On April 9, 2025 OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, reported that it has completed the acquisition of the listeria-based cancer immunotherapy assets of Advaxis Immunotherapies from Ayala Pharmaceuticals (Press release, OS Therapies, APR 9, 2025, View Source [SID1234651863]). The Company is now positioned as the world leader in listeria-based cancer immunotherapies, poised to become a new commercial category of immunotherapy in oncology upon approval of the Company’s lead asset OST-HER2 in the prevention of recurrence in fully-resected, lung metastatic osteosarcoma targeted for year-end 2025. New manufacturing-based intellectual property protects the listeria-based immunotherapy platform and cancer immunotherapy candidates into 2040.

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"We are thrilled to have now consolidated all of the intellectual property for the listeria cancer immunotherapy platform into OS Therapies, positioning us to fully expand it in the years ahead and improve the standard of care across cancer treatment in the years ahead," said Paul Romness, CEO of OS Therapies. "We now have late-stage, mid-stage and early-stage cancer immunotherapy candidates, a rich pipeline of preclinical cancer immunotherapy candidates and a long IP runway to in order to fully leverage this powerful cancer immunotherapy platform."

A video explaining how the listeria platform works is available here.

Clinical-stage Cancer Immunotherapy Programs Acquired

OST-AXAL (previously AXAL/ADXS/HPV) for Human Papilloma Virus (HPV) associated cancers completed 1st (AIM2CERV) of 2 Phase 3 trials;
OST-503 (previously ADXS-503) for Non-Small Cell Lung Cancer (NSCLC) & Glioblastoma reported positive Phase 2 data in NSCLC;
OST-PSA (previously ADXS-504/ADXS31142) for Prostate Cancer.
Pre-clinical Cancer Immunotherapy Programs Acquired

8 un-named OST-HOT Listeria constructs designed for off-the shelf treatment of common cancers with shared hotspot mutations and cancer-testes antigen targets.

"The listeria cancer immunotherapy platform holds tremendous potential to improve the outcomes for cancer patients worldwide" said Dr. Robert Petit, Chief Medical & Scientific Officer of OS Therapies. "Immune-checkpoint inhibitors have revolutionized cancer treatment in settings where tumor antigens have generated a sufficient T cell response. However, in many cancers these treatments don’t help because T cell responses against key tumor antigens have not developed. The OST Listeria platform specifically delivers relevant cancer targets directly to the immune system and generates new T cell responses that can be used to fight these cancers and help eliminate metastases. With OST-HER2 and the rest of the listeria platform, we have the potential to generate novel, more potent immune and targeted immune responses against solid tumors, metastatic disease and micro metastases from early-stage to late-stage cancers. I am thrilled to be able to guide the OST-HER2 asset through approval in osteosarcoma, and then fully explore that listeria platform’s potential to improve treatment outcomes for cancer patients."

The global cancer immunotherapy market size was valued at $126 billion in 2023 and is projected to surpass around $296 billion by 2033, according to Nova One Advisor.

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 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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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 CiMaas reported a new grant from LIOF to further explore the recently developed and patented feeder cell technology (Press release, CiMaas, APR 9, 2025, View Source [SID1234651850]). A GMP grade feeder cells master bank has been previously generated and serves as starting material.

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Previously we have seen identical expansion rates and cytotoxicity of the expanded NK cells, and within this grant we will more extensively validate the NK cell expansion, activation and functional characteristics in comparison to the original protocol in which irradiation technology was used.

Finally with in the grant we will validate all characteristics in large-scale NK cell batches with numbers ready for clinical applications in cancer.

On April 9, 2025 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported the publication of a comparative analysis from the randomized cohort of the Company’s Phase 3 FOCUS study in Annals of Surgical Oncology (Press release, Delcath Systems, APR 9, 2025, View Source [SID1234651852]). The study, titled "An Open-label, Randomized Study of Melphalan/Hepatic Delivery System Versus Best Alternative Care in Patients with Unresectable Metastatic Uveal Melanoma," indicates that treatment with the Melphalan/Hepatic Delivery System (Melphalan/HDS) shows a trend toward favorable clinical outcomes compared to best alternative care (BAC), which included the physician’s choice of dacarbazine, transarterial chemoembolization (TACE), ipilimumab or pembrolizumab in patients with unresectable metastatic uveal melanoma (mUM) with liver involvement.

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The FOCUS study was initially designed and conducted as a randomized controlled trial but was amended to a single-arm design. As a result, comparative efficacy analyses were designated as exploratory. A total of 85 patients were enrolled during the randomized portion of the trial, with 72 receiving study treatment (40 Melphalan/HDS; 32 BAC).

Key Findings from the Randomized Portion of the FOCUS Study:

All efficacy endpoints of the trial demonstrated substantial and consistent improvements in patients treated with Melphalan/HDS over BAC, including:
Median progression-free survival in patients treated with Melphalan/HDS was 9.1 months, nearly three times longer than the 3.3 months observed in patients treated with BAC
Median overall survival was 18.5 months for Melphalan/HDS compared to 14.5 months with BAC
Objective response rate was 27.5% with Melphalan/HDS, nearly three times higher than 9.4% with BAC
Disease control rate was 80.0% with Melphalan/HDS, substantially higher than the 46.9% observed with BAC
Median hepatic progression-free survival was 11.4 months for Melphalan/HDS – more than three times longer than the 3.3 months for BAC
The safety profile of patients treated with Melphalan/HDS was consistent with prior reports and primarily hematologic in nature. No treatment-related deaths were observed.
"These results further support the use of our hepatic delivery system as a liver-directed treatment option for patients with metastatic uveal melanoma," said Dr. Vojislav Vukovic, Chief Medical Officer at Delcath. "Melphalan/HDS delivered meaningful improvements across all clinical endpoints, including progression-free survival, overall survival, disease control, and hepatic outcomes. The findings, while exploratory in nature, reinforce our belief that effective management of liver disease is key to improving outcomes in this patient population, and we are proud to contribute a therapy with both clinical impact and the ability to be administered repeatedly."

The publication is available online at: View Source

About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT

Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company’s proprietary products, HEPZATO KIT (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure.

In the United States, HEPZATO KIT is regulated and approved as a combination drug and device product by the FDA. HEPZATO KIT is approved as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see full Prescribing Information, including BOXED WARNING, at www.hepzatokit.com.

In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is marketed under the trade name CHEMOSAT, where it has been used in major cancer centers to treat a wide range of cancers of the liver.