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 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 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it will participate in the following investor conferences in September (Press release, UroGen Pharma, AUG 21, 2025, View Source [SID1234655426]).

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Wells Fargo Healthcare Conference

Date / Time: September 3rd, at 2:15 PM ET
Format: Fireside Chat
Location: Boston, MA

Cantor Fitzgerald Global Healthcare Conference

Date / Time: September 4th, at 3:55 PM ET
Format: Fireside Chat
Location: New York, NY

H.C. Wainwright 27th Annual Global Healthcare Conference

Date / Time: September 8th, at 9:00 AM ET
Format: Fireside Chat
Location: New York, NY

The conference webcasts will be available through the Events section of the Company’s Investor Relations website. Replays will be available for approximately 90 days following the event.

On August 21, 2025 Jecho Biopharmaceuticals Co., Ltd. (hereinafter referred to as "Jechobio"), a global, clinical stage biopharmaceutical company advancing medicines focusing in oncology, reported that the National Medical Products Administration (NMPA) has delivered a Notice of Approval for Drug Clinical Trial for JLM019 injection in the treatment of advanced malignant tumors (Press release, Jecho Laboratories, AUG 21, 2025, View Source [SID1234655425]).

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"The NMPA’s clearance of our Investigational New Drug application is an important regulatory milestone for Jechobio. JLM019 represents a potential first-in-class next generation IO therapy. We look forward to the expected dosing of the first patient with JLM019 in the next few months," said Dr. Xiaodong Xiao, CEO of Jechobio.

Jechobio anticipates the enrollment of the first patient in the dose escalation portion of its clinical trial in Q4 2025.

About JLM019

JLM019 is an innovative CD80/PD-1 dual-targeted Fc fusion protein that simultaneously blocks immunosuppression and activates immunostimulation. JLM019 injection exhibits broad-spectrum anti-tumor properties and has demonstrated significant anti-tumor activity in multiple solid tumor models, offering hope for the treatment of patients with advanced cancer.

On August 21, 2025 Kite, a Gilead Company (Nasdaq: GILD), reported that it has entered into a definitive agreement to acquire Interius BioTherapeutics, a privately held biotechnology company developing in vivo CAR therapeutics, for $350 million (Press release, Interius BioTherapeutics, AUG 21, 2025, View Source [SID1234655424]).

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This acquisition complements Kite’s expertise in cell therapy by incorporating Interius’s integrating in vivo platform. This approach enables the generation of CAR T-cells directly within the patient’s body and may offer a more durable and long-lasting therapeutic effect by inserting DNA into the patient’s genome. Unlike traditional CAR T therapies that require cell harvesting, engineering and reinfusion, Interius’s innovative, off-the-shelf yet personalized approach is designed to be delivered via a single intravenous infusion, eliminating the need for preconditioning chemotherapy and complex cell processing.

"In vivo therapy is a promising frontier with the potential to transform how we approach treating patients, shifting to more accessible and scalable solutions," said Cindy Perettie, Executive Vice President of Kite. "By combining Interius’s teams and their novel platform with Kite’s deep expertise and footprint in cell therapy research, development and manufacturing, we aim to advance best-in-class in vivo therapies to bring them to patients more efficiently."

The modular architecture of Interius’s platform allows for rapid adaptation across disease states and scale of manufacturing, enabling the potential to expand access to cell therapies for patients who previously could not benefit from them, particularly those with rapidly progressing disease.

"This marks a pivotal step for Interius and the future of in vivo therapy, which has the potential to reduce treatment timelines, broaden access to care and improve outcomes for patients with aggressive or advanced disease," said Phil Johnson, President and CEO, Interius BioTherapeutics. "With the addition of Kite’s deep expertise and global infrastructure, we’re well-positioned to move quickly into multiple therapeutic areas, expand access to cell therapies and deliver meaningful innovation to patients."

Interius’s team and operations will integrate into Kite’s established research team, creating a center of excellence in Philadelphia to accelerate the development of next-generation in vivo therapies.

Terms of the Agreement

Under the terms of the acquisition agreement with Interius, Kite will acquire all of the outstanding share capital of Interius for a total of $350 million in cash consideration, subject to customary adjustments, which is payable at closing. This transaction with Interius is expected to reduce Gilead’s GAAP and non-GAAP 2025 EPS by approximately $0.23-$0.25. Closing of the transaction is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.

TD Cowen is acting as exclusive financial advisor to Kite and Evercore is serving as exclusive financial advisor to Interius.