Antibody-drug conjugates (ADCs)

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MRK's ADC Candidate Gets FDA Breakthrough Therapy Tag for Lung Cancer
ZACKS· 2025-08-19 16:41
Group 1: FDA Breakthrough Therapy Designation - Merck's B7-H3-directed ADC, ifinatamab deruxtecan (I-DXd), received FDA's Breakthrough Therapy designation for treating extensive-stage small cell lung cancer in adults whose disease progressed after platinum-based chemotherapy [1][8] - The Breakthrough Therapy designation accelerates the development and review of drugs for serious conditions when early clinical evidence indicates significant improvement over existing treatments [2] Group 2: Clinical Studies and Data - The FDA's decision was based on data from the phase II IDeate-Lung01 study, which evaluated the safety and efficacy of I-DXd, supported by the phase I/II IDeate-PanTumor01 study [3][8] Group 3: Stock Performance - Year to date, Merck's shares have decreased by 15.3%, while the industry has seen a decline of 2.8% [4] Group 4: Collaboration and Development - Merck acquired global co-development and co-commercialization rights to I-DXd and two other ADCs from Daiichi Sankyo for a potential total consideration of up to $22 billion, although Daiichi retains exclusive rights for development in Japan [6][9] - I-DXd is also being evaluated in phase III studies for esophageal and prostate cancers, and it has an orphan drug designation for small-cell lung cancer in multiple regions [5][8] Group 5: ADC Market Competition - ADCs are viewed as a disruptive innovation in the pharmaceutical industry, enhancing cancer treatment by targeting tumors with cytotoxic drugs [11] - Daiichi Sankyo has multiple ADCs in clinical development and markets Enhertu in partnership with AstraZeneca, which is approved for various cancer indications [12] - Pfizer entered the ADC market by acquiring Seagen for $43 billion, adding several ADCs to its portfolio that have contributed significantly to its revenues [13][14]
CytomX Therapeutics Announces Second Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-08-07 20:10
Core Insights - CytomX Therapeutics announced positive interim data from the ongoing Phase 1 study of CX-2051, an EpCAM Antibody Drug Conjugate, in patients with advanced colorectal cancer (CRC) [1][6] - The company completed a $100 million underwritten offering of common stock, with net proceeds of $93.4 million, enhancing its financial position to support ongoing and future clinical trials [6][8] - The anticipated data update for CX-2051 is expected in Q1 2026, with a Phase 2 study initiation planned for the first half of 2026 [1][3] Pipeline Program Updates - CX-2051 is currently undergoing dose expansions at 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, administered every three weeks, with approximately 70 patients involved in the Phase 1 study [6] - CX-801, a masked interferon alpha-2b, is in Phase 1 dose escalation, with preliminary data expected in Q4 2025 [6] - Combination studies for CX-2051 in earlier lines of CRC therapy are being planned for 2026 [6] Financial Performance - Total revenue for Q2 2025 was $18.7 million, a decrease from $25.1 million in Q2 2024, primarily due to the completion of performance obligations in collaborations and reduced activities with Moderna [8][10] - Total operating expenses decreased to $19.9 million in Q2 2025 from $33.6 million in Q2 2024, reflecting a reduction in research and development expenses [9][10] - The company ended Q2 2025 with $158.1 million in cash, cash equivalents, and investments, compared to $79.9 million at the end of Q1 2025, providing a cash runway until Q2 2027 [7][8] Research Collaborations - CytomX has established strategic collaborations with major oncology leaders, including Amgen, Astellas, Bristol Myers Squibb, Regeneron, and Moderna, to advance its research and development efforts [12][14]
IDEAYA Biosciences and Hengrui Pharmaceuticals Announce Oral Presentation at IASLC 2025 World Conference on Lung Cancer for IDE849 (SHR-4849), a Potential First-in-Class DLL3-TOP1 ADC
Prnewswire· 2025-07-22 17:01
Core Insights - IDEAYA Biosciences and Jiangsu Hengrui Pharmaceuticals announced an oral presentation on IDE849 (SHR-4849) at the IASLC 2025 World Conference on Lung Cancer, focusing on its efficacy and safety in small-cell lung cancer (SCLC) patients [1][3] - IDE849 is a potential first-in-class DLL3-targeting Topoisomerase-1 (TOP1) payload antibody drug conjugate (ADC), addressing significant unmet medical needs in various solid tumors [1][3] Group 1: Presentation Details - The oral presentation will take place on September 7, 2025, from 4:45-6:00 PM (CET) and will cover a Phase 1 study of SHR-4849 (IDE849) in relapsed SCLC [4] - A poster presentation will also be held on September 8, 2025, discussing the combination mechanism and pre-clinical synergy data between TOP1-payload based ADCs and IDE161, a proprietary PARG inhibitor [2][5] Group 2: Clinical Development - The Phase 1 trial for IDE849 is ongoing in China, with data from over 70 SCLC patients expected to be presented, including results from dose escalation and multiple expansion doses [6] - The U.S. Phase 1 trial of IDE849 in SCLC patients was initiated in the third quarter of 2025 [6] Group 3: Company Strategy - IDEAYA aims to evaluate rational combinations of therapies to improve clinical outcomes for cancer patients, including the use of IDE849 as a monotherapy and in combination with immunotherapy and IDE161 [2][3] - The company has a robust pipeline focused on synthetic lethality and ADCs, including bispecifics, to address unmet medical needs in cancer [7]
OBI Pharma Enters ADC Collaboration with TegMine Therapeutics utilizing GlycOBI® and TegMiner™ Enabling Technologies
Globenewswire· 2025-06-06 07:00
Core Insights - OBI Pharma and TegMine Therapeutics have entered into a Master Services Agreement (MSA) to collaborate on antibody-drug conjugates (ADCs) [1][2] - The partnership aims to leverage OBI's GlycOBI ADC enabling technologies to identify ADC therapeutic candidates for clinical development [2][3] Company Overview - OBI Pharma is a clinical-stage global oncology company based in Taiwan, established in 2002, focusing on developing novel cancer therapies for patients with high unmet medical needs [5] - TegMine Therapeutics, founded in 2017 and based in San Francisco, specializes in developing next-generation antibody-based therapies targeting cancer-associated glycans and glycoproteins [8][9] Technology and Innovation - OBI's GlycOBI technology is a unique glycan-based ADC platform that is compatible with various antibodies, linkers, and payloads, allowing for site-specific homogenous ADCs [4] - The GlycOBI platform utilizes proprietary enzymatic and linker technologies to enhance conjugation efficiency and reduce aggregation propensity, leading to improved antitumor activity and stability [4][6] Strategic Collaboration - The collaboration is expected to combine the strengths of both companies, with OBI's ADC technology complementing TegMine's focus on targeting cancer-specific glycans [3] - Both companies anticipate developing ADCs with unprecedented tumor specificity and therapeutic impact, addressing significant medical needs [3]