ADC June News Roundup: Key Updates and Highlights

Before we dive into #ADC news for June, it's worth mentioning that 强生公司 has launched the Pitching ADC Advancements QuickFire Challenge. If you are innovating in the space, be sure to check out this opportunity. The program offers rolling application reviews and virtual pitch opportunities starting in July.

Regulatory

• Telix Pharmaceuticals Limited Completes Zircaix? BLA Submission for Kidney Cancer Imaging [Link]
• Innovent Biologics Receives FDA Fast Track Designation for IBI343 for Pancreatic Cancer [Link]
• HER3-DXd BLA Submission Receives CRL from FDA Due to Inspection Findings [Link]
• FDA Places Partial Hold on BioNTech SE - 宜联生物医药 ADC after Multiple Deaths [Link]
• BioNTech SE and Duality Biologics Receive FDA Fast Track Designation for BNT324/DB-1311 in Prostate Cancer [Link]
• Tubulis GmbH Receives FDA Fast Track Designation for TUB-040 in Ovarian Cancer [Link]
• Abdera Therapeutics Announces FDA Fast Track Designation for ABD-147 in SCLC [Link]
• Huadong Medicine Received Clinical Trial Approval for HDM2005 [Link]

Clinical Trials

• Angiex Inc. Initiates a Phase 1 Study For its Anti-TM4SF1 ADC in Solid Tumors [Link]
• Monopar Therapeutics Inc. Initiates a Phase 1 Trial for MNPR-101-Zr in Solid Tumors [Link]
• OBI Pharma Announces Phase 1/2 Study Initiation for OBI-992 in Solid Tumors [Link]
• Pheon Therapeutics Announces Phase 1 Study for PHN-010 [Link]
• FS-1502 Exhibits Lower Toxicity Than Other Anti-HER2 ADCs in mBC [Link]
• Tubulis GmbH Doses First Patient in Phase 1/2 Trial Investigating TUB-040 in Ovarian and Lung Cancer [Link]
• 辉瑞 and Seagen Announce a Phase 1 Study for SGN-MesoC2 in Solid Tumors [Link]
• 礼来 Initiates a Phase 1 Trial for LY4052031 in Urothelial and Solid Tumors [Link]
• Teva Pharmaceuticals Announces a Phase 1 Study for TEV-5627, a Novel anti-PD1-IL2 Conjugate, in Solid tumors [Link]
• SystImmune Initiates A Phase 2 Study for BL-M07D1 in Breast Cancer [Link]

Pipelines

• Monopar Therapeutics Inc. Presents Promising Preclinical Data for MNPR-101-Zr [Link]
• Syndivia Adds a Trop-2 ADC to Its Arsenal [Link]
• BiVictriX Therapeutics Ltd Releases Favorable Preclinical Safety Profile for its BVX001 Bispecific ADC in AML [Link]
• 诺和诺德 Is Developing Once-Monthly Fc-Insulin conjugates [Link]
• Adcoris is Developing ADC2336 in Ovarian Cancer [Link]
• Dyne Therapeutics Exhibits the Ability to Deliver Enzyme Replacement Therapy for Pompe Disease in Preclinical Studies [Link]
• Debiopharm Adds Debio 0633 to Its Pipeline [Link]

Data Readouts

• Corbus Pharmaceuticals ' Nectin-4 Targeting ADC Continues to Demonstrate Encouraging Results [Link]
• ADCETRIS? Shows Meaningful OSS Improvement in R/R DLBCL [Link]
• ENHERTU? Demonstrated Clinically Meaningful Benefit in HER2 Low and Ultralow MBC [Link]
• FibroGen, Inc. 's FOR46 Demonstrated Clinically Meaningful Early Signals of Efficacy in mCRPC [Link]
• Blenprep Combination Reduced Risk of Progression or Death versus SOC in R/R MM [Link]
• Innovent Biologics Presented Encouraging Clinical Efficacy and Tolerability Data for IBI363 in NSCLC and Solid Tumors [Link]
• Innovent Biologics Reveals Positive Clinical Signal for IBI343 in Pancreatic and Biliary Tract Cancers [Link]
• Telix Pharmaceuticals Limited Announces Positive rPFS Clinical Data for TLX591 in Prostate Cancer [Link]
• 迈威（上海）生物科技股份有限公司 's 9MW2821 Demonstrated Encouraging Multi-Cancer Efficacy [Link]
• 基石药业 's ROR1 ADC (CS5001) Demonstrates Clinical Activity in Both Solid and Tumors and Lymphoma [Link]
• Bio-Thera Solutions Presents Potential Bes-in-Class Phase 1/2 Data for its FRα Asset [Link]
• AbbVie Announces Positive Phase 2 Data for ELAHERE? in Ovarian Cancer [Link]
• Avidity Biosciences, Inc. Announces Unprecedented AOC 1020 Clinical Data in FSHD [Link]
• Following Positive Clinical Data, 荷商葛蘭素史克藥廠 Prepares for Blenrep Relaunch [Link]

Deals and Partnerships

• Debiopharm and Genome & Company Enter an Exclusive Agreement for the Development of First-in Class Oncology ADCs [Link]
• VGXI Announces a Strategic Partnership with Sutro Biopharma, Inc. to Support Luvelta Production [Link]
• ArriVent Biopharma Annoucned a Multi-Target Collaboration with Alphamab Oncology [Link]
• Biolojic Design, Ltd. Enters into a Multi-Target Drug Discovery Collaboration with Merck KGaA, Darmstadt, Germany [Link]
• BiVictriX Therapeutics Ltd Awarded ￡370,000 grant from Innovate UK [Link]
• Tesseract Medicines Medicines Announces $20 Million Seed Financing [Link]
• Y-Biologics Partners with Rigachem Bioscience to Develop Innovative ADCs [Link]
• 荷商葛蘭素史克藥廠 terminates Blenrep-Ogsiveo deal with SpringWorks [Link]
• Monopar Therapeutics Inc. and NorthStar Medical Radioisotopes, LLC Amend & Extend Collaboration [Link]
• Bright Peak Therapeutics Announces $90 Million in Series C Financing [Link]
• InduPro Announces $85 Million Series A, Appoints Prakash Raman as CEO [Link]
• Day One Biopharmaceuticals Enters Licensing Agreement with MabCare Therapeutics for an Anti-PTK7 ADC [Link]
• Radiopharm Theranostics Receives Strategic Investment for up to A$18 Million [Link] and Completes A$70 Million Placement [Link]
• Manhattan BioSolutions, Inc. and the Institute of Chemical Biology & Drug Discovery Partner to Advance Taxoids as Innovative ADC Payloads [Link]

New Companies and Updates

• Adcytherix Launches with €30 Million in Seed Funding [Link]
• BiVictriX Therapeutics Ltd Releases Full 2023 Year Results [Link]
• JonesTrading Releases Report on Radiopharm Theranostics [Link]
• Telix Pharmaceuticals Limited Announces Launch of Proposed Initial Public Offering in the United States [Link]
• Avidity Biosciences, Inc. Announces Proposed Public Offering of Common Stock [Link]
• BioLoomics Appoints Kurt Gish as CSO [Link]
• Arbitration Dispute Between Daiichi Sankyo US and Seagen Ends [Link]

Manufacturing and Facilities

• MediMabBio Opens facilities at Abingdon Science Park, UK [Link]
• Kemwell Biopharma and RevOpsis Therapeutics Enter into Strategic Manufacturing Partnership [Link]

Publications and Media

• Matthew Pillar from Bioprocess Online and Cytiva are Hosting an ADC Manufacturing Webinar [Link]
• Review: Clinical Translation of ADC Dosing in Solid Tumors From Preclinical Mouse Data [Link]
• Review: The Evolution of ADCs: Toward Accurate DAR and Multi-specificity [Link]
• Podcast: Matthew Pillar Sits Down with Daiichi Sankyo US 's CEO, Ken Keller [Link] and Mythic Therapeutics, Inc. 's CSO and Founder Brian Fiske [Link]
• BioNTech SE Co-Founder, ?zlem Türeci, Says Company has "to be in the ADC game" [Link]
• “We want to be part of that wave,” says Pedro Valencia, PhD , AbbVie ’s VP of Solid Tumor Pipeline Strategy and Execution [Link]
• The Antibody Society Releases Its "Antibodies to Watch in 2024: mid-year update" [Link]
• How ADCs aim to take down cancer [Link]
• Route Design and Scale-Up of a Top I Inhibitor Payload [Link]
• Development of MICA-Specific Nanobodies for Diagnosis and Immunotherapy [Link]
• Glycoengineering-Based Anti-PD-1-iRGD Peptide Conjugate Boosts Antitumor Efficacy [Link]
• Patent: Novel Branched ADC Linker Capable of Simultaneously Carrying Two Payloads [Link]