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

On July 18, 2019 Diplomat Pharmacy, Inc. (NYSE: DPLO), reported that it will release its second-quarter 2019 operating results before market open Friday, August 9. A conference call and live webcast will be held at 8:30 a.m. ET (Press release, Diplomat Speciality Pharmacy, JUL 18, 2019, View Source [SID1234537594]).

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Shareholders and interested participants can listen to a live broadcast by calling 833.286.5805 (647.689.4450 for international callers) and entering participation code 7394702, starting about 15 minutes before the call. A live webcast of the conference call will be available on the investor relations section of Diplomat’s website at ir.diplomat.is. The site will host an audio recording and supplemental investor information for 90 days.

On July 18, 2019 CTI BioPharma Corp. (Nasdaq: CTIC) ("CTI" or "the Company") reported the outcome of a Type B, End-of-Phase-2a meeting with the U.S. Food and Drug Administration ("FDA" or "the Agency") for the continued development of its investigational myelofibrosis treatment candidate, pacritinib (Press release, CTI BioPharma, JUL 18, 2019, View Source;p=RssLanding&cat=news&id=2404063 [SID1234537593]). Following this meeting, CTI plans to evaluate 200 mg of pacritinib administered twice daily (BID) in 180 patients with myelofibrosis and severe thrombocytopenia. The Company plans to initiate the Phase 3 PACIFICA study in the third quarter of 2019.

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"We are pleased to be able to move the pacritinib program forward and are now in the process of finalizing an amendment to the PAC203 protocol, which the FDA will review, to allow a transition to the new PACIFICA Phase 3 study, in which we plan to compare the 200 mg BID dose of pacritinib to Physician’s Choice in myelofibrosis patients with severe thrombocytopenia, an important unmet medical need," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "We anticipate initiating the trial in the third quarter, which would put us on track for topline Phase 3 data in mid-2021."

The randomized, open-label Phase 2 PAC203 dose-finding study was designed to evaluate the safety and efficacy of three dosing regimens of oral pacritinib in 150 patients with myelofibrosis. The Company expects topline safety and efficacy results from the Phase 2 portion of the PAC203 study in the third quarter of 2019 and is targeting presentation of the Phase 2 results at a scientific conference before the end of 2019.

The previous Phase 3 PERSIST program consisted of the PERSIST-1 trial, which was conducted in a broad set of patients without limitations on platelet counts, and the PERSIST-2 trial, which was conducted in patients with low platelet counts. An ad-hoc analysis of pooled data from PERSIST-1 and PERSIST-2 evaluated results from patients with platelet counts of less than 50,000 per microliter and showed that 23% (n=104) of patients administered pacritinib had a ≥35% spleen volume reduction (SVR), compared to 2% (n=48) (p=0.0007) given the best available therapy, which in the PERSIST-1 trial excluded JAK2 inhibitors and in the PERSIST-2 trial included the approved JAK2 inhibitor, ruxolitinib. The most common treatment-emergent adverse events of any grade occurring in 20% or more of patients treated with pacritinib within 24 weeks during the PERSIST-1 and PERSIST-2 trials were gastrointestinal (generally manageable diarrhea, nausea and vomiting) and hematologic (anemia and thrombocytopenia).

The Company is currently amending the protocol for the ongoing Phase 2 PAC203 study to include the new PACIFICA Phase 3 portion, in which CTI intends to compare the safety and efficacy of 200 mg of pacritinib administered twice daily to Physician’s Choice in 180 myelofibrosis patients with severe thrombocytopenia (platelet counts of less than 50,000 per microliter) at approximately 120 sites worldwide. Patients will be randomized in a ratio of 2:1 between pacritinib and Physician’s Choice. The primary endpoint of the trial is the percentage of patients who achieve at least 35% reduction in spleen volume at week 24. Dr. Srdam Verstovsek, Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, and Dr. John Mascarenhas, Associate Professor of Medicine Myeloproliferative Disorders Program, Tisch Cancer Institute, Mount Sinai School of Medicine, will be co-principal investigators in the PACIFICA study. In addition, Professor Claire Harrison, Professor of Medicine, Guy’s and St Thomas’ NHS Foundation Trust, London, will chair the study’s Steering Committee.

About Myelofibrosis and Severe Thrombocytopenia
Myelofibrosis is a type of bone marrow cancer that results in formation of fibrous scar tissue and can lead to severe anemia, weakness, fatigue and an enlarged spleen and liver. Patients with severe thrombocytopenia are estimated to make up more than one-third of patients treated for myelofibrosis, or approximately 18,000 people.1 Severe thrombocytopenia, defined as blood platelet counts of less than 50,000 per microliter, has been shown to result in overall survival rates of just 15 months.2 Thrombocytopenia in patients with myelofibrosis is associated with the underlying disease but has also been shown to correlate with treatment with ruxolitinib, currently the only approved treatment for myelofibrosis, which can lead to dose reductions and as a result may potentially reduce clinical benefit. Survival in patients who have discontinued ruxolitinib therapy is further compromised, with an average overall survival of seven to 14 months.3,4 There are currently no approved therapies available to treat myelofibrosis patients with severe thrombocytopenia, or patients who have failed ruxolitinib treatment, thereby making this a significant unmet medical need.

About Pacritinib
Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in conditions such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and chronic lymphocytic leukemia (CLL), due to its inhibition of c-fms, IRAK1, JAK2 and FLT3.