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 Mitra Biotech reported a partnership with Glenmark Pharmaceuticals focused on advancing Glenmark’s proprietary immuno-oncology drug pipeline utilizing Mitra’s CANscript platform (Press release, Mitra Biotech Pvt, SEP 12, 2018, View Source [SID1234529416]).

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CANscript is a human, immune-relevant ex vivo platform that allows drug developers to understand drug performance in human tissue, which in turn allows for an informed approach to clinical development and patient response. CANscript recreates the in vivo tumor microenvironment, maintaining the heterogeneity of the tumor while preserving its immune compartment. This uniquely positions the platform to provide drug developers with answers to mechanistic questions about their immuno-oncology drug candidates and prioritize the most promising candidates for advancement into clinical trials.

"Glenmark recognizes the value of Mitra’s unique CANscript platform to support translational and clinical studies, especially in immuno-oncology and with newer modalities like bispecific antibodies," said Venkat Reddy, Senior Vice President and Global Head of Translational Sciences at Glenmark Pharmaceuticals. "We are pleased to have access to proprietary technology from Mitra to assist us in accelerating understanding of the clinical relevance and potential utility of our T cell engagers (GBR1302 and GBR1342) in human biopsies. We are confident that this partnership will benefit our clinical programs."

The CANscript platform delivers powerful treatment response predictions with exceptionally high correlation to clinical outcomes for a more effective and efficient cancer drug development approach. CANscript has been validated using thousands of cancer patient cases, with a published 90% overall correlation1 between the platform’s treatment predictions and actual clinical outcomes.

"We are very pleased that Glenmark has selected us as a trusted partner to advance their immuno-oncology pipeline," said Andrea Jackson, Vice President, Biopharma at Mitra. "CANscript is already enabling Glenmark improve their decision-making around their portfolio as they move these molecules into the clinic."

Glenmark’s immuno-oncology pipeline currently includes three bispecific monoclonal antibody (bsAb) candidates being studied in a wide range of tumor types. GBR 1302, a HER2xCD3 bsAb and GBR 1342, a CD38XCD3 bsAb are currently in Phase 1; and GBR 1372, an EGFRxCD3 bsAb, is in preclinical development.

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.