anticancer attributes: the small size of Pentarins allows for rapid and deep penetration into the tumor tissue, the ligand’s targeting ability allows for specific binding and retention in tumor cells, and the chemical linker is tuned to optimize the release of the potent, cell killing payload inside the cancer cells for efficacy.

On September 12, 2018 Novocure (NASDAQ:NVCR), a global oncology company developing a proprietary platform technology called Tumor Treating Fields, and Zai Lab (NASDAQ:ZLAB), a Shanghai-based innovative biopharmaceutical company, reported an exclusive license agreement for Tumor Treating Fields, including the brand name Optune, in Greater China and a global strategic development collaboration (Press release, NovoCure, SEPT 12, 2018, View Source [SID1234529407]). This agreement will enable Novocure to access the Chinese market and is intended to accelerate clinical trial enrollment. For Zai Lab, this agreement will add a complementary commercial stage oncology asset to its innovative pipeline.

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"The Zai Lab team is passionate about bringing innovative treatments to patients in need, a passion we share at Novocure," said Novocure’s Executive Chairman Bill Doyle. "We believe this collaboration supports our mission of making Tumor Treating Fields available to patients throughout the world and will accelerate the development of Tumor Treating Fields in indications beyond glioblastoma (GBM)."

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. Tumor Treating Fields is currently marketed under the brand name Optune in the U.S., the EU, Switzerland, Japan and certain other countries for the treatment of GBM and is in advanced clinical development for multiple solid tumor indications. Novocure reported trailing 12-month revenues from Optune of $217 million as of June 30, 2018, representing 60 percent year-over-year revenue growth Q2 2018 versus Q2 2017. While Optune is not yet approved for commercialization in China, the technology was included and recommended with Level 1 evidence as a treatment for GBM in China’s Glioma Treatment Guideline published in 2016.

"There are approximately 45,000 newly diagnosed GBM patients annually in China," said Lvhua Wang, Associate Director of China National Cancer Center and Vice President of China Society of Clinical Oncology. "Temozolomide is currently the only approved therapy for GBM in China so there are limited choices for one of the most deadly cancers. I am eagerly anticipating Tumor Treating Fields approval in China."

Novocure granted Zai Lab an exclusive license to commercialize Tumor Treating Fields in China, Hong Kong, Macau and Taiwan. Zai Lab will be responsible for regulatory submissions in Greater China and will work to establish Tumor Treating Fields as an oncology treatment in this territory.

Preclinical and clinical research demonstrated that Tumor Treating Fields’ mechanism of action affected fundamental aspects of cell division and may have broad applicability across a variety of solid tumors. In addition to GBM, Novocure and Zai Lab will collaborate on development activities for Tumor Treating Fields in multiple solid tumor indications, including Novocure’s ongoing phase 3 pivotal trials in non-small cell lung cancer (NSCLC) and pancreatic cancer, and a phase 3 pivotal trial in ovarian cancer planned to open later this year. In addition, Zai Lab will conduct a phase 2 pilot trial to investigate Tumor Treating Fields in gastric cancer in China. China has one of the highest incidence rates of gastric cancer in the world, with approximately 680,000 new cases annually. Gastric cancer is the second leading cause of cancer death in men and women in China.

"Optune has demonstrated strong efficacy in a very challenging and difficult to treat cancer, GBM," said Dr. Samantha Du, CEO of Zai Lab. "Optune was approved in Japan without the need for a local bridging trial and we hope for similar rapid development in China. In addition, Tumor Treating Fields has the potential to treat a variety of solid tumors, which we believe are complementary to Zai Lab’s existing late-stage oncology assets and represent strong commercial synergy for us."

Novocure will receive a $15 million upfront payment and is eligible to receive additional payments upon achievement of certain development, regulatory and commercial milestones. Novocure is also eligible to receive a royalty on net sales of the licensed products in Greater China ranging from 10 percent to the mid-teens.

China Renaissance served as sole financial advisor to Novocure for the transaction.

On September 12, 2018 Celltrion, Inc. (KRX:068270) reported that the U.S. Food and Drug Administration (FDA) has scheduled the Biologics License Application (BLA) for CT-P10, a proposed monoclonal Antibody (mAb) biosimilar to Rituxan1 (rituximab), for discussion by the Oncologic Drugs Advisory Committee (ODAC) on October 10, 2018 (Press release, Celltrion, SEPT 12, 2018, View Source [SID1234529405]). Rituxan is a Biogen and Genentech USA, Inc.’s rituximab product.

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The ODAC reviews and evaluates data concerning the safety and effectiveness of investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.

"We are fully committed to preparing for this advisory committee meeting and look forward to the discussion about CT-P10," said Woosung Kee, Chief Executive Officer of Celltrion. "The development of biosimilars is of great importance in the field of oncology, and has the potential to enrich our therapeutic arsenal and to increase accessibility to therapies for patients at an affordable price."

Celltrion and Teva Pharmaceutical Industries, Ltd. entered into an exclusive partnership to commercialize CT-P10 in the U.S. and Canada in October 2016.

1 Rituxan is a registered trademark of Biogen and Genentech USA, Inc.

About CT-P10

Celltrion’s CT-P10, a proposed biosimilar to Biogen and Genentech USA, Inc.’s Rituxan, is currently approved in more than 47 countries across the globe. CT-P10 is the world’s first monoclonal antibody (mAb) biosimilar approved by the European Commission (EC) for the treatment of oncology and launched in Europe in 2017. The final U.S. prescribing information for CT-P10 will include the specific uses for which the product is indicated in the U.S. Rituximab, the active substance in CT-P10, has been designed to bind specifically to the transmembrane protein CD20 found on both malignant and normal B cells

On September 12, 2018 Propanc Biopharma, Inc. (OTCQB: PPCB) ("Propanc Biopharma" or the "Company"), a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors, such as pancreatic, ovarian and colorectal cancers, reported that the Company received a positive reception after presenting at the prestigious 25th Annual NewsMakers in the Biotech Industry Conference last Friday, September 7th, at the Millennium Broadway Hotel and Conference Center in New York, as well as certain business updates discussed below (Press release, Propanc, SEPT 12, 2018, View Source [SID1234529404]). Management wishes to thank their gracious hosts at BioCentury for the opportunity to present at the prestigious conference, where only 45 companies were handpicked to present their stories to institutional investors in the biotech sector.

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The presentation was well attended, where James Nathanielsz, the Chief Executive Officer of the Company, discussed recent scientific advancements of its lead product candidate, PRP, and its ability to suppress the cancer stem cell population, which the Company plans to submit for publication to a peer reviewed scientific journal.

"We have demonstrated using both in vitro (cell line) and in vivo (animal) data that PRP effectively suppresses cancer stem cells ("CSCs") by suppressing key genes, which are critical to controlling their population and reducing the risk of tumor recurrence, clinically. Furthermore, we discovered a key gene target for drug developers, Rac1B, which increased as a result of PRP treatment. This gene suppresses cellular motility and proliferation of CSCs by ultimately inhibiting TGF-β, a known growth factor responsible for tumorigenesis and metastasis," said Mr. Nathanielsz. "We remain excited by these important discoveries, as suppressing the CSCs population whilst avoiding potential unwanted side effects towards normal stem cells means we have a targeted therapy that can control the spread of cancer. Metastasis, or spreading cancer, remains the main cause of patient death from cancer."

During the presentation at the conference, Mr. Nathanielsz explained the current anticipated timelines for commencing the Company’s engineering run and full scale GMP manufacturing batch of PRP, emphasising that management’s focus was to identify a suitable source of capital as it prepares for filling its drug product for clinical trials, as well as the goal of reducing the Company’s debt on the balance sheet by increasing equity investment. Management was pleased to receive interest at the conference and is currently looking into potential financing options with its advisors and investment banking team.

In addition, Mr. Nathanielsz met with Zack’s Small Cap Research during the conference, to discuss and evaluate the strength of the Company’s intellectual property portfolio, which management believes is greatly undervalued in comparison to other cancer stem cell companies, taking into consideration the Company’s recent advancements of two patents into national phase (i.e. the approval process for a patent within a jurisdiction from an individual patent office), with a third patent entering national phase in key global regions later this year.

"We wish to assure our shareholders that we are working extremely diligently to identify potential suitable sources of capital to support the growth of the Company, including advancing our lead product, PRP, as well as strengthening our balance sheet, as we look to progress towards commencing a first-in-human study of PRP. Presenting at the NewsMakers Conference was a fantastic opportunity to present to sophisticated healthcare investors managing billions of dollars in their portfolios, who understand the space we’re in, and appreciate the uniqueness of our technology. We will continue to provide shareholder updates as we progress with our goals," continued Mr. Nathanielsz.

The Company’s presentation was filed as an exhibit to the Company’s Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission on September 7, 2018, and is also available on the Company’s website at View Source

To view Propanc Biopharma’s "Mechanism of Action" video on anti-cancer product candidate, PRP, please click on the following link: View Source

To be added to Propanc Biopharma’s email distribution list, please click on the following link: View Source and submit the online request form.