On April 9, 2025 Phio Pharmaceuticals Corp. (Nasdaq: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL siRNA gene silencing technology to eliminate cancer, reported that the Safety Monitoring Committee (SMC) recommended dose escalation in Phio’s Phase 1b clinical trial (NCT 06014086) for Phio’s lead product candidate, PH-762 (Press release, Phio Pharmaceuticals, APR 9, 2025, View Source [SID1234651854]).

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Phio’s Phase 1b clinical trial is a multi-center, dose-escalating trial designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in cutaneous squamous cell carcinoma, melanoma, or Merkel cell carcinoma. This trial assesses the tumor response and determines the recommended dose for further study of PH-762. In the third cohort of this trial, three patients with cutaneous squamous cell carcinoma were enrolled. For these patients, injections were well tolerated with no serious adverse events and there were no dose-limiting toxicities. Pathology results related to efficacy of PH-762 in the third cohort are forthcoming.

"We are impressed with the continuing safety profile of PH-762 having now progressed through the first 3 escalating doses," said Mary Spellman, MD, Phio’s acting Chief Medical Officer.

Previously, seven patients diagnosed with cutaneous carcinomas were treated in dose cohorts 1 and 2. The second cohort enrolled a total of 4 patients who were diagnosed with cutaneous squamous cell carcinoma. At Day 36 (tumor excision) in the second cohort, two patients had a complete response (100% tumor clearance), and one patient had a partial response (90% clearance). All three patients in cohort 1 and one patient in cohort 2 maintained stable disease.

"We are optimistic that the clinical trial will continue to demonstrate that PH-762 may present a viable non-surgical alternative to existing modes of therapy for skin cancer" said Robert Bitterman, President and CEO of Phio Pharmaceuticals.

On April 9, 2025 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported that it will highlight key data associated with its lead candidate, INO-3107, at several upcoming conferences, including an opportunity to join other leading voices at the inaugural National HPV Conference (Press release, Inovio, APR 9, 2025, View Source [SID1234651853]). INOVIO will also discuss its novel DNA-encoded monoclonal antibody technology at a preconference workshop at the World Vaccine Congress.

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National HPV Conference (Indianapolis, IN)
April 15:

Oral presentation: DNA Immunotherapy (INO-3107) Results in a 72% Overall Response Rate in Year 1 for Treatment of Recurrent Respiratory Papillomatosis Caused by HPV-6 & 11
Panel: Recurrent Respiratory Papillomatosis: Lessons Learned, Clinical Advances and Patient Experiences – Moderated by Kim McClellan, RRP Foundation President
World Vaccine Congress (Washington, DC)
April 21:

Oral presentation: A New Frontier in mAb Therapeutics: DNA-Encoded Monoclonal Antibodies (DMAb) as Next Gen DNA Medicine
April 23:

Oral presentation: DNA Immunotherapeutics in the Treatment of Cancers and Virally-Mediated Diseases
Festival of Biologics (San Diego, CA)
April 23:

Oral presentation: Advancing DNA Medicine: INO-3107 for Recurrent Respiratory Papillomatosis
Available abstracts will be shared on INOVIO’s website following presentations.

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.

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 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.