Anton Gokin, Scientific and Business Insights Expert at BostonGene, shared a post on LinkedIn:
“Latest Updates in Oncology Market and Science!
- TOLREMO therapeutics gets two FDA Fast Track designations for TT125-802 (CBP/p300 inhibitor) for pretreated, advanced NSCLC with EGFR or KRAS G12C mutations.
- D3 Bio receives FDA Breakthrough Therapy Designation for D3S-001 (KRAS G12C inhibitor) for pretreated metastatic NSCLC and Orphan Drug Designation for KRAS G12C-mutated CRC.
R and D and Trial Results
- Eli Lilly and Company announced that Verzenio (CDK4/6i) showed a statistically significant and clinically meaningful OS benefit in the monarchE Ph3 trial for high-risk, HR+, HER2- early breast cancer.
- Merck and Daiichi Sankyo initiated a Ph3 trial of patritumab deruxtecan (HER3-directed ADC) for metastatic HR+, HER2- breast cancer.
- Akeso Biopharma ivonescimab (bispecific PD-1/VEGF Ab) showed a ‘clinically meaningful’ OS benefit in its Ph3 HARMONi-A trial for EGFR-mutated NSCLC.
- PDS Biotechnology PDS0101 (a T-cell immunoth) + Keytruda showed 39.3 mo median OS in Ph2 HNSCC, significantly improving on SoC.
- BeOne Medicines reports positive topline Ph1/2 data for sonrotoclax (BCL2 inhibitor) in r/r MCL, paving the way for accelerated approval
- Elicera Therapeutics AB reports active lymphoma eliminated in 4/6 patients, Phase I/IIa study of ELC-301 (iTANK-armed CAR T-cell therapy) for B-cell lymphoma.
- Antegenes reported positive results from its Ph1/2 programs, ATG-022 (CLDN18.2 ADC) in gastric cancer and ATG-037 (CD73 inhibitor) in CPI-resistant melanoma and NSCLC.
- Marker Therapeutics, Inc.. reports encouraging Ph1 APOLLO data for MT-601 (MAR-T cell therapy) in relapsed lymphoma with high ORRs.
Finance and Investment
- BeOne Medicines sells ex-China royalties on Amgen’s Imdelltra (bispecific T-cell engager) toRoyalty Pharmaa for an upfront payment of $885M, accelerating value from the SCLC drug.
- Wugen secured a $115M equity financing round to advance its allogeneic CAR-T therapy, WU-CART-007, for T-cell malignancies.
- Incyclix Bio secured an $11.25M Series B extension to complete its Ph1/2 trial for INX-315 (CDK2i) in CDK4/6i-resistant ER+/HER2- BC.
Partnerships and Deals
- Immuneering Corporation and Eli Lilly and Company partner to evaluate IMM-1-104 (MEK inhibitor) with Lilly’s olomorasib (KRAS G12C inhibitor) in a planned Ph2 trial for KRAS G12C-mutant NSCLC.
- Appia Bio, a cell therapy company and former Kite Pharma collaborator, is shutting down after failing to secure further funding needed to advance its platform into the clinic.
- Northwest Biotherapeutics will acquire Advent Bioservices, securing manufacturing capabilities for its late-stage DCVax-L (dendritic cell therapy) to treat glioblastoma.
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