On August 21, 2025 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the European Commission has approved a new film-coated tablet formulation of BRUKINSA (zanubrutinib) for all approved indications (Press release, BeOne Medicines, AUG 21, 2025, View Source [SID1234655427]).

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"Developed to meet the real-world needs of patients, the new BRUKINSA tablet formulation aims to simplify treatment, reduce pill burden, and enhance ease of administration, reflecting our continuous focus on patient-centered innovation," said Giancarlo Benelli, Senior Vice President and Head of Europe, BeOne. "With more than 200,000 patients treated globally and the broadest label of any BTK inhibitor in Europe, BRUKINSA’s differentiated clinical profile continues to make an impact for people facing certain B-cell cancers."

The recommended dose of BRUKINSA continues to be 320 mg daily. The BRUKINSA tablets are 160 mg each, allowing patients to halve their daily pill intake from four pills to two. Additionally, they are smaller than the capsules and have film coatings, which make them easier to swallow.

Important Safety Information

The current European Summary of Product Characteristics (SmPC) of BRUKINSA is available from the website of the European Medicines Agency.

The information provided in this press release is intended for a global audience.

About BRUKINSA (zanubrutinib)

BRUKINSA is an orally available, small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. Additionally, BRUKINSA is the only BTK inhibitor to demonstrate PFS superiority to a first-generation BTK inhibitor in a Phase 3 study.

The global BRUKINSA clinical development program includes approximately 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved for at least one indication in more than 75 markets, and more than 200,000 patients have been treated globally.

ON August 21, 2025 Oncopeptides, a biotech company focused on difficult-to-treat cancers, reported the financial report for the second quarter 2025 (Press release, Oncopeptides, AUG 21, 2025, View Source [SID1234655620]).

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"This is our third consecutive quarter of more than 30 percent quarter-on-quarter sales growth," says Sofia Heigis, CEO of Oncopeptides. "The results reflect robust organic growth in our largest market, Germany, combined with faster-thanexpected market access in both Spain and Italy. With July sales also confirming our strong topline momentum with tripled sales compared to the same month last year, we remain confident we are on track to profitability by the end of 2026."

Financial overview April – June
• Net sales amounted to SEK 19.2 (8.2) million
• Operating profit amounted to SEK -56.2 (-73.3) million
• Profit after tax amounted to SEK -62.8 (-73.2) million
• Earnings per share, before and after dilution -0.30 (-0.48) SEK
• Cash and cash eq

Significant events April – June
• New Real-World Data support effectiveness and tolerability of Pepaxti in heavily pretreated Multiple Myeloma patients.
• Oncopeptides launches new Real-World Evidence study of Pepaxti in Spain, first patient enrolled.
• U.S. Food and Drug Administration removes clinical hold of OPD5.

Events after the period
• Oncopeptides’ drug Pepaxti included in European Guidelines for the treatment of multiple myeloma.
• Oncopeptides announces acceptance of poster presentations of Spanish and Italian Real-World data at IMS Annual Meeting.
• Oncopeptides Partners with SD Pharma to further broaden Pepaxti’s reach in Spain.
• Oncopeptides announces rights issue.

On August 21, 2025 Krystal Biotech, Inc. (the "Company") (NASDAQ: KRYS), a commercial-stage biotechnology company, reported an update on development plans for KB707, the Company’s redosable immunotherapy designed to drive sustained, localized expression of interleukin-2 (IL-2) and interleukin-12 (IL-12) in the tumor microenvironment and promote systemic immune-mediated tumor clearance following inhaled or intratumoral delivery to solid tumors (Press release, Krystal Biotech, AUG 21, 2025, View Source [SID1234655428]).

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Based on promising early evidence of efficacy in the treatment of non-small cell lung cancer (NSCLC), the Company was granted an End of Phase 2 meeting with the United States Food and Drug Administration (FDA) in October to discuss potential development pathways to support the registration of inhaled KB707.

"The acceleration of our work on inhaled KB707 is a reflection of both the clear and acute unmet need that exists for new treatments of NSCLC and the promising efficacy profile we have observed to date with inhaled KB707," said Suma Krishnan, President of Research and Development of Krystal Biotech. "We look forward to meeting with the FDA and bringing another urgently needed therapeutic option to patients."

Evidence supporting the prioritization of inhaled KB707, including monotherapy activity and durable responses in heavily pre-treated patients with NSCLC, was disclosed by the Company at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting earlier this year. As of data cut-off of April 15, 2025, the objective response rate in this heavily pre-treated NSCLC patient cohort was 36%. Median duration of response and progression free survival were not reached. Inhaled KB707 continued to be safe and generally well tolerated and amenable to administration in an outpatient setting, with no Grade 4 or 5 adverse events observed.

Enrollment continues in the Company’s KYANITE-1 study, a Phase 1/2 open label, multi-center, dose escalation and expansion study evaluating inhaled KB707 in patients with locally advanced or metastatic solid tumors of the lung. Details of the study can be found at www.clinicaltrials.gov under NCT identifier NCT06228326.

With the prioritization of inhaled KB707, the Company has paused enrollment in OPAL-1, a Phase 1/2 open label, multi-center, dose escalation and expansion study evaluating intratumoral KB707 in patients with locally advanced or metastatic solid tumor malignancies. Patients on OPAL-1 continue to be followed and based on safety and efficacy results from OPAL-1, the Company may adjust development plans for intratumoral KB707. Details of the study can be found at www.clinicaltrials.gov under NCT identifier NCT05970497.

On August 20, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the Chinese National Intellectual Property Administration (CNIPA) has issued a Notice of Allowance for a new patent related to its breast cancer vaccine technology (Press release, Anixa Biosciences, AUG 20, 2025, https://ir.anixa.com/news/detail/1094/anixa-biosciences-receives-notice-of-allowance-from-chinese-national-intellectual-property-administration-for-patent-covering-breast-cancer-vaccine-technology [SID1234655398]). This patent, exclusively licensed from Cleveland Clinic, will provide composition of matter protection for the Company’s novel approach to breast cancer treatment and prevention in China.

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With this allowance, Anixa continues to expand the international scope of its intellectual property portfolio, reinforcing its leadership in the field of cancer immunotherapy. The Chinese patent complements patents issued in the United States and other key global jurisdictions, and represents an important step toward future regulatory and commercial efforts outside the U.S.

"This newly allowed patent further illustrates the continued recognition of the novelty and potential of our breast cancer vaccine," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "As we continue advancing clinical development in the U.S., this allowance further strengthens our ability to pursue strategic global opportunities in regions with a high burden of breast cancer."

Breast cancer has become the most commonly diagnosed cancer among women in China, with incidence rising steadily over the past two decades and hundreds of thousands of new cases each year. As one of the world’s largest and fastest-growing patient populations, addressing this challenge is a critical public health priority, requiring innovative preventative solutions such as Anixa’s vaccine.

Anixa’s vaccine is based on immunizing against human α-lactalbumin, a protein associated with lactation that is aberrantly expressed in certain types of breast cancer. This "retired" protein strategy, developed at Cleveland Clinic and licensed exclusively to Anixa, aims to selectively prime the immune system to prevent tumor formation while avoiding harm to normal tissue.

By reinforcing its global patent estate, Anixa is laying the groundwork for future international development and commercialization strategies. The Company’s broader vaccine platform also targets other high-incidence cancers and is designed to transform how the medical community approaches cancer prevention.

On August 20, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported that Shaun Bagai, Chief Executive Officer, will present at the H.C. Wainwright 27th Annual Global Investment Conference (Press release, Renovorx, AUG 20, 2025, View Source [SID1234655414]). The conference will be held at the Lotte New York Palace Hotel in New York City, September 8-10, 2025.

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Mr. Bagai will be conducting a virtual presentation, which will be available for the duration of the conference, and afterwards on the Company’s IR website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Mr. Bagai will discuss RenovoRx’s ongoing commercialization efforts and the organic revenue growth reflecting the strong clinical need and market demand for RenovoCath as a standalone targeted drug-delivery product among both new and existing customers.

Mr. Bagai’s presentation will also highlight the latest developments in RenovoRx’s ongoing Phase III TIGeR-PaC clinical trial, including the Data Monitoring Committee’s (DMC) recent recommendation to continue the trial following its review of the second pre-planned interim analysis which was triggered by the 52nd death. The TIGeR-PaC trial is evaluating RenovoRx’s novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as IAG) for the treatment of locally advanced pancreatic cancer (LAPC).

Presentation Details:

Date: Monday, September 8, 2025
Time: 7:00 A.M. ET
Location: Lotte New York Palace Hotel, New York
Speaker: Shaun Bagai, CEO
Webcast: View Source

To schedule a one-on-one investor meeting with Mr. Bagai, please contact KCSA Strategic Communications at [email protected].

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.