Whitehawk Therapeutics Advances to Clinical Stage with IND Clearance for HWK-007 and Announces IND Submission for HWK-016

Rhea-AI Summary

Whitehawk Therapeutics (Nasdaq: WHWK) announced FDA clearance of the IND for HWK-007, a PTK7-targeted ADC, and disclosed an IND submission in December 2025 for HWK-016, a MUC16-targeted ADC. HWK-007 Phase 1 is actively recruiting and will initially evaluate lung, ovarian and endometrial cancers; HWK-016 Phase 1 is anticipated to begin recruiting this quarter and will initially target ovarian and endometrial cancers. Both programs use Whitehawk's ADC platform with a cleavable linker and a TOP1 inhibitor payload. The company expects initial clinical data from both trials in early 2027.

Positive

• FDA cleared IND for HWK-007
• HWK-007 Phase 1 is actively recruiting
• IND for HWK-016 submitted in December 2025
• Initial clinical data from both programs expected early 2027

Negative

• Both programs are early-stage (Phase 1) with no clinical efficacy yet
• HWK-016 Phase 1 is only anticipated to start this quarter, not yet recruiting

News Market Reaction

+1.50%

1 alert

+1.50% News Effect

On the day this news was published, WHWK gained 1.50%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

HWK-007 trial phase: Phase 1 HWK-016 IND timing: Mid-December 2025 Initial data timing: Early 2027

3 metrics

HWK-007 trial phase Phase 1 Actively recruiting PTK7-targeted ADC trial

HWK-016 IND timing Mid-December 2025 IND submitted for MUC16-targeted ADC

Initial data timing Early 2027 First clinical data from HWK-007 and HWK-016 trials

Market Reality Check

Price: $2.70 Vol: Volume 114,843 is at 0.81...

normal vol

$2.70 Last Close

Volume Volume 114,843 is at 0.81x the 20-day average of 142,035, not a high-volume reaction. normal

Technical Price $2.67 is trading above the 200-day MA at $1.97 and sits 29.18% below the 52-week high of $3.7699.

Peers on Argus

WHWK gained 5.95% while peers showed mixed moves: IFRX +0.84%, IPA +3.5%, ORMP +...

1 Up

WHWK gained 5.95% while peers showed mixed moves: IFRX +0.84%, IPA +3.5%, ORMP +4.14%, PTHS -2.03%, SRZN +12.19%. Only one momentum-scanner peer (ANIX +6.71%) appeared, supporting a stock-specific reaction.

Historical Context

5 past events · Latest: Dec 01 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 01	Management appointment	Positive	-3.4%	Appointment of experienced oncology CMO to guide ADC development.
Nov 26	Conference participation	Positive	+7.0%	Piper Sandler fireside discussion increasing investor visibility.
Nov 11	Conference presentation	Neutral	+2.3%	Jefferies London presentation and webcast access for investors.
Nov 06	Earnings and pipeline	Negative	-6.7%	Q3 2025 net loss with higher expenses despite strong cash position.
Oct 24	Scientific data update	Positive	-1.6%	Real-world PTK7 expression data supporting HWK-007 ADC targeting.

Pattern Detected

Recent history shows negative reactions to scientific/operational progress (PTK7 data, CMO hire) but aligned selloff on weaker earnings, with some positive moves around conference visibility.

Recent Company History

Over the last few months, Whitehawk moved from preclinical positioning toward the clinic. On Oct 24, 2025 it highlighted broad PTK7 expression across >157,000 tumors, supporting its ADC strategy. Subsequent filings and earnings on Nov 6, 2025 detailed a cash-rich, loss-making transition to ADC R&D. Investor outreach via Jefferies and Piper Sandler conferences in November coincided with positive price moves, while the Dec 1, 2025 CMO hire saw a small decline. Today’s IND clearance and submission advance the same ADC programs into Phase 1 execution.

Market Pulse Summary

This announcement advances Whitehawk from planning to execution, with HWK-007 now in an actively rec...

Analysis

This announcement advances Whitehawk from planning to execution, with HWK-007 now in an actively recruiting Phase 1 trial and HWK-016 moving toward a Phase 1 start following a December 2025 IND submission. Initial clinical data are expected in early 2027, marking a multi-year development horizon. In context of prior PTK7 expression data and a strengthened balance sheet, investors may focus on enrollment pace, safety findings, and early efficacy signals across lung, ovarian, and endometrial cancers.

Key Terms

antibody-drug conjugate, ADC, investigational new drug (IND), DNA topoisomerase I (TOP1) inhibitor, +2 more

6 terms

antibody-drug conjugate medical

"Phase 1 trial for PTK7-targeted antibody-drug conjugate (ADC) HWK-007"

An antibody-drug conjugate is a targeted medicine that combines an antibody, which can identify specific cells, with a powerful drug designed to destroy those cells. This approach allows for precise treatment, minimizing damage to healthy tissue. For investors, developments in this area can signal advances in cancer therapies and potential growth opportunities in the biotech sector.

ADC medical

"PTK7-targeted antibody-drug conjugate (ADC) HWK-007 IND submitted"

An antibody-drug conjugate (ADC) is a targeted cancer medicine that pairs an antibody that recognizes specific markers on tumor cells with a potent cell-killing drug, connected so the toxic payload is delivered directly to the cancer. For investors, ADCs matter because successful ADCs can improve patient outcomes and reduce side effects compared with traditional chemotherapy, shaping clinical trial success, regulatory approval chances, commercial demand, and a company’s valuation much like a guided missile versus a general bomb.

investigational new drug (IND) regulatory

"announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND)"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

DNA topoisomerase I (TOP1) inhibitor medical

"linker that delivers a DNA Topoisomerase I (TOP1) inhibitor payload"

A DNA topoisomerase I (TOP1) inhibitor is a drug that blocks an enzyme (TOP1) responsible for loosening and untwisting DNA so cells can copy their genes; inhibiting it causes DNA breaks that preferentially kill fast‑dividing cancer cells. Investors watch TOP1 inhibitors because they represent a specific anti‑cancer strategy with clear clinical benefits and known safety and resistance issues, so trial results and regulatory decisions can strongly influence a drug’s commercial value.

bioconjugation technical

"a stabilizing bioconjugation strategy that includes carbon-bridge cysteine re-pairing"

Bioconjugation is the process of chemically linking a therapeutic or diagnostic molecule to a biological carrier, such as a protein or antibody, so the cargo is delivered precisely to a desired cell or tissue. For investors, it matters because this “targeted delivery” approach can make treatments more effective and safer, create high-value specialty products with complex manufacturing and patent protection, and carry distinct regulatory and commercial risks and rewards.

cysteine re-pairing technical

"bioconjugation strategy that includes carbon-bridge cysteine re-pairing"

Cysteine re-pairing describes the reshuffling of chemical links (disulfide bonds) between cysteine amino acids inside a protein, changing how the protein folds and holds its shape. Like rearranging the rungs on a ladder, this can alter a protein’s stability, activity or how the immune system recognizes it, so investors watch it as a quality, safety and efficacy factor for biologic drugs and manufacturing consistency.

AI-generated analysis. Not financial advice.

Actively recruiting Phase 1 trial for PTK7-targeted antibody-drug conjugate (ADC) HWK-007

IND submitted mid-December 2025 for MUC16-targeted ADC HWK-016, anticipated Phase 1 start this quarter

Initial clinical data from both programs anticipated in early 2027

MORRISTOWN, N.J., Jan. 8, 2026 /PRNewswire/ -- Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) 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 (TOP1) inhibitor payload. Whitehawk expects to report initial clinical data from these trials in early 2027.

"These are important regulatory and execution milestones, underscoring the strength of our preclinical data and our ability to advance multiple programs in parallel," said Dave Lennon, PhD, President and CEO of Whitehawk Therapeutics. "At Whitehawk, we are taking a unique approach to the development of next-generation ADCs, combining validated tumor biology with a differentiated ADC architecture. Our platform's design features are intended to maximize tumor targeting while minimizing off-target toxicity, enabled by highly selective antibodies, a stabilizing bioconjugation strategy that includes carbon-bridge cysteine re-pairing, and controlled delivery of a potent TOP1 inhibitor payload. As our lead programs enter the clinic, our focus will be on efficient clinical execution to generate data that validates this approach with meaningful outcomes for patients."

About HWK-007
HWK-007 is a differentiated next-generation ADC targeting Protein Tyrosine Kinase 7 (PTK7). PTK7 is an oncofetal transmembrane pseudokinase that drives early embryonic development, has restricted expression in adult tissues and frequent overexpression in a wide range of cancers. PTK7 is the third most highly expressed tumor marker among clinically validated and emerging ADC targets, present in ~70% of tumors. There are no approved PTK7-directed ADCs.

HWK-007-101 is a Phase 1, multicenter, open-label study in adult participants that will employ a sequential dose-escalation and expansion design to evaluate the safety, pharmacokinetics and preliminary antitumor activity of HWK-007 in participants with advanced or metastatic solid tumors that are refractory to standard therapies.

About HWK-016
HWK-016 is a differentiated next-generation ADC targeting the membrane-bound portion of Mucin 16 (MUC16). MUC16 is a glycoprotein with low level of expression in normal adult tissues, and broad overexpression in gynecological tumors including ovarian, cervical and endometrial. In ovarian cancer, for example, MUC16 is present at rates up to 3-10 times higher than clinically validated and emerging ADC targets.

Shed MUC16 (CA125) is a validated biomarker for cancer screening and disease monitoring in gynecologic cancers. When ADCs bind to this cleaved portion of the MUC16 protein in circulation, it is cleared from the patient systemically rather than reaching the tumor. HWK-016 is designed to overcome this by directly targeting the membrane-bound, non-shed portion of MUC16.

HWK-016-101 is a planned Phase 1, multicenter, open-label study in adult participants that will employ a sequential dose-escalation and expansion design to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of HWK-016 in participants with advanced or metastatic solid tumors that are refractory to standard therapies.

About Whitehawk Therapeutics 
Whitehawk Therapeutics is a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved cancer treatments. Whitehawk's advanced three-asset ADC portfolio is engineered to overcome the limitations of first-generation predecessors to deliver a meaningful impact for patients with difficult-to-treat cancers. These assets are in-licensed from WuXi Biologics under an exclusive development and global commercialization agreement. More information on the Company is available at www.whitehawktx.com and connect with us on LinkedIn.

Forward-Looking Statements 
This press release contains certain forward-looking statements regarding the business of Whitehawk Therapeutics that are not a description of historical facts within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on the Company's current beliefs and expectations and may include, but are not limited to, statements relating to: the potential therapeutic value and market opportunity for the Company's ADC portfolio; our plans related to the Company's development of its portfolio of ADC assets, including the anticipated timing of the initiation, enrollment and data releases of clinical trials for HWK-007 and HWK-016 and the planned trial design of such clinical trials; expectations regarding the beneficial characteristics, design features, safety, efficacy, therapeutic effects and the size of the potential targeted markets with respect to the Company's ADC assets; and the sufficiency of the Company's existing capital resources and the expected timeframe to fund the Company's future operating expenses and capital expenditure requirements. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, uncertainties associated with preclinical and clinical development of the ADC portfolio, including potential delays in the commencement, enrollment and completion of clinical trials; failure to demonstrate the efficacy of the ADC portfolio in preclinical and clinical studies; the risk that unforeseen adverse reactions or side effects may occur in the course of testing of the ADC assets; and risks related to the Company's estimates regarding future expenses, capital requirements and need for additional financing.

Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, including under the caption "Item 1A. Risk Factors," and in Whitehawk's subsequent Quarterly Reports on Form 10-Q, and elsewhere in Whitehawk's reports and other documents that Whitehawk has filed, or will file, with the SEC from time to time and available at www.sec.gov.

All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Whitehawk undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contact:
IR@whitehawktx.com

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SOURCE Whitehawk Therapeutics, Inc.

FAQ

What did Whitehawk Therapeutics (WHWK) announce on January 8, 2026?

The company announced FDA IND clearance for HWK-007 and an IND submission in Dec 2025 for HWK-016.

Which cancers will Whitehawk's HWK-007 Phase 1 trial evaluate for WHWK?

HWK-007 Phase 1 will initially evaluate activity in lung, ovarian and endometrial cancers.

When does Whitehawk expect initial clinical data for HWK-007 and HWK-016 (WHWK)?

The company expects to report initial clinical data from both trials in early 2027.

What payload and linker technology do Whitehawk ADCs use for WHWK's programs?

Both programs use a cleavable, highly stable linker delivering a TOP1 inhibitor payload.

Is HWK-016 recruiting now for Whitehawk (WHWK)?

No; an IND for HWK-016 was submitted in December 2025 and a Phase 1 trial is anticipated to start this quarter.