On June 5, 2025 Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide ("Alvotech"), and Dr. Reddy’s Laboratories Ltd., (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as "Dr. Reddy’s"), reported that the companies have entered into a collaboration and license agreement to co-develop, manufacture and commercialize a biosimilar candidate to Keytruda (pembrolizumab) for global markets. Keytruda (pembrolizumab) is indicated for the treatment of numerous cancer types (Press release, Alvotech, JUN 5, 2025, View Source [SID1234653753]). In 2024, worldwide sales of Keytruda were US$29.5 billion [1]. The collaboration combines Dr. Reddy’s and Alvotech’s proven capabilities in biosimilars, thereby, speeding up the development process and extending the global reach for this biosimilar candidate.

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Under the terms of the agreement, the parties will be jointly responsible for developing and manufacturing the biosimilar candidate and sharing costs and responsibilities. Subject to certain exceptions, each party will have the right to commercialize the product globally.

"We are very pleased to enter into this collaboration for pembrolizumab with Dr. Reddy’s. This agreement demonstrates Alvotech’s ability to leverage its dedicated R&D and manufacturing platform for biosimilars, accelerating the expansion of our pipeline by pursuing growing global markets. It further enables us to increase the availability of cost-effective, critical biologic medications to patients world-wide," said Róbert Wessman, chairman and CEO of Alvotech.

"We are happy to collaborate with Alvotech for the pembrolizumab biosimilar. This demonstrates our ability to develop and manufacture high quality and affordable treatment options for patients worldwide. Additionally, oncology has been a top focus therapy area for us and this collaboration will further enhance our capabilities in oncology, as pembrolizumab currently represents one of the most critical therapies in immuno-oncology," said Erez Israeli, CEO of Dr. Reddy’s.

Use of trademarks

Keytruda is a registered trademark of Merck Sharp & Dohme Corp.

Sources

[1] View Source Accessed on June 4, 2025.

On June 5, 2025 Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused biotechnology company developing innovative therapies for difficult-to-treat cancers, reported that the first patient has been dosed in a Phase 1b clinical trial sponsored by Kazia (Press release, Kazia Therapeutics, JUN 5, 2025, View Source [SID1234653739]). The study evaluates paxalisib, the Company’s dual PI3K/mTOR inhibitor, in combination with olaparib or pembrolizumab for patients with advanced breast cancer.

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This multi-center, open-label, randomized trial is designed to assess the safety, tolerability, and preliminary efficacy of multiple paxalisib-based treatment combinations. The study also includes deep biomarker profiling to support future development and early signals of clinical activity.

"The start of patient dosing in this Kazia-sponsored study marks an important milestone in the evolution of paxalisib beyond brain cancer and into broader solid tumor applications," said Dr. John Friend, Chief Executive Officer of Kazia. "By leveraging the dual inhibition of PI3K and mTOR, this trial builds on compelling preclinical data showing epigenetic modulation in aggressive breast cancer pre-clinical models. We believe the combinations explored here may provide a more effective therapeutic strategy by simultaneously targeting tumor metabolism, DNA repair, and immune evasion."

About the Study

This Phase 1b trial (ACTRNXXX) will enroll patients with advanced breast cancer into two treatment arms:

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Arm A: Patients are randomized to receive either 15mg or 30mg of paxalisib (once daily) in combination with olaparib (300mg orally, twice daily), administered in 28-day cycles.

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Arm B: Patients are randomized to receive paxalisib (15mg or 30mg once daily) and pembrolizumab (200mg IV every 21 days) alongside standard-of-care chemotherapy: either nanoparticle albumin-bound paclitaxel or a gemcitabine-carboplatin regimen, depending on clinical indication.

Participants will be evaluated for:

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Adverse events and overall tolerability

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Changes in circulating tumor cells ("CTCs") and CTC clusters

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Immune cell signatures and overall immune functio

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Clinical activity and tumor response signals

Strategic Significance

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For investors, this trial expands the clinical footprint of paxalisib into solid tumors beyond the central nervous system, targeting a significant commercial opportunity in advanced and metastatic breast cancers, including triple-negative breast cancer.

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For potential partners and acquirers, the novel biomarker-driven design provides an early window into how paxalisib may enhance or sensitize tumors to immune checkpoint inhibitors and DNA repair-targeted therapy.

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For the scientific community, the study is structured to generate translational data that may clarify the mechanistic interactions between dual PI3K/mTOR inhibition, immune modulation, and chemotherapy-induced cytotoxicity.

"The integration of paxalisib into combination regimens reflects our strategy of building value through differentiated science and high-quality collaborations," added Dr. Friend. "As this study progresses, we aim to share interim updates that may further underscore the potential of paxalisib to impact multiple indications with poor prognoses."

On June 5, 2025 Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, reported it has updated its award-winning ArteraAI Prostate Test with new insights to help higher-risk patients optimize treatment decisions (Press release, Artera, JUN 5, 2025, View Source [SID1234653754]). Artera recently presented its validation data at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, demonstrating the test’s ability to identify high-risk, non-metastatic prostate cancer patients most likely to benefit from the addition of abiraterone to standard therapy from those who don’t.

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The STAMPEDE trial helped to establish abiraterone, an androgen receptor pathway inhibitor (ARPI), along with radiation and long-term androgen deprivation therapy (LT-ADT) as the standard of care treatment for high-risk patients, but clinicians and patients have been hesitant with its usage due to concerns around side effects, complex follow-up care, and added cost. Artera’s MMAI model was used to analyze the STAMPEDE trial patient cohort and identified that only 25% of high-risk non-metastatic patients derived meaningful benefit from abiraterone intensification, suggesting the opportunity to spare up to 75% of this cohort from unnecessary toxicities.

The commercially available ArteraAI Prostate Test provides personalized prognostic and predictive test results to guide treatment decisions. For lower-risk patients, the test can help determine if active surveillance is a suitable option, and for intermediate-risk patients, the test can predict if short-term androgen deprivation therapy (ST-ADT) is beneficial. With this new product enhancement, the ArteraAI Prostate Test will increase its clinical impact for higher-risk patients.

"We are very excited to improve the clinical utility of our test in order to better serve a patient population faced with difficult choices to make about their cancer care," said Timothy Showalter, Chief Medical Officer of Artera. "It’s a real testament to the team here at Artera, from clinical development to engineering and beyond, that we’re able to quickly take insights from the clinical research realm, rigorously validate it and to deploy it so quickly to help patients."

Prostate cancer is one of the most common cancers, with over 300,000 new diagnoses each year. While high-risk disease only constitutes ~15% of cases, 10-year survival rate is poor at only 65%. Because of the cancer’s aggressiveness, clinicians will often deploy multiple therapeutic agents at the same time, but this increases drug toxicities and can be costly. The appeal of precision medicine is to be able to determine which therapies will be beneficial and avoid under- or over-treatment.

"Abiraterone has already hugely improved the outlook for hundreds of thousands of men with advanced prostate cancer," said Nick James, MD, PhD, lead investigator of the STAMPEDE trial. "We know that for many men with cancer that has not yet spread, it can also have spectacular results. We’re excited to now have a test that can pick out the people who will respond best to abiraterone, and those who will do well from standard treatment alone – hormone therapy and radiotherapy."

On June 4, 2025 First Ascent Biomedical (FA), an innovative biotech company specializing in transforming cancer treatment through functional precision medicine, reported a new collaboration with the Fight Colorectal Cancer Foundation (Fight CRC) to launch a prospective feasibility study aimed at transforming colorectal cancer treatment (Press release, First Ascent Biomedical, JUN 4, 2025, https://firstascentbiomedical.com/first-ascent-biomedical-and-fight-colorectal-cancer-foundation-announce-groundbreaking-study-to-advance-precision-oncology-for-colorectal-cancer-patients/?utm_source=rss&utm_medium=rss&utm_campaign=first-ascent-biomedical-and-fight-colorectal-cancer-foundation-announce-groundbreaking-study-to-advance-precision-oncology-for-colorectal-cancer-patients [SID1234653708]). Funded by a $350,000 grant from Fight CRC, and spearheaded by Anjee Davis, chief executive officer, this innovative study will leverage First Ascent’s cutting-edge xDRIVE tumor profiling technology to deliver rapid, personalized treatment insights for patients fighting colon cancer in Minnesota.

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"Fight CRC is committed to empowering patients through innovation," said Davis. "This grant underscores our strategic focus on enhancing care through advanced research, particularly for those with limited treatment options."

The study, set to begin enrollment in April or May 2025, will focus on 25 patients with metastatic colorectal cancer. By integrating functional drug testing, genetic analysis, and artificial intelligence, First Ascent’s xDRIVE platform will provide oncologists with detailed tumor profiling data and tailored treatment options, aiming to enhance patient outcomes.

Leading the clinical efforts are Hao Xie, MD, PhD, a gastrointestinal cancer specialist and precision medicine expert, and Dr. Boardman, whose work in cancer genetics and early detection has advanced the field of colorectal cancer care. Noah Berlow, PhD, First Ascent’s Chief Technology Officer and the study’s principal investigator, brings his expertise in AI-driven cancer research to oversee the project. Together, this team is poised to demonstrate the power of rapid, individualized tumor profiling to better understand each patient’s unique cancer.

"This collaboration with the Fight Colorectal Cancer Foundation is another important step in transforming how we approach cancer treatment," said Jim Foote, founder and chief executive officer, First Ascent Biomedical. "We are honored to be part of this effort."

The study is expected to complete enrollment within nine months and will provide actionable data to oncologists for patients requiring advanced treatment options. Patients interested in participating must be seen in Rochester, MN. Information will soon be available on ClinicalTrials.gov.

On June 4, 2025 Continuity Biosciences, LLC, a developer of advanced drug delivery technologies, reported the acquisition of Focal Medical, Inc., a North Carolina-based biopharmaceutical company pioneering site-specific chemotherapy using iontophoresis (Press release, Continuity Biosciences, JUN 4, 2025, View Source [SID1234653724]). The acquisition represents a key step in Continuity’s strategy to become a leader in device targeted therapeutics for intractable solid tumors.

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Founded by leading scientists and clinicians, Focal Medical has developed a proprietary platform that delivers chemotherapy directly to tumors using iontophoresis—this minimally-invasive technique utilizes a mild electrical current to drive therapeutic compounds into targeted tissues. This method enhances local drug concentration while minimizing systemic toxicity, a critical need in the treatment of pancreatic and other solid-tissue cancers.

Focal Medical’s lead product candidate, an iontophoresis device directed gemcitabine therapy for pancreatic cancer, has been cleared by the U.S. Food and Drug Administration (FDA) through an Investigational New Drug (IND) application. Phase 1b clinical trials are expected to begin later this year.

"This is a transformative milestone for Continuity Biosciences," said Ramakrishna Venugopalan, PhD, MBA, Chief Executive Officer of Continuity Biosciences. "Focal Medical’s approach to localized drug delivery aligns perfectly with our vision to improve bioavailability, reduce systemic exposure, and deliver better outcomes for patients. We are thrilled to bring this promising platform into our portfolio and into the clinic."

Through the acquisition, Continuity Biosciences obtains Focal Medical’s entire patent estate, iontophoresis technology platform and specialized equipment, scientific know-how, and licensing agreements with the University of North Carolina at Chapel Hill. In addition, key scientific staff and leadership from Focal will join Continuity, further enhancing its internal capabilities. A dedicated research and development facility in Cary, NC that supports ongoing platform and pipeline advancement is also part of the acquisition and will be expanded to support other delivery platforms.