On June 23, 2026 Gilead Sciences, Inc. (Nasdaq: GILD) reported that the European Commission (EC) has granted marketing authorization for Trodelvy (sacituzumab govitecan-hziy) as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy. Trodelvy is the first antibody-drug conjugate (ADC) to be approved in first-line metastatic TNBC in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein.

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"This approval brings a profound sense of hope to a community that has long been waiting for progress," said Dr. Javier Cortes, Head of the International Breast Cancer Center, Madrid and Barcelona, Spain. "For women diagnosed with metastatic TNBC, particularly those who are younger, every second counts, and having an effective treatment option that can delay the progression of their disease is invaluable. This is the kind of meaningful advance our community needs."

For many living with metastatic TNBC, the most aggressive form of breast cancer, first-line therapy may be their only line of treatment, creating an urgent need for effective treatment options to be used as early as possible.

"This approval represents a significant step forward in how we treat people with first-line metastatic TNBC in Europe," said Mika Kakefuda Derynck, MD, Senior Vice President, Clinical Development, Oncology at Gilead Sciences. "We have long recognized the challenges that patients and clinicians face with this aggressive cancer, and we believe this approval will provide a much-needed new option for people with metastatic TNBC."

The EC’s marketing authorization is based on data from the Phase 3 ASCENT-03 study which demonstrated a highly statistically significant and clinically meaningful progression-free survival for Trodelvy compared to standard of care chemotherapy as a first-line treatment. In ASCENT-03, Trodelvy demonstrated a 38% reduced risk of disease progression or death in patients who are not candidates for PD-1/PD-L1 inhibitors. The ASCENT-03 study utilized a patient-centered crossover design, which allowed patients in the chemotherapy arm to receive Trodelvy after their disease progressed. The EC’s approval, based on the strength of the PFS data, confirms the study’s objective to demonstrate using Trodelvy earlier provides a clinical benefit over chemotherapy for metastatic TNBC patients.

Continued Global Regulatory Filings for Trodelvy in First-Line Metastatic TNBC

Gilead has submitted a supplemental filing to the European Medicines Agency for Trodelvy in combination with Keytruda (pembrolizumab) for patients with PD-L1 positive unresectable locally advanced or metastatic TNBC, based on data from the Phase 3 ASCENT-04 study. This application is currently under review. If approved, Trodelvy has the potential to be a backbone treatment in 1L metastatic TNBC, across PD-L1 status in Europe. In the U.S., Gilead has also submitted supplemental filings to the Food and Drug Administration (FDA) for Trodelvy for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC as a single agent for patients who are not candidates for PD-(L)1 inhibitor-based therapy, or in combination with Keytruda or Keytruda Qlex in patients whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test.

KEYTRUDA and KEYTRUDA QLEX are trademarks of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

About Triple-Negative Breast Cancer In Patients Who Are Not Candidates for PD-1/PD-L1 Inhibitors

TNBC is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC disproportionally impacts younger, premenopausal, and Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2 expression. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of mBC.

About Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.

Outside of Europe, Gilead has submitted supplemental applications to the U.S. Food and Drug Administration (FDA) for approval of Trodelvy based on the ASCENT-03 and ASCENT-04 studies.

Healthcare professionals have substantial clinical experience with Trodelvy, with more than 75,000 breast cancer patients treated since 2020. In addition to its first-line indication approval, Trodelvy is currently approved in more than 60 countries for patients with second-line or later mTNBC and in over 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer. It is the only ADC with four positive Phase 3 trials in HER2-negative metastatic breast cancer and the only Trop-2-directed ADC to demonstrate a meaningful overall survival benefit in two distinct types of metastatic breast cancer.

Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across different tumor types, including in small cell lung cancer and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.

U.S. Indications for Trodelvy

TRODELVY (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
U.S. Important safety information FOR TRODELVY
BOXED WARNING: NEUTROPENIA AND DIARRHEA

TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS

Severe hypersensitivity reaction to TRODELVY.
WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.

Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

ADVERSE REACTIONS

In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.

UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.

Please see full Prescribing Information, including BOXED WARNING.

(Press release, Gilead Sciences, JUN 23, 2026, View Source [SID1234668920])

On June 23, 2026 BostonGene, leading developer of AI models for tumor and immune biology, reported its participation at The BIO International Convention (BIO 2026), the largest and most comprehensive event for biotechnology. Representing the full ecosystem of biotech, the convention brings together 20,000 industry leaders from around the world from June 22 – 25 at the San Diego Convention Center in San Diego, California.

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Presentation details:

Title: Clinical Trial Advantage Through Patient Biology
Date & time: Tuesday, June 23 at 2:30 PM PT
Location: Theater 1
Speaker: David Arthur, VP of Strategy, BostonGene
The presentation will focus on BostonGene’s AI solutions, which integrate multi-dimensional molecular, cellular, and patient data across tumor and immune biology. By converting complex biological datasets into clear insights, these models improve the accuracy of predicting patient responses and toxicity risks, ultimately accelerating drug development and de-risking clinical trials across multiple cancer indications.

Through three distinct case studies, the session will demonstrate how the multimodal AI models operate across different modalities to:

Prioritize indications: Utilizing tissue-based immune microenvironment modeling to identify high-yield indications and guide cohort selection.

Optimize clinical differentiation strategies: Creating integrated models to predict indication effect sizes, reducing clinical trial enrollment requirements and maximizing the probability of technical success.

Refine patient stratification: Developing ready-to-use immune-profiling scores from blood-based signatures to accurately enrich patient cohorts, boost therapy response rates, and optimize trial designs.
To learn more or to schedule a meeting with BostonGene during the event, please contact Hannah Oman at [email protected]. For additional details, visit the BIO 2026 website.

(Press release, BostonGene, JUN 23, 2026, View Source [SID1234668919])

On June 23, 2026 Araris Biotech AG, a company advancing a differentiated pipeline of antibody-drug conjugates ("ADCs") therapies, and Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, both members of the Taiho group, reported that the first patient has been dosed in a Phase 1 clinical trial of ARC-02, a CD79b-targeted antibody-drug conjugate (ADC) for the treatment of non-Hodgkin lymphoma (NHL).

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ARC-02 selectively binds CD79b-positive B-cells and delivers monomethyl auristatin E (MMAE), a clinically validated anti-cancer payload, directly to tumor cells. It is the first clinical candidate generated using Araris’ proprietary AraLinQ ADC technology and Arastatin linker-payload, designed for precise intracellular release and minimization of impact on healthy tissue.

"Dosing the first patient with ARC-02 marks a pivotal milestone for Araris as we enter the clinic and begin translating our innovative ADC platform into potential benefits for patients," said Philipp Spycher, PhD, CSO and scientific founder of Araris.

"While ARC-02 is initially being developed for hematological malignancies, the differentiated safety profile observed in preclinical studies may also support its broader application across additional disease indications, including autoimmune diseases," said Isabella Attinger-Toller, PhD, CTO and co-founder of Araris.

"This milestone represents the first human experience with the novel Araris platform and marks Taiho’s expansion into the clinical development of ADCs for oncology," said Harold Keer, MD, PhD, Chief Medical Officer at Taiho Oncology. "We look forward to results from this trial and advancing other agents from Araris into the clinic."

About AraLinQ

AraLinQ is Araris’ ADC technology, which enables site-specific payload attachment to a privileged attachment site on a specific amino acid residue (Q295) within the native antibody Fc framework. Preclinical data demonstrate that when a payload is attached to this site using Araris’ proprietary linkers, the antibody maintains nearly identical performance (e.g. pharmacokinetics and effector functions) to the unconjugated, original antibody. Furthermore, the linker-payload is connected to the antibody through a very strong isopeptide bond resulting in exceptional stability. Once entering a cancer cell via antibody-mediated internalization, the linker can be easily broken to release the payload. All three of these properties are key factors to enable efficient payload delivery and maximize ADC efficacy. AraLinQ linkers are hydrophilic, rendering them soluble and avoiding their clumping in water-based solutions like blood. In addition, this linker can have unique branching structures that make it possible to create ADCs that carry multiple payloads of different types. AraLinQ allows for the generation of ADCs in one step using "off-the-shelf," antibodies that are native or engineered. The process is fast, cost-efficient and can be easily upscaled without the need for custom antibody synthesis.

About ArastatinTM

Arastatin is a novel linker-payload technology based on MMAE and an Araris proprietary hydrophilic peptide linker. Arastatin is designed specifically to be used with Araris’ site-specific ADC technology AraLinQ which enables the direct conjugation of the MMAE linker-payload to Q295 of native, off-the-shelf antibodies in one step. In preclinical studies, Arastatin based ADCs were found to be highly potent, stable and well-tolerated among different antibodies compared to commercially available ADCs.

(Press release, Araris Biotech, JUN 23, 2026, View Source [SID1234668918])

On June 23, 2026 Combotope Therapeutics ApS ("Combotope"), a biotechnology company focused on discovering tumor-selective antibodies against cancer-specific glycan-protein targets, reported a strategic research collaboration with Boehringer Ingelheim. The partnership will leverage Combotope’s proprietary SMART-Phage platform to generate highly tumor-selective antibodies for next-generation cancer therapies.

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Combotope’s approach is designed to identify antibodies that bind tumor-specific glycan structures (e.g., Tn and STn) together with their protein carriers ("combotopes"). These combined sugar-and-protein markers are often far more common on cancer cells than on healthy tissue, providing a clearer "address label" to guide antibody-based medicines. This is especially relevant for hard-to-treat cancers where established targeted options are limited, and may open up new cancer-selective opportunities across modalities such as antibody-drug conjugates (ADCs).

"At Combotope, we focus on cancer-specific glycan-protein targets that conventional antibody approaches cannot selectively address," said Ola Blixt, CEO of Combotope. "By combining glycan and protein recognition, we aim to enable a new class of tumor-selective antibodies and expand the range of viable targets in oncology. We are excited to partner with Boehringer Ingelheim to translate this approach into potentially differentiated therapies."

The parties will initially collaborate on multiple oncology targets provided by Boehringer Ingelheim, with the potential to expand and address additional oncology targets over time. For each target, Combotope will apply its SMART-Phage antibody discovery platform to generate tumor-selective, high-affinity antibodies that recognize glycan-protein epitopes, supported by a defined antibody characterization data package. Boehringer Ingelheim will then assume responsibility for further research, development, manufacturing, and commercialization of resulting antibody-based therapies.

Under the terms of the agreement, Combotope will receive an upfront payment and research funding per target. The company is also eligible to receive development, regulatory, and commercial milestone payments across multiple targets, in addition to royalties on net sales of any resulting products. Boehringer Ingelheim will hold global development and commercialization rights for products arising from the collaboration. Financial terms were not disclosed.

(Press release, Combotope Therapeutics, JUN 23, 2026, View Source [SID1234668917])

On June 23, 2026 Haisco Pharmaceutical Group Co., Ltd. (Ticker Code: 002653) reported that it has entered into an exclusive licensing agreement with Nuvectis, a U.S. biotechnology company. Under the agreement, Haisco has granted Nuvectis the exclusive rights to develop, manufacture, and commercialize its independently developed innovative drug HSK42360 worldwide, excluding Greater China, as well as its independently developed innovative drug HSK39297 worldwide, excluding Greater China, India, and certain Southeast Asia territories.

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HSK42360 is a best-in-class BRAF paradoxical breaker inhibitor designed to overcome acquired resistance to current BRAF inhibitors. It demonstrates strong potential in primary brain tumors and brain metastases and is currently being evaluated in a Phase I clinical trial in China. HSK39297 is a best-in-class potential once-daily (QD) CFB inhibitor. Two NDA applications for PNH have been submitted in China, while several additional indications are advancing through Phase 2 and Phase 3 clinical development in China.

"This collaboration is highly aligned with our global development strategy and is expected to generate sustainable value and long-term returns," said Dr. Pangke Yan, Chief Executive Officer of Haisco. "By partnering with a U.S. biotechnology company such as Nuvectis, Haisco aims to accelerate the global development of innovative oncology and complement therapies and bring high-quality treatment options to patients worldwide."

The collaboration strengthens Haisco’s global presence and enhances the value of its pipeline by leveraging Nuvectis’ proven research and development capabilities, extensive industry experience, and established track record in oncology and kidney diseases.

Under the terms of the agreement, Haisco will receive an upfront and near-term payment of USD $40 million and is eligible to receive up to USD $1.421 billion in additional development, regulatory, and commercial milestone payments, as well as tiered royalties on future net sales. The first four milestones may be payable by Licensee in cash and/or common stock, provided that the equity consideration shall represent less than 40% of the total milestone value. If the Licensee sublicenses all or part of the rights to a third party, or if a Change of Control occurs during the restricted period, Haisco shall be entitled to share in the corresponding sublicense income and Change-of-Control payments. In addition, the effectiveness of the agreement is subject to certain financing conditions which Nuvectis is required to meet to ensure sufficient capital for the development of the licensed products.

(Press release, Haisco Pharmaceutical, JUN 23, 2026, View Source [SID1234668916])