On September 12, 2018 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that the first patient has been enrolled in the Phase I dose escalation and expansion study (STELLAR-001*) evaluating IPH5401 in combination with durvalumab (Imfinzi), an anti-PD-L1 immune checkpoint inhibitor, for the treatment of patients with solid tumors, including non-small-cell lung cancer (NSCLC) with secondary resistance to prior immuno-oncology (IO) treatment and IO-naïve hepatocarcinoma (HCC) (Press release, Innate Pharma, SEP 12, 2018, View Source [SID1234529425]).

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"We are pleased to have started the first clinical study for IPH5401," commented Pierre Dodion, Chief Medical Officer of Innate Pharma. "Despite significant recent advances in immunotherapy, immune escape of tumor cells remains a major challenge. We believe that IPH5401 has a high potential for cancer patients in multiple indications and could play an important role in PD-1/PD-L1 combination strategies for patients who are non-responsive, have a poor response or who have stopped responding to PD-1/PD-L1 immunotherapies."

Both durvalumab and IPH5401 are cancer immunotherapies, a potent class of treatments that use the body’s own immune system to help fight cancer. Durvalumab blocks PD-L1 interactions with PD-1 and CD80, countering the tumor’s immune-evading tactics and inducing an immune response. Preclinical findings suggest that C5aR blockade increases immune-mediated tumor killing and efficacy of checkpoint inhibitors (CRI-CIMT-EATI-AACR ICI 2017, poster #B184). Complement cascade factor 5a (C5a), secreted by tumor cells, attracts and stimulates C5aR-overexpressing myeloid-derived suppressor cells (MDSC) and neutrophils in the tumor microenvironment. Part of the innate immune system, these types of cells promote tumor growth by secreting inflammatory mediators, immunosuppressive cytokines and angiogenic factors. They potently suppress T and NK cells and hamper the activities of PD-1/PD-L1 checkpoint blockers.

The two-part study design includes an initial dose escalation phase to explore three doses of IPH5401 in combination with durvalumab in selected solid tumors. The first cohort will include a two-week run-in period evaluating the safety of IPH5401 prior to performing the combination dosing. At the highest dose of IPH5401, two dosing schedules will be evaluated. The recommended dosing regimen will then be used in the subsequent expansion part of the study in NSCLC with secondary resistance to IO and IO-naïve HCC; both tumors constitute patient populations with a high unmet medical need.

In January 2018, Innate Pharma and MedImmune, the global biologics research and development arm of AstraZeneca, entered into a non-exclusive clinical trial collaboration to evaluate the combination of IPH5401 and durvalumab in a Phase I study for patients with selected solid tumors. The study is conducted by Innate and the costs are equally shared by both parties.

Clinical trial sites are located in France and the US. For more information on the STELLAR-001 clinical study (NCT03665129), please visit clinicaltrials.gov.

On September 12, 2018 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported that it will host a live audio webcast at the Morgan Stanley Global Healthcare Conference in New York, NY (Press release, Teva, SEP 12, 2018, View Source;p=RssLanding&cat=news&id=2367115 [SID1234529445]).

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What: Teva Presentation at the Morgan Stanley Global Healthcare Conference in New York, NY.

Who: Michael McClellan, Chief Financial Officer

When: Friday, September 14, 2018 at 9:20am (ET)

Where: Teva’s Investor Relations website at ir.tevapharm.com. The webcast can also be accessed through the following URL: https://cc.talkpoint.com/morg007/091218a_as/?entity=140_5NHE0JF

How: Register for the event approximately 10 minutes before the scheduled start time. An archive of the webcast will be available on Teva’s Investor Relations website.

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 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 Personalis, Inc., a leading provider of advanced genomic sequencing and analytics to support the development of personalized cancer vaccines and other next-generation cancer immunotherapies, reported that they are scheduled to present at the 3rd Annual Rational Combinations 360o event in Philadelphia, PA on September 13, 2018 at 1:50 PM ET (Press release, Personalis, SEP 12, 2018, View Source [SID1234529427]).

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The presentation, entitled "Demystifying Tumor Immunogenomics: Key Challenges and Solutions," will discuss how the Personalis ACE ImmunoID Platform overcomes the limitations associated with conventional NGS approaches that are used in the preclinical and clinical development of new oncology therapeutics.

ACE ImmunoID is a universal immunogenomics platform, purpose-built for modern precision oncology applications, combining highly-sensitive exome and transcriptome sequencing with advanced analytics. The platform provides a multidimensional view of the tumor, its microenvironment, as well as its repertoire of tumor-specific neoantigens.

The Personalis presentation will be delivered by Erin N. Newburn, PhD, Associate Director, Field Applications Scientist.