Taiho and Cullinan announce phase 2b trial success for zipalertinib in NSCLC
- The REZILIENT1 trial met its primary endpoint of overall response rate in patients with NSCLC harboring EGFR exon 20 insertion mutations.
- The trial involved zipalertinib monotherapy, an orally available small molecule targeting EGFR mutations.
- Full results will be presented at an upcoming international medical conference.
- Plans for U.S. regulatory approval submission are set for the second half of 2025.
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ITM announces positive topline results of phase 3 COMPETE trial with ITM-11 in GEP-NETs
- ITM-11, a targeted radiopharmaceutical therapy, met the primary endpoint of prolonging progression-free survival in the Phase 3 COMPETE trial.
- The trial compared ITM-11 to everolimus in patients with Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors.
- ITM-11 was well-tolerated with favorable safety results, and secondary endpoints like overall survival and quality of life are being evaluated.
- ITM plans to discuss a potential New Drug Application (NDA) submission with the FDA in 2025.
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March Biosciences receives FDA orphan drug designation for MB-105 for T-cell lymphoma
- March Biosciences' MB-105, a CD5-targeted CAR-T cell therapy, receives FDA orphan drug designation for relapsed/refractory CD5-positive T-cell lymphoma.
- Orphan drug designation offers benefits like tax credits, user fee exemptions, and seven years of market exclusivity post-approval.
- MB-105 has shown a 44% overall response rate in Phase 1 trials for T-cell lymphoma and is set to advance to Phase 2 trials in early 2025.
- The company secured $28.4 million in Series A financing to support Phase 2 development and manufacturing capabilities.
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Roche’s Itovebi shows significant survival benefit in HR-positive advanced breast cancer
- The phase III INAVO120 study demonstrated a significant overall survival benefit for Itovebi (inavolisib) in combination with palbociclib and fulvestrant.
- The Itovebi-based regimen more than doubled progression-free survival compared to palbociclib and fulvestrant alone.
- The U.S. FDA approved the Itovebi-based regimen in October 2024 for specific breast cancer patients.
- Full results will be presented at an upcoming medical meeting, and data are under review by global health authorities.
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Lantheus to acquire Evergreen Theragnostics for $250 million
- Lantheus will acquire Evergreen Theragnostics for an upfront payment of $250 million, with potential milestone payments up to $752.5 million.
- The acquisition enhances Lantheus' radiopharmaceutical capabilities with Evergreen's scalable manufacturing infrastructure.
- OCTEVY, a diagnostic agent for neuroendocrine tumors, will complement Lantheus' therapeutic candidate PNT2003.
- The transaction is expected to close in the second half of 2025, pending regulatory approvals.
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BeyondSpring sells equity in SEED Therapeutics to fund Plinabulin trials
- BeyondSpring sold a portion of its Series A-1 Preferred Shares in SEED Therapeutics for $35.4 million.
- The sale will help fund late-stage clinical trials of Plinabulin, a first-in-class anti-cancer agent.
- Plinabulin has shown promising results in multiple studies, including the DUBLIN-3 phase 3 trial for NSCLC.
- BeyondSpring retains a 14.4% stake in SEED, ensuring continued involvement in its innovative TPD technology.
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Drug monitoring committee authorizes continuation of Intensity Therapeutics' phase 3 sarcoma trial
- The Data Monitoring Committee (DMC) has authorized the continuation of the INVINCIBLE-3 Study without modifications after a periodic review.
- The trial is a global, open-label, randomized study evaluating INT230-6 against standard chemotherapy in patients with soft tissue sarcoma.
- INT230-6 is administered intratumorally and aims to improve overall survival and safety, with exploratory quality of life assessments.
- The study is recruiting in the U.S., Canada, and Europe, with authorizations from regulatory bodies in the U.S., Canada, Europe, and Australia.
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European Commission approves Blincyto in Philadelphia chromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukemia
- The European Commission has approved Blincyto as part of consolidation therapy for adult patients with newly diagnosed Philadelphia chromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL).
- The approval is based on the Phase 3 E1910 clinical trial, which showed that Blincyto added to multiphase consolidation chemotherapy significantly improved overall survival compared to chemotherapy alone.
- The trial demonstrated a 5-year overall survival rate of 82.4% for the Blincyto plus chemotherapy group versus 62.5% for the chemotherapy-only group.
- Blincyto is the first globally approved Bispecific T-cell Engager (BiTE) immuno-oncology therapy targeting CD19 surface antigens on B cells.
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ImmunityBio collaborates with BeiGene on phase 3 trial for NSCLC
- ImmunityBio and BeiGene have partnered for a phase 3 trial combining ANKTIVA and tislelizumab for NSCLC.
- The trial, ResQ201A-NSCLC, aims to confirm efficacy and safety, building on previous QUILT 3.055 study results.
- ANKTIVA, an IL-15 superagonist, has shown potential in rescuing T cells and enhancing CPI efficacy.
- The trial will enroll 462 participants globally, with overall survival as the primary endpoint.
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IASO Bio's new drug application for equecabtagene autoleucel accepted by Singapore HSA
- IASO Bio's NDA for Equecabtagene Autoleucel, a CAR-T therapy for relapsed/refractory multiple myeloma, accepted by Singapore's HSA.
- Previously approved by China's NMPA in June 2023 for similar indications.
- Plans to implement a 'Manufactured in China, supplied overseas' model for global distribution.
- Next steps include initiating registration in multiple countries to expand global reach.
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Dewpoint Therapeutics announces DPTX3496 as a development candidate for cancer treatment
- Dewpoint Therapeutics has nominated DPTX3496, an oral small molecule, as a development candidate for colorectal, breast, and lung cancers.
- DPTX3496 targets beta catenin to address Wnt-driven cancers, showing tumor regression in preclinical models.
- The candidate is in IND-enabling studies, with an IND filing planned for the second half of 2025.
- Dewpoint is collaborating with ConcertAI and Evotec to optimize patient stratification and accelerate IND filing timelines.
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OS Therapies acquires listeria-based immuno-oncology programs from Ayala Pharmaceuticals
- OS Therapies has entered into an agreement to acquire listeria monocytogenes-based immuno-oncology programs from Ayala Pharmaceuticals.
- The acquisition includes Phase 2 lung cancer and Phase 1 prostate cancer programs, enhancing OS Therapies' pipeline.
- OS Therapies will pay $0.5 million in cash and issue $7.5 million in common shares to Ayala.
- The transaction is expected to close in 60 days, subject to customary closing conditions.
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Agenus publishes data on botensilimab plus balstilimab in metastatic sarcomas
- Agenus published data in the Journal of Clinical Oncology on botensilimab (BOT) and balstilimab (BAL) for relapsed/refractory metastatic sarcomas.
- The Phase 1 study showed a 19.2% overall response rate (ORR) and a 65.4% disease control rate (DCR) in heavily pretreated patients.
- The combination was well tolerated, with the most common adverse event being manageable diarrhea/colitis.
- These results support further investigation of BOT/BAL in multiple tumor types resistant to existing therapies.
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Zentalis Pharmaceuticals shares updated clinical data on azenosertib in platinum-resistant ovarian cancer
- DENALI Part 1b study shows an Objective Response Rate (ORR) of ~35% in heavily-pretreated Cyclin E1+ platinum-resistant ovarian cancer (PROC) patients.
- Azenosertib demonstrated a well-characterized safety profile with no new safety signals across multiple studies.
- The FDA has aligned with Zentalis on the seamless study design for DENALI Part 2, expected to begin in the first half of 2025.
- Topline data from the registration-intent DENALI Part 2 study is anticipated by the end of 2026, potentially supporting accelerated approval.
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Imvax completes $29 million financing and confirms timing for phase 2b trial results of IGV-001 in glioblastoma
- Imvax has closed a $29 million financing round, raising a total of $86 million over 21 months.
- The funds support a Phase 2b trial of IGV-001 for newly diagnosed glioblastoma (ndGBM).
- The trial is a randomized, multicenter, double-blind, placebo-controlled study with 100 participants.
- Topline results are expected in mid-2025, with the primary endpoint being progression-free survival (PFS).
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