Arvinas Announces First Patient Dosed in Phase 1/2 Clinical Trial of ARV-6723, the Company’s First Immuno-Oncology Candidate

– ARV-6723 is an investigational, oral PROTAC designed to degrade HPK1, a negative regulator of immune activation, in advanced solid tumors –

NEW HAVEN, Conn., Sept. 28, 2026 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that the first participant has been dosed in its Phase 1/2 clinical trial of ARV-6723, an investigational, oral PROteolysis TArgeting Chimera (PROTAC) designed to degrade hematopoietic progenitor kinase 1 (HPK1) in advanced solid tumors. ARV-6723 is Arvinas’ first clinical candidate in immuno-oncology (IO) and the first HPK1 PROTAC degrader to enter the clinic in the United States.

HPK1 acts as a negative regulator of immune activation and is expressed across multiple cell types including T cells, B cells, natural killer cells, and dendritic cells, making it a compelling IO target. HPK1 also plays an important role in shaping the tumor microenvironment. ARV-6723 is designed to degrade and remove the HPK1 protein and its signaling scaffolding, potentially addressing functions of HPK1 that may not be fully addressed by traditional inhibitors.

In preclinical studies, ARV-6723 demonstrated potent and selective HPK1 degradation, enhanced immune activity, and antitumor activity as a single agent and in combination with an immune checkpoint inhibitor across tumor models with differing levels of immune responsiveness, including multiple anti-PD-1-resistant models. Notably, in seven preclinical models, ARV-6723 demonstrated meaningful single-agent activity where neither an HPK1 inhibitor nor anti-PD-1 therapy showed benefit. These data support the clinical evaluation of ARV-6723 both as monotherapy and in combination with an anti-PD-1 therapy.

“The advancement of ARV-6723 into the clinic represents an important step in expanding the application of targeted protein degradation into immuno-oncology,” said Randy Teel, Ph.D., President and Chief Executive Officer at Arvinas. “Resistance to immunotherapy remains a significant challenge; to date, combinations targeting other immune pathways have not provided a reliable way to prevent or reverse it. The encouraging preclinical data for ARV-6723 – including activity in models resistant to immune checkpoint inhibitors – support clinical investigation of its potential to address this unmet need for patients.”

The ARV-6723-101 Phase 1/2 clinical trial (NCT07749586) is a global, multicenter trial designed to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of orally administered ARV-6723 as a monotherapy or in combination with pembrolizumab in adults with advanced solid tumors. The first-in-human trial will initially evaluate the safety of ARV-6723 as a monotherapy treatment and subsequently in combination with an anti-PD-1 therapy, while also evaluating whether deep and sustained HPK1 degradation translates into meaningful antitumor effects in patients. The initial monotherapy cohort of this trial is enrolling patients who have received a prior immune checkpoint inhibitor and have no suitable standard treatment options.

About Arvinas
Arvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROTAC (PROteolysis TArgeting Chimera) protein degrader platform, Arvinas is pioneering the development of protein degradation therapies designed to harness the body’s natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas, with its partner Pfizer, developed the first U.S. Food and Drug Administration (FDA)-approved PROTAC, a type of heterobifunctional protein degrader, which has been outlicensed to Rigel Pharmaceuticals, Inc. for exclusive global development, manufacturing, and commercialization.

Arvinas is currently progressing multiple investigational drugs through clinical development programs, including ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; ARV-102, targeting LRRK2 for neurodegenerative disorders; ARV-027, targeting the polyglutamine-expanded androgen receptor, or polyQ-AR, in skeletal muscle for spinal-bulbar muscular atrophy, also known as Kennedy’s disease; and ARV-6723, targeting HPK1 for advanced solid tumors. Arvinas has also advanced ARV-806, targeting KRAS G12D for solid tumors, in the clinic, and previously announced plans to seek an out-licensing agreement for any additional clinical trials of ARV-806, including dose expansion or combination clinical trials. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit www.arvinas.com and connect on LinkedIn and X.

About ARV-6723
ARV-6723 is an investigational, oral PROTAC designed to degrade hematopoietic progenitor kinase 1 (HPK1) and is Arvinas’ first clinical candidate in the immuno-oncology space. HPK1 is a negative regulator of immune activation expressed across multiple immune cell types, including T cells, B cells, natural killer cells, and dendritic cells. Preclinically, ARV-6723 demonstrated potent, selective HPK1 degradation and greater tumor growth inhibition across low- and high-immunogenic tumor models, including anti-PD-1 resistant tumor models. By removing HPK1, ARV-6723 may address both its kinase-dependent and kinase-independent functions and enhance antitumor immune activity. ARV-6723 is currently being evaluated in a first-in-human Phase 1/2 clinical trial in patients with advanced solid tumors.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties, including statements regarding: the potential of ARV-6723, including its degradation of hematopoietic progenitor kinase 1 (“HPK1”), and its potential treatment of advanced solid tumors; whether by removing HPK1, ARV-6723 may address both its kinase-dependent and kinase-independent functions and enhance antitumor immune activity; preclinical ARV-6723 data supporting the clinical evaluation of ARV-6723 both as monotherapy and in combination with an anti-PD-1 therapy; whether ARV-6723's design to degrade and remove the HPK1 protein and its signaling scaffolding will address functions of HPK1 that may not be fully addressed by traditional inhibitors; Arvinas’ plans with respect to ARV-6723 and its development; and Arvinas’ plans to outlicense ARV-806. All statements, other than statements of historical fact, contained in this press release, including statements regarding Arvinas’ strategy, development plans, future operations, prospects, plans, and objectives of management and the statements identified in the prior paragraph, are forward-looking statements. The words “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “target,” “goal,” “aim,” “whether,” “will,” “would,” “could,” “reliance,” “should,” “look forward,” “seek,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Arvinas may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations disclosed in the forward-looking statements Arvinas makes as a result of various risks and uncertainties, including but not limited to: whether Arvinas will be able to successfully conduct and complete development for its product candidates, including ARV-6723, on its current timelines or at all; risks related to clinical trial results and the interpretation thereof, including with respect to ARV-6723; that the results of preclinical studies may not be predictive of the results of clinical trials; Arvinas’ ability to protect its intellectual property portfolio; Arvinas’ reliance on third parties; whether Arvinas will be able to raise capital when needed; whether Arvinas’ cash and cash equivalents will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; and other important factors discussed in the “Risk Factors” section of Arvinas’ Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent other reports filed with the U.S. Securities and Exchange Commission. The forward-looking statements contained in this press release reflect Arvinas’ current views with respect to future events, and Arvinas assumes no obligation to update any forward-looking statements, except as required by applicable law. These forward-looking statements should not be relied upon as representing Arvinas’ views as of any date subsequent to the date of this release.

Contacts
Investors:
Jeff Boyle
+1 (347) 247-5089
Jeff.Boyle@arvinas.com

Media:
Kirsten Owens
+1 (203) 584-0307
Kirsten.Owens@arvinas.com