Fulvestrant

Study to evaluate rupitasertib, Evexta Bio’s first-in-class oral dual-node, S6K and AKT1/3 inhibitor in combination with giredestrant in second-line ER+, HER2-, ESR1-mutated advanced / metastatic breast cancer; expected to initiate in Q4 2026 First clinical collaboration and supply agreement for Evexta Bio with rupitasertib and for Roche with giredestrant; results to inform future strategy for rupitasertib combination in ER+ HER2- advanced /metastatic breast cancer PARIS--(BUSINESS WIRE)--Evexta Bio S.A., a precision oncology company, founded by Truffle Capital (founder of Abivax and Carvolix), and focused on the discovery and development of targeted therapies, today announced a clinical collaboration and supply agreement with plans to initiate a Phase 1b study combining its lead investigational compound, rupitasertib, with Roche’s investigational compound giredestrant, a selective estrogen receptor degrader (SERD), for the treatment of ER+, HER2-, ESR1-mutated advanced / metastatic breast cancer. Rupitasertib, is a first-in-class oral dual-node PI3K/AKT/mTOR (PAM) pathway inhibitor, which selectively inhibits S6K and AKT1/3. Rupitasertib was purposefully and rationally designed to target S6K for potent PAM inhibition and AKT1/3 to block the AKT compensatory feedback loop, while sparing AKT2 to avoid hyperglycemia, which we believe will lead to a superior efficacy and safety pro to other PAM pathway inhibitors. Under the terms of the agreement, Roche will supply giredestrant and Evexta Bio will conduct the Phase 1b study assessing the safety, tolerability, and preliminary anti-tumor activity of rupitasertib in combination with giredestrant in ER+, HER2-, ESR1-mutated advanced / metastatic breast cancer. The study is intended to enroll at least 15 patients and is expected to be initiated in Q4 2026. Dr. Shawn M. Leland, PharmD, RPh, Board Chairman of Evexta Bio stated: “We are very pleased and excited to partner with Roche on Evexta Bio’s first clinical collaboration with rupitasertib. ER+, HER2-, ESR1-mutated breast cancer remains a significant unmet medical need. We are looking forward to being able to provide ER+, HER2-, ESR1-mutated breast cancer patients with the option to receive an all-oral regimen of a first-in-class, dual-node PAM pathway inhibitor and a SERD.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); About Evexta Bio ( ) Evexta Bio is a biopharmaceutical company exploring the new frontiers of oncology in search of daring novel therapeutic approaches with the potential to save lives. Now, in the clinic, the company is currently developing two proprietary therapeutic assets with novel mechanisms of action across several indications: Rupitasertib, a first-in-class oral S6K inhibitor with efficient AKT1/AKT3 inhibition to control the AKT compensatory feed-back loop. Rupitasertib will be studied in a phase 1b clinical trial in ER+ HER2- ESR1 mutated advanced / metastatic breast cancer in combination with Roche’s giredestrant. EVX020, a first-in-class KIF20A kinesin inhibitor having shown potent nonclinical efficacy in hematological and solid tumor models. Founded by Truffle Capital, supported by Merck KGaA (Darmstadt, Germany) as shareholder, Evexta Bio has forged alliances with leaders in academia and industry, including CNRS, Paoli Calmettes Institute (Marseille, France) and Merck KGaA. The company is supported by seasoned management team, board of directors and medical advisory board. Contacts Armand Rigaudy armandrigaudy@primatice.com +33 (0)7 88 96 41 84

UPPSALA, SE / ACCESS Newswire / August 4, 2026 / Biovica International (STO:BIOVIC-B)(STO:BIOVIC.B)(FRA:9II) - Biovica, a company specializing in blood-based cancer monitoring, today announced that new results involving DiviTum ® TKa have been published in the peer-reviewed journal Clinical Cancer Research. The study evaluated a new treatment combination for patients with advanced breast cancer whose disease had progressed after previous CDK4/6 inhibitor treatment. The combination included avutometinib, a drug targeting a pathway linked to resistance to CDK4/6 inhibitors, together with abemaciclib and fulvestrant. Importantly, all patients who experienced clinical benefit had low TKa levels early during treatment, while higher levels were seen in patients who did not benefit. These findings support the potential of DiviTum TKa to identify treatment benefit early, an important step toward its future use in treatment decisions and clinical drug development. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); " This publication provides a clear example of how DiviTum TKa may offer clinically relevant information early during treatment. For Biovica, the results strengthen the scientific foundation for expanding the use of DiviTum TKa across new treatment classes and clinical studies, while further supporting the relevance of our Pharma Services offering" said Theis Kipling, CEO of Biovica. The study included 16 patients, and the TKa results were exploratory. An ongoing Phase II study will further evaluate TKa alongside other biomarkers, providing an opportunity to validate and build on these results. The article, titled Avutometinib, Abemaciclib, and Fulvestrant in Patients with HR+/HER2- Metastatic Breast Cancer Previously Treated with CDK4/6 Inhibitor: A Single-Arm Phase I Trial, was published in Clinical Cancer Research. Contact Theis Kipling, CEO Telefon: +46 (0) 76 666 36 52 E-post: theis.kipling@biovica.com Anders Morén, CFO Phone: +46 73 125 92 46 E-mail: anders.moren@biovica.com Biovica - Treatment decisions with greater confidence Biovica develops and commercializes blood-based biomarker assays that help oncologists monitor cancer progression. Biovica's assay, DiviTum ® TKa, measures cell proliferation by detecting the TKa biomarker in the bloodstream. The assay has demonstrated its ability to provide insight to therapy effectiveness in several clinical trials. The first application for the DiviTum ® TKa test is treatment monitoring of patients with metastatic breast cancer. Biovica's vision is: "Improved care for cancer patients." Biovica collaborates with world-leading cancer institutes and pharmaceutical companies. DiviTum ® TKa has received FDA 510(k) clearance in the US and is CE-marked in the EU. Biovica's shares are traded on the Nasdaq First North Premier Growth Market (BIOVIC B). FNCA Sweden AB is the company's Certified Adviser. For more information, please visit: Attachments New publication strengthens the case for DiviTum TKa in early treatment assessment SOURCE: Biovica International View the original press release on ACCESS Newswire