July 23, 2024 - 🧬 [nGram] Today’s Oncology Scoop: Immutep's FDA Meeting, MAIA's Phase 2 Updates, Frontier-AbbVie Milestone


  1. Immutep announces successful meeting with FDA on phase III design in non-small cell lung cancer
    • Immutep received positive feedback from the FDA on the TACTI-004 Phase III trial design for efti in combination with KEYTRUDA and standard chemotherapy.
    • The trial will enrol approximately 750 patients with first-line metastatic non-small cell lung cancer (NSCLC), regardless of PD-L1 expression.
    • The trial design is based on positive efficacy and safety data from the TACTI-002 Phase II and INSIGHT-003 trials.
    • The dual primary endpoints will be progression-free survival and overall survival, with a pre-planned interim analysis.
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  2. MAIA Biotechnology announces new updates from Phase 2 trial of novel cancer treatment agent
    • MAIA Biotechnology reports positive updates from its Phase 2 trial, THIO-101, for advanced non-small cell lung cancer (NSCLC).
    • The trial involves THIO sequenced with the immune checkpoint inhibitor cemiplimab (Libtayo) in patients who failed two or more standard-of-care therapies.
    • 6 patients have remained on treatment for at least 12 months, showing lower toxicity and ongoing benefits.
    • THIO-101 is a multicenter, open-label, dose-finding Phase 2 trial designed to evaluate the safety, tolerability, and clinical efficacy of THIO followed by cemiplimab.
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  3. MitoCareX confirms potential significant role of its drug target in non-small cell lung cancer
    • MitoCareX Bio, a venture of SciSparc Ltd., validated the significant involvement of its target SLC25 carrier protein in NSCLC cells.
    • The discovery was demonstrated using genetic manipulations and 3D spheroid systems, mimicking human solid tumors.
    • NSCLC accounts for 80%-85% of all lung cancer cases globally, with the market projected to reach $59.77 billion by 2030.
    • MitoCareX is developing a predictive AI model to uncover novel anti-cancer small molecule scaffolds targeting the SLC25 protein.
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  4. TCBP announces dosing of 6th patient in ACHIEVE study in patients with acute myeloid leukemia
    • The sixth patient in the ACHIEVE UK clinical trial was treated with a higher dose of TCB-008.
    • The ACHIEVE study is an open-label, phase II trial evaluating TCB-008 in patients with AML or MDS/AML.
    • Cohort A includes relapsed/refractory patients, while Cohort B includes patients in remission with residual disease.
    • The trial allows for up to 24 patients in each cohort, with potential advancement to a Phase III Pivotal Trial.
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  5. Precision Biologics granted patent for NEO-201 targeting Treg cells
    • Precision Biologics received a patent from the USPTO for its monoclonal antibody, NEO-201, on July 16, 2024.
    • NEO-201 targets regulatory T cells (Treg cells) and granulocytic myeloid-derived suppressor cells (gMDSCs), enhancing cancer immunotherapy efficacy.
    • The patent covers methods for isolating and detecting Treg cells and using NEO-201 in combination therapies.
    • Ongoing Phase 2 trial is evaluating NEO-201 with pembrolizumab (Keytruda) in patients with solid tumors resistant to prior checkpoint inhibitors.
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  6. TransCode Therapeutics announces pricing of public offering
    • TransCode Therapeutics priced a public offering of 10,000,000 shares at $0.30 per share.
    • The offering is expected to generate gross proceeds of $3,000,000 before expenses.
    • Proceeds will be used for product development, including clinical trials for TTX-MC138, and general corporate purposes.
    • The offering is expected to close on July 24, 2024, subject to customary conditions.
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  7. Frontier Medicines announces milestone payment in AbbVie partnership
    • Frontier Medicines advanced lead candidates targeting a key transcription factor for cancer cell survival.
    • This progress triggered a milestone payment from AbbVie.
    • The partnership aims to develop small molecule therapeutics against difficult-to-drug protein targets.
    • Frontier is eligible for milestone payments exceeding $1 billion and royalties on commercialized products.
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