On April 9, 2025 Cellis reported that it will be present at the upcoming AACR (Free AACR Whitepaper) Annual Meeting, taking place April 25–30 in Chicago, where leaders in oncology research gather to shape the future of cancer treatment (Press release, Cellis, APR 9, 2025, View Source [SID1234651849]). We’re proud to contribute to this global conversation with new developments in macrophage-based therapies.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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We invite you to visit our three poster presentations:

PO.ET02.08
Harnessing macrophage-drug conjugates for allogeneic cell-based therapy of solid tumors
April 28, 9:00 AM – 12:00 PM | Section 23

PO.CL06.01
Macrophage-ferritin-drug conjugates: a novel approach to overcome glioblastoma drug resistance and induce long-term tumor immunity
April 28, 2:00 PM – 5:00 PM | Section 27

PO.IM01.16
Macrophage-based immunotherapy of platinum-resistant ovarian cancer
April 29, 2:00 PM – 5:00 PM | Section 40

We look forward to insightful discussions and potential collaborations in Chicago.

On April 9, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a new patent related to the Company’s innovative breast cancer vaccine technology (Press release, Anixa Biosciences, APR 9, 2025, https://ir.anixa.com/news/detail/1076/anixa-biosciences-receives-notice-of-allowance-from-u-s-patent-and-trademark-office-for-patent-covering-breast-cancer-vaccine-technology [SID1234651848]). The patent along with others related to this technology, has been exclusively licensed to Anixa Biosciences, by Cleveland Clinic. The patent will expand the scope of immunogenic compositions utilized in Anixa’s breast cancer vaccine.

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This newly allowed patent covers methods of immunizing patients against breast cancer by administering an immunogenic composition containing the human α-lactalbumin protein, a protein typically found in breast tissue during lactation but also expressed in certain breast cancers, making it an attractive target for immunoprevention strategies.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, stated, "This patent strengthens our intellectual property portfolio and highlights the novelty of our breast cancer vaccine. Our intellectual property portfolio includes multiple issued and pending patents in the U.S. and international jurisdictions."

On April 8, 2025 GenScript reported its financial annual report (Presentation, GenScript, APR 8, 2025, View Source [SID1234654247]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On April 8, 2025 Xspray reported the company has re-submitted its application for market approval for Dasynoc, the company’s lead product candidate, an amorphous dasatinib for the treatment of leukemia (Press release, Xspray, APR 8, 2025, View Source [SID1234652254]). The application procedure thus runs according to the most recently communicated plan. Within 2-4 weeks, the FDA is expected to announce a new PDUFA date, i.e. the date they intend to decide on the application.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Xspray Pharma has submitted its response to the CRL (Complete Response Letter) that the company received from the FDA in July 2024. The CRL addressed the company’s NDA application for market approval in the US of the product candidate Dasynoc, an amorphous dasatinib drug for the treatment of CML (chronic myeloid leukemia) and ALL (acute lymphoblastic leukemia). The response will now be reviewed by the FDA, which can apply two different processing times – two or six months from the re-submission date.

"Manufacturing and quality review of new tablet batches, which were required to address the FDA’s questions, have gone according to plan at Xspray’s US contract manufacturer, and live up to all the set quality requirements," says Per Andersson, CEO of Xspray Pharma. "We are well prepared to launch Dasynoc on the US market upon approval later this year," says Per Andersson.

The submission of the updated FDA application follows the plan communicated in January of this year. Xspray Pharma reiterates the assessment that the company has sufficient funding to take Dasynoc to approval, regardless of whether the FDA’s review takes two or six months from the re-submission.

For further information, please contact:

Per Andersson, CEO
Xspray Pharma AB (publ)
Tel: + 46 (0)8 730 37 00
E-mail: [email protected]

On April 8, 2025 Rondo Therapeutics, a privately held biopharmaceutical company pioneering the development of next-generation T cell-engaging bispecific antibodies for the treatment of solid tumors, reported the publication detailing the discovery and preclinical development of RNDO-564, a CD28 x Nectin-4 bispecific antibody in the Journal for ImmunoTherapy of Cancer (JITC) (Press release, Rondo Therapeutics, APR 8, 2025, View Source [SID1234651847]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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CD28 co-stimulatory bispecific antibodies are designed to boost T cell-mediated tumor killing and overcome T cell exhaustion in the solid tumor microenvironment. The publication describes the identification of a diverse panel of CD28-targeting binders with a range of potencies. Utilizing this panel, RNDO-564 was designed with optimal potency to elicit robust, safe, and durable tumor killing activity both in vitro and in vivo.

The full article, titled "A Potency-optimized CD28-activating Bispecific Antibody for the Targeted Treatment of Nectin-4 Positive Cancers," is available online at JITC.

Key findings for RNDO-564

Elicits robust Nectin-4 and signal-1 dependent T-cell mediated killing of Nectin-4-expressing tumor cells.
Enhances T-cell function in settings with mixed Nectin-4 positive and negative target cells.
Restores tumor cell killing function of serially stimulated T cells in vitro.
Fully eliminates established tumors in in vivo mouse model as monotherapy and in combination with a checkpoint inhibitor.
Preliminary tolerability studies in non-human primates demonstrate safety and support clinical evaluation of RNDO-564.
Demonstrates robust cytotoxic activity against bladder cancer cells that are resistant to antibody drug conjugates.
"The data serve as proof-of-concept for Rondo’s immune engager platform for solid tumors," said Starlynn Clarke, Senior Director of Preclinical Biology of Rondo Therapeutics. "We are excited about the clinical potential of CD28 T-cell engagers as a new modality for solid tumors, as they address the limitations of CD3 T-cell engagers, ADCs, and checkpoint inhibitors."

Rondo’s immune-engager platform delivers bispecific antibody therapeutics tailored to specific tumor targets, indications, and treatment regimens, offering a transformative alternative to traditional "one size fits all" strategies, unlocking the potential for durable responses in patients with solid tumors.