July 23, 2024 - 🧬 [nGram] Today’s Oncology Scoop: Immutep's FDA Success, BeiGene's New Facility, and More

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.
   Read more
   
   

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.
   Read more
   
   

3. 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.
   Read more
   
   

4. MitoCareX confirms potential significant role of its drug target in non-small cell lung cancer

   • MitoCareX Bio Ltd. validated the involvement of its SLC25 carrier protein target in NSCLC using genetic manipulations and 3D spheroid systems.
   • NSCLC accounts for 80%-85% of all lung cancer cases globally and is projected to reach a market value of $59.77 billion by 2030.
   • MitoCareX previously identified several small molecules for anti-cancer treatments using its MITOLINE™ algorithm.
   • The company is developing a predictive AI model to uncover more novel anti-cancer small molecule scaffolds targeting the SLC25 protein.
   Read more
   
   

5. 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.
   Read more
   
   

6. TCBP announces dosing of 6th patient in ACHIEVE study in patients with acute myeloid leukemia

   • The sixth patient in the ACHIEVE UK study was treated with a higher dose of TCB-008.
   • The ACHIEVE trial is an open-label, phase II study evaluating TCB-008 in AML or MDS/AML patients.
   • 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.
   Read more
   
   

7. 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.
   • 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.
   Read more
   
   

8. BeiGene opens flagship U.S. biologics manufacturing and clinical R&D facility

   • BeiGene has inaugurated its flagship U.S. facility in Hopewell, N.J., at the Princeton West Innovation Campus.
   • The 42-acre site includes state-of-the-art biologics manufacturing and a clinical research and development center.
   • The $800 million investment will create hundreds of high-tech jobs by the end of 2025.
   • The facility features 400,000 square feet of commercial-stage biologic pharmaceutical manufacturing capacity.
   Read more