The post-ASCO-Conference Survey asked attendees, including practicing oncologists, attending this year’s annual meeting of the American Society of Clinical Oncology about ADCs.
Although practicing oncologists generally agreed that targeted therapies and bispecific antibodies remain of interest, based on the presented data, about 75% said that they view ADCs as practice-changing.
However, while the development of novel ADCs does indeed face challenges, the same group of oncologists realize that these novel agents offer great potential for the treatment of the unmet medical needs of patients – hence their hopes and enthusiasm for ADCs remain high.
The post-ASCO-Conference Survey showed that practicing oncologists were especially interested in data from three Phase 3 clinical trials:
- ECHELON-3 study (NCT04404283)
- Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL
- Destiny-Breast06 (DB-06) study (NCT04494425)
- Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator’s Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
- DREAMM-8 study (NCT04484623)
- Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma
In addition, data from the Phase 2 OptiTROP-Lung01 trial (NCT05351788), which investigates a combination of a novel Trophoblast Cell Surface Antigen 2 (TROP 2) targeting ADC (sacituzumab tirumotecan; SKB264/MK-2870) in combination with a novel PD-L1 antibody (KL-A167) was welcomed enthusiastically as it demonstrated promising efficacy and a manageable safety profile in treatment-naïve Non-Small Cell Lung Cancer (NSCLC).
- SKB264 Combination Therapy in Patients With Advanced or Metastatic Non-small Cell Lung Cancer.[Article]
Regulatory
- Mabwell Receives US Food and Drug Administration (FDA) ZW191 for 9MW2821 [Link]
- Zymeworks Inc. Announces IND Clearance for ZW191 [Link]
- Merck & Co Receives Positive EU CHMP Opinion for KEYTRUDA® Plus Padcev® in Urothelial Cancer [Link]
- Blenrep Combinations in Multiple Myeloma Application Accepted for Review by the European Medicines Agency [Link]
- BioAtla, Inc. Granted Fast Track Designation for CAB-ROR2-ADC in Head and Neck Cancer [Link]
- Korean Ministry of Food and Drug Safety Approves KEYTRUDA® Plus Padcev® Combination in Urothelial Cancer [Link]
- AstraZeneca and Daiichi Sankyo US‘s Enhertu Turned Away by NICE on Pricing Grounds [Link] and AstraZeneca‘s CEO Criticizing ‘Severity Scoring’ [Link]
- FDA Grants Orphan Drug Designation to Mabwell‘s 7MW3711 [Link]
- Huadong Medicine’s HDM2005 Granted IND Approval in the U.S. [Link]
Clinical Trials
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co. Initiates a Phase 3 Trial for FDA018 in Breast Cancer [NCT06519370]
- Sichuan Baili Pharmaceutical Co. Initiates 2 Trials for BL-B01D1 in Lung Cancer [NCT06498986 | NCT06500026]
- Hansoh Bio Initiates Trial for HS-20093 in Lung Cancer [NCT06498479]
- Gilead Sciences Initiates a Phase 3 Trodelvy Trial in Endometrial Cancer [NCT06486441]
- Jiangsu HengRui Medicine Initiates a Phase 2/3 Trial for HRS-4642 in Solid Tumors [NCT06520488]
- Sichuan Baili Pharmaceutical Co. Initiates 2 Trials for BL-B16D1 in Solid Tumors [NCT06469008 | NCT06493864]
- MacroGenics Stops Further Dosing in Phase 2 Trial for Vobra Duo in Prostate Cancer [Link]
Pipelines
- VERAXA Biotech Launches New BiTAC to Develop Antibody Therapeutics with Unprecedented Safety Features. [Link]
- AC Immune Unveils Novel ADC Technology For Improved Efficacy In Neurodegenerative Diseases [Link]
- Bliss Biopharmaceutical Releases Favorable Preclinical Data for BB-1701 [Link]
- PINOTBIO Unveils ADC Pipeline PBX-7 Series [Link]
- China Resources Biopharmaceuticals is Developing CRB-2107 for the Treatment of Cancer
- AbTx is Developing AbTx-102 for the Treatment of Breast Cancer [Link]
- April Bio Co. Ltd is developing APB-ADC for Solid Tumors [Link]
- Praesidia Biotherapeutics Adds PB-001 and PB-021 to its Arsenal [Link]
- BeiGene is Developing BG-C477 for the Treatment of Lung and GI Cancers [Link]
- EdisBiotech is Developing an anti-ED2 ADC for the Treatment of Solid Tumors [Link]
- Innovent Biologics to Present Phase 1 Data for its IBI343 at ESMO [Link]
Deals and Partnerships
- Eisai US End its Collaboration with Bristol Myers Squibb for MORab-202 [Link]
- ABL Bio Aims to Become a Global ADC Leader, Secures $310M for R&D, and is Negotiating Bispecific Technology Transfer Agreement [Link]
- Myricx Bio Announces $114M Series A [Link]
- Ipsen and Foreseen Biotechnology Announce Licensing Agreement for FS001 [Link]
- Orum Therapeutics and Vertex Pharmaceuticals Announce Multi-Target License Agreement to Develop Novel Degrader ADCs [Link]
- SOTIO Biotech Enter Multi-Target ADC Agreement with Biocytogen [Link]
- Sanyou Biopharmaceuticals Collaborates on ADC with Huadong Medicine [Link]
- Nectin Therapeutics Enters a License Agreement with Immunome [Link]
- ABL Bio Aims to Become a Global ADC Leader and Secures $310M for R&D [Link]
- Genome & Company Issues $3.26M Convertible Bounds to Support R&D [Link]
- OBI Pharma‘s GlycOBI® Seeks Collaborative Partnerships for Development [Link]
- IDEAYA Biosciences Announces Option and License Agreement for First-in-Class B7H3/PTK7 Biscpecific Program with Biocytogen [Link]
New Companies and Updates
- Myricx Bio Announces Board Changes [Link]
- Sutro Biopharma Appoints Barbara Leyman as Chief Business Development Officer [Link]
- Heidelberg Pharma Reports on First Half-Year 2024 and Business Updates [Link]
- Telix Pharmaceuticals Limited Announces $391 Million Convertible Bonds Offering [Link]
- Radiopharm Theranostics Targets Nasdaq Listing by End of 2024 [Link]
- Samsung Biologics to Complete its Standalone ADC Facility this Year [Link]
- OBI Pharma‘s GlycOBI® and EndoSymeOBI® Two Trademarks Approved by Taiwan Intellectual Property Office [Link]
- Hummingbird Bioscience Appoints Kon Yew Kwek, BMBCh, DPhil as Chief Medical Officer [Link]
- FibroGen Reduced Workforce by 75% [Link]
- Olon Announces Acquisition of GTP Bioways [Link]
Publications and Media
- Paper: Economics of ADCs: Innovation, Investment and Market Dynamics [Link]
- Bayer Patent: ADCs with Enzymatically Cleavable Groups [Link]
- Mersana Therapeutics: Tumor Cell-Directed STING Agonist ADC Induces Immune Responses [Link]
- WuXi XDC Patent: Innovative Linkers with Improved Properties [Link]
- GeneQuantum Healthcare (Suzhou) Co. Patent: Novel Multi-Payload Linker [Link]
- Antikor Biopharma‘s CEO, Mahendra Deonarain, Discusses ADC Development Using OptiLinked Smaller Antibody Fragments [Link]
- Paper: Can We Do Better with Mylotarg? Model-Based Assessment of Opportunities to Improve Therapeutic Index [Link]
- Paper: T Cell Receptor-Directed ADCs for the Treatment of T Cell-Derived Cancers [Link]
- Podcast: Elevation Oncology‘s CEO, Joseph Ferra, Discusses the Use of ADCs to Treat Gastric Cancer [Link]
- Paper: Digestion-Free Absolute Quantification of Conjugated Payload from ADCs Using Middle-Down Fragmentation Mass Spectrometry [Link]
- ASCO 2024: What the Post-Conference Survey Reveals [Link]
- Paper: First Site-Specific Conjugation Method for Native Goat IgG Antibodies Via Glycan Remodeling at the Conserved Fc Region [Link]
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