Antibody Drug Conjugates (ADCs)
Search documents
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]
Akari Therapeutics (AKTX) Conference Transcript
2025-05-29 19:20
Summary of Akari Therapeutics Conference Call (May 29, 2025) Company Overview - **Company**: Akari Therapeutics (AKTX) - **Focus**: Development of antibody drug conjugates (ADCs) with novel immuno-oncology payloads aimed at improving cancer treatment outcomes [2][5] Key Points and Arguments Novel Approach to ADCs - Akari is innovating ADCs by using immuno-oncology payloads that differ from traditional cytotoxic agents, aiming to enhance efficacy and safety in cancer treatment [3][5] - The lead asset, AKTX-101, targets TROP-2, a marker on cancer cells, and is conjugated with a novel payload called pH-1 [9][10] Mechanism of Action - The pH-1 payload targets the spliceosome, leading to cancer cell death and priming the immune system to attack similar cancer cells [8][27] - This approach aims to create immunological memory, allowing the immune system to recognize and attack cancer cells upon re-exposure [34] Clinical Development and Safety - Preclinical data shows robust activity for AKTX-101 as a single agent and in combination with checkpoint inhibitors, with favorable safety profiles observed in nonhuman primate studies [10][12] - Akari is advancing its lead ADC into IND-enabling studies to prepare for Phase 1 trials [20] Market Potential and Competitive Landscape - The ADC market is experiencing significant interest, with major pharmaceutical companies investing heavily in this space, indicating a strong opportunity for Akari's differentiated approach [22][23] - Akari's unique payload distinguishes it from competitors, which primarily use microtubule inhibitors or topo-I inhibitors [24][27] Future Directions - Akari plans to explore additional targets for its pH-1 payload, including colon, lung, and prostate cancers, which represent significant unmet medical needs [12][20] - The company is open to partnerships for further development and commercialization of its ADC platform [21][36] Additional Important Content - The transition from an inflammation-focused portfolio to oncology was driven by the potential of the pH-1 platform and the strategic direction of the company [39] - Akari's leadership team includes experienced professionals from major pharmaceutical companies, enhancing its capability to execute its vision [14][15][18] Conclusion - Akari Therapeutics is positioned to leverage its innovative ADC platform to address significant challenges in cancer treatment, with a focus on enhancing patient outcomes through novel immuno-oncology strategies [36][37]
Akari Therapeutics to Present at LIVE! with Webull Corporate Connect: Virtual Biotech Investment Webinar
Globenewswire· 2025-05-22 13:00
Company Overview - Akari Therapeutics is an oncology biotechnology company focused on developing next-generation spliceosome payload antibody drug conjugates (ADCs) [3] - The company utilizes an innovative ADC discovery platform to generate and optimize ADC candidates for various targets [3] Lead Product Candidate - Akari's lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and delivers a novel PH1 payload directly into tumors [3] - PH1 is a spliceosome inhibitor designed to disrupt RNA splicing within cancer cells, leading to cancer cell death and activation of immune cells [3] - Preclinical studies indicate that AKTX-101 has significant activity and prolonged survival compared to traditional ADCs [3] Synergistic Potential - AKTX-101 has shown potential for synergy with checkpoint inhibitors, demonstrating prolonged survival both as a single agent and in combination with these inhibitors [3] Upcoming Presentation - Abizer Gaslightwala, President and CEO of Akari, will present recent corporate events at the Virtual Biotech Investment Webinar on May 29, 2025 [1][2]
ADC Therapeutics Reports First Quarter 2025 Financial Results and Provides Operational Update
Prnewswire· 2025-05-14 12:00
Core Insights - ADC Therapeutics reported promising data from the LOTIS-7 trial, showing an overall response rate (ORR) of 95.5% and a complete response (CR) rate of 90.9% for ZYNLONTA® in combination with glofitamab in patients with relapsed/refractory DLBCL [1][3][9] - The company expects its cash runway to extend into the second half of 2026, allowing for multiple catalysts to be funded [1][9] - The CEO expressed confidence in ZYNLONTA's potential as a best-in-class treatment in a dynamic market, particularly as the company progresses with the LOTIS-5 confirmatory trial [2][3] Financial Performance - For Q1 2025, ZYNLONTA generated net product revenues of $17.4 million, slightly down from $17.8 million in Q1 2024 [9][21] - License revenues and royalties increased significantly to $5.6 million from $0.2 million in the same period last year, driven by a milestone payment related to ZYNLONTA's approval in Canada [9][21] - Research and development expenses rose to $28.9 million from $25.7 million year-over-year, reflecting increased spending on next-generation ADCs [9][21] - The net loss for Q1 2025 was $38.6 million, an improvement from a net loss of $46.6 million in Q1 2024 [9][21] Clinical Development Updates - The LOTIS-7 trial has reached 40 patient enrollments in its dose expansion arm, with updates expected in the second half of 2025 [1][3] - The LOTIS-5 trial's safety run-in data will also be presented at EHA2025, showing no new safety signals and encouraging antitumor activity [3] - An abstract for marginal zone lymphoma data will be presented at ICML, highlighting the high rate of complete responses in a phase 2 study [3] 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 [11][12] - ZYNLONTA has received accelerated approval from the FDA and conditional approval from the European Commission for treating relapsed or refractory DLBCL after two or more lines of systemic therapy [8][12]
Sutro Biopharma Reports First Quarter 2025 Financial Results and Business Highlights
GlobeNewswire News Room· 2025-05-08 20:31
Core Insights - Sutro Biopharma is shifting its focus from luvelta to its pipeline of novel exatecan and dual-payload ADCs, with STRO-004 being prioritized as the lead clinical candidate due to strong preclinical data indicating its best-in-class potential [2][3][6] - The company aims to deliver three new INDs over the next three years, starting with STRO-004 expected to enter clinical studies in the second half of 2025 [2][6][7] - Sutro's financial results for Q1 2025 show revenue of $17.4 million, an increase from $13.0 million in Q1 2024, primarily driven by the Astellas collaboration [13][19] - As of March 31, 2025, Sutro had cash, cash equivalents, and marketable securities totaling $249.0 million, down from $316.9 million at the end of 2024, with a cash runway expected into early 2027 [12][21] Corporate and Program Updates - The company completed a strategic portfolio review in March, leading to the prioritization of wholly-owned next-generation ADC programs while deprioritizing the development of luvelta [3][6] - Sutro is currently conducting an IND-enabling toxicology study for a dual-payload ADC program in collaboration with Astellas, which has triggered a $7.5 million milestone payment [6][8] - The restructuring plan includes a nearly 50% reduction in organizational headcount and the decommissioning of its manufacturing facility by the end of 2025 [11] Pipeline Developments - STRO-004, a next-generation Tissue Factor-targeting ADC, is set to enter clinical studies in the second half of 2025, focusing on solid tumors [7] - STRO-006, an integrin beta-6 ADC, is expected to enter clinical development in 2026 [7] - Sutro anticipates filing an IND for its first wholly-owned dual-payload ADC in 2027 [7] Financial Highlights - Total operating expenses for Q1 2025 were $85.9 million, compared to $69.6 million in Q1 2024, with R&D expenses at $51.6 million and G&A expenses at $13.3 million [14][20] - The net loss for Q1 2025 was $75.97 million, compared to a net loss of $58.21 million in Q1 2024, with a net loss per share of $0.91 [20][19] - Restructuring costs for Q1 2025 amounted to $21.0 million, with expectations for continued recognition of these costs in future periods [16]
ADC Therapeutics to Host First Quarter 2025 Financial Results Conference Call on May 14, 2025
Prnewswire· 2025-05-08 11:15
Core Insights - ADC Therapeutics SA is a global leader in antibody drug conjugates (ADCs) and will host a conference call on May 14, 2025, to report Q1 2025 financial results and operational updates [1][2][3] Company Overview - ADC Therapeutics is advancing proprietary ADC technology aimed at transforming treatment for patients with hematologic malignancies and solid tumors [3] - The company is based in Lausanne, Switzerland, with operations in London and New Jersey [5] Product Development - ADC Therapeutics' 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, alongside multiple ADCs in ongoing clinical and preclinical development [4]