CD79B

– ARV-393 demonstrated strong synergistic antitumor activity, including complete regressions, in combination with standard-of-care chemotherapy, biologics, and select investigational oral small molecule inhibitors – – Findings support continued evaluation of ARV-393 combinations in non-Hodgkin lymphoma – NEW HAVEN, Conn., April 28, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company working to develop a new class of drugs based on targeted protein degradation, today presented data from preclinical combination studies of ARV-393, the company’s investigational PROteolysis TArgeting Chimera (PROTAC) B-cell lymphoma 6 protein (BCL6) degrader. BCL6 is a transcriptional repressor protein and a known driver of B-cell lymphomas. Data demonstrated synergistic antitumor activity, including complete regressions, in combination with standard of care (SOC) chemotherapy, SOC biologics, and investigational oral small molecule inhibitors (SMIs) in high grade B-cell lymphoma (HGBCL) and aggressive diffuse large B-cell lymphoma (DLBCL) models. The results from these preclinical studies were shared in a poster presentation at the 2025 American Association for Cancer Research (AACR) annual meeting in Chicago, Illinois. Key findings from the studies included: ARV-393 in combination with SOC chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]), induced significantly greater tumor growth inhibition compared with rituximab, CHOP, R-CHOP, or ARV-393 alone, with complete tumor regressions in all mice treated with the ARV-393 and R-CHOP combination.ARV-393 in combination with SOC biologics targeting CD20 (rituximab), CD19 (tafasitamab), or CD79b (polatuzumab vedotin) resulted in tumor regressions and demonstrated significantly stronger tumor growth inhibition compared with each agent alone.In preclinical models, ARV-393 increased CD20 expression, providing additional support for the exploration of combinations with CD20-targeted agents and in the context of low or loss of CD20 expression.ARV-393 in combination with investigational small molecule inhibitors targeting clinically validated oncogenic drivers of lymphoma, such as BTK (acalabrutinib), BCL2 (venetoclax), or EZH2 (tazemetostat), resulted in superior tumor growth inhibition compared with each agent alone, with tumor regressions in all mice treated with the combinations. “Given that combination regimens are the foundation of lymphoma treatment, we are encouraged by the strength of these preclinical combination data, which demonstrate complete tumor regressions in aggressive lymphoma models,” said Noah Berkowitz, M.D., Ph.D., Chief Medical Officer at Arvinas. “We believe these preclinical data demonstrate potential for broad combinability of ARV-393 and provide a compelling rationale for considering combination strategies as we work to bring forward new therapeutic options for lymphoma patients.” A Phase 1 study of ARV-393 is enrolling patients with relapsed/refractory non-Hodgkin lymphoma, including DLBCL (NCT06393738). Additional detail on the ARV-393 data presentation at AACR 2025: Poster Title: ARV-393, a PROteolysis TArgeting Chimera (PROTAC) BCL6 Degrader, Combined With Biologics or Small-Molecule Inhibitors Induces Tumor Regressions in Diffuse Large B-Cell Lymphoma ModelsAbstract: 1655Session Title: Degraders and Glues 2 Session Type: Experimental and Molecular TherapeuticLocation: Poster Section 18Poster Board Number: 15Date: Monday, April 28, 2025Lecture Time: 9:00 a.m. – 12:00 p.m. CT About ARV-393ARV-393 is an investigational, orally bioavailable PROteolysis TArgeting Chimera (PROTAC) designed to degrade B-cell lymphoma 6 protein (BCL6), a transcriptional repressor and major driver of B-cell lymphomas. During B-cell development, tightly controlled BCL6 protein expression regulates >600 genes to facilitate rapid B-cell proliferation and tolerance of somatic hypermutation and gene recombination for antibody generation. Deregulated BCL6 expression is common in B-cell lymphoma and promotes cancer cell survival, proliferation, and genomic instability. PROTAC-mediated degradation has the potential to address the historically undruggable nature of BCL6. ARV-393 is currently in a Phase 1 clinical trial in patients with relapsed/refractory non-Hodgkin lymphoma. About ArvinasArvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROteolysis TArgeting Chimera (PROTAC) protein degrader platform, the Company 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 is currently progressing multiple investigational drugs through clinical development programs, including vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; and ARV-102, targeting LRRK2 for neurodegenerative disorders. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit www.arvinas.com and connect on LinkedIn and X. Forward-Looking StatementsThis 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 for Arvinas’ investigational oral PROteolysis TArgeting Chimera (PROTAC) degrader ARV-393 to treat relapsed/refractory non-Hodgkin lymphoma; the preclinical data for ARV-393 demonstrating the potential for broad combinability and supporting continued evaluation of ARV-393 combinations in non-Hodgkin lymphoma associated with B-cell lymphoma 6 protein (“BCL6”) dysfunction; and PROTAC-mediated degradation having the potential to address the historically undruggable nature of BCL6.. All statements, other than statements of historical facts, contained in this press release, including statements regarding Arvinas’ strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “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-393, including whether Arvinas initiates and completes clinical trials for its product candidates and receives results from its clinical trials on its expected timelines or at all; Arvinas’ ability to protect its intellectual property portfolio; whether Arvinas’ cash and cash equivalent resources 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, 2024 and subsequent other reports on file 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) 247-5089Jeff.Boyle@arvinas.com Media:Kirsten Owens+1 (203) 584-0307Kirsten.Owens@arvinas.com

A small Swiss drug developer is being scooped up for its pipeline of three antibody-drug conjugates that offer a next-generation approach to the area of oncology R&D that has ballooned in recent years. Otsuka subsidiary Taiho Pharmaceutical said Monday morning it will buy Araris Biotech for $400 million upfront and up to $740 million in additional biobucks. Taiho becomes the latest drugmaker to pounce on the ADC field; nearly every large pharma has either bought and/or licensed ADCs in the past few years. With its technology, the Zurich startup can attach more than one cytotoxic payload onto an antibody to “mimic really conventional chemotherapy,” Araris CEO and co-founder Dragan Grabulovski told Endpoints News in January. Other companies are also working on dual- or multi-payload ADCs . The move comes just two months after the 15-employee biotech said it was teaming up with Roche’s Japanese subsidiary Chugai for an undisclosed amount upfront and up to $780 million in milestones. Araris says its high linker solubility allows it to decrease clumping and let the ADC “properly bind” to cancerous cells. The company says its manufacturing process is also leaner, with the use of off-the-shelf antibodies. At the time, Grabulovski told Endpoints his biotech would seek to raise a Series B in the first half of this year. The startup has raised about $45 million to date from Samsung Ventures, 4BIO, b2venture, Pureos Bioventures, redalpine, Schroders Capital, VI Partners, Wille AG and the Institute for Follicular Lymphoma Innovation. The duo previously inked a research collaboration in November 2023. They expect the deal to close in the first half of this year. Taiho parent Otsuka bought small molecule drug discovery startup Jnana Therapeutics last year. “Since November 2023, Taiho has had the chance to evaluate our technology, to test it with their own antibodies, and throughout this collaboration, we came into discussions early this year about a potential acquisition, which now we have signed the documents today,” Grabulovski told Endpoints on Monday morning. The company still progressed with the Series B fundraising but iced those plans once the Taiho deal talks advanced, he said. The partnership with Chugai will continue, he added. Taiho said Monday that Araris’ three ADCs, for solid tumors and blood cancers, would enter clinical trials between this year and 2026. The biotech’s ADCs target CD79b, Nectin-4 and NaPi2b. “I would also underscore the massive potential synergies with Taiho’s clinical development experience in oncology and their robust salesforce globally as we are going after some of the highest potential, highest profile targets present across multiple solid tumor indications,” said Dima Kuzmin, chair of Araris and managing partner at 4BIO, which seeded Araris in 2020. Also on Monday morning, AstraZeneca said it made a small deal of its own, paying $425 million upfront for a UK cell therapy maker called EsoBiotec .

REDWOOD CITY, CA, USA & SHENZHEN, China I February 24, 2025 I LTZ Therapeutics, an immunotherapy-focused biotech company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for LTZ-301, a first-in-class myeloid engager immunotherapy intended to treat relapsed or refractory non-Hodgkin lymphoma (r/r NHL). LTZ-301 is the first asset in the company’s platform to enter clinical trials to determine an initial proof of concept for their myeloid engager approach, to foster immunotherapy. LTZ expects to initiate its Phase 1, open-label, multicenter study in Q2 2025. “The FDA’s clearance, signaling the initiation of our Phase I study for LTZ-301, represents a significant milestone for the company,” said Robert Li, Ph.D., Founder and CEO of LTZ. “We look forward to advancing our lead asset into the clinic to evaluate our myeloid engager approach and its potential as an effective therapy for cancer and other indications, such as autoimmune diseases. Additionally, the recent appointment in October 2024 of Dr. Wayne Godfrey, as LTZ’s Chief Medical Officer, strengthens our company’s scientific and clinical leadership – providing us with great optimism as we move forward in our next phase of clinical development. We’re also delighted to welcome Dr. Alan J. Korman, a globally recognized pioneer in cancer immunology, to LTZ’s scientific advisory board.” LTZ’s approach focuses on the fusion of reverse translational science, with a deep understanding of tumor microenvironment (TME) biology – especially myeloid biology. Macrophages appear to be one of the most prevalent immune cell populations in TME of various hematologic and solid tumors. Therefore, effectively engaging and activating macrophages to kill cancer cells offers significant therapeutic potential for patients. LTZ is developing its own novel Myeloid Engager Platform to primarily enhance the phagocytic function of monocytes and macrophages of different polarization states to foster anti-tumor immunity. “The company’s preclinical results have demonstrated promising activity and safety, suggesting applicability of LTZ’s platform to treat a variety of cancer indications and autoimmune diseases – where the unmet need is incredibly high,” said Dr. Godfrey. “Through our first in-human trial, we aim to advance our understanding of the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of LTZ-301, targeting CD79b-expressing B-cell lymphoma. I’m excited about the potential of LTZ’s innovative scientific approach and the opportunity to work with LTZ’s accomplished scientific team, with the end goal of improving patient outcomes.” About LTZ-301 LTZ-301 is a novel myeloid engager bi-specific antibody that depletes CD79b+ B-cells via enhancing Fc-gamma receptor (FcγR)-independent antibody dependent cellular phagocytosis (ADCP). CD79b is a unique tumor antigen receptor that is highly expressed in B-cell malignancies, including the ones of relapse/resistance to the existing CD19 or CD20-based therapies. LTZ-301 works by redirecting monocytes and macrophages toward CD79b+ B-cells, leading to enhanced phagocytosis and depletion of cancer cells. The initial study of LTZ-301 will be conducted in patients with r/r NHL for whom no standard therapy is available or where standard treatment has failed. Preclinical studies of LTZ-301 demonstrated potent pharmacology in both in vitro and in vivo studies with a favorable safety profile. About LTZ LTZ Therapeutics is an immunotherapy-focused biotech company pursuing the development of novel therapies, with the company’s novel Myeloid Engager Platform, to improve clinical outcomes in patients with cancer and autoimmune diseases. With main operations in Redwood City, California and Shenzhen China as well as a team out of Heidelberg Germany, LTZ is dedicated to developing novel immunotherapies capable of overcoming resistance and boosting anti-tumor immunity based on reverse translational science and emerging disease biology of tumor microenvironment. For more information, please visit https://www.ltztherapeutics.com/ . SOURCE: LTZ Therapeutics