June 11, 2024 - 🧬 [nGram] Today’s Oncology Scoop: FDA Clears Lomonitinib, SL-172154 Orphan Drug, Ultimovacs Phase I Update

  1. Eilean Therapeutics announces FDA clearance of investigational new drug application for lomonitinib for the treatment of acute myeloid leukemia
    • Eilean Therapeutics received FDA clearance for the IND application of lomonitinib (ZE46-0134).
    • The clearance allows the initiation of a Phase 1 clinical trial in the US for FLT3 mutated relapsed/refractory AML.
    • Lomonitinib is a potent and selective pan-FLT3/IRAK4 inhibitor targeting clinically relevant FLT3 mutations and escape pathways.
    • The Phase 1 study has already started in Australia, and the US trial will further expand global testing.
    • Lomonitinib has shown an excellent safety profile and rapid target engagement in healthy volunteer studies.
    • The drug aims to provide a deeper and longer duration of response in R/R AML patients, potentially becoming the best-in-class FLT3 inhibitor.
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  2. InnoCare announces clearance of clinical trial of TYK2 inhibitor ICP-332 by U.S. FDA
    • InnoCare Pharma received FDA clearance for the IND application of ICP-332, a novel TYK2 inhibitor.
    • ICP-332 demonstrated significant efficacy and safety in a China Phase II study for moderate-to-severe atopic dermatitis (AD).
    • The detailed data was presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting.
    • Currently, no TYK2 inhibitors have marketing approval for AD treatment globally.
    • TYK2 is a key kinase in the JAK-STAT signaling pathway, crucial for inflammatory disease pathogenesis.
    • InnoCare is focused on developing innovative therapies for autoimmune diseases, including ICP-332.
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  3. Global registrational phase III study of olverembatinib for the treatment of patients with SDH-deficient GIST approved by the China CDE
    • Ascentage Pharma announced the approval of a global registrational Phase III study of olverembatinib by China's CDE.
    • The study will evaluate the efficacy and safety of olverembatinib in patients with SDH-deficient GIST who have failed prior systemic treatment.
    • This is a global, multicenter, single-arm, open-label, pivotal registrational Phase III study.
    • Results from the study can support a future New Drug Application (NDA) for olverembatinib in SDH-GIST.
    • Olverembatinib has shown a clinical benefit rate (CBR) of 92.3% in patients with SDH-deficient GIST.
    • Olverembatinib is already approved in China for two indications related to chronic myeloid leukemia (CML).
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  4. Shattuck Labs announces orphan drug designation for SL-172154 for AML treatment
    • The U.S. FDA has granted orphan drug designation to Shattuck Labs' SL-172154 for the treatment of acute myeloid leukemia (AML).
    • Orphan drug designation provides benefits like market exclusivity for seven years, tax credits for clinical trials, and waiver of application fees.
    • SL-172154 is an investigational ARC® fusion protein designed to inhibit the CD47/SIRPα checkpoint and activate the CD40 costimulatory receptor.
    • Shattuck Labs plans to present additional data from the Phase 1B dose expansion clinical trial of SL-172154 at the European Hematology Association 2024 Congress.
    • AML is a hematologic malignancy with a poor prognosis, especially in older patients, with a five-year relative survival rate of approximately 32%.
    • Multiple Phase 1 clinical trials for SL-172154 are ongoing for patients with platinum-resistant ovarian cancer and AML.
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  5. Ultimovacs provides update from Phase I study in malignant melanoma
    • Ultimovacs announced encouraging overall survival (OS) data from the UV1-103 Phase I clinical trial in malignant melanoma.
    • The study evaluates UV1 cancer vaccine in combination with pembrolizumab as first-line treatment for advanced non-resectable or metastatic malignant melanoma.
    • All patients alive at 3 years remain alive at 4 years, with an OS rate of 69.5% after a minimum follow-up of 4 years.
    • The trial enrolled 30 patients in two cohorts differing in GM-CSF adjuvant concentration.
    • The next key milestone is the readout of the FOCUS trial in Q3 2024, using the same treatment combination.
    • The safety profile of UV1 combined with pembrolizumab is comparable to pembrolizumab alone.
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  6. Arcus Biosciences completes patient enrollment in phase 3 trial evaluating a domvanalimab-containing regimen in first-line metastatic upper GI cancers
    • Arcus Biosciences has completed patient enrollment for the STAR-221 Phase 3 study in collaboration with Gilead Sciences.
    • The trial evaluates the combination of domvanalimab, zimberelimab, and chemotherapy in patients with advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma.
    • The study enrolled approximately 1,050 participants and aims to assess overall survival in PD-L1-high tumors and the intent-to-treat population.
    • Secondary endpoints include progression-free survival, objective response rate, and duration of response.
    • Earlier Phase 2 EDGE-Gastric study results showed a median progression-free survival of 12.9 months with the same regimen.
    • No unexpected safety signals were observed, and the regimen was generally well tolerated.
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  7. Leo Cancer Care to use Series C financing to grow global footprint
    • Leo Cancer Care secures Series C funding to advance upright radiation therapy globally.
    • Investors include McLaren Healthcare Corporation, Cone Health, Wisconsin Alumni Research Foundation, Macmillan Cancer Support, and Aviko Radiopharmaceuticals.
    • The Marie system offers a unique upright patient positioning and CT imaging system, enhancing patient comfort and treatment accuracy.
    • Funding will support expansion into Asian markets, particularly Singapore, Japan, and South Korea.
    • Strategic investors reflect confidence in Leo Cancer Care's innovative system and align with the company's goals.
    • Leo Cancer Care's upright patient positioning system recently gained 510(k) regulatory clearance in the United States, with a similar process underway in Europe.
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  8. Essential Pharma reaches agreement with AGC Biologics for late phase clinical manufacturing of its immunotherapy candidate for the treatment of high-risk neuroblastoma
    • Essential Pharma has signed a strategic agreement with AGC Biologics for the production of Hu14.18, a humanized monoclonal antibody.
    • AGC Biologics will support process development, scale-up, and manufacturing as Essential Pharma prepares for clinical activities and regulatory interactions.
    • The partnership aims to accelerate the late-stage development of Hu14.18, which shows promise for treating high-risk neuroblastoma, primarily affecting young children.
    • Essential Pharma acquired Renaissance Pharma in April 2024 and is now responsible for Hu14.18's development.
    • A Phase II trial incorporating Hu14.18 into first-line and post-consolidation therapy for HRNB patients showed positive outcomes, with a 3-year event-free survival (EFS) of 73.7% and overall survival (OS) of 86.0%.
    • Next steps include intense regulatory agency interactions and late-stage clinical development.
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  9. Sellas announces completion of enrollment and initial positive data in phase 2a trial of SLS009 in r/r AML
    • Enrollment completed ahead of schedule with 30 patients in the Phase 2a trial of SLS009 for relapsed/refractory acute myeloid leukemia (r/r AML).
    • Initial data shows an overall response rate (ORR) of 33% in the 60 mg QW cohort and 50% in the 30 mg BIW cohort.
    • The 45 mg QW dose showed a median overall survival (OS) of 5.4 months compared to 2.5 months with standard care; median OS for 60 mg QW and 30 mg BIW cohorts has not been reached.
    • 100% ORR observed in patients with ASXL1 mutation in the 30 mg BIW cohort.
    • The trial will continue with two expansion cohorts focusing on patients with ASXL1 mutations and myelodysplasia-related molecular mutations other than ASXL1.
    • Additional updates and data are expected in Q3 2024.
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  10. Bright Peak Therapeutics announces $90 million in Series C financing to advance first-in-class PD1-IL18 immunoconjugate program into clinical trials
    • Bright Peak Therapeutics raised $90 million in Series C financing.
    • The financing round was led by Johnson & Johnson Innovation – JJDC.
    • New investors include Venrock, KB Investment, and Northleaf Capital Partners.
    • Existing investors such as Versant Ventures, Fidelity Management & Research Company, and RA Capital Management also participated.
    • Funds will be used to advance BPT567, a PD1-IL18 immunoconjugate, into a Phase 1/2a clinical trial in solid tumors expected to begin in 2H 2024.
    • BPT567 aims to provide simultaneous blockade of the PD(L)-1 checkpoint pathway and targeted delivery of IL-18 signaling.
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