On July 1, 2023 Hamlet Pharma reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Alpha1H, a highly selective synthetic peptide for treatment of non-muscle invasive bladder (NMIBC) (Press release, HAMLET Pharma, JUL 1, 2023, View Source;utm_medium=rss&utm_campaign=fda-clearance-of-ind-application-for-alpha1h-for-the-treatment-of-non-muscle-invasive-bladder-cancer [SID1234633007]). Working closely with their US based partner, Target Health LLC, a New Jersey-based, full-service CRO, the FDA’s ‘Study May Proceed’ letter begins a hopeful new chapter for the treatment of NMIBC patients globally. Studies with Alpha1H show a combination of a lack of toxicity with a high selectivity for cancerous cells, resulting in massive cell shedding in solid tumors.

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" This milestone for Alpha1H underscores the urgency of our mission to bring this innovative therapy to unmet needs in the treatment of NMIBC patients. The FDA’s clearance of the Hamlet IND bolsters our plans to expand clinical research in the future for this important compound." says Catharina Svanborg, Chairman of the Board/Founder, Lead Researcher.

About the Alpha1H Clinical Program – The clinical trial, now open with the US FDA, clears the path to next phases with possible future trials in the US and other international markets.

Treatment of non-muscle-invasive bladder cancer includes transurethral resection of bladder tumor (TURBT) followed by intravesical BCG immunotherapy. Alpha1H treatment acts as an ablative-type treatment for early-stage patients and is administered during the period after diagnosis and prior to TURBT. This period is usually a non-interventional period, and Alpha1H would be considered an adjuvant treatment which could benefit patients awaiting TURBT and improve outcomes.

With no toxicity detected in studies to date, Alpha1H acts as an anti-cancer therapeutic, based on a synthetic-variant of the protein-lipid complex in human breast milk, alpha-lactalbumin and oleic acid. The alpha-lactalbumin protein, known to be essential for the survival of lactating mammals, targets and killing tumor cells with great precision, Hamlet Pharma is developing this peptide-based molecular approach as an effective cancer drug pipeline with a high degree of selectivity against a variety of cancers.

On June 30, 2023 Sinocell Engineering Co., Ltd. ("Sinocell") reported that the National Medical Products Administration (NMPA) has officially approved the marketing application for the company’s independently developed bevacizumab injection, Ambezu (Press release, Sinocelltech, JUN 30, 2023, View Source [SID1234656254]). The approval of Ambezu further enriches the company’s commercialized product pipeline in the oncology field, bringing high-quality, affordable treatment options to more patients in China and contributing to the development of the Chinese pharmaceutical industry.

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Anbezumab is a recombinant humanized anti-VEGF monoclonal antibody injection independently developed by the company . It is a biosimilar to bevacizumab injection (Avastin). The approved indications include metastatic colorectal cancer, advanced, metastatic or recurrent non-small cell lung cancer, recurrent glioblastoma, hepatocellular carcinoma, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, and cervical cancer.

Specific VEGF-targeted antibody drugs can reduce angiogenesis within tumors by blocking the binding of free VEGF to VEGF receptors (VEGFRs), thereby causing tumor tissue to lose the nutritional environment required for survival and proliferation and improving the tumor immune activation environment.

On June 30, 2023 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported the publication of a study in JCO Precision Oncology1 in which DecisionDx-Melanoma provided significant, independent risk stratification of patients with cutaneous melanoma (CM), beyond American Joint Committee on Cancer Eighth Edition (AJCC8) stage, which may help inform more personalized patient management decisions (Press release, Castle Biosciences, JUN 30, 2023, View Source [SID1234633018]). Additionally, data from the study shows that testing with DecisionDx-Melanoma was associated with lower melanoma-specific and overall mortality relative to untested patients. The study can be found here.

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"Management decisions for melanoma patients, such as referrals for sentinel lymph node biopsy or frequency and intensity of surveillance, are guided by a patient’s risk of disease recurrence or metastasis, and improvements in the accuracy of risk prediction can inform these decisions," said Matthew Goldberg, M.D., F.A.A.D., board-certified dermatologist and dermatopathologist, and senior vice president, medical, of Castle Biosciences. "The independent risk-stratification provided by DecisionDx-Melanoma has already been demonstrated in numerous retrospective and prospective studies. This large study of real-world, unselected, clinically tested patients who received our test as part of their ongoing melanoma care further supports these findings.

"The statistically significant risk stratification for survival between patients who received a Class 1A test result (lowest risk of metastasis) and those with a Class 2B test result (highest risk of metastasis) highlights the value that testing with DecisionDx-Melanoma can bring to personalizing patient care decisions when interpreted in the context of the extensive, published clinical utility data for DecisionDx-Melanoma, including the recently published study from Dhillon et al."2

In the study, to assess the effect of the DecisionDx-Melanoma test on survival outcomes, a group of tested patients (n=3,258) was matched to a group of patients who did not receive DecisionDx-Melanoma test results as part of their clinical care (n=9,774); the matching was performed using propensity score matching with three untested patients for each tested patient and was based on 11 clinicopathologic and socioeconomic variables.

Key findings of the study include:

DecisionDx-Melanoma independently risk-stratified patients according to their risk of dying from melanoma, consistent with previously published retrospective and prospective studies.
DecisionDx-Melanoma was an independent predictor of patient outcomes; a Class 2B (high risk) DecisionDx-Melanoma test result was an independent predictor of melanoma-specific survival (HR= 7.00, 95% CI 2.70-18.00) and overall survival (HR= 2.39, 95% CI 1.54-3.70). Additionally, a Class 2B result conferred the highest risk of all clinicopathologic factors included in multivariable analyses that included ulceration status, Breslow thickness and nodal status, the three risk factors used in the AJCC8 staging system.
DecisionDx-Melanoma testing was associated with 29% lower melanoma-specific mortality (HR=0.71, 95% CI 0.53-0.94) and 17% lower overall mortality (HR=0.83, 95% CI 0.70-0.99) relative to patients who did not receive DecisionDx-Melanoma testing.
"We believe that DecisionDx-Melanoma will be a practice-changing test, providing personalized information based on the genomic profile of a patient’s tumor that can help guide more informed and risk-aligned patient care decisions," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We are looking forward to continuing our collaboration with the NCI SEER Program’s Registries to provide DecisionDx Melanoma data to the SEER registries as part of public health reporting to further advance research and patient care."

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by more than 40 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through March 31, 2023, DecisionDx-Melanoma has been ordered more than 128,000 times for patients diagnosed with cutaneous melanoma. More information about the test and disease can be found at www.CastleTestInfo.com.

On June 30, 2023 Toragen, Inc., a San Diego-based clinical-stage biotechnology company focused on developing uniquely selective drugs targeting cancers caused by viruses, reported that it has initiated a Phase 1 clinical trial to evaluate its first drug candidate (TGN-S11) (Press release, Toragen, JUN 30, 2023, View Source [SID1234633017]). It is believed that HPV survives within the cells and can eventually cause cancer by blocking immune responses and going undetected by the immune system. Toragen’s drug candidate, TGN-S11, inhibits the E5 oncogene of HPV in pre-clinical studies. Toragen believes this will allow the HPV-infected cancer cells to be detected by killer T-cells which could trigger an immune response that could be beneficial in cancer treatment.

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This Phase 1 trial is an open-label, non-randomized, dose escalation/dose expansion trial in cohorts of patients with relapsed, resistant, or metastatic HPV-associated cancers. The expansion phase will begin in parallel, one dose level lower than the highest dose deemed safe in the dose escalation phase in combination with a PD-1 checkpoint inhibitor. The trial is anticipated to enroll up to 55 patients at approximately six sites in the United States.

"We are excited to announce the enrollment of our first patient in our first clinical trial with TGN-S11. Not only were we able to rapidly achieve our goal of beginning this clinical trial, but we are thrilled to transition Toragen to a clinical-stage company," said Dr. Sandra Coufal, Toragen’s CEO. "This is a historic milestone for the company and moves forward our mission to improve outcomes for patients with HPV-induced cancers."

On June 30, 2023 Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell targeting therapies based on its proprietary Alluminox platform, reported that new interim evaluation data from the ASP-1929-103 study has been presented at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2023 Annual Meeting held from June 24 to 27 (Press release, Rakuten Medical, JUN 30, 2023, View Source [SID1234633016]). ASP-1929-103 is a Phase 2, open-label, single-arm, window of opportunity study* of Alluminox treatment (photoimmunotherapy: PIT) using an antibody-dye conjugate ASP-1929 with fluorescence imaging (ClinicalTrials.gov Identifier: NCT05182866) in patients with operable primary or recurrent head and neck squamous cell carcinoma (HNSCC) or cutaneous squamous cell carcinoma (cuSCC).

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The oral presentation was given by Liza Lindenberg, M.D., of the National Cancer Institute (NCI), which has a Cooperative Research and Development Agreement to conduct ASP-1929-103 study. ASP-1929-103 is the very first clinical trial of Alluminox treatment in operable cancer. As part of this trial, early time point (1 day) 18F-FDG PET/CT imaging was investigated as a potential response indicator of Alluminox treatment.

The preliminary, descriptive imaging analysis based on interim evaluation of 6 patients in ASP-1929-103 study presented during the meeting showed that 18F-FDG PET/CT imaging demonstrates a therapeutic response 1 day after Alluminox treatment using ASP-1929. PET/CT is an imaging modality for combined acquisition of positron emission tomography (PET) and computed tomography (CT) pictures. 18F-fluorodeoxyglucose (18F-FDG) is the radiotracer used for this PET study. Like glucose (sugar), 18F-FDG is taken up by cells, particularly rapidly dividing cells such as cancer cells. Following uptake, 18F-FDG accumulates in the cytoplasm rather than undergoing further metabolism which results in signal amplification from labeled cells.

Key findings presented at SNMMI 2023
"Early 18F-FDG Response after Near-Infrared Photoimmunotherapy for Head and Neck and Cutaneous Squamous Cell Carcinoma" (Abstract: P50) presented by Liza Lindenberg, M.D., Molecular Imaging Branch, NCI, NIH

– 18F FDG PET/CT demonstrates a therapeutic response 1 day after a single ASP-1929 PIT treatment
– Delayed 18F-FDG PET/CT imaging may decrease confounding inflammatory uptake on scans
– Pathologic tumor response may add complementary information to 18F-FDG PET/CT in PIT

Disclaimer: These early findings may change upon trial completion and final data analysis.

ASP-1929-103 study overview
ASP-1929-103 is a Phase 2, open-label, single-arm, window of opportunity study* of Alluminox treatment (PIT) using an anti-EGFR antibody-dye conjugate, ASP-1929 with fluorescence imaging in patients with operable primary or recurrent HNSCC or cuSCC. The study, sponsored by Rakuten Medical in collaboration with NCI and Shimadzu Corporation (Shimadzu), will enroll 22 patients in the US to evaluate the efficacy and safety of a single Alluminox treatment using ASP-1929 administered prior to standard of care surgical tumor resection. The feasibility of the Shimadzu fluorescence imaging system for real-time monitoring and recording of the fluorescence of the IRDye 700DX portion of ASP-1929 will also be assessed.

* Window of opportunity study takes place in the period between a cancer diagnosis and the subsequent initiation of standard treatment, during which, the patient receives a non-standard drug or treatment of interest over a short period of time 1.2.
1. Aroldi F, Lord SR. Window of opportunity clinical trial designs to study cancer metabolism. Br J Cancer. 2020;122(1):45-51. doi:10.1038/s41416-019-0621-4.
2. Schmitz S, Duhoux F, Machiels JP. Window of opportunity studies: Do they fulfil our expectations? Cancer Treat Rev. 2016 Feb;43:50-7. doi: 10.1016/j.ctrv.2015.12.005. Epub 2015 Dec 31. PMID: 26827692.