HER2 Positive Breast Cancer

This collaboration will provide early-stage HER2-positive breast cancer patients with access to the targeted therapy that can reduce the risk of cancer recurrence and spread ATHENS, Greece and LOS ANGELES, April 30, 2025 (GLOBE NEWSWIRE) -- Er-Kim, an international pharmaceutical company specializing in the commercialization of novel therapies in the EMEA region, today announced that it has signed an agreement with Puma Biotechnology, Inc. (NASDAQ: PBYI) to commercialize NERLYNX® (neratinib) in select countries in Eastern Europe and Central Asia. NERLYNX is designed to block human epidermal growth factor receptor 2 (HER2) in order to treat and limit breast cancer metastasis. Under the agreement, Er-Kim is appointed as the distribution partner for NERLYNX in Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, Turkmenistan, and Uzbekistan. NERLYNX is a prescription medicine used alone to treat adults with early-stage HER2-positive breast cancer and who have previously been treated with trastuzumab-based therapy. NERLYNX is also approved for use with a medicine called capecitabine to treat adults with HER2-positive breast cancer that has spread to other parts of the body (metastatic) and who have received 2 or more anti-HER2 therapy medicines for metastatic breast cancer. According to the International Agency for Research on Cancer (IARC), globally, breast cancer is the most common cancer type among women and the second most common cancer type overall. An estimated 2.3 million new breast cancer cases and 670,000 breast cancer-related deaths occurred worldwide in 2022. However, the burden of breast cancer is not evenly distributed across different world regions. “While breast cancer affects individuals globally, treatment availability varies considerably across regions,” said Cem Zorlular, Chief Executive Officer of Er-Kim. “That is why we are pleased to be working with Puma Biotechnology to support access to NERLYNX in Russia and most of the Commonwealth of Independent States (CIS) for patients with early-stage breast cancer. Er-Kim has a long history of providing treatments in the EMEA region, particularly in women's health.” About Er-Kim Established in 1981, Er-Kim stands at the forefront of biopharmaceutical innovation, partnering with over 40 global leaders to revolutionize patient care in key international markets. Our pioneering business models, tailored for sustainability and flexibility, have positioned us as a full-service solution, extending our reach to over 600 million patients through our fully owned affiliates. With a dedicated team of over 280 professionals worldwide and revenues exceeding EUR 260M, Er-Kim is not just a partner but a trailblazer in healthcare, continually setting new standards in commercialization and patient access. For more information, please visit http://www.er-kim.com/. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early- stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA™-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. Media contact: Rosalia ScampoliMarketcom PRTel: (914) 815-1465rscampoli@marketcompr.com

AstraZeneca is migrating into the final phases of a possible Covid-19 vaccine. Credit: Shutterstock AstraZeneca has discontinued a Phase III trial of Truqap (capivasertib) after a review concluded that the study was unlikely to meet its endpoints. The CAPItello-280 study (NCT05348577) was investigating Truqap in combination with docetaxel and androgen-deprivation therapy (ADT) compared to docetaxel and ADT with placebo in patients with metastatic castration-resistant prostate cancer (mCRPC). The pharma giant decided to scrap the study after an Independent Data Monitoring Committee (IDMC) said it was unlikely that the combination would meet the dual primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) versus the comparator arm. AstraZeneca said the safety and tolerability profile for Truqap was consistent with other trials. This is another blow for one of AstraZeneca’s flagship oncology products, which failed to meet the primary endpoint of overall survival (OS) in either patient group in the Phase III CAPItello-290 trial (NCT03997123) in June 2024. The CAPItello-290 study was investigating the drug in combination with paclitaxel in patients with locally advanced (inoperable) or metastatic triple-negative breast cancer (TNBC). In November 2024, however , the drug did prove efficacious in the Phase III CAPItello-281 trial, meeting the primary endpoint of radiographic progression-free survival in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Truqap is an adenosine triphosphate (ATP)-competitive inhibitor that targets all three AKT isoforms (AKT1/2/3). It was approved by the US Food and Drug Administration (FDA) in November 2023 for use in combination with Faslodex for the treatment of advanced HR-positive breast cancer. The drug was given priority review and assessed through Project Orbis, a programme that facilitates the simultaneous submission and evaluation of oncology medications by collaborating with international partners. The drug has since been approved for use in Europe and the UK, with access available through the NHS. GlobalData forecasts that Truqap will reach blockbuster status in 2027, with global sales in 2030 set to hit $1.78bn. GlobalData is the parent company of Clinical Trials Arena .

TAIPEI, Taiwan I April 29, 2025 I AP Biosciences, a clinical-stage biopharmaceutical company dedicated to transforming cancer therapy through innovative bispecific antibodies, today announced the presentation of new preclinical data for its lead asset, AP402, at the 2025 American Association for Cancer Research (AACR) Annual Meeting in San Diego, California. The data, presented in a poster titled “AP402, a bispecific antibody targeting p95HER2 and CD137, shows potent antitumor activity,” highlight the therapeutic potential of AP402 to address treatment-resistant HER2-positive cancers through conditional T-cell engagement. “The findings presented at AACR reinforce the rationale for advancing AP402 into clinical studies,” said Jeng Her, Ph.D., Founder and Chief Executive Officer of AP Biosciences. “By selectively targeting p95HER2—a truncated HER2 isoform implicated in therapeutic resistance—and conditionally activating CD137, AP402 offers a unique mechanism to recruit and stimulate immune effector cells while minimizing the risk of systemic toxicity. These data demonstrate the strength of our T-cube platform in delivering targeted immune activation precisely within the tumor microenvironment.” Results Summary In conclusion, the preclinical data show that AP402 effectively engages innate and adaptive immune responses, demonstrates robust antitumor activity in p95HER2-expressing tumor models, and is well tolerated in non-human primates. These findings support the continued development of AP402, which recently entered clinical evaluation in Australia ( NCT06669975 ). About AP402 AP402 is a first-in-class bispecific antibody developed by AP Biosciences to target p95HER2, a truncated variant of HER2 associated with resistance to Herceptin and poorer prognosis. This variant is present in approximately 30–40% of HER2-positive breast cancer patients. By leveraging p95HER2 recognition to cluster CD137, the design enables localized T-cell activation within the tumor microenvironment, helping to minimize systemic cytokine-related toxicity. The binding domains for p95HER2 and CD137 are strategically positioned on opposite ends to enhance bridging between HER2 variant-expressing cancer cells and CD137-expressing T-cells, ensuring efficient immune cell recruitment without spatial hindrance. This novel mechanism has positioned AP402 as a promising therapeutic approach to addressing tumors that have developed resistance to traditional anti-HER2 therapies, offering potential new hope for patients with refractory/recurrent cancers. About AP Biosciences AP Biosciences is a Taiwan-based clinical-stage biopharmaceutical company committed to developing innovative antibody-based therapies for cancer and other diseases. Applying its proprietary Omni-Mab and T-cube platforms, AP Biosciences is pioneering next generation bispecific antibodies that activate the immune system precisely where it’s needed, for both established and treatment-resistant cancers. SOURCE: AP Biosciences