On August 26, 2024 Delcath Systems, Inc. (Nasdaq: DCTH) ("Company" or "Delcath"), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported the publication of an independent study conducted by investigators at the University Hospital of Leipzig, Germany, in the European Society for Medical Oncology journal of Gastrointestinal Oncology (Press release, Delcath Systems, AUG 26, 2024, View Source [SID1234646093]). The study, titled "Hepatic chemosaturation with melphalan in patients with primary or secondary liver tumors with or without extrahepatic tumor manifestation," highlights the efficacy and safety of repeated chemosaturation treatments using Delcath’s CHEMOSAT Hepatic Delivery System.

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Key Findings from the Independent Study:

Patient Population: This retrospective study evaluated the efficacy of CHEMOSAT in 33 previously treated patients with unresectable intrahepatic metastases from various cancers: uveal melanoma (N=19), cholangiocarcinoma (N=8), hepatocellular carcinoma (N=2), and one patient each with ciliary body melanoma, acinar cell carcinoma, pancreatic cancer, or tonsil cancer (N=4). In addition to hepatic metastases, 7 out of 33 patients also had limited extrahepatic disease, which was found not to significantly impact overall survival.
Disease Control Rate: The study reported a disease control rate (DCR) of 91%, with 30 out of 33 patients experiencing either objective tumor response or stable disease. Notably, 6 patients (18.2%) achieved complete response (CR) in the liver, including 5 patients with uveal melanoma and 1 patient with cholangiocarcinoma, who received a median of 5 treatment cycles.

Hepatic Progression-Free Survival: Median hepatic progression-free survival (hPFS) was 52 weeks across all patients, with particularly strong outcomes for specific cancers:
69 weeks (16 months) median hPFS in patients with uveal melanoma.
38 weeks (8.5 months) median hPFS in patients with cholangiocarcinoma.
Importance of Repeated Treatments: The investigators’ approach of using CHEMOSAT in the form of regularly repeated treatment cycles as clinically indicated (Figure 1), similar to systemic chemotherapy, resulted in long-term disease control in the majority of patients and was well tolerated.
Tolerability and Safety: The safety profile of CHEMOSAT was consistent with published literature. Most patients experienced transient hematological adverse events, which were routinely managed with supportive care. Importantly, no significant liver damage was reported, even in patients who underwent multiple treatment cycles. Treatment was discontinued in 2 patients due to adverse events, and 2 patients withdrew consent during the treatment period.

Dr. Vojislav Vukovic, Chief Medical Officer of Delcath Systems, commented, "The results of this independent study reinforce the potential of our CHEMOSAT Hepatic Delivery System as an essential tool in the management of primary and secondary liver tumors, particularly for patients with limited treatment options. The high rate of disease control observed, even in patients with extrahepatic tumor spread, underscores the importance of continuing to explore and refine this treatment approach in larger, prospective trials."

On August 26, 2024 Diakonos Oncology Corp., a clinical-stage immuno-oncology company, reported the final closing of an oversubscribed seed financing of $11.4 million (Press release, Diakonos Oncology, AUG 26, 2024, View Source [SID1234646109]). The round was led by biotechnology investment firm Restem Group Inc., with participation from existing investors.

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To date, funds have enabled the company to establish manufacturing operations, add key leadership positions, and complete enrollment for the Phase 1 study of lead asset DOC1021 in the treatment of glioblastoma (GBM). The additional capital will fund operations into late 2025 and allow Diakonos to initiate the Phase 2 trial in GBM prior to closing a Series A round.

"We greatly appreciate the support of these investors in sharing our passion for improving the lives of patients suffering from deadly cancers such as glioblastoma," said Mike Wicks, Diakonos CEO. "The fact that this financing is nearly triple our initial target also shows they share our confidence in the effectiveness of our unique cancer therapy. This investment will fund operations through the final readout of key safety and efficacy data from our Phase 1 trial and will allow the company to ramp up preparations for pipeline expansion and the initiation of our Phase 2 GBM trial which is expected to begin in the fourth quarter of this year."

"We are thrilled to invest in this groundbreaking company that is at the forefront of cancer treatment innovation. As a firm deeply involved in the cell therapeutic field, we recognize the immense potential of their pioneering work with dendritic cell therapies and we are confident that this can become a new standard of care for cancer in the future," said Andres Isaias, Executive Chairman of Restem Group Inc.

About DOC1021

DOC1021 is a first-of-its-kind dendritic cell vaccine (DCV) that initiates a complete cytotoxic TH1 immune response against a patient’s cancer through our proprietary double loading technology. Enrollment in the two-year Phase 1 trial was completed in December 2023.

In addition to the lead GBM study, two other clinical trials of Diakonos’ DCV are ongoing for the treatment of pancreatic cancer and angiosarcoma. Diakonos has received Fast Track designations from the FDA for both the GBM and pancreatic cancer programs. The company has also received Orphan Drug Designation for the GBM program.

Diakonos’ DCVs activate robust cytotoxic TH1 cell signaling pathways that better harness a patient’s immune system to target and eliminate cancer cells. This is achieved without any genetic modification of the patient’s immune cells and without the need for toxic preconditioning.

On August 26, 2024 Genmab A/S (Nasdaq: GMAB) reported that its Chief Executive Officer Jan van de Winkel, Ph.D. and Chief Financial Officer Anthony Pagano will participate in a fireside chat at the Morgan Stanley 22nd Annual Global Healthcare Conference at 1:05 PM EDT / 7:05 PM CEST on September 4, 2024 (Press release, Genmab, AUG 26, 2024, View Source [SID1234646094]). A webcast of the event, which will include brief opening remarks followed by a question-and-answer session, will be available on Genmab’s website at View Source

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On August 26, 2024 The South Korean biotech company GI Innovation reported that it has signed a clinical trial collaboration and supply agreement with MSD (a tradename of Merck& Co., Inc., Rahway, NJ, USA) to evaluate the combination of GI-102 and MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with immunotherapy-resistant liver cancer, melanoma, and renal cell carcinoma (Press release, GI Innovation, AUG 26, 2024, View Source [SID1234646110]).

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This agreement marks GI Innovation’s second clinical trial collaboration with MSD, following a previous collaboration for GI-101A.

The Phase 2 clinical trial including GI-102 in combination with KEYTRUDA will enroll patients with resistance or non-response to immuno-oncology treatments, leaving them with no further treatment options. GI Innovation is focused on three indications with significant market potential and potential likelihood of success: metastatic liver cancer, melanoma, and renal cell carcinoma. The company has already demonstrated strong anti-cancer efficacy with a 42.9% overall response rate (ORR) in a monotherapy trial of GI-102 in melanoma patients who failed to respond to standard-of-care treatment (3 partial responses out of 7 patients). Complete tumor regression was previously observed in 60% of mice treated with GI-102 monotherapy in a preclinical liver cancer model.

Fourteen hospitals in South Korea and world-renowned sites in the U.S. have agreed to join the trial, including the Mayo Clinic (campuses in Rochester, Florida, and Arizona), Cleveland Clinic and Memorial Sloan Kettering Cancer Center. In South Korea, the trial will take place at leading hospitals including Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, Severance Hospital of Yonsei University, and St. Vincent’s Hospital.

"We are pleased to enter into another clinical trial collaboration and supply agreement with MSD, a world leader in immuno-oncology. We aim to maximize the therapeutic value of GI-102 by combining it with KEYTRUDA, MSD’s anti-PD-1 therapy", said Dr Myung-Ho Jang, GI Innovation’s Chief Scientific Officer.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway NJ, USA.

On August 26, 2024 LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT and LIXTW) ("LIXTE" or the "Company"), reported the dosing of the first patient in a new clinical trial in collaboration with the Netherlands Cancer Institute (NKI) and supported by F. Hoffmann-La Roche Ltd. ("Roche") for treatment of unresponsive (MSI Low) metastatic colorectal cancer (Press release, Lixte Biotechnology, AUG 26, 2024, View Source [SID1234646095]).

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As part of the clinical trial (NCT06012734, clinicaltrials.gov), LIXTE is providing its lead compound, LB-100, and Roche is providing atezolizumab (Tecentriq , a PDL1 inhibitor) through the imCORE Network, a global academic-industry partnership that aims to accelerate cancer immunotherapy research through institution-sponsored studies.

"Our objective with this trial is to bring immunotherapy as an effective treatment option to approximately 85 percent of all colorectal cancer patients, who thus far have not been responsive to traditional protocols," said Neeltje Steeghs, M.D., Ph.D., medical oncologist at NKI.

Bas van der Baan, LIXTE’s Chief Executive Officer, said, "We are pleased to begin this important trial, which is being funded by Roche. This is the second recent clinical trial combining LB-100 with immunotherapy that is funded by a major pharmaceutical company, following the start of a clinical trial earlier this year with GSK for treatment of clear cell ovarian cancer."