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 concluded regulatory preparations for the TACTI-004 Phase III trial design with positive FDA feedback.
   • The trial will evaluate efti in combination with KEYTRUDA and standard chemotherapy in first-line NSCLC.
   • TACTI-004 will enroll approximately 750 patients regardless of PD-L1 expression.
   • The trial is based on positive efficacy and safety data from the TACTI-002 Phase II and INSIGHT-003 trials.
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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 remain on treatment for over 12 months, showing lower toxicity and ongoing benefits.
   • THIO-101 is a multicenter, open-label, dose-finding Phase 2 trial evaluating 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 study was treated with a higher dose of TCB-008 after MHRA approval.
   • ACHIEVE is an open-label, phase II study evaluating TCB-008 in patients with AML or MDS/AML.
   • Cohort A includes relapsed/refractory patients, while Cohort B includes patients with residual disease post-remission.
   • Patients will receive up to four doses of TCB-008, with each dose containing up to 230,000,000 cells.
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5. Precision Biologics granted patent for NEO-201 targeting Treg cells

   • Precision Biologics received a USPTO patent for NEO-201 on July 16, 2024.
   • NEO-201 is a humanized IgG1 monoclonal antibody targeting Treg cells and gMDSCs.
   • 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 Keytruda in patients with metastatic cancers 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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