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In Brief This Week: PreludeDx, Lucid Diagnostics, Sumitomo, AnHeart, Salarius, Syros

NEW YORK –  PreludeDx said this week that it has entered into an agreement with the Three Rivers Provider Network to offer its DCISionRT test to the network’s 200 million members. The test is intended to determine disease recurrence risk and radiation therapy benefit in patients with ductal carcinoma in situ. The proprietary provider network includes more than 5,000 hospitals and 75,000 ancillary facilities. 


Lucid Diagnostics said this week that its laboratory, LucidDx Labs, has entered into participating provider agreements with preferred provider organizations Prime Healthcare, Three Rivers Provider Network, and Galaxy Health Network, along with specialized diagnostic laboratory network Alivio Health. Patients covered by the clients of the four networks will be able to access Lucid’s EsoGuard DNA test for esophageal precancer. The agreement provides rates of reimbursement as a percent of charges for services rendered by LucidDx Labs to covered patients. 


Sumitomo Pharma Oncology this week received orphan drug designation from the US Food and Drug Administration for its menin and mixed-lineage leukemia (MLL) protein inhibitor, DSP-5336, as a treatment for acute myeloid leukemia. Sumitomo is currently studying DSP-5336 in a Phase I/II clinical trial in patients with relapsed or refractory acute myeloid leukemia and acute lymphocytic leukemia with or without MLL rearrangement or NPM1 mutation. 


The US Food and Drug Administration this week granted breakthrough therapy designation to AnHeart Therapeutics' investigational ROS-1 inhibitor taletrectinib for advanced ROS1-positive non-small cell lung cancer patients who are treatment-naïve or previously received Pfizer's Xalkori (crizotinib). The FDA granted the designation based on early data from the ongoing Phase II TRUST trial in China as well as two completed Phase I trials in the US and Japan. The studies showed encouraging objective response rates and disease control rates with taletrectinib, including in patients with brain metastases. AnHeart is also evaluating the agent in the global TRUST-II clinical trial 


Salarius Pharmaceuticals this week added four sites to its Phase I/II trial of LSD1 inhibitor seclidemstat in Ewing's sarcoma and FET-rearranged sarcomas: Seattle Cancer Care Alliance — comprising the Fred Hutchinson Cancer Research Center, Seattle Children's Hospital, and University of Washington Medical Center and Oregon Health & Sciences University in Portland. The trial is currently enrolling at 15 sites across the US. Salarius expects to report interim data from the trial in the second half of this year. 


Syros Pharmaceuticals said this week that the European Medicines Agency gave a positive opinion on its application for orphan drug designation for tamibarotene for the treatment of myelodysplastic syndrome. The company is studying tamibarotene in combination with azacytidine in the SELECT-MDS-1 Phase III trial involving RARA-positive patients with newly diagnosed higher-risk MDS. The US Food and Drug Administration granted orphan designation to the drug for MDS in February of this year. 


In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.