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Friday, June 12, 2020

Thermo Fisher facing potential speed bump in Qiagen deal

Stephane Mardel, CEO of investment and advisory group United First Partners, tells Bloomberg that Thermo Fisher Scientific (TMO +1.2%) may have to boost its €39-per-share offer for Qiagen (QGEN -0.6%) after proxy advisor Glass Lewis recommended voting against “Top Up” resolutions.
TMO may have to sweeten its bid in order to ensure that enough QGEN shares are tendered. The current threshold is 75%.
The risk of the deal not going through appears minimal however.
https://seekingalpha.com/news/3582697-thermo-fisher-facing-potential-speed-bump-in-qiagen-deal

ADC’s lonca shows encouraging action in blood cancer studies

ADC Therapeutics SA (ADCT +0.8%) announces positive data from two clinical trials evaluating antibody-drug conjugate loncastuximab tesirine (lonca) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The results were virtually presented at EHA.
Interim data from the open-label, single-arm Phase 2 LOTIS 2 study assessing lonca monotherapy showed a 48.3% (n=70/145) overall response rate (ORR), including a 24.1% (n=35/145) complete response rate.
Patients who failed to respond to first-line or last-line prior therapy showed ORRs of 37.9% and 36.9%, respectively.
Median duration of response increased to 10.3 months from 6.7 months in mid-October 2019.
The most common serious/life-threatening treatment-emergent adverse events were neutropenia (25.5%) with low incidence of febrile (fever) neutropenia (3.4%), thrombocytopenia (17.9%), GGT increase (enzyme biomarker for liver damage) (16.6%) and anemia (10.3%).
Preliminary data from the open-label, single-arm Phase 1/2 LOTIS 3 trial evaluating the combination of lonca and AbbVie and J&J’s Imbruvica (ibrutinib) showed an ORR of 75.0% and a CR of 58.3% at the recommended Phase 2 dose.
The most common treatment-emergent adverse events were thrombocytopenia (20%) and anemia (12%).
A Phase 3 trial, LOTIS 5, is next up.
https://seekingalpha.com/news/3582683-adcs-lonca-shows-encouraging-action-in-blood-cancer-studies

X4 Pharma’s mavorixafor action positive in rare immune deficiency disorder

X4 Pharmaceuticals (XFOR +3.5%) announces results from an open-label Phase 2 extension study evaluating lead candidate mavorixafor in patients with WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome, a rare inherited immune deficiency disorder caused by mutations in a gene that encodes a protein called CXCR4. The data were virtually presented at EHA.
Sustained dose-dependent increases in white blood cells, neutrophil count and lymphocyte count were achieved which correlated with fewer infections and reduced numbers of warts. Specifically, yearly infection events dropped from 4.63 to 2.27 while the number of warts dropped by an average of 75%.
On the safety front, mavorixafor, a small molecule inhibitor of CXCR4, was well-tolerated over periods of two years or more without serious treatment-related adverse events.
A Phase 3 study is in process. Topline data should be available in 2022.
https://seekingalpha.com/news/3582669-x4-pharmas-mavorixafor-shows-positive-action-in-rare-immune-deficiency-disorder

Cost of cancer care projected to rise 34% by 2030

The cost of cancer-related care is projected to increase 34 percent in the next decade, according to a study published in Cancer Epidemiology, Biomarkers & Prevention.
Researchers looked at 13 years of cancer statistics from the Surveillance, Epidemiology, and End Results Medicare database and used claims from 2007 to 2013 to estimate costs by cancer site, phases of care and stage of diagnosis. Overall cancer care costs, including medical care and oral prescriptions, were $183 billion in 2015, and researchers project that number will increase to $246 billion by 2030, based only on population growth.
The study revealed considerable variation in costs by cancer site and stage. Researchers found that costs at the end-of-life stages were highest at $105,500 per patient per year, followed by the initial phases at $41,800.
https://www.beckershospitalreview.com/oncology/cost-of-cancer-care-projected-to-rise-34-by-2030.html

Sierra Oncology’s momelotinib shows long-term benefit in myelofibrosis

Sierra Oncology (SRRA +7.2%) announces long-term safety and dose intensity data on momelotinib, a JAK1, JAK2 and ACVR1 inhibitor, in more than 550 myelofibrosis patients. The results were presented at EHA.
Over periods as long as 10 years, increases in hemoglobin levels were sustained compared to decreases in those receiving Incyte’s Jakafi (ruxolitinib). Higher mean platelet counts were also observed in patients receiving momelotinib.
No new safety signals or evidence of cumulative toxicity have been observed, including patients receiving full-dose momelotinib.
https://seekingalpha.com/news/3582652-sierra-oncologys-momelotinib-shows-long-term-benefit-in-myelofibrosis

Takeda’s ixazomib successful in late-stage multiple myeloma study

Takeda Pharmaceutical Company Limited (TAK +1.8%) announces results from two clinical trials evaluating Ninlaro (ixazomib) in multiple myeloma (MM) patients. The results were presented at EHA.
The Phase 3 TOURMALINE-MM4 study assessing Ninlaro alone as first-line maintenance therapy in MM patients not treated with stem cell transplant met the primary endpoint demonstrating a statistically significant improvement in progression-free survival (PFS) versus placebo with 34% (hazard ratio = 0.66) less risk of cancer progression or death. Specifically, median PFS in the treatment arm was 17.4 months compared to 9.4 months in the control arm. Overall survival, a secondary endpoint, has not yet matured.
Updated data from the US MM-6 study showed an increase in response rate to 70% from 62% in MM patients receiving Velcade (bortezomib) who switched to Ninlaro-based treatment.
Ninlaro, combined with lenalidomide and dexamethasone, is approved for relapsed/refractory MM in more than 65 countries.
https://seekingalpha.com/news/3582634-takedas-ixazomib-successful-in-late-stage-multiple-myeloma-study

Imara reports positive IMR-687 data in sickle cell disease

Imara (IMRA -13.6%presents interim results from its ongoing Phase 2a clinical trial of IMR-687 in adult patients with sickle cell disease (SCD) at the 25th European Hematology Association Annual Congress.
The data demonstrated that IMR-687, a highly selective and potent small molecule inhibitor of PDE9 was safe and well tolerated as a monotherapy and in combination with hydroxyurea (HU).
In the higher dose cohort, IMR-687 monotherapy showed a statistically significant (p=0.022) increase in the number of F-cells, which are red blood cells containing fetal hemoglobin (HbF) compared to placebo after 24 weeks of dosing.
A dose-dependent increase in HbF levels in adult patients with SCD in the monotherapy arm was also observed.
IMR-687 was well tolerated. There was no hypotension or neutropenia observed in either the monotherapy or combination arms.
https://seekingalpha.com/news/3582642-imara-reports-positive-imrminus-687-data-in-sickle-cell-disease