The purpose of this study is to evaluate the intracranial response rate of a combination of asciminib/trastuzumab for the treatment of patients with metastatic HER2+ breast cancer with brain metastases.

Start Date01 Nov 2025

Sponsor / Collaborator

Duke University

[+1]

NCT07140393

/ Not yet recruitingPhase 1/2

An Open, Multicenter Phase IB/II Clinical Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor

The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combination with other anti tumor therapy in subjects with solid tumor ; to evaluate HRS4508 DLT, MTD and RP2D, to evaluate the incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0), to evaluate ORR by researchers based on RECIST v1.1, to evaluate the pharmacokinetic (PK) characteristics of HRS-4508 SHR-1811, Capecitabine.

Start Date01 Oct 2025

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

NCT07116824

/ Not yet recruitingPhase 2

A Phase II Trial to Evaluate the Safety and Efficacy of HB1801 Combination Therapy as First-line Treatment in HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer

This study is designed to evaluate the safety and efficacy of HB1801 combination therapy as first-line treatment in HER2-positive unresectable locally advanced or metastatic breast cancer.

Start Date15 Sep 2025

Sponsor / Collaborator

CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.

100 Clinical Results associated with Trastuzumab

100 Translational Medicine associated with Trastuzumab

100 Patents (Medical) associated with Trastuzumab

14,166

Literatures (Medical) associated with Trastuzumab

31 Dec 2025·Human Vaccines & Immunotherapeutics

Discussion on the mechanism of HER2 resistance in esophagogastric junction and gastric cancer in the era of immunotherapy

Review

Author: Li, Weiling ; Zhao, Jun ; Fan, Wenxuan ; Gao, Yangjun ; Zhang, Yan ; Hu, Wenqing ; Su, Fei ; Zhang, Xiaoling ; Du, Yunyi

Human epidermal growth factor receptor 2 (HER2) is a critical biomarker and therapeutic target in gastric/gastroesophageal junction (G/GEJ) cancers, despite the initial success of HER2-targeted therapies, such as trastuzumab, resistance to these drugs has emerged as a major impediment to effective long-term treatment. This review examines the mechanisms of drug resistance in HER2-positive G/GEJ cancer, the primary mechanisms of resistance explored include alterations in the HER2 receptor itself, such as mutations and changes in expression levels, as well as downstream signaling pathways, and interactions with the tumor microenvironment (TME). Furthermore, the review discusses the Novel therapeutic approaches, including the use of antibody-drug conjugates (ADCs) and combination therapies are assessed for their potential to enhance outcomes. By integrating recent research findings and clinical trials, this review aims to provide oncologists and researchers with insights into developing more effective treatments for patients with drug-resistant HER2-positive G/GEJ cancer.

31 Dec 2025·mAbs

Tuning antibody stability and function by rational designs of framework mutations

Article

Author: Ng, Joseph C F ; Patel, Semil ; Cheung, Anthony ; Karagiannis, Sophia N ; Fraternali, Franca ; McCraw, Alexandra ; Chu, Tooki ; Grandits, Melanie ; Chauhan, Jitesh ; De Sciscio, Maria Laura ; Iancu, Daniela ; Kosmider, Alice ; Liu, Yi ; Guo, Dongjun ; Chenoweth, Alicia

Artificial intelligence and machine learning models have been developed to engineer antibodies for specific recognition of antigens. These approaches, however, often focus on the antibody complementarity-determining region (CDR) whilst ignoring the immunoglobulin framework (FW), which provides structural rigidity and support for the flexible CDR loops. Here we present an integrated computational-experimental workflow, combining static structure analyses, molecular dynamics simulations and in vitro physicochemical and functional assays to generate rational designs of FW mutations for modulating antibody stability and activity. We first showed that recent antibody-specific language models lacked insights in FW mutagenesis, in comparison to approaches that use antibody structure information. Using the widely used breast cancer therapeutic trastuzumab as a use case, we designed stabilizing mutants which were distal to the CDR and preserved the antibody's functionality to engage its cognate antigen (HER2) and induce antibody-dependent cellular cytotoxicity. Interestingly, guided by local backbone motions predicted using molecular dynamics simulations, we designed a FW mutation on the trastuzumab light chain that retained antigen-binding effects, but lost Fab-mediated and Fc-mediated effector functions. This highlighted the effects of FW on immunological functions engendered in distal areas of the antibody, and the importance of considering attributes other than binding affinity when assessing antibody function. Our approach incorporates interdomain dynamics and distal effects between FW and the Fc domains, expands the scope of antibody engineering beyond the CDR, and underscores the importance of a holistic perspective that considers the entire antibody structure in optimizing antibody stability, developability and function.

31 Dec 2025·mAbs

Hybrid IgE-IgG1 antibodies (IgEG): a new antibody class that combines IgE and IgG functionality

Article

Author: Partington, Leanne ; Bax, Heather J. ; Grandits, Melanie ; Amin, Oliver E. ; Birtley, James ; Wilson, Tim ; Devlin, John ; Karagiannis, Sophia N. ; Palhares, Lais C. G. F. ; Macleod, Olivia ; FitzGerald, Kevin ; Hardaker, Elizabeth

IgG-based anti-cancer therapies have achieved promising clinical outcomes, but, especially for patients with solid tumors, response rates vary. IgE antibodies promote distinct immune responses compared to IgG and have shown anti-tumoral pre-clinical activity and preliminary efficacy and safety profile in clinical testing. To improve potency further, we engineered a hybrid IgE-IgG1 antibody (IgEG), to combine the functions of both isotypes. Two IgEGs were generated with variable regions taken from trastuzumab (Tras IgEG) and from a novel anti-HER2 IgE (26 IgEG). Both IgEGs expressed well in mammalian cells and demonstrated IgE-like stability. IgEGs demonstrated both IgE and IgG1 functionality in vitro. A lack of type I hypersensitivity associated with IgEG incubation with human blood is suggestive of acceptable safety. In vivo, IgEGs exhibited distinct pharmacokinetic profiles and produced anti-tumoral efficacy comparable to IgE. These findings highlight the potential of IgEG as a new therapeutic modality in oncology.

789

News (Medical) associated with Trastuzumab

18 Aug 2025

·www.prnewswire.com

Accord BioPharma Announces Commercial Launch of IMULDOSA® (ustekinumab-srlf) Prefilled Syringes at Lowest WAC Price Among Branded Biosimilars to STELARA® (ustekinumab)

Company's third biosimilar expands access to proven targeted biologic therapy with patient-centric support services and resources RALEIGH, N.C., Aug. 18, 2025 /PRNewswire/ -- Accord BioPharma, Inc., the specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced today the commercial launch of IMULDOSA® (ustekinumab-srlf), a biosimilar to STELARA® (ustekinumab). IMULDOSA prefilled syringes, which would represent the majority of the presentations in the ustekinumab market, are priced at the lowest wholesaler acquisition cost (WAC) among all branded ustekinumab biosimilars at a 92% discount from STELARA. FDA-approved for the same indications as the reference product, IMULDOSA represents Accord BioPharma's third in-market biosimilar and furthers the company's mission to expand patient access to potentially life-changing biologic therapies.¹ Accord BioPharma is committed to providing patients with greater access to ustekinumab through this significant cost reduction. This IMULDOSA launch will lay the foundation for Accord BioPharma's immunology franchise, demonstrating the company's commitment to addressing critical needs in immune-mediated inflammatory conditions. Addressing Critical Patient Needs in the U.S. Millions of Americans suffer from chronic, immune-mediated inflammatory conditions, such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.² These conditions are often not only incredibly painful and debilitating, but can also impact a person's quality of life, emotional well-being, and self-image.³⁻⁵ While biologics such as STELARA have had a transformative impact on the lives of many people in the U.S., they often come with a high cost that can prohibit access. Accord BioPharma's ustekinumab biosimilar IMULDOSA has been proven to be highly similar to STELARA with no clinically meaningful differences.¹ Please see below for full Indications and Important Safety Information. As Accord BioPharma prepared for the commercial launch of IMULDOSA, the company solicited feedback from their patient advisory board on the development of patient support materials. The company is grateful for their invaluable input in these co-creation sessions. Expanding Access for Eligible Patients Accord BioPharma has priced IMULDOSA to maximize patient access across all formulations. The prefilled syringes feature the lowest WAC price among branded ustekinumab biosimilars at a 92% discount from STELARA, while the vial formulation offers a 33% discount. Accord BioPharma is launching IMULDOSA with a $0 co-pay program for eligible patients so that more people living with plaque psoriasis, psoriatic arthritis, and Crohn's disease and ulcerative colitis can receive a proven targeted biologic therapy. "At Accord BioPharma, we believe that cost shouldn't be a barrier to accessing proven, life-changing therapies," said Chrys Kokino, Accord U.S. President. "The launch of IMULDOSA represents our commitment to going beyond simply providing biosimilar alternatives to delivering comprehensive solutions that can make a meaningful difference in patients' lives. With our third biosimilar now available, we're demonstrating that Accord BioPharma is at the forefront of biosimilar transformation, backed by the 50-year heritage of our parent company, Intas Pharmaceuticals." Backed by Proven Heritage and Commitment Accord BioPharma believes deeply in the power of biosimilars to reshape the future of treatment. With the support of Intas, an established global leader with nearly five decades of experience, Accord BioPharma is transforming the conventional treatment landscape across several priority therapeutic areas by introducing biosimilars to the U.S. market. "The launch of IMULDOSA in the United States represents our unwavering commitment to making high-quality, more cost-effective biologic therapies more accessible within immunology's critical therapeutic areas," said Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals. "Through Accord BioPharma, we are establishing ourselves in the U.S. as a trusted, reliable ally highly attuned to the needs of our stakeholders and dedicated to transforming patient care." Current Portfolio of Brands Accord BioPharma's portfolio has experienced sizable growth within the past year. In addition to launching IMULDOSA, Accord BioPharma recently assumed U.S. operations for the full UDENYCA® (pegfilgrastim-cbqv) franchise, including the UDENYCA pre-filled syringe, the UDENYCA autoinjector, and UDENYCA ONBODY®. The company is also marketing HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), and CAMCEVI® (leuprolide) 42 mg injectable emulsion. Please refer to the Important Safety Information and full Prescribing Information for all products. Intas Pharmaceuticals, Ltd. has an exclusive agreement with Bio-Thera Solutions to enable Accord BioPharma to bring Bio-Thera's golimumab candidate BAT2506 – a biosimilar to Simponi® (golimumab) – to the U.S. market, further expanding Accord BioPharma's pipeline. Accord BioPharma has also submitted Biologics License Applications to the FDA for biosimilar versions of several other biologics. Contact: [email protected] IMPORTANT SAFETY INFORMATION IMULDOSA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in IMULDOSA. Infections Ustekinumab products may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections were observed in patients receiving ustekinumab products. Serious infections requiring hospitalization, or otherwise clinically significant infections, reported in clinical trials included the following: Plaque psoriasis: diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis and urinary tract infections. Psoriatic arthritis: cholecystitis. Crohn's disease: anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeria meningitis. Ulcerative colitis: gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis. Avoid initiating treatment with IMULDOSA in patients with any clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of IMULDOSA in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with IMULDOSA and discontinue IMULDOSA for serious or clinically significant infections until the infection resolves or is adequately treated. Theoretical Risk for Vulnerability to Particular Infections Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria (including nontuberculous, environmental mycobacteria), salmonella (including nontyphi strains), and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with ustekinumab products may be susceptible to these types of infections. Consider appropriate diagnostic testing (e.g., tissue culture, stool culture, as dictated by clinical circumstances). Pre-treatment Evaluation for Tuberculosis Evaluate patients for tuberculosis infection prior to initiating treatment with IMULDOSA. Avoid administering IMULDOSA to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering IMULDOSA. Consider anti-tuberculosis therapy prior to initiation of IMULDOSA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Closely monitor patients receiving IMULDOSA for signs and symptoms of active tuberculosis during and after treatment. Malignancies Ustekinumab products are immunosuppressants and may increase the risk of malignancy. Malignancies were reported among subjects who received ustekinumab in clinical trials. In rodent models, inhibition of IL-12/IL-23p40 increased the risk of malignancy. The safety of ustekinumab products has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been post-marketing reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving ustekinumab products who had pre-existing risk factors for developing non-melanoma skin cancer. Monitor all patients receiving IMULDOSA for the appearance of non-melanoma skin cancer. Closely follow patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment. Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue IMULDOSA. Posterior Reversible Encephalopathy Syndrome (PRES) Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn's disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab product initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab products. Monitor all patients treated with IMULDOSA for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue IMULDOSA. Immunizations Prior to initiating therapy with IMULDOSA, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with IMULDOSA should not receive live vaccines. Avoid administering BCG vaccines during treatment with IMULDOSA or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving IMULDOSA because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of IMULDOSA may not elicit an immune response sufficient to prevent disease. Noninfectious Pneumonia Cases of interstitial pneumonia, eosinophilic pneumonia and cryptogenic organizing pneumonia have been reported during post-approval use of ustekinumab products. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and in certain cases administration of corticosteroids. If diagnosis is confirmed, discontinue IMULDOSA and institute appropriate treatment. Most Common Adverse Reactions The most common adverse reactions associated with ustekinumab products are: Psoriasis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue Crohn's Disease, induction (≥3%): vomiting Crohn's Disease, maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis Ulcerative colitis, induction (≥3%): nasopharyngitis Ulcerative colitis, maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea INDICATIONS IMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy active psoriatic arthritis (PsA) moderately to severely active Crohn's disease (CD) moderately to severely active ulcerative colitis Pediatric patients 6 years and older with: moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy active psoriatic arthritis (PsA) To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or . IMULDOSA is supplied as single-dose prefilled syringes for subcutaneous use in 45 mg/0.5 mL and 90 mg/mL strengths or as a single-dose vial for intravenous infusion in 130 mg/26 mL (5 mg/mL) strength. For more information, please see the full Prescribing Information and Medication Guide. About Accord BioPharma Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., seeks to provide more affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma believes in the ability of biosimilars to increase access and options for patients and deliver savings to the U.S. healthcare system, and is striving to offer one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com. References: 1. IMULDOSA (ustekinumab-srlf). Prescribing Information. Accord BioPharma; October 2024 2. Johns Hopkins University, Department of Pathology. Prevalence of Autoimmune Diseases. 2025. 3. Bakshia, N., Hartb, A. , Lee, M., et al. PAIN 2021; 62:2466–2471 4. Armuzzi, A., Liguori, G. Digestive and Liver Disease 2021;53(7):803-808 5. Ponikowska, M., Vellone, E., et al. Psoriasis: Targets and Therapy 2025;15:175–183 All trademarks, logos and brand names are the property of their respective owners. SOURCE Accord BioPharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalLicense out/inVaccineAcquisitionImmunotherapy

14 Aug 2025

·investors.boltbio.com

Bolt Biotherapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update

Next-generation claudin 18.2 ISAC BDC-4182 now in Phase 1 dose-escalation study Cash balance of $48.5 million as of June 30, 2025 anticipated to fund key milestones through mid-2026 REDWOOD CITY, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today reported financial results for the second quarter ended June 30, 2025, and provided a business update. “In the second quarter we focused on advancing BDC-4182, the first next-generation Boltbody™ ISAC in our pipeline,” said Willie Quinn, President and Chief Executive Officer. “We are now conducting a Phase 1 dose-escalation study for patients with gastric and gastroesophageal cancer in Australia, and will expand to other countries in the second half of 2025. We look forward to presenting initial data in the first half of 2026. We also continue to seek a partner for further development of our dectin-2 agonist antibody BDC-3042, which demonstrated activity in lung cancer patients in the form of a partial response (PR) at the highest dose tested. Patients at the highest doses also had a strong immune response consistent with our expectations based on preclinical data.” Recent Highlights and Anticipated Milestones Our BDC-4182 Phase 1 study opened for enrollment for patients with gastric and gastroesophageal cancer in the first half of 2025. BDC-4182 is a next-generation Boltbody™ ISAC clinical candidate targeting claudin 18.2, a clinically validated target in oncology with expression in gastric/gastroesophageal junction cancer, pancreatic cancer, and other tumor types. Preclinically, monotherapy treatment with BDC-4182 generated complete regressions in multiple models and BDC-4182 was tolerated in toxicology studies. BDC-4182 outperformed cytotoxic claudin 18.2 ADCs, using MMAE or Topo1, in multiple preclinical studies. Collaborations with Genmab and Toray continue to progress. Genmab and Bolt are advancing multiple development candidates, while the companies also continue research and development on additional programs. The Toray collaboration combines the Company’s immunostimulatory linker-payloads with Toray antibodies targeting Caprin-1, a tumor-specific antigen that is strongly expressed on the cell membrane in multiple solid tumor types. Seeking a partner for further BDC-3042 development. In May, Bolt hosted a KOL conference call with BDC-3042 investigator Dr. Dumbrava to discuss the results from the Phase 1 dose-escalation clinical study of BDC-3042 that were presented at the American Associates for Cancer Research (AACR) Annual Meeting that took place in April 2025. Bolt completed the dose escalation and is seeking a partner. Cash, cash equivalents, and marketable securities were $48.5 million as of June 30, 2025. Cash on hand is expected to fund multiple milestones and operations through mid-2026. Second Quarter 2025 Financial Results Collaboration Revenue – Total collaboration revenue was $1.8 million for the quarter ended June 30, 2025, compared to $1.3 million for the same quarter in 2024. Revenue in the comparative periods was generated from services performed under the R&D collaborations as we fulfill our performance obligations. Research and Development (R&D) Expenses – R&D expenses were $7.5 million for the quarter ended June 30, 2025, compared to $15.4 million for the same quarter in 2024. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses, a decrease in clinical expenses primarily related to the discontinued development of trastuzumab imbotolimod, formerly known as BDC-1001 in May 2024. General and Administrative (G&A) Expenses – G&A expenses were $3.5 million for the quarter ended June 30, 2025, compared to $4.9 million for the same quarter in 2024. The decrease between the comparable periods was mainly due to a decrease in salary and related expenses primarily as a result of the May 2024 restructuring. Restructuring Charges – Restructuring charges were zero for the quarter ended June 30, 2025, compared to $3.6 million for the same quarter in 2024, consisting of $2.9 million of one-time termination benefits such as severance costs and related benefits and $0.7 million of non-cash stock-based compensation expense as a result of the restructuring plan. Loss from Operations – Loss from operations was $9.2 million for the quarter ended June 30, 2025, compared to $22.6 million for the same quarter in 2024. Other Developments Reverse Stock Split On June 6, 2025, we effected a one-for-twenty (1:20) reverse stock split of its outstanding common stock, effective as of June 6, 2025 (the “Reverse Stock Split”). As a result of the Reverse Stock Split, every 20 shares of the Company’s issued and outstanding common stock automatically converted into one issued and outstanding share of common stock, without any change in par value per share. In part, due to the Reverse Stock Split, on June 24, 2025, Nasdaq notified the Company that it had regained compliance with Nasdaq’s minimum bid price requirement. About the Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) PlatformBolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This increases the population of activated immune system cells in the tumor microenvironment and promotes a robust immune response with the goal of generating durable therapeutic responses for patients with cancer. About Bolt Biotherapeutics, Inc. Bolt Biotherapeutics is a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer. Bolt Biotherapeutics’ pipeline candidates are built on the Company’s deep expertise in myeloid biology and cancer drug development. The Company’s pipeline includes BDC-4182, a next-generation Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) clinical candidate targeting claudin 18.2. BDC-4182 is currently in a Phase 1 dose escalation trial that includes patients with gastric and gastroesophageal cancer. The Company has strategic collaborations with Genmab and Toray built around the Company’s Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) platform technology and its expertise in myeloid biology. The Company is seeking to partner its Dectin-2 agonist, BDC-3042, that recently completed a first-in-human Phase 1 dose escalation trial. For more information, please visit https://www.boltbio.com/. Forward-Looking StatementsThis press release contains forward-looking statements about us and our industry that involve substantial risks and uncertainties and are based on our beliefs and assumptions and on information currently available to us. All statements other than statements of historical facts contained in this press release, including statements regarding our ability to partner BDC-3042, the advancement and success of our BDC-4182 clinical trials, the anti-tumor potency, safety and tolerability, and characteristics of our product candidates, the initiation of future clinical trials, the potential value of collaborations, and the expected duration of our cash runway, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “on track,” “plan,” “potential,” “predict,” “project,” “should,” “will,” or “would,” or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements represent our current beliefs, estimates and assumptions only as of the date of this press release and information contained in this press release should not be relied upon as representing our estimates as of any subsequent date. These statements, and related risks, uncertainties, factors and assumptions, include, but are not limited to: the potential product candidates that we develop may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; such product candidates may not be beneficial to patients or become commercialized; and our ability to maintain our current collaborations and establish further collaborations. These risks are not exhaustive. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future. Further information on factors that could cause actual results to differ materially from the results anticipated by our forward-looking statements is included in the reports we have filed or will file with the Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. These filings, when available, are available on the investor relations section of our website at investors.boltbio.com and on the SEC’s website at www.sec.gov. Investor Relations and Media Contact: Matthew DeYoung Argot Partners (212) 600-1902 boltbio@argotpartners.com

Phase 1ImmunotherapyFinancial StatementAACR

13 Aug 2025

·www.globenewswire.com

Greenwich LifeSciences Announces Expansion of Flamingo-01 into Romania

STAFFORD, Texas, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the addition of clinical sites in Romania. The Company's application to expand Flamingo-01 into Romania has been formally approved by European regulators, thus adding Romanian sites to the approximately 150 approved sites in Spain, France, Germany, Italy, Poland and the US. At present, there are approximately 123 actively enrolling sites globally. According to the latest data collected by the European Cancer Information System (click here), a total of 12,861 new cases of breast cancer were diagnosed in Romania in 2022, which is the most common cancer diagnosed in women, representing approximately 28% of all cancers in women. Breast cancer is the leading cause of death from cancer in women in Romania with 3,877 deaths in 2022. The Company is collaborating with Dr. Nicoleta Antone, who is leading one of the largest academic breast cancer focused centers in Cluj Napoca, Romania, and her colleagues from at least 3 other sites in Romania. The Romanian clinical sites will be listed here with an interactive map. Dr. Antone will be serving as the national principal investigator in Romania for FLAMINGO-01. She is Head of Breast Cancer Centre at the Chiricuta Institute of Oncology in Cluj Napoca, Romania. She has been the Chair of the Romania Breast Cancer Group since 2021 and a member of the Women's Empowerment Cancer Advocacy Network since 2015. CEO Snehal Patel commented, "Romania is the first of several additional countries in Europe that we hope to add to Flamingo-01 as we now focus on mid-sized population countries with large population centers. We have visited the sites in Romania multiple times to assess study feasibility and provide training, and we are impressed with their facilities and commitment to the study. We look forward to working with Dr. Antone and her colleagues and have sufficiently advanced start-up activities this summer to be potentially screening and enrolling our first Romanian patients in the coming months." About FLAMINGO-01 and GLSI-100 FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. For more information on FLAMINGO-01, please visit the Company's website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com About Breast Cancer and HER2/neu Positivity One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. About Greenwich LifeSciences, Inc. Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company's website at www.greenwichlifesciences.com and follow the Company's Twitter at https://twitter.com/GreenwichLS. Forward-Looking Statement Disclaimer Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled "Risk Factors" in Greenwich LifeSciences' Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law. Company ContactSnehal PatelInvestor RelationsOffice: (832) 819-3232Email: info@greenwichlifesciences.com Investor & Public Relations Contact for Greenwich LifeSciencesDave GentryRedChip Companies Inc.Office: 1-800-RED CHIP (733 2447)Email: dave@redchip.com

Phase 3Immunotherapy

100 Deals associated with Trastuzumab

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KEGG	Wiki	ATC	Drug Bank
D03257	Trastuzumab	L01XC03	DB00072

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 Positive Colorectal Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	28 Mar 2022
HER2 positive salivary gland cancer	Japan	Chugai Pharmaceutical Co., Ltd.	25 Nov 2021
HER2-positive gastric cancer	Japan	Chugai Pharmaceutical Co., Ltd.	10 Mar 2011
Stomach Cancer	United States	Genentech, Inc.	20 Oct 2010
Breast Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	04 Apr 2001
Early Stage Breast Carcinoma	European Union	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Iceland	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Liechtenstein	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Norway	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	European Union	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Iceland	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Liechtenstein	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Norway	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	European Union	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Iceland	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Liechtenstein	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Norway	Roche Registration GmbH	28 Aug 2000
Hormone receptor positive breast cancer	European Union	Roche Registration GmbH	28 Aug 2000
Hormone receptor positive breast cancer	Iceland	Roche Registration GmbH	28 Aug 2000
Hormone receptor positive breast cancer	Liechtenstein	Roche Registration GmbH	28 Aug 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bladder Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Colorectal Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Gallbladder Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Hematologic Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Lung Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Ovarian Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Pancreatic Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Prostatic Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Salivary Gland Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Skin Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04858529 (neoCARHP, ASCO2025 \| NEWS) Manual	Phase 3	HER2 Positive Breast Cancer Neoadjuvant HER2 Positive	766	THP	zflfwcrhhy(rieokovcdj) = ouzuhmkfkq cfgqersebr (bildynoegx, 59.2 - 68.8) View more	Positive	02 Jun 2025
				TCbHP	zflfwcrhhy(rieokovcdj) = ohdoajttld cfgqersebr (bildynoegx, 61.0 - 70.5) View more
NCT05980481 (ASCO2025) Manual	Phase 2/3	HER2-positive gastric cancer First line HER2-expressing	51	Disitamab vedotin (DV) (2.5 mg/kg) + toripalimab (Tor) + CAPOX (HER2-positive pts)	crpgswtaru(edgdrqlyvi) = acvjskarsv rfljbvtmip (igmbdnxccm, 41.0 - 86.7) View more	Positive	30 May 2025
				Disitamab vedotin + toripalimab +trastuzumab (staring dose of 8 mg/kg followed by 6 mg/kg, Q3W) (HER2-positive pts)	crpgswtaru(edgdrqlyvi) = mvyihceyfm rfljbvtmip (igmbdnxccm, 56.6 - 96.2) View more
ASCO2025	Not Applicable	HER2-positive gastric cancer First line HER2-positive	22	Trastuzumab plus CAPOX	bllfbscyrm(cgtjavdtoj) = vgznqmhtpv ihabcynmyi (iihhzdnzcp )	Positive	30 May 2025
				Trastuzumab plus modified FOLFOX-6	bllfbscyrm(cgtjavdtoj) = owafuiglns ihabcynmyi (iihhzdnzcp )
ASCO2025	Not Applicable	HER2 Positive Breast Cancer HER2 positive	76	Trastuzumab	bygvmeedpa(vxttafvmwl) = mavgcqqfut ypnavcgtzr (nrmysylpoc ) View more	-	30 May 2025
NCT03913234 (BR 18-2 MINI, ASCO2025)	Phase 1/2	Advanced breast cancer First line HR+ \| HER2+	77	Ribociclib 600 mg QD + Letrozole 2.5 mg QD + Trastuzumab 8 mg/kg loading then 6 mg/kg every 3 weeks	yubzqlnlkp(rlkibkscgg) = ykixsrlufs yqierxbuyq (syyriililu, 19.6 - NA) View more	Positive	30 May 2025
JPRN-jRCTs071190007 (TROX study, ASCO2025)	Phase 2	HER2-positive gastric cancer HER2-positive	67	SOX plus Trastuzumab Biosimilar Therapy	xpeqviilza(nkconkyuxk) = yfnlisowtv ykcrbrzyfx (pxegwptnkk, 67.6 - 84.7) View more	Positive	30 May 2025
				CapeOX plus Trastuzumab Biosimilar Therapy	xpeqviilza(nkconkyuxk) = zrjngklrbe ykcrbrzyfx (pxegwptnkk, 69.9 - 92.6) View more
ASCO2025	Not Applicable	HER2 Positive Breast Cancer Neoadjuvant TILs	221	Trastuzumab	wspnixrajb(khgqjpqljb) = wnplhxepyj hbsmoscjga (nprlcpwfok )	Positive	30 May 2025
ASCO2025	Not Applicable	HER2 Positive Breast Cancer Neoadjuvant \| Adjuvant	3,300	Trastuzumab-pertuzumab combined with taxanes	zezefxlhun(cxoydyfdnz) = vtqoieehds sbisnlvbxy (bxvnidfndm, 14.52 - 21.32)	-	30 May 2025
				Trastuzumab-pertuzumab combined with eribulin	kxegbgciik(sbyrbgpbgy) = nmdizbdfis tplztlpqmk (zzgzyutagc, 0.65 - 0.85)
UNICANCER (ASCO2025)	Not Applicable	Metastatic human epidermal growth factor 2 positive carcinoma of breast Third line HR+ \| HR-	101	Tucatinib, Trastuzumab, Capecitabine (TTC)	phlfccjywj(rmdkccuvin) = yrkvudeeod ulmsczkseh (lvybkdvcfw, 3.9 - 5.8) View more	Positive	30 May 2025
ASCO2025	Phase 4	Neoplasms	21	Bevacizumab (Innovator)	juggwxxafz(fmfstubusq) = zhrqmroonx vwxzvvzasx (vsqdgcvtjp ) View more	Positive	30 May 2025
				Rituximab (Innovator)	juggwxxafz(fmfstubusq) = ntelwdouhc vwxzvvzasx (vsqdgcvtjp ) View more

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