On July 18, 2019 Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of solid tumors, reported it has received the approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with a Phase 1/2a clinical trial of TG6002 administered by intrahepatic artery (IHA) infusion in colorectal cancer patients with unresectable liver metastases (CRLM) (Press release, Transgene, JUL 18, 2019, View Source [SID1234537599]).

TG6002 is a next-generation oncolytic virus (OV), which has multiple mechanisms of action. It has been engineered to combine the killing of cancer cells (oncolysis), the production of 5-FU, a widely used chemotherapeutic agent, in the tumor site, and the eliciting of an immune response against tumor cells. TG6002 expresses the proprietary FCU1 gene in the cancer cells it has infected, leading to local conversion of the pro-drug 5-FC (administered orally) into 5-FU. This is particularly important as most gastrointestinal tumors are 5-FU sensitive. TG6002 has been shown to induce both response in the primary tumor and an immune-mediated regression of distant metastases in preclinical experiments1.

"Current systemic therapies prolong survival of CRLM patients at the cost of significant side effects. We believe that TG6002 therapy administered via an IHA infusion potentially offers an additional effective and well tolerated treatment modality for these difficult to treat patients. By administering it via the intrahepatic artery, we believe we can conveniently deliver more concentrated doses of TG6002 to the tumor, to achieve better outcomes for unresectable colorectal cancer, whilst limiting systemic exposure. In parallel, Transgene is conducting a Phase 1/2 trial to investigate TG6002 in colorectal cancer patients when given intravenously," said Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene.

Dr. Adel Samson, MB ChB PhD, Medical Oncologist at St. James’ University Hospital, is the Chief Investigator of the trial.
This trial is a single-arm open-label Phase 1/2a trial evaluating the safety, pharmacokinetics and efficacy of repeated and ascending doses of TG6002 administered by IHA route in combination with oral 5-FC, a non-cytotoxic pro-drug that can be converted in 5-FU. The study is expected to start in Q4 2019 and could enroll up to 75 patients.

— End–

About TG6002
TG6002 is a next generation oncolytic immunotherapy. It has been designed to induce the breakdown of cancer cells (oncolysis) and allow the local production of chemotherapy (5-FU) in the tumor. TG6002 is a modified Vaccinia virus, with double gene deletion (TK-RR-), and expressing the proprietary FCU1 gene in the cancer cells it has infected, leading to the local conversion of the non-cytotoxic pro-drug, flucytosine (5-FC), into 5-FU, a widely used cancer chemotherapy. The oncolytic virus TG6002 has shown efficacy and good safety profile in several preclinical models. Transgene believes that TG6002 may represent a new therapeutic option in recurrent cancer patients.
Another Phase 1/2 trial using TG6002 administered intravenously is ongoing in Europe in patients with advanced gastrointestinal tumors.

About Colorectal cancer
Colorectal cancer (CRC) is the second most commonly diagnosed cancer in Europe and a leading cause of death both in Europe and worldwide. In 2012, there were 447,000 new cases of CRC in Europe with 215,000 deaths and worldwide, there were 1.4 million new cases with 694,000 deaths (Ferlay J. et al., 2013, Ferlay J. et al., 2015). Approximately half of all CRC patients develop liver metastases, only a small proportion of whom being suitable for potentially curative hepatic resection (Leporrier J, 2006). Over the last decade, the clinical outcome for patients with metastatic CRC (mCRC) has improved. Today, the median overall survival (OS) for patients with mCRC is ∼30 months.

On July 18, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported the appointment of Friedrich Graf Finckenstein, M.D., as chief medical officer (Press release, Iovance Biotherapeutics, JUL 18, 2019, View Source [SID1234537598]). Dr. Graf Finckenstein brings over 19 years of experience in clinical development and translational research to the company.

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"We are very pleased to have Dr. Finckenstein join Iovance as we move forward with pivotal studies for lifileucel in metastatic melanoma and LN-145 in metastatic cervical cancer," said Maria Fardis, Ph.D., president and chief executive officer of Iovance Biotherapeutics. "Dr. Finckenstein’s experience with prior approval of checkpoint therapy as well as his breadth of involvement with translational medicine will be of great value to Iovance while we progress our late-stage development programs toward commercialization and expand the utility of TIL in new indications."

"I am very pleased to be part of a dedicated team working on bringing a novel cell therapy to patients with very limited approved therapeutic options," commented Friedrich Graf Finckenstein, M.D. "I’m excited to be able to contribute to development of TIL therapy as we work on the important next steps involved in preparing for regulatory submission."

Dr. Graf Finckenstein is a physician-scientist with decades of experience in clinical medicine, laboratory cancer research, and drug development in the biopharmaceutical industry. Prior to joining Iovance he was Global Head of Oncology Translational Medicine at Roche Pharma Research and Early Development (pRED) in Basel, Switzerland, where he led all clinical development aspects in the Oncology Discovery and Translational Area, including the design and conduct of clinical trials, exploratory development studies and translational medicine, biomarker and personalized healthcare strategy. Prior to that, Dr. Graf Finckenstein held multiple clinical leadership roles at Bristol-Meyers Squibb Company, where he worked on an array of products from early clinical development to late stage, including key contributions to the approval of Opdivo in lung cancer. Dr. Graf Finckenstein has a medical degree from the University of Hamburg in Germany. He holds a German medical license, a pediatric board certification, and has conducted basic cancer research at the Ludwig Institute, San Diego Branch, the Children’s Hospital Los Angeles and the University of Hamburg.

On July 18, 2019 Immunocore Limited, a leading T cell receptor biotechnology company, and Pulse Infoframe, Inc. (Pulse), a data aggregation and analytics company, reported plans to support the first global patient registry in uveal melanoma (UM), a rare and aggressive form of melanoma, which affects the eye, typically has a poor prognosis and for which there is no currently accepted optimal management or treatment (Press release, Immunocore, JUL 18, 2019, View Source [SID1234537597]).1 The insights gained through the academic registry will provide a more comprehensive understanding of the disease and may help to shape the way future research is conducted.

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The registry will include institutions from across the US, UK and Australia, and is currently being developed by leaders in the field of uveal melanoma, including:

Richard Carvajal, MD, Director of Experimental Therapeutics and Director of the Melanoma Service at Columbia University Medical Center, Columbia University, US
Joseph Sacco, PhD, Clinical Senior Lecturer at the University of Liverpool and Honorary Consultant in Medical Oncology at Clatterbridge Cancer Centre, UK
Anthony Joshua, MBBS, PhD, Director of Cancer Services at St Vincent’s Hospital and conjoint Associate Professor with the University of New South Wales, Australia
"The rarity of uveal melanoma makes it difficult to collect the data needed to better understand how the disease manifests and evolves, and who is likely to respond to treatment and why," said Dr. Carvajal. "For the first time we’ll have the opportunity to prospectively collect and analyse global real-world data, including patient-reported outcomes. This will help to guide medical research, innovative trial design and recruitment, potentially paving the way for accelerated treatment advances."

Research generated from the registry will examine risk factors, genetics, epidemiology, treatment cost-effectiveness and real-world outcomes from a database of patients with uveal melanoma. The goal is to create a benchmark framework, or ecosystem, for collecting and assessing clinical outcomes, as well as providing necessary data for future genetic, sub-phenotype and biomarker research.

"We’re excited to be working with the research community to address the need for a more comprehensive understanding of uveal melanoma," said Mohammed Dar, MD, Head of Clinical Development and Chief Medical Officer at Immunocore. "We believe that this registry will provide critical insight that may help to advance the development of future treatments, including clinical and genetic information about potential subsets of people living with this devastating disease."

Enrolment into the registry is expected to begin in August at five sites in the US, three sites in the UK, and three sites in Australia.

"At Pulse, we strive to support the entire ecosystem that researchers, clinicians and patients require to generate the real-world evidence necessary to advance clinical outcomes, support patient advocacy and promote disease awareness," said Femida Gwadry-Sridhar, RPh, PhD, CEO and Founder at Pulse. "We are pleased to partner with Immunocore and key academic leaders on this patient registry, which will provide a detailed look into uveal melanoma from a global perspective."

About Uveal Melanoma

Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye, typically has a poor prognosis and for which there is no currently accepted optimal management or treatment.1 Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, with approximately 8,000 new patients diagnosed globally each year (1,600-2,000 cases/year in the US).1,2,3,4 Up to 50% of people with uveal melanoma will eventually develop metastatic disease.1 When the cancer spreads beyond the eye, only approximately 40% of patients will survive for one year.1

On July 18, 2019 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and theranostics, reported its consolidated first-half revenues for the period ending June 30, 2019 (Press release, Theradiag, JUL 18, 2019, View Source;utm_medium=rss&utm_campaign=theradiag-announces-first-half-revenue-up-9 [SID1234537596]).

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As of 30th June 2019, Theradiag posted first-half revenues of €5.0 million in 2019, up 9% from €4.6 million in H1 2018.

Theranostics posted a 12% growth, primarily driven by LISA TRACKER kits for routine use, for which sales exceeded €2.0 million in the first half of 2019 (vs. €1.8 million in H1 2018).

The partnership entered into with IDS during the first half, covering R&D and the exclusive distribution of TRACKER kits in 33 new countries (including Germany, Latin America and the Middle East) is well underway and is progressing according to plan. The development of the next generation of automated technologies is making progress and will allow to speed up the automation of diagnostics. This solution, providing laboratories with greater flexibility and efficiency, will further enhance Theradiag’s competitive advantage. Regarding the marketing of the innovative TRACKER range, training sessions have begun in certain priority regions, and are being rolled-out as planned.

The Diagnostic In Vitro (IVD) business posted revenue growth of 7%, amounting to €2.9 million in the first half of 2019, including significant non-recurring instrumentation sales.

"The growth recorded in the first half is encouraging, and reflects the efforts made at the start of the year to set up business agreements and continue to develop our unique range of monitoring tests. All of our actions are taken in the aim of constantly innovating and improving our tests, offering patients clinical benefits and bringing medico-economic advancements to the healthcare system. This first half has shown that when the key elements of our business model are firmly in place, we see results. We remain focused on our targets for the year: keep innovation at the heart of our positioning, prioritize growth, particularly abroad – with a focus on operations in the United States. Theradiag has confirmed its goal to continue improving its financial indicators, in order to return to profitability from the end of 2019." commented Bertrand de Castelnau, Theradiag’s Chief Executive Officer.

Pierre Morgon, Chairman of the Theradiag Board of Directors added: "The Theradiag team continues to implement its strategy of setting up partnerships focusing on theranostics. By enhancing the quality and performance of testing solutions in this segment, the company is shifting its focus towards more profitable products."

Next financial press release

Interim 2019 results on Thursday, September 19, 2019, after market close

On July 18, 2019 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00 a.m. ET on Friday, August 2, 2019 to discuss its second quarter operating results (Press release, ImmunoGen, JUL 18, 2019, View Source [SID1234537595]). Management will also provide a brief update on the business.

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CONFERENCE CALL INFORMATION

To access the live call by phone, dial +1-323-794-2093; the conference ID is 9100112. The call may also be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the webcast, a replay of the call will be available at the same location through August 16, 2019