June 26, 2024 - 🧬 [nGram] Today’s Oncology Scoop: Lyell's CAR-T, Simcere's Cetuximab, Junshi's Toripalimab

  1. Lyell Immunopharma reports dose-dependent clinical activity from phase 1 trial of LYL797
    • Initial data from Phase 1 trial of LYL797 shows dose-dependent antitumor activity in ROR1+ relapsed/refractory triple-negative breast cancer (TNBC).
    • At the highest dose (150 x 10^6 CAR T cells), a 40% objective response rate (ORR) and 60% clinical benefit rate (CBR) were observed.
    • No significant safety signals in patients without lung involvement; treatable pneumonitis observed in patients with lung metastases.
    • Development expanding to new tumor types including ROR1+ relapsed/refractory platinum-resistant ovarian cancer, endometrial cancer, multiple myeloma, and chronic lymphocytic leukemia.
    • IND submission completed for LYL119, a next-generation ROR1-targeted CAR T cell product candidate.
    • Dose escalation continues in separate cohorts, with prophylactic steroids now administered to all patients.
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  2. Simcere Zaiming announce approval of cetuximab beta in China by the NMPA
    • Simcere Zaiming's Enlituo® (cetuximab beta) received approval from the China National Medical Administration (NMPA).
    • Enlituo® is indicated for use with the FOLFIRI regimen as a first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC).
    • Approval was based on phase 2/3 and phase 3 clinical trials showing significant improvements in progression-free survival, objective response rate, and overall survival.
    • The phase 3 study involved 505 subjects and demonstrated a PFS of 13.133 months with Enlituo® plus FOLFIRI versus 9.567 months with FOLFIRI alone.
    • Enlituo® is the first EGFR monoclonal antibody drug developed in China with independent intellectual property rights for first-line mCRC treatment.
    • Efforts are underway to accelerate the commercialization of Enlituo® to benefit more cancer patients in China.
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  3. Junshi Biosciences announces approval of the sNDA for toripalimab for the 1st-line treatment of advanced TNBC
    • The National Medical Products Administration (NMPA) approved the supplemental new drug application (sNDA) for toripalimab in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC).
    • The approval is based on the TORCHLIGHT study (NCT04085276), a Phase III clinical trial conducted in 56 centers across China.
    • Interim results published in Nature Medicine showed that toripalimab combined with paclitaxel significantly prolonged progression-free survival (PFS) and overall survival (OS) in PD-L1-positive patients with advanced TNBC.
    • The median PFS in the toripalimab group was 8.4 months, and the median OS was extended by 13.3 months, reducing the risk of disease progression or death by 35% and the risk of death by 38%.
    • Toripalimab has a consistent safety profile with no new safety signals identified.
    • This approval marks the first immunotherapy for TNBC in China, setting a new standard for first-line treatment.
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  4. Carisma Therapeutics granted FDA fast track designation for CT-0525 for the treatment of HER2-overexpressing solid tumors
    • Carisma Therapeutics received FDA Fast Track designation for CT-0525.
    • CT-0525 is an ex vivo gene-modified autologous CAR-Monocyte cellular therapy.
    • The therapy targets solid tumors that overexpress HER2.
    • Phase 1 clinical trial is currently enrolling patients with advanced or metastatic HER2-overexpressing solid tumors.
    • Initial Phase 1 data is expected by the end of 2024.
    • The trial aims to assess safety, tolerability, and manufacturing feasibility of CT-0525.
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  5. CDR-Life announces pipeline expansion of highly tumor-targeted T cell engagers
    • CDR-Life Inc. expands its pipeline with two new T cell engagers: CDR813 and CDR505.
    • CDR813 targets PRAME in HLA-A*02:01 patients, relevant for various cancers including NSCLC, endometrial cancer, melanoma, and ovarian cancer.
    • CDR505 targets KK-LC-1 in HLA-A*01 patients, addressing a novel target in common cancer populations.
    • Preclinical data on CDR505 was presented at the AACR Annual Meeting in April 2024.
    • The expansion aims to address significant unmet medical needs in cancer treatment.
    • CDR-Life's platform focuses on developing potent and selective TCE therapeutics for hard-to-treat solid tumors.
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  6. Allarity Therapeutics’ dual PARP/Tankyrase inhibitor, stenoparib, continues to show extended clinical benefit in advanced ovarian cancer
    • Multiple patients in the Phase 2 trial of stenoparib for advanced recurrent ovarian cancer have been on treatment for over 30 weeks.
    • Stenoparib has shown significant tumor shrinkage and long-term disease stability in heavily pre-treated patients.
    • The company has halted patient enrollment to focus on developing a follow-on trial aimed at accelerating regulatory approval.
    • The trial is a Phase 2, open-label, single-arm study with sites in the US and UK, using Allarity’s DRP® companion diagnostic for patient selection.
    • Patients were administered a revised dosing regimen of stenoparib to optimize daily drug exposure and target inhibition.
    • Stenoparib is a dual-targeted inhibitor of PARP1/2 and Tankyrase 1 and 2, showing potential as a promising therapeutic for advanced ovarian cancer.
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  7. Soligenix announces positive clinical results from a comparative study evaluating HyBryte against Valchlor in the treatment of cutaneous T-cell lymphoma
    • HyBryteâ„¢ demonstrated a more rapid and robust treatment response compared to Valchlor® during a 12-week treatment course.
    • The open-label study enrolled 10 patients, with treatment success defined as a ≥50% improvement in mCAILS score after 12 weeks.
    • 60% of HyBryteâ„¢ patients achieved a 50% or better improvement in their mCAILS score versus 20% of Valchlor® patients.
    • HyBryteâ„¢ had a more favorable safety profile, with no adverse events related to the therapy, compared to 60% of Valchlor® patients experiencing adverse events.
    • The study supports the positive data from the previous Phase 3 FLASH study and indicates a rapid response to HyBryteâ„¢ therapy.
    • A confirmatory Phase 3 replication study (FLASH2) is planned to be initiated later this year.
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  8. Immutep signs exclusive license agreement with Cardiff University for next generation anti-LAG-3 molecules for cancer
    • Immutep Limited has signed a License Agreement with Cardiff University for exclusive rights to develop and commercialize anti-LAG-3 small molecules.
    • The collaboration has identified promising compounds that block LAG-3, an immune checkpoint that reduces the immune system’s response to fight cancer.
    • The compounds were identified through chemical library screening, molecular modeling, and synthetic chemistry.
    • The goal is to develop an orally-available small molecule anti-LAG-3 treatment for cancer patients at a lower cost compared to existing monoclonal and bi-specific antibodies.
    • A joint patent application has been filed to protect the new intellectual property.
    • Cardiff University will receive an upfront payment of £25,000, milestone payments upon first commercial sale, and low single-digit sales-based royalties.
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  9. Bluesphere bio partners with NMDP biotherapies for first-in-human TCR-based product candidate trial
    • BlueSphere Bio collaborates with NMDP BioTherapies to advance its first clinical trial for high-risk leukemias.
    • The trial (TCX-101) will evaluate BSB-1001, a TCR T-cell therapy, in combination with allogeneic hematopoietic stem cell transplantation (alloHSCT).
    • NMDP BioTherapies will provide HLA-matched healthy donor hematopoietic stem cells and manage supply chain logistics.
    • BSB-1001 targets the blood-restricted antigen HA-1, aiming to reduce graft versus host disease (GvHD) while enhancing the graft versus leukemia effect.
    • The trial will enroll patients with active disease or high risk of relapse, with the first patient expected to be enrolled in 4Q2024.
    • NMDP BioTherapies will offer bioinformatics consulting to identify suitable donors and ensure compliance with FDA and BlueSphere requirements.
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  10. TwoStep Therapeutics launches with funding to advance broadly applicable targeting platform for solid tumors
    • TwoStep Therapeutics officially launched with a $6.5 million seed round led by NFX.
    • Funding will advance their therapeutic pipeline focusing on targeted cytotoxic drug delivery and immunotherapy for solid tumors.
    • Their platform uses a unique polyspecific integrin-binding peptide (PIP) to target multiple tumor-associated integrins.
    • The technology aims to treat a wide range of solid tumors, overcoming limitations of single-antigen targeting approaches.
    • The company was founded by experts from Stanford University, including Nobel Laureate Carolyn Bertozzi.
    • TwoStep Therapeutics is one of the first companies to emerge from Stanford's Innovative Medicines Accelerator.
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