Immunophotonics and Swiss Cancer Institute Complete SAKK 66/17 Phase 1b/2a Multicenter Clinical Trial for Treatment of Solid Tumors

On August 21, 2025 Immunophotonics, Inc., a clinical-stage biotech company focused on developing novel immune-stimulating drugs to augment routine tumor destruction techniques, reported the completion of its multicenter clinical trial (SAKK 66/17) conducted in collaboration with the Swiss Cancer Institute (formerly known as SAKK) (Press release, Immunophotonics, AUG 21, 2025, View Source [SID1234655435]). This milestone — along with completion of the Company’s INJECTABL-1 trial covering different indications, which the Company announced in July 2025 — marks a significant advancement in evaluating the immunologically mediated anticancer effects of intratumoral injection of IP-001 following thermal ablation in patients with advanced solid tumors.

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The SAKK 66/17 trial was designed to assess the safety and tolerability of IP-001 in combination with thermal ablation in patients with various types of advanced solid tumors, with a second phase assessing efficacy for melanoma and soft-tissue sarcoma. With treatment completed for all patients in both phases, data analysis is now underway.

Prof. Dr. Markus Joerger, Principal Investigator for the study at the Cantonal Hospital St. Gallen Clinic for Medical Oncology and Hematology commented: "This collaboration between Immunophotonics and Swiss Cancer Institute highlights the importance of partnerships in advancing cancer treatments. With the completion of this trial, we made the next important step in the development of a new treatment option for patients with advanced solid tumors. The results could have a meaningful impact in the fight against cancer."

The results of this trial provide further evidence regarding safety and efficacy of IP-001 in a broader patient population. Immunophotonics and Swiss Cancer Institute remain committed to advancing the development of this potential cancer treatment and bringing it to patients in need.

About IP-001

IP-001 is a proprietary glycan polymer that generates tumor antigen depots and acts as a potent, multimodal immune stimulant intended to induce immunological responses to eradicate cancer. IP-001 is designed to (1) prolong the availability of the targeted tumor antigens, (2) facilitate the recruitment and activation of innate immune cells such as antigen-presenting cells (APCs), (3) increase the uptake of the tumor antigens into the APCs, and (4) lead to a downstream adaptive immune response against the tumor cells. Activation of a systemic, adaptive immune response allows immune effector cells to seek out and eliminate tumor cells throughout the body.

Jazz Pharmaceuticals to Participate in the 2025 Wells Fargo Healthcare Conference

On August 21, 2025 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the Company will participate in the 2025 Wells Fargo Healthcare Conference. Company management will participate in a fireside chat on Wednesday, September 3, 2025, at 6:30 a.m. PDT / 9:30 p.m. EDT / 2:30 p.m. IST (Press release, Jazz Pharmaceuticals, AUG 21, 2025, View Source [SID1234655434]).

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An audio webcast of the fireside chat will be available via the Investors section of the Jazz Pharmaceuticals website at View Source A replay of the webcasts will be archived on the website for 30 days.

Krystal Biotech Announces Update on Development Plans for Oncology Program KB707 and Prioritization of Inhaled KB707 for the Treatment of Non-Small Cell Lung Cancer

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.

European Commission Approves Tablet Formulation of BeOne Medicines’ BRUKINSA® for All Approved Indications

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.

UroGen Pharma to Present at Upcoming Investor Conferences

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.