Pierre Fabre Laboratories announce IND filing for PFL-002/VERT-002, a potential treatment for patients with solid tumors, including non-small cell lung cancer with MET alterations
- Pierre Fabre Laboratories filed an IND application with the FDA for PFL-002/VERT-002.
- The Phase I/II trial will assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy.
- The trial targets NSCLC patients with MET alterations, including those with resistance to other treatments.
- PFL-002/VERT-002 is a monoclonal antibody developed by Vertical Bio, acting as a degrader of c-MET.
- The first patient enrollment is expected by the end of 2024.
- Pierre Fabre Laboratories is expanding its precision oncology portfolio with several new assets.
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Cellectis receives orphan drug designation for UCART22 for acute lymphoblastic leukemia
- Cellectis announced that the European Commission (EC) granted Orphan Drug Designation (ODD) to UCART22 for treating Acute Lymphoblastic Leukemia (ALL).
- UCART22 is an allogeneic CAR T-cell product targeting CD22, evaluated in the BALLI-01 Phase 1/2 study.
- ALL accounts for 12% of all leukemia cases and progresses rapidly, often fatal within weeks or months if untreated.
- Preliminary clinical data showed a 67% response rate at Dose Level 2 for UCART22-P2, compared to 50% at Dose Level 3 for UCART22-P1.
- The ODD provides regulatory, financial, and commercial incentives for developing treatments for rare diseases with no satisfactory options.
- Cellectis plans to update on the progress of BALLI-01 by the end of 2024.
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FDA approved phase II/III clinical study of KPG-121 in combination with abiraterone as a first line treatment for mCRPC
- The FDA has approved a Phase II/III clinical trial of KPG-121 in combination with abiraterone for first-line treatment of metastatic castration-resistant prostate cancer (mCRPC).
- KPG-121, discovered by Kangpu Biopharmaceuticals, targets the Cereblon (CRBN) E3 ubiquitin ligase complex, promoting anti-proliferation and anti-angiogenesis activities.
- In xenograft models, KPG-121 significantly improves anti-tumor efficacy when combined with androgen-receptor antagonists compared to androgen-receptor antagonist therapy alone.
- A Phase I study in the US (NCT03569280) demonstrated that KPG-121 was well tolerated and showed a favorable pharmacokinetic profile and promising efficacy.
- Kangpu Biopharmaceuticals focuses on developing innovative small molecules for treating solid tumors, hematologic malignancies, autoimmune diseases, and inflammatory disorders.
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Cyclacel’s fadraciclib demonstrates efficacy in patient-derived colorectal cancer models at the 2024 ASCO annual meeting
- Fadraciclib, a novel CDK2/9 inhibitor, shows potential as a treatment for metastatic colorectal cancer (CRC).
- Preclinical data presented at the ASCO Annual Meeting demonstrated significant tumor growth inhibition in CRC patient-derived organoids (PDOs) and xenografts (PDX).
- Fadraciclib induced anaphase catastrophe, a novel cancer-specific mechanism, and triggered apoptosis in CRC models.
- The study involved 18 CRC PDOs treated with standard chemotherapy, palbociclib, or fadraciclib, with fadraciclib showing superior efficacy.
- Fadraciclib's ability to inhibit CDK2/9, downregulate MYC protein levels, and induce apoptosis was validated through various assays.
- Cyclacel is currently enrolling patients in the proof of concept part of the 065-101 study, with initial data expected in the second half of 2024.
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Live from ASCO 2024: oral report released latest data of olverembatinib in SDH-deficient GIST, including a CBR of 92.3%
- Ascentage Pharma presented updated clinical data of olverembatinib at the 60th ASCO Annual Meeting.
- The Phase I study enrolled 26 patients with SDH-deficient GIST, showing a clinical benefit rate (CBR) of 92.3%.
- 6 patients achieved partial responses (PR) and 18 achieved stable diseases (SD) lasting longer than four treatment cycles.
- The median progression-free survival (PFS) was 25.7 months.
- Olverembatinib has been granted Breakthrough Therapy Designation by China's NMPA for SDH-deficient GIST.
- The drug is also being evaluated for other indications, including hematologic malignancies.
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CARsgen presents updated results on satri-cel in Nature Medicine and at 2024 ASCO
- CARsgen Therapeutics announced final follow-up results of the CT041-CG4006 trial of satri-cel, published in Nature Medicine on June 3, 2024.
- Data were also presented at the 2024 ASCO Annual Meeting on June 3, 2024.
- Satri-cel is an autologous CAR T-cell product candidate targeting Claudin18.2, aimed at treating gastrointestinal cancers.
- The study showed promising efficacy and manageable safety profiles in patients with Claudin18.2-positive advanced gastrointestinal cancers.
- Ongoing trials include Phase II and Phase I trials in China and North America for gastric and pancreatic cancers.
- Satri-cel has received multiple designations from the U.S. FDA and EMA, including RMAT, PRIME eligibility, and Orphan Drug designations.
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MediciNova receives notice of allowance for new patent covering MN-166 (ibudilast) for the prevention of metastasis of various solid cancers
- MediciNova has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent covering MN-166 (ibudilast).
- The patent covers the prevention of metastasis in various cancers, including pancreatic, lung, breast, colorectal, melanoma, and ovarian cancers.
- The allowed claims include the use of MN-166 in combination with therapies such as chemotherapy, immunotherapy, radiotherapy, and others.
- The patent covers oral administration, a wide range of doses, different dosing frequencies, and treatment periods.
- Once issued, the patent is expected to expire no earlier than July 2042.
- MN-166 (ibudilast) is in late-stage clinical development for neurodegenerative diseases and is also being evaluated for glioblastoma, Long COVID, and other conditions.
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Quantro Therapeutics reaches a milestone in the collaboration with Boehringer Ingelheim to develop first-in-class cancer treatments
- QUANTRO Therapeutics achieved a key milestone in its R&D collaboration with Boehringer Ingelheim.
- The milestone involved successful application of QUANTRO’s QUANTROseq Transcriptional Fingerprint technology.
- All pre-set goals for technical proof-of-concept, cross-validation of HTS screening technology, and identification of high-quality hits were accomplished.
- The joint R&D program, initiated in 2022, aims to develop first-in-class cancer treatments targeting previously undruggable transcription factors.
- QUANTRO will receive an undisclosed milestone payment, with the total potential transaction value exceeding EUR 500 million.
- Next steps include advancing the identified hits to the discovery and development stages.
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Cue Biopharma presents updated data from phase 1 trial of CUE-101 in recurrent/metastatic HPV+ head and neck cancer at the 2024 ASCO annual meeting
- Overall response rate (ORR) of 46% and 12-month overall survival (OS) of 96% in first line (1L) recurrent/metastatic (R/M) HPV+ head and neck squamous cell carcinoma (HNSCC) treated with CUE-101 and pembrolizumab.
- Median overall survival (mOS) of 20.8 months in second line (2L) and beyond HPV+ HNSCC patients treated with CUE-101 monotherapy, compared to historical mOS of 7.5 and 8.4 months in third-party checkpoint inhibitor trials.
- ORR of 46% and Disease Control Rate (DCR) of 79% in patients with combined positive score (CPS) ≥1, compared to an ORR of 19% with pembrolizumab alone in the historical KEYNOTE-048 trial.
- 12-month OS of 96% and median progression free survival (PFS) of 5.8 months compared to 3.2 months with pembrolizumab alone in the KEYNOTE-048 trial.
- No unanticipated, significant safety concerns have emerged in either the combination or monotherapy trials, and adverse events have been readily managed.
- CUE-101 data will be presented in an oral presentation at the 2024 ASCO Annual Meeting.
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Ascentage Pharma releases updated data on lisaftoclax at ASCO 2024
- Ascentage Pharma presented updated results from a global, multicenter Phase Ib/II study of lisaftoclax at the ASCO 2024 Annual Meeting.
- The study evaluated lisaftoclax alone or in combination with ibrutinib or rituximab for treating Waldenström macroglobulinemia (WM).
- Lisaftoclax combined with ibrutinib showed a 90.9% objective response rate (ORR) in treatment-naïve WM patients, with manageable adverse events and no drug-drug interactions.
- The study enrolled 46 patients across three arms, with varying doses of lisaftoclax administered in 28-day cycles.
- Efficacy results showed ORRs of 41.7%, 90.9%, and 37.5% for Arms A, B, and C, respectively, with no significant differences based on CXCR4 mutation status in Arms B and C.
- Safety results indicated that lisaftoclax was well tolerated, with no maximum-tolerated dose reached and manageable adverse events, including neutropenia and tumor lysis syndrome.
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