July 9, 2024 - 🧬 [nGram] Today’s Oncology Scoop: SELLAS Orphan Drug, iOnctura NSCLC Trial, Radionetics-Lilly Deal

  1. SELLAS receives European Medicines Agency orphan drug designation for SLS009 for the treatment of acute myeloid leukemia
    • SELLAS Life Sciences Group has been granted Orphan Drug Designation (ODD) by the European Commission for SLS009, a CDK9 inhibitor, for treating acute myeloid leukemia (AML).
    • The designation follows positive preliminary Phase 2 data and a previous FDA ODD designation.
    • The Phase 2a clinical trial is evaluating the safety, tolerability, and efficacy of SLS009 in combination with aza/ven at two dose levels.
    • The trial continues to enroll patients with myelodysplasia-related mutations, focusing on ASXL1 mutations.
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  2. iOnctura announces expansion of roginolisib clinical trial program to NSCLC
    • iOnctura expands its clinical trial program for roginolisib to include non-small-cell lung cancer (NSCLC).
    • The Phase II study will be conducted in collaboration with the ETOP IBCSG Partners Foundation and GSK across European sites.
    • The trial will evaluate the combination of roginolisib with dostarlimab, with or without docetaxel, in NSCLC patients resistant to first-line checkpoint inhibitor therapy.
    • GSK will supply dostarlimab for the trial, while iOnctura retains worldwide rights to roginolisib.
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  3. Radionetics Oncology announces strategic agreement with Lilly
    • Radionetics Oncology, a leader in targeted radiopharmaceuticals, has entered into a strategic agreement with Eli Lilly.
    • Radionetics received a $140 million upfront cash payment from Lilly.
    • Lilly obtained the exclusive right to acquire Radionetics for $1 billion upon conclusion of an exercise period.
    • Radionetics' platform focuses on small molecule radioligands targeting GPCRs, offering a unique approach to cancer treatment.
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  4. Taiho Pharmaceutical exercises option for an exclusive license to quemliclustat in Japan and certain territories in Asia
    • Taiho Pharmaceutical has exercised its option for quemliclustat, a CD73 inhibitor, in Japan and certain other Asian territories.
    • Taiho will make an option exercise payment and additional payments upon achieving clinical, regulatory, and commercialization milestones.
    • Arcus plans to initiate the global Phase 3 PRISM-1 study in 2024, comparing quemliclustat plus chemotherapy to chemotherapy alone for metastatic pancreatic ductal adenocarcinoma.
    • Quemliclustat is also being co-developed by Arcus and Gilead Sciences in combination with other molecules for lung and upper gastrointestinal cancers.
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  5. Capital Health partnering with TVAX Biomedical to offer brain cancer immunotherapy trial
    • Capital Health Cancer Center joins TVAX Biomedical's clinical trial for glioblastoma (GBM).
    • The trial uses a patient's own tumor cells to create a vaccine, aiming to generate a specific immune response.
    • Capital Health is the only participating site in the Northeast U.S., with other sites in Los Angeles, Orlando, and Kansas City.
    • The trial is open to adults aged 18-80 with a new diagnosis of GBM with active or 'unmethylated' MGMT.
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  6. PharmAbcine announces safety approval for the first dose cohort in phase 1a/b clinical trial of PMC-309 in patients with advanced or metastatic solid tumors
    • PMC-309 received safety approval for the first dose cohort (0.2mg/kg) in a Phase 1a/b clinical trial in Australia.
    • The second dose cohort (0.5mg/kg) is currently underway, with two patients already administered and a third scheduled.
    • PMC-309 is an IgG1 monoclonal antibody targeting VISTA, showing excellent binding affinity in various pH conditions within the tumor microenvironment.
    • The trial involves 67 patients and includes monotherapy and combination therapy with KEYTRUDA® to determine the maximum tolerated dose and recommended Phase 2 dose.
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  7. Interius BioTherapeutics receives HREC approval and CTN clearance from the TGA to commence a phase 1 clinical trial for its first-in-class in vivo CAR therapeutic for B cell malignancies
    • Interius BioTherapeutics has received HREC approval and CTN clearance from the Australian TGA to start a Phase 1 clinical trial for INT2104.
    • The trial will begin in the fourth quarter of 2024 and will evaluate the safety of a single INT2104 infusion in adults with refractory/relapsing B cell malignancies.
    • The Phase 1 study is a global, two-part, multicenter, open-label, single dose design with a dose escalation portion.
    • INT2104 is an off-the-shelf, single dose treatment administered systemically through intravenous infusion, targeting CD20-positive B cells.
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  8. Merus announces first patient dosed in phase 2 trial of petosemtamab in 2L CRC
    • Merus has dosed the first patient in a phase 2 trial of petosemtamab combined with standard chemotherapy for second-line metastatic colorectal cancer (mCRC).
    • The open-label trial will assess the safety and preliminary antitumor activity of petosemtamab with FOLFIRI or FOLFOX chemotherapy in approximately 40 patients.
    • Participants must not have been previously treated with EGFR inhibitors and their tumors should not have a KRAS mutation.
    • The trial will measure tumor EGFR expression but will not use it as a selection criterion.
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  9. Immix Biopharma doses 1st patient in U.S. AL amyloidosis trial with CAR-T NXC-201
    • Immix Biopharma has dosed the first patient in the U.S. NEXICART-2 trial at Memorial Sloan Kettering Cancer Center.
    • The trial aims to evaluate the safety and efficacy of NXC-201 in relapsed/refractory AL amyloidosis patients with adequate cardiac function.
    • NEXICART-2 builds on positive data from the ex-U.S. NEXICART-1 study, which showed a 92% overall response rate.
    • The study will enroll 40 patients and evaluate three dose levels, with primary endpoints being complete response rate and overall response rate.
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  10. Abata Therapeutics announces FDA clearance of investigational new drug application for clinical evaluation of ABA-101 in progressive multiple sclerosis
    • FDA has cleared Abata Therapeutics' IND application for ABA-101, a TCR-Treg cell therapy for progressive multiple sclerosis.
    • The first-in-human Phase 1 study is expected to begin by the end of the year.
    • ABA-101 is designed for MS patients with progressive disease and specific genetic markers, targeting CNS-compartmentalized inflammation.
    • Preclinical studies showed ABA-101 to be safe with strong anti-inflammatory effects and tissue-specific targeting.
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