Antibody Drug Conjugates (ADCs)

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Sutro Biopharma Reports Second Quarter 2025 Financial Results and Business Highlights
Globenewswire· 2025-08-07 20:30
Core Insights - Sutro Biopharma is advancing its pipeline of novel antibody-drug conjugates (ADCs), with plans to initiate a first-in-human trial for STRO-004 in the second half of 2025, targeting solid tumors [1][6] - The company has generated significant preclinical data supporting the potential of its ADC candidates, particularly in the dual-payload ADCs, which are seen as transformative for cancer treatment [2][6] - Sutro has entered a research collaboration with the FDA to enhance regulatory standards for ADCs, indicating a commitment to improving drug development processes [1][14] Financial Highlights - As of June 30, 2025, Sutro reported cash, cash equivalents, and marketable securities totaling $205.1 million, down from $249.0 million as of March 31, 2025, providing a cash runway into early 2027 [1][9] - Revenue for the second quarter of 2025 was $63.7 million, a significant increase from $25.7 million in the same quarter of 2024, primarily driven by the Astellas collaboration [10] - Total operating expenses for the quarter were $67.1 million, a decrease from $74.4 million in the prior year, with R&D expenses at $38.4 million and G&A expenses at $10.3 million [11][18] Pipeline Developments - STRO-004 is on track for a clinical trial initiation in the second half of 2025, with a favorable preclinical safety profile observed [6][7] - STRO-006, targeting integrin beta-6, is expected to enter clinical development in 2026 for multiple solid tumors [6] - The dual-payload ADC program is progressing, with an IND filing anticipated in 2027, and a collaboration with Astellas has led to a $7.5 million milestone payment [6][10] Corporate Updates - Greg Chow has been appointed as Chief Financial Officer, indicating a strengthening of the management team [1][14] - The company is focused on implementing operational efficiencies to extend its cash runway while prioritizing pipeline execution to enhance shareholder value [2]
ADC Therapeutics to Host Second Quarter 2025 Financial Results Conference Call on August 12, 2025
Prnewswire· 2025-08-05 20:05
Company Overview - ADC Therapeutics SA is a commercial-stage global leader in the field of antibody drug conjugates (ADCs) [3] - The company is headquartered in Lausanne, Switzerland, with operations in London and New Jersey [5] Upcoming Events - ADC Therapeutics will host a conference call and live webcast on August 12, 2025, at 8:30 a.m. EDT to report financial results for Q2 2025 and provide operational updates [1] Product Development - The company's CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy [4] - ZYNLONTA is also being developed in combination with other agents and in earlier lines of therapy [4] - ADC Therapeutics is advancing IND-enabling activities for a next-generation PSMA-targeting ADC utilizing a differentiated exatecan-based payload with a novel hydrophilic linker [4]
Akari Therapeutics Releases Virtual Investor “What This Means” Segment
Globenewswire· 2025-07-29 13:15
Core Insights - Akari Therapeutics is focused on developing novel immuno-oncology payload antibody drug conjugates (ADCs) for cancer treatment [2][4] - The company’s lead candidate, AKTX-101, utilizes a novel spliceosome modulator payload, PH1, which has shown significant preclinical activity [4] Company Overview - Akari Therapeutics is an oncology biotechnology company that has developed PH1, a spliceosome modulator designed to disrupt RNA splicing within cancer cells [4] - PH1 is differentiated from traditional ADC payloads that typically use Topoisomerase1 inhibitors or tubulin inhibitors, and it has demonstrated the ability to induce cancer cell death while activating immune cells [4] - AKTX-101 targets the Trop2 receptor on cancer cells, delivering the PH1 payload directly into tumors, and has shown prolonged survival in preclinical studies compared to traditional ADCs [4] Research and Development - The company is conducting ongoing research to further understand the effects of PH1 and its potential to disrupt key drivers of cancer cell growth [3][4] - Akari is generating validating data on PH1 to advance its lead asset and explore other undisclosed targets [4]
Akari Therapeutics Continues Key Research on its Novel Antibody Drug Conjugate Payload PH1 to Further Demonstrate its Unique Ability to Target Cancers Fueled by Oncogenic Drivers
Globenewswire· 2025-07-23 12:55
Core Insights - Akari Therapeutics is advancing its research on PH1, a novel spliceosome modulator that induces cancer cell death and activates the immune system to combat cancer [1][4] - The company is focused on developing antibody drug conjugates (ADCs) utilizing the PH1 payload, with ongoing preclinical studies expected to yield new data by year-end [1][3] Company Overview - Akari Therapeutics specializes in oncology biotechnology, developing innovative ADCs with a unique mechanism of action through the PH1 payload, which disrupts RNA splicing [4] - The lead candidate, AKTX-101, targets the Trop2 receptor and has shown significant activity and prolonged survival in preclinical studies compared to traditional ADCs [4] Research and Development - Ongoing research aims to explore the effects of PH1 on key oncogenic drivers such as KRAS, BRAF, and FGFR3, with preliminary data anticipated soon [2][3] - The PH1 payload has demonstrated the ability to induce cytotoxicity in cancer cells and activate immune responses, potentially leading to improved therapeutic outcomes [2][6]
Akari Therapeutics Participates in the Virtual Investor “What's Your Story” Summer Spotlight On-Demand Conference
Globenewswire· 2025-07-22 12:45
Company Overview - Akari Therapeutics is an oncology biotechnology company focused on developing novel immuno-oncology payload antibody drug conjugates (ADCs) for cancer treatment [1][3] - The company has developed its first novel payload, PH1, which is a spliceosome inhibitor designed to disrupt RNA splicing within cells [3] - PH1 is differentiated from current ADC payloads that utilize Topoisomerase1 inhibitors or tubulin inhibitors, showing potential to induce cancer cell death while activating immune cells [3] Lead Candidate - Akari's lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and delivers the PH1 payload directly into tumors [3] - In preclinical studies, AKTX-101 has demonstrated significant activity and prolonged survival compared to traditional ADCs [3] - The candidate has potential synergistic effects with checkpoint inhibitors, showing prolonged survival both as a single agent and in combination with these inhibitors [3] Recent Developments - Abizer Gaslightwala, the CEO of Akari, participated in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference, discussing his dedication to the company and its programs [1][2] - The on-demand video webcast of the conference is available on virtualinvestorco.com and the company's website [2]
ADC Therapeutics Makes Grant to New Employee Under Inducement Plan
Prnewswire· 2025-07-01 20:05
Core Points - ADC Therapeutics SA has granted options to purchase 17,000 common shares to a new employee as an inducement for employment [1][2] - The grants were approved by the Compensation Committee under the Company's Inducement Plan to motivate and reward employees [2] - The options will vest 25% on the first anniversary of the grant date and 1/48th monthly thereafter, fully vesting by the fourth anniversary [3] Company Overview - ADC Therapeutics is a global leader in antibody drug conjugates (ADCs) and is focused on transforming treatment for hematologic malignancies and solid tumors [4] - The company's ADC ZYNLONTA has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory diffuse large B-cell lymphoma [5] - ADC Therapeutics is headquartered in Lausanne, Switzerland, with operations in London and New Jersey [6]
Whitehawk Therapeutics (AADI) Fireside Chat Transcript
2025-06-26 15:00
Summary of Whitehawk Therapeutics Fireside Chat - June 26, 2025 Company Overview - Whitehawk Therapeutics, formerly known as Adi Bioscience, underwent a transformation completed in Q1 2025, focusing on developing an advanced ADC (antibody-drug conjugate) portfolio after selling its mTOR inhibitor product to Kaken Pharmaceuticals for $100 million [3][4][15]. Pipeline and Technology - The company is developing a three-asset ADC portfolio targeting various cancers, including lung, ovarian, and gastrointestinal cancers, with a focus on established tumor biology and clinically validated tumor markers [4][5][14]. - All three programs are currently in preclinical stages, with IND (Investigational New Drug) filings anticipated by mid-2026 [6][13]. - The ADC platform utilizes a linker payload technology designed for greater stability, reduced off-target toxicity, and improved therapeutic index [5][12][13]. Key Programs 1. **HAWK 007 (PTK7-targeted ADC)** - PTK7 is broadly overexpressed in various solid tumors, with expression rates of 60-70% in cancer patients [20][21]. - The program aims to demonstrate differentiation from previous compounds, with a focus on lung cancer, ovarian cancer, and triple-negative breast cancer [24][26]. - Initial phase one trials will target patients with moderate to high expression of PTK7, aiming for a minimum response rate of 40% in lung cancer and 50% in ovarian cancer [56]. 2. **HAWK 016 (MUC16-targeted ADC)** - MUC16 is a circulating biomarker in ovarian cancer, with the approach focusing on targeting the membrane-bound portion to avoid complications from circulating biomarkers [60][63]. - The program will initially focus on gynecological cancers, with potential expansion into pancreatic and non-small cell lung cancers in the future [70]. 3. **HAWK 206 (SEZ6-targeted ADC)** - This program is in the early stages, with a biparatopic approach aimed at enhancing internalization and efficacy in neuroendocrine tumors and small cell lung cancer [71][78]. Competitive Landscape - The ADC market is competitive, with other companies like Zymeworks and Day One Pharmaceuticals developing next-generation ADCs. Whitehawk believes its platform offers superior optimization in terms of linker stability, hydrophilicity, and therapeutic index [36][46]. - The company aims to differentiate its products by demonstrating better efficacy and safety profiles compared to existing therapies [30][46]. Financial Position and Future Outlook - Whitehawk started Q2 2025 with approximately $185 million in cash, providing operational runway into early 2028 to generate clinical data before seeking additional funding [88][90]. - The company plans to release more preclinical data in 2026, focusing on a comprehensive view of its products' potential before public disclosures [89][90]. Conclusion - Whitehawk Therapeutics is positioned to make significant advancements in the ADC space with its innovative platform and targeted therapies. The upcoming IND filings and clinical trials will be critical in validating its approach and establishing its market presence.
ADC Therapeutics Announces $100 Million Private Placement Extending Expected Cash Runway into 2028
Prnewswire· 2025-06-12 10:45
Core Viewpoint - ADC Therapeutics has announced a $100 million PIPE financing to support the development and commercialization of its ADC product ZYNLONTA and other strategic initiatives [1][2]. Financing Details - The PIPE involves the sale of 13 million common shares at $3.53 each and pre-funded warrants for 15.7 million common shares at $3.43 each, with gross proceeds expected to be approximately $100 million before fees [1][2]. - The financing is set to close on June 16, 2025, pending customary conditions [2]. Use of Proceeds - The net proceeds from the PIPE will be utilized for ZYNLONTA's clinical development, commercialization activities, working capital, and general corporate purposes [2]. Strategic Developments - The company will advance its preclinical exatecan-based ADC targeting prostate-specific membrane antigen (PSMA) while discontinuing other preclinical solid tumor programs [3]. - A workforce reduction of approximately 30% is planned, with the majority of this restructuring expected to be completed by September 30, 2025, incurring one-time cash charges of $6 to $7 million [3]. Long-term Growth Positioning - These strategic moves are anticipated to reduce operating expenses significantly and extend the company's cash runway into 2028 [4]. - Key anticipated catalysts include ongoing clinical trials such as LOTIS-7 and LOTIS-5, with significant data expected in the coming years [4][8]. Clinical Development Updates - LOTIS-7 Phase 1b trial data for ZYNLONTA plus glofitamab is expected in the second half of 2025, with full enrollment of 100 patients anticipated by the first half of 2026 [8]. - Topline results from the LOTIS-5 Phase 3 trial are expected in late 2025 or early 2026, with potential regulatory submissions following [8]. Company Overview - ADC Therapeutics is a leader in the field of antibody drug conjugates (ADCs), focusing on transforming treatment paradigms for hematologic malignancies and solid tumors [14][15].
ADC Therapeutics Announces Updated Data from LOTIS-7 Clinical Trial Presented at the European Hematology Association 2025 Congress
Prnewswire· 2025-06-12 10:30
Core Insights - ADC Therapeutics announced promising results from the LOTIS-7 Phase 1b trial, showing a 93.3% overall response rate (ORR) and an 86.7% complete response (CR) rate in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) treated with ZYNLONTA® and glofitamab [1][3][4] Efficacy Data - Among 30 efficacy evaluable patients, 28 achieved an overall response, with 26 achieving complete responses [3] - 25 out of 26 patients who achieved CR remained in CR at the data cut-off [1][3] - Median time to CR was 80 days for the 120 µg/kg dose and 42 days for the 150 µg/kg dose [3] - 12 patients converted from stable disease or partial response to CR over time [3] - Of 6 patients previously treated with CAR-T, 5 achieved CR [3] Safety Profile - The combination treatment was generally well tolerated, with no dose-limiting toxicities (DLTs) reported [3] - Among 41 safety evaluable patients, the most common grade 3 or higher treatment-emergent adverse events (TEAEs) included neutropenia (24.4%), anemia (9.8%), and increased liver enzymes [3] - Cytokine release syndrome (CRS) was observed in 23.8% of patients at the 150 µg/kg dose, all Grade 1, while 55% experienced CRS at the 120 µg/kg dose [3] Study Expansion - The company is expanding enrollment for the LOTIS-7 trial to 100 patients at the 150 µg/kg dose of ZYNLONTA [1][4] - The updated data will be presented at the European Hematology Association 2025 Congress and the 18th International Conference on Malignant Lymphoma [4] About ZYNLONTA - ZYNLONTA is a CD19-directed antibody drug conjugate (ADC) approved for treating adult patients with r/r large B-cell lymphoma after two or more lines of systemic therapy [9][13] - The drug works by binding to CD19-expressing cells and delivering a potent payload that leads to tumor cell death [8]
MRK's ADC Drug Combo Shows Antitumor Activity in Lymphoma Study
ZACKS· 2025-06-02 15:56
Core Insights - Merck (MRK) announced positive data from the dose confirmation phase of the phase II/III waveLINE-003 study for zilovertamab vedotin, an antibody drug conjugate (ADC) targeting relapsed or refractory diffuse large B-cell lymphoma (DLBCL) [1][2] Study Results - The waveLINE-003 study showed a 56.3% objective response rate (ORR) for zilovertamab vedotin (1.75 mg/kg) in combination with standard-of-care rituximab and gemcitabine-oxaliplatin (R-GemOx), with eight patients achieving complete response (CR) and one partial response [2][6] - The phase II portion of the study indicated a promising response rate and manageable safety profile for zilovertamab vedotin in combination with standard care [3] Development Activities - Zilovertamab vedotin is a first-in-class ADC targeting ROR1, a protein overexpressed in various hematologic malignancies, representing a potential innovation in cancer treatment [4] - The ADC is being evaluated in additional mid-to-late-stage studies for DLBCL, including phase III waveLINE-010 and phase II waveLINE-007 studies for previously untreated DLBCL patients [7] - A new phase II waveLINE-011 study has been initiated to compare zilovertamab vedotin plus rituximab and R-CHP against polatuzumab vedotin with R-CHP for DLBCL treatment [8] Other Developments - Merck also reported data from the phase I KANDLELIT-001 study for its KRAS G12C inhibitor candidate, MK-1084, showing manageable safety and antitumor activity in advanced colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) patients [9][10] - The phase III KANDLELIT-012 study is evaluating MK-1084 in combination with cetuximab and mFOLFOX6 for first-line treatment of KRAS G12C-mutant CRC, while the phase III KANDLELIT-004 study is investigating its use with Keytruda for metastatic NSCLC [11]