Whitehawk Therapeutics Receives FDA Clearance for HWK-007 IND
Whitehawk Therapeutics announced that the U.S. FDA has cleared the Investigational New Drug application for HWK-007, its PTK7-targeted ADC. Whitehawk's Phase 1 trial for HWK-007 is now actively recruiting and will initially evaluate activity in lung and ovarian cancers, two PTK7-expressing tumor types with established precedent data, as well as endometrial cancer, one of the highest PTK7-expressing tumor types. The company also announced the submission of an IND for HWK-016, its MUC16-targeted ADC, to the FDA in December 2025. A Phase 1 trial is anticipated to start recruiting this quarter and is expected to initially evaluate activity in two high MUC16-expressing gynecologic cancers, ovarian and endometrial. Both next-generation ADC programs leverage Whitehawk's advanced ADC technology platform consisting of a highly stable yet cleavable linker that delivers a DNA Topoisomerase I inhibitor payload. Whitehawk expects to report initial clinical data from these trials in early 2027.
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Whitehawk Initiates Phase 1 Trial for HWK-007, Initial Data Expected Early 2027
- Trial Initiation: Whitehawk Therapeutics has received FDA clearance for its Phase 1 trial of HWK-007, which is now actively recruiting participants to evaluate its efficacy in lung and ovarian cancers, potentially offering new treatment options for patients.
- IND Submission: The company submitted an IND for HWK-016 to the FDA in December 2025, with plans to initiate Phase 1 trials this quarter targeting high MUC16-expressing ovarian and endometrial cancers, thereby expanding its therapeutic pipeline.
- Technological Edge: Both HWK-007 and HWK-016 leverage Whitehawk's advanced ADC technology platform, which combines a highly stable yet cleavable linker to enhance tumor targeting while minimizing off-target toxicity, aiming to improve treatment outcomes.
- Market Opportunity: PTK7 is the third most highly expressed tumor marker among clinically validated ADC targets, present in approximately 70% of tumors, positioning Whitehawk's new drugs to fill a significant market gap and address unmet medical needs.
Whitehawk Initiates Phase 1 Trial for HWK-007, Initial Data Expected Early 2027
- Trial Launch: Whitehawk Therapeutics has announced the active recruitment for its Phase 1 trial of HWK-007, aimed at evaluating its efficacy in PTK7-expressing tumors such as lung and ovarian cancers, marking a significant advancement in the company's oncology drug development.
- IND Submission: The company submitted an IND for HWK-016 to the FDA in December 2025, with a Phase 1 trial expected to start this quarter focusing on high MUC16-expressing ovarian and endometrial cancers, further expanding its antibody-drug conjugate (ADC) pipeline.
- Platform Advantages: Whitehawk's ADC technology platform features a highly stable yet cleavable linker designed to maximize tumor targeting while minimizing off-target toxicity, which is expected to provide more effective treatment options for patients and enhance market competitiveness.
- Data Release Expectations: The company anticipates reporting initial clinical data for both HWK-007 and HWK-016 in early 2027, which will provide crucial validation for the efficacy of its ADC programs and potentially drive future market opportunities.
Whitehawk Appoints Dr. Dugan as CMO to Advance ADC Programs into Clinical Development
- Leadership Enhancement: Whitehawk Therapeutics appoints Dr. Margaret Dugan, who has over 30 years of global oncology drug development experience, as Chief Medical Officer, aiming to leverage her expertise to enhance the company's clinical development capabilities in antibody-drug conjugates (ADCs) and accelerate their clinical progress.
- Rich Clinical Development Experience: Dr. Dugan has overseen more than 12 Phase 1 clinical programs and successfully facilitated regulatory approvals for drugs like capmatinib and ceritinib, which will provide valuable regulatory strategy support for Whitehawk's ADC portfolio, enhancing its market competitiveness.
- Rapid Advancement of Clinical Programs: While serving as CMO at Dracen Pharmaceuticals, Dr. Dugan successfully advanced the company's first clinical program through Phase 1 and secured Fast Track designation, an experience that will aid Whitehawk in achieving swift clinical translation for its ADC projects.
- Innovative Treatment Prospects: Dr. Dugan emphasizes that Whitehawk's ADC portfolio features unique target selection and differentiated profiles, which are expected to offer significant therapeutic opportunities for patients with difficult-to-treat cancers, further solidifying the company's strategic position in oncology treatment.
Whitehawk Therapeutics to Participate in the Piper Sandler 37th Annual Healthcare Conference
Company Announcement: Whitehawk Therapeutics, Inc. will have its President and CEO, Dave Lennon, participate in a fireside discussion at the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025.
Event Details: The discussion will be accessible via a live webcast on the Whitehawk Therapeutics investor relations website, with a replay available for about 30 days post-event.
Company Focus: Whitehawk Therapeutics specializes in oncology therapeutics, utilizing advanced technologies to enhance antibody drug conjugate (ADC) cancer treatments.
Portfolio Information: The company has a three-asset ADC portfolio designed to address the limitations of earlier treatments, with these assets licensed from WuXi Biologics under an exclusive agreement.
Whitehawk Therapeutics to Present at Jefferies Global Healthcare Conference in London
Company Announcement: Whitehawk Therapeutics, Inc. will have its President and CEO, Dave Lennon, present at the Jefferies Global Healthcare Conference in London on November 18, 2025, at 11:30 AM GMT.
Webcast Availability: A live webcast of the presentation will be accessible on the Whitehawk Therapeutics investor relations website and will be available for replay for about 30 days post-event.
Company Overview: Whitehawk Therapeutics focuses on oncology therapeutics, utilizing advanced technologies to enhance antibody drug conjugate (ADC) cancer treatments, particularly for challenging cancers.
Partnership Details: The company’s ADC portfolio is developed under an exclusive agreement with WuXi Biologics, aimed at improving treatment outcomes for patients with difficult-to-treat cancers.
Whitehawk Therapeutics Reports Third Quarter 2025 Financial Results and Recent Highlights
Financial Results: Whitehawk Therapeutics reported a net loss of $17.7 million for Q3 2025, an increase from $12.5 million in Q3 2024, while cash reserves rose to $162.6 million, expected to fund operations into 2028.
Clinical Development Progress: The company is on track to file Investigational New Drug (IND) applications for its ADC candidates HWK-007 and HWK-016 by the end of 2025, with a third candidate, HWK-206, expected by mid-2026.
Research Highlights: Whitehawk presented data at the AACR-NCI-EORTC conference, confirming PTK7 as a significant tumor marker, which supports the potential of their ADC candidate HWK-007 for treating PTK7-expressing cancers.
Operational Focus: The company emphasizes efficient capital deployment and execution, aiming to achieve clinical milestones and enhance its understanding of tumor biology through its advanced ADC portfolio.
Whitehawk Initiates Phase 1 Trial for HWK-007, Initial Data Expected Early 2027
- Trial Initiation: Whitehawk Therapeutics has received FDA clearance for its Phase 1 trial of HWK-007, which is now actively recruiting participants to evaluate its efficacy in lung and ovarian cancers, potentially offering new treatment options for patients.
- IND Submission: The company submitted an IND for HWK-016 to the FDA in December 2025, with plans to initiate Phase 1 trials this quarter targeting high MUC16-expressing ovarian and endometrial cancers, thereby expanding its therapeutic pipeline.
- Technological Edge: Both HWK-007 and HWK-016 leverage Whitehawk's advanced ADC technology platform, which combines a highly stable yet cleavable linker to enhance tumor targeting while minimizing off-target toxicity, aiming to improve treatment outcomes.
- Market Opportunity: PTK7 is the third most highly expressed tumor marker among clinically validated ADC targets, present in approximately 70% of tumors, positioning Whitehawk's new drugs to fill a significant market gap and address unmet medical needs.
Whitehawk Initiates Phase 1 Trial for HWK-007, Initial Data Expected Early 2027
- Trial Launch: Whitehawk Therapeutics has announced the active recruitment for its Phase 1 trial of HWK-007, aimed at evaluating its efficacy in PTK7-expressing tumors such as lung and ovarian cancers, marking a significant advancement in the company's oncology drug development.
- IND Submission: The company submitted an IND for HWK-016 to the FDA in December 2025, with a Phase 1 trial expected to start this quarter focusing on high MUC16-expressing ovarian and endometrial cancers, further expanding its antibody-drug conjugate (ADC) pipeline.
- Platform Advantages: Whitehawk's ADC technology platform features a highly stable yet cleavable linker designed to maximize tumor targeting while minimizing off-target toxicity, which is expected to provide more effective treatment options for patients and enhance market competitiveness.
- Data Release Expectations: The company anticipates reporting initial clinical data for both HWK-007 and HWK-016 in early 2027, which will provide crucial validation for the efficacy of its ADC programs and potentially drive future market opportunities.
Whitehawk Appoints Dr. Dugan as CMO to Advance ADC Programs into Clinical Development
- Leadership Enhancement: Whitehawk Therapeutics appoints Dr. Margaret Dugan, who has over 30 years of global oncology drug development experience, as Chief Medical Officer, aiming to leverage her expertise to enhance the company's clinical development capabilities in antibody-drug conjugates (ADCs) and accelerate their clinical progress.
- Rich Clinical Development Experience: Dr. Dugan has overseen more than 12 Phase 1 clinical programs and successfully facilitated regulatory approvals for drugs like capmatinib and ceritinib, which will provide valuable regulatory strategy support for Whitehawk's ADC portfolio, enhancing its market competitiveness.
- Rapid Advancement of Clinical Programs: While serving as CMO at Dracen Pharmaceuticals, Dr. Dugan successfully advanced the company's first clinical program through Phase 1 and secured Fast Track designation, an experience that will aid Whitehawk in achieving swift clinical translation for its ADC projects.
- Innovative Treatment Prospects: Dr. Dugan emphasizes that Whitehawk's ADC portfolio features unique target selection and differentiated profiles, which are expected to offer significant therapeutic opportunities for patients with difficult-to-treat cancers, further solidifying the company's strategic position in oncology treatment.
Whitehawk Therapeutics to Participate in the Piper Sandler 37th Annual Healthcare Conference
Company Announcement: Whitehawk Therapeutics, Inc. will have its President and CEO, Dave Lennon, participate in a fireside discussion at the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025.
Event Details: The discussion will be accessible via a live webcast on the Whitehawk Therapeutics investor relations website, with a replay available for about 30 days post-event.
Company Focus: Whitehawk Therapeutics specializes in oncology therapeutics, utilizing advanced technologies to enhance antibody drug conjugate (ADC) cancer treatments.
Portfolio Information: The company has a three-asset ADC portfolio designed to address the limitations of earlier treatments, with these assets licensed from WuXi Biologics under an exclusive agreement.
Whitehawk Therapeutics to Present at Jefferies Global Healthcare Conference in London
Company Announcement: Whitehawk Therapeutics, Inc. will have its President and CEO, Dave Lennon, present at the Jefferies Global Healthcare Conference in London on November 18, 2025, at 11:30 AM GMT.
Webcast Availability: A live webcast of the presentation will be accessible on the Whitehawk Therapeutics investor relations website and will be available for replay for about 30 days post-event.
Company Overview: Whitehawk Therapeutics focuses on oncology therapeutics, utilizing advanced technologies to enhance antibody drug conjugate (ADC) cancer treatments, particularly for challenging cancers.
Partnership Details: The company’s ADC portfolio is developed under an exclusive agreement with WuXi Biologics, aimed at improving treatment outcomes for patients with difficult-to-treat cancers.
Whitehawk Therapeutics Reports Third Quarter 2025 Financial Results and Recent Highlights
Financial Results: Whitehawk Therapeutics reported a net loss of $17.7 million for Q3 2025, an increase from $12.5 million in Q3 2024, while cash reserves rose to $162.6 million, expected to fund operations into 2028.
Clinical Development Progress: The company is on track to file Investigational New Drug (IND) applications for its ADC candidates HWK-007 and HWK-016 by the end of 2025, with a third candidate, HWK-206, expected by mid-2026.
Research Highlights: Whitehawk presented data at the AACR-NCI-EORTC conference, confirming PTK7 as a significant tumor marker, which supports the potential of their ADC candidate HWK-007 for treating PTK7-expressing cancers.
Operational Focus: The company emphasizes efficient capital deployment and execution, aiming to achieve clinical milestones and enhance its understanding of tumor biology through its advanced ADC portfolio.
